What's New

Comparative Effectiveness Research and Personalized Medicine: Policy, Science, and Business

NPCNow — Mon, 02 Nov 2009 21:46:59 GMT

Nearly 250 attendees participated in an all-day conference, "Comparative Effectiveness Research and Personalized Medicine: Policy, Science, and Business," that explored the intersection of comparative effectiveness research and personalized medicine. Co-hosted by the National Pharmaceutical Council and the Personalized Medicine Coalition, the conference examined how comparative effectiveness research (CER) and personalized medicine can work together to deliver quality care that improves patient outcomes, although speakers cautioned that much more work is ahead to ensure alignment of these two important scientific movements.

Through three panel discussions and keynote speeches by Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality, and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, conference attendees:

Gained a better understanding of the legislative proposals under consideration in Congress;
Considered important questions about how CER will be conducted, how much will be invested in that research, what entities will oversee the research, and how the results will be used to drive clinical and reimbursement decisions;
Listened to speakers debate the impact of CER on patient health outcomes if it does not take into account the molecular makeup of patients, since evidence has shown that patient subgroups may respond differently to therapeutic options based on demographic characteristics, genetic variation, and coexisting medical conditions; and
Learned about the business implications of CER and personalized medicine on pharmaceutical innovation.

Materials distributed to conference attendees include:

Issue Brief: "21st Century Science: Comparative Effectiveness Research and Personalized Medicine"
"Comparative Effectiveness Research and Personalized Medicine: From Contradiction to Synergy," a report by The Lewin Group

To view presentations (in PDF format) from the conference, click on a speaker's name.

CONFERENCE AGENDA

9:15am - 9:45am
SETTING THE STAGE

Cliff Goodman, PhD, Senior Vice President, The Lewin Group

9:45am - 11:30am
PANEL 1 - PERSONALIZED COMPARATIVE EFFECTIVENESS RESEARCH: POLICY CONSIDERATIONS

Andrew Dawson, U.S. House Committee on Ways and Means, Subcommittee on Health
Amy Miller, Personalized Medicine Coalition
Neera Tanden, U.S. Department of Health and Human Services
Andrew Wu, U.S. Senate Committee on Finance
Moderator: Cole Werble, FDC-Windhover, Elsevier Business Intelligence

12:15pm - 1:30pm
AFTERNOON KEYNOTES

Carolyn M. Clancy, MS, Agency for Healthcare Research and Quality
Janet Woodcock, MD, U.S. Food and Drug Administration

1:30pm - 3:00pm
PANEL 2 - OPPORTUNITIES FOR A PERSONALIZED MEDICINE APPROACH TO COMPARATIVE EFFECTIVENESS RESEARCH

Amy P. Abernethy, Duke Comprehensive Cancer Institute
Robert S. Epstein, MS, MS, Medco Health Solutions
Adolph P. Falcon, MPP, National Alliance for Hispanic Health
Michael Lauer, MD, FACC, FAHA, National Heart, Lung and Blood Institute, National Institutes of Health
Moderator: Jeffrey Cossman, MD, The Critical Path Institute

3:15pm - 4:45pm
PANEL 3 - BUSINESS IMPLICATIONS OF COMPARATIVE EFFECTIVENESS RESEARCH WITH STRATIFIED POPULATIONS

Pierre Cassigneul, XDx, Inc.
Robert Honigberg, MD, MBA, MS&T Consulting LLC
Teresa L. Lee, JD, MPH, AdvaMed
Newell McElwee, PharmD, MSPH, Merck & Co., Inc.
Moderator: John Iglehart, Health Affairs

4:45pm - 5:00pm
CLOSING REMARKS

Cliff Goodman, PhD, Senior Vice President, The Lewin Group

Podcast on the Intersection of Comparative Effectiveness Research and Personalized Medicine

NPCNow — Wed, 28 Oct 2009 01:41:11 GMT

One of the most intensely debated topics in healthcare reform today is comparative effectiveness research, which compares available treatment options - like drug vs. device, drug vs. drug, or surgery vs. conservative care, for example, using a range of research methods. CER, a component of evidence-based medicine, andpersonalized medicine are two important scientific trends being discussed today.

CER has traditionally used broad population averages as a means to compare and evaluate different treatments and health interventions. But as molecular science, health information technology, and novel epidemiologic methods mature and converge, it's important for CER and federal policies to take into account the emerging knowledge of different patient responses to treatments.

To take a closer look at this issue, Dr. Les Paul, vice president for clinical and scientific affairs at the National Pharmaceutical Council, speaks with Dr. Wayne Rosenkrans. Dr. Rosenkrans is a Distinguished Fellow at the Center for Biomedical Innovation at MIT. He is also Chairman, President and a member of the board of directors of the Personalized Medicine Coalition, a Washington DC based organization working with government and other agencies on evolving healthcare policy for Personalized Healthcare.

Leaders in Healthcare to Examine Impact of Comparative Effectiveness Research on Personalized Medicine

NPCNow — Tue, 27 Oct 2009 19:26:23 GMT

NPC-PMC Conference to Focus on Science, Policy and Business Implications

Contacts:
Andrea Hofelich, National Pharmaceutical Council, 703-715-2741 (O) 703-944-3137 (C)
Elizabeth Schwinn, Personalized Medicine Coalition, 202-589-1770 (O) 202-5103034 (C)

Arlington, VA (October 27, 2009) -- As Congress continues its efforts to reform the health care system, the National Pharmaceutical Council (NPC) and the Personalized Medicine Coalition (PMC) will host a conference tomorrow to explore a key topic in the debate: using comparative effectiveness research (CER) to determine which health care treatments are most effective while improving the quality of patient care through personalized medicine.

"Understanding how CER and personalized medicine may be aligned with each other and putting them into practice will have policy, science, and business implications for years to come. Health care stakeholders recognize that getting it right, by fostering a sound environment for innovation, will help to pave the way for effective cures for diseases in the future," said NPC President Dan Leonard.

"Unless CER is done properly with attention to the latest developments in molecular biology, it will not help patients because it will not account for individual variation," said Edward Abrahams, Ph.D., PMC's executive director. "CER usually asks what works best for most while personalized medicine asks what works best for whom."

Earlier this year, the federal government allocated $1.1 billion for CER, which compares available treatment options utilizing a range of research methods. Although the goal of CER is to inform health care providers and patients, and further enhance the quality and value of patient care, there is a concern that CER will not be effective unless it takes into account the genetic makeup of patients. Evidence has shown that patient subgroups may respond differently to therapeutic options based on demographic characteristics, genetic variation, and coexisting medical conditions, and such differences can have a big impact on how well a medicine works for them. The health care reform legislation approved by both the Senate Health, Education, Labor and Pensions Committee and the Senate Finance Committee acknowledge these concerns to differing extents. Similarly, an Institute of Medicine committee also highlighted the need for CER to be used to "improve health care at both the individual and population levels."

The conference, "Comparative Effectiveness Research and Personalized Medicine: Science, Policy and Business" will feature leading government, business and science stakeholders, including Dr. Janet Woodcock, Director of the Food and Drug Administration's Center for Drug Evaluation and Research; Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality; Dr. Amy Abernethy, Associate Director of the Duke Comprehensive Cancer Institute; Dr. Robert Epstein, Chief Medical Officer, Medco Health Solutions; Dr. Newell McElwee, Executive Director of U.S. Outcomes Research for Merck & Co.; and Adolph Falcon, Vice President for Science and Policy at the National Alliance for Hispanic Health, among others. In their comments, speakers will examine how CER has been conducted in the past; how it needs to change; and what the implications are for pharmaceutical and other medical companies.

The conference also will highlight a report from The Lewin Group that systematically examines the intersection of CER and personalized medicine and defines key issues to address in developing a policy to advance the two together. Copies of the report brief are available online at http://www.regonline.com/custImages/253701/CER and PM Issue Brief.pdf.

About the National Pharmaceutical Council
NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

About the Personalized Medicine Coalition
The Personalized Medicine Coalition (PMC), representing a broad spectrum of academic, industrial, patient, provider, and payer communities, seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. For more information on the Personalized Medicine Coalition, please visit www.PersonalizedMedicineCoalition.org.

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NPC Board of Directors Elects Pfizer's Marie-Caroline Sainpy as Chairman

NPCNow — Tue, 27 Oct 2009 19:16:41 GMT

Contact:�Andrea Hofelich 703-715-2741 or ahofelich@npcnow.org

Washington, DC (October 27, 2009) -- The National Pharmaceutical Council's Board of Directors today announced that it has elected Marie-Caroline Sainpy, Regional President for the NE Primary Care Business Unit at Pfizer Inc, to serve as Chairman for 2009-2010.

Ms. Sainpy has served in a variety of senior roles at Pfizer, which she joined in 1982. Prior to her current position, she was Senior Vice President/General Manager of the Customer Business Unit and Commercial Operations for the US. Prior to joining Pfizer Ms. Sainpy worked for Organon's U.S. Pharmaceutical Division, and Lazard Fr�res in New York. She has served on NPC's Board since 2007, most recently as Vice Chairman.

"NPC welcomes Ms. Sainpy as chairman," said NPC President Dan Leonard. "She shares our commitment to high standards of research and encouraging pharmaceutical innovation to improve patients' lives."

She takes on the chairmanship at a critical time, with Congress debating health care reform and increasing funding in the area of comparative effectiveness research, and with employers becoming more engaged in insurance design and improving employee health and productivity. As a result, during the last year NPC has taken a more active role in participating with health care stakeholders to demonstrate and communicate the value of biopharmaceuticals and vaccines through practical, evidence-based tools.

"As health reform drives the government into a greater role in determining guidelines and reimbursement of patient care, NPC will play an increasingly important part in providing analysis to help ensure that patient access and clinical quality are important factors in policy determinations," said Ms. Sainpy.

The NPC Board also elected Kevin T. Rigby, Vice President of Public Affairs and Communications at Novartis Pharmaceuticals, to serve as its Vice Chairman, and Robert A. McMahon, President of U.S. Commercial Operations at Merck & Co., as Treasurer.

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NPC Commends Senate Finance Committee Chairman Baucus for Comparative Effectiveness Research Provisions in Chairman's Mark

NPCNow — Thu, 17 Sep 2009 14:29:23 GMT

For Immediate Release

Contact: Andrea Hofelich, ahofelich@npcnow.org, 703-715-2741

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September 16, 2009, Washington, DC - The National Pharmaceutical Council (NPC) commended U.S. Senate Finance Committee Chairman Max Baucus for his commitment to comparative effectiveness research (CER), which was outlined in the chairman's mark of the America's Healthy Future Act of 2009 that was unveiled today.

"A well-crafted comparative effectiveness research program like the one outlined in the chairman's mark can help to support the dialogue between health care providers and patients, and further enhance the quality and value of patient care," said NPC President Dan Leonard. "That in turn can help keep Americans healthier, improve their quality of life, and even increase productivity through fewer sick days and hospital stays."

A key component of the chairman's mark includes the establishment of a private, non-profit corporation to set the research agenda and conduct CER and to be governed by a multi-stakeholder board. As outlined by the mark, CER would encompass all health care services; be rigorous and transparent; consider the needs of subpopulations; and utilize a full range of types and sources of evidence. In addition, the proposed CER entity would provide evidence to encourage good decision making by health care professionals and patients, and would be required to disseminate study results in a timely manner. All of these points were espoused by NPC in its comments submitted earlier this year to the Institute of Medicine's CER Priority Setting Committee, the Agency for Healthcare Research and Quality and the Federal Coordinating Council for Comparative Effectiveness Research, which was responsible for developing a definition, criteria for research, and a strategic framework for CER.

In addition, by establishing a standing methodology committee, the chairman's mark acknowledges the importance of rigorous scientific methods needed to conduct CER, noted Leonard.

"We commend Chairman Baucus for developing a thoughtful approach to CER that will improve on the evidence currently available to health care providers and patients. Even more important, there is a clear commitment to ensuring that CER will not be used to deny patients access to necessary treatments," concluded Leonard.

NPC also has developed a CER toolkit that provides an overview of CER definitions, its history, and legislation currently under consideration. The toolkit is available in the issues section of NPC's website, www.npcnow.org, under "evidence-based medicine."

About the National Pharmaceutical Council

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. As a research and education organization, NPC does not take positions on legislation. For more information, visit www.npcnow.org.�

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NPC Response to President Obama's Health Care Address to Congress

NPCNow — Thu, 10 Sep 2009 20:41:42 GMT

Comparative Effectiveness Research Can Enhance Quality, Value of Patient Care

FOR IMMEDIATE RELEASE

Contact: Andrea Hofelich, ahofelich@npcnow.org, 703-715-2741

September 10, 2009, Washington, DC - In response to President Obama's health care reform address to Congress, National Pharmaceutical Council (NPC) President Dan Leonard said comparative effectiveness research (CER) should not be overlooked as a way to improve physician decision making and ultimately, the quality of patient care.

"First, we commend President Obama for his commitment to improving America's health care system. It is a challenging task, given the complexity of the health care system, the rise in the prevalence of chronic conditions, and our aging population.

"Second, given the $1.1 billion allocated earlier this year for comparative effectiveness research, it clearly should be an integral part of any health care reform package. As the debate moves forward in Congress, it is important for the federal government to support the dialogue between health care providers and patients, and thus enhance the quality and value of patient care, through a well-crafted comparative effectiveness research program.

"We look forward to continued discussions on this important issue and to the thoughtful examination of key issues and approaches that might be considered."

Earlier this year, NPC submitted comments to the Institute of Medicine's CER Priority Setting Committee, the Agency for Healthcare Research and Quality and the Federal Coordinating Council for Comparative Effectiveness Research, which was responsible for developing a definition, criteria for research, and a strategic framework for CER. In its comments, NPC said that CER should provide evidence to encourage good decision making by health care professionals and patients; encompass all health care services; be rigorous and transparent; consider the needs of subpopulations; utilize a full range of types and sources of evidence; and disseminate study results in a timely manner.

NPC is supportive of the commitment to CER included in the health care framework released earlier this week by Senate Finance Committee Chairman Max Baucus.� An important component of the health care framework includes a not-for profit institute to set the research agenda and conduct CER and to be governed by a multi-stakeholder board.� "Like all interested parties, NPC looks forward to seeing final legislation from the Senate encompassing all of these considerations," said Leonard.

About the National Pharmaceutical Council

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NPC Podcast: Briefing on Value-Based Insurance Design

NPCNow — Tue, 01 Sep 2009 08:25:36 GMT

The National Pharmaceutical Council (NPC) hosted a media teleconference on August 24 to discuss its new report on Value-Based Insurance Design (VBID) -- an important approach being used by leading edge employers for improving patient health outcomes. Featuring case studies, NPC's report, "The Value-Based Insurance Design Landscape Digest," takes a closer look at how VBID is helping employers nationwide "get more health out of every health care dollar."

Teleconference speakers included:

NPC President Dan Leonard
A. Mark Fendrick, MD, who is Co-Director of the Center for VBID and a professor in the Departments of Internal Medicine and Health Management and Policy at the University of Michigan and author of NPC's report. Dr. Fendrick explained the VBID concept and how companies are putting it into practice.
Midwest Business Group on Health President and CEO Larry Boress, MPA, whose organization launched Taking Control of Your Health, a VBID program with Chicago metropolitan employers, is featured as one of the case studies in the report. He discussed how his organization is working with employers to implement VBID programs.

Value-Based Insurance Design: Helping Employers Improve the Value of Health Care

NPCNow — Mon, 24 Aug 2009 16:00:00 GMT

Focus of New Report Funded by the National Pharmaceutical Council

Washington, DC - As members of Congress continue to debate proposals for health care reform, the National Pharmaceutical Council (NPC) has released a new report on an important approach being used by leading edge employers for improving patient health outcomes - Value-Based Insurance Design (VBID). Featuring case studies, the report takes a closer look at how VBID is helping employers nationwide "get more health out of every health care dollar."

The report, "Value-Based Insurance Design Landscape Digest," authored by Dr. A. Mark Fendrick, Co-Director of the Center for Value-Based Insurance Design at the University of Michigan, explains how companies are using VBID to lower or eliminate financial barriers to the purchase of "high-value" drugs or health care services with the intention of improving adherence to therapy and avoiding more expensive future medical costs, such as hospitalization. These benefit design changes are most often coupled with education and other strategies for consumer engagement in order to have maximum impact.

"Under a VBID program, the alignment of financial incentives - for patients and providers - encourages the use of high-value care, while discouraging the use of low-value or unproven services. Ultimately, this can produce more health at any level of health care expenditure," said Dr. Fendrick.

In the report, Fendrick explains how VBID encompasses several key principles: value equals the clinical benefit achieved for the money spent; health care services differ in the health benefits they produce; and the value of health care services depends upon the individual who receives them. The more clinically beneficial a therapy is for a patient, the lower the patient's cost share. Thus, VBID encourages the use of medically necessary therapies and services and reduces barriers to access for these services.

The report also highlights how companies like Caterpillar, Inc., Hannaford Brothers Company, and UnitedHealthcare, among others, have improved employee health via one of the four basic approaches to VBID:

Design by service, in which copayments or coinsurance are waived or reduced for select drugs or services, such as statins or cholesterol tests, no matter which patients are using them.
Design by condition, in which copayments or coinsurance are waived or reduced for medications or services, based on the specific clinical conditions with which patients have been diagnosed.
Design by condition severity, in which copayments or coinsurance are waived or reduced for high-risk members who would be eligible for enrollment in a disease management program.
Design by disease management participation, in which high-risk members who actively participate in a disease management program are provided reduced or waived copayments or coinsurance.

"VBID, along with comparative effectiveness research, could assist public and private payers in realizing the best value for their health care dollar while improving the quality of health care services and employee health," said NPC President Dan Leonard. "These programs already are leading to a healthier workforce, with reductions in absenteeism, medical disability, and productivity losses associated with health conditions. Implementing them on a wider scale could help policy makers reach their goal of improving quality in the system while 'bending the curve' of overall health care spending in the right direction."

The study and a video interview with Dr. Fendrick are available on NPC's website at www.npcnow.org.

About the National Pharmaceutical Council

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based biopharmaceutical companies. For more information, visit www.npcnow.org.

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Value-Based Insurance Design Landscape Digest

NPCNow — Mon, 24 Aug 2009 16:00:00 GMT

The "Value-Based Insurance Design Landscape Digest" defines the concept of value-based insurance design (VBID), outlines key objectives, design features and potential barriers to implementation, and describes evaluation tools for measuring the outcomes of VBID programs. The report also highlights how companies like Caterpillar, Inc., Hannaford Brothers Company, and UnitedHealthcare, among others, have adopted VBID programs and reviews the clinical and economic implications of VBID."

NPC Participates in Translational Medicine Alliance Forum 2009

NPCNow — Wed, 05 Aug 2009 15:26:33 GMT

Attendees at the Translational Medicine Alliance Forum 2009 in Philadelphia, PA, heard from NPC's vice president for clinical and scientific affairs, Dr. Les Paul, and other pharmaceutical industry experts about the growing trend toward personalized medicine.

During a panel discussion titled, "Road to Personalized Medicine - Barriers and Opportunities," Dr. Paul pointed out that:�

Practical personalized medicine is a reality today for selected biopharmaceuticals�
The trajectory of the development of biomarker based therapeutics is likely to accelerate rapidly
Stakeholders should expect both important drug-dependent and drug independent biomarker discoveries throughout the lifecycle of a drug
Learning which drugs work for whom with the highest net benefit, at which dose, and, if possible, why, will require risk taking, tolerance for uncertainty, patience, and courage
But, over time, a new way to practice medicine will continue to emerge.

View the 2009 video highlights and the posted presentations here.

The Future Costs, Risks and Rewards of Drug Development

NPCNow — Mon, 03 Aug 2009 15:57:20 GMT

This article, published in the July 2009 issue of PharmacoEconomics, discusses the evolving field of pharmacogenomics - which is the science of using genomic markers to predict drug response - and how it may impact the future costs, risks and returns to pharmaceutical research and development (R&D). Authors Joseph Cook and Graeme Hunter of NERA Economic Consulting and John A. Vernon of the University of North Carolina at Chapel Hill uncover a number of factors and issues that are likely to influence the expected returns and, hence, the incentive to invest in new pharmaceutical R&D in tandem with the development of pharmacgenomics.

New Study Shows that Pharmacogenomics Could Benefit Patients, Spur Investment in Innovation

NPCNow — Mon, 03 Aug 2009 15:36:40 GMT

For Immediate Release
Contact: Andrea Hofelich, ahofelich@npcnow.org, 703-715-2741

July 31, 2009, Washington, DC - A new study funded by the National Pharmaceutical Council (NPC) shows that pharmacogenomics - the field of scientific research focused on learning how genetic profiles predict the body's response to medicines - has the potential to lead to higher levels of research and development (R&D) investment and an increased pace of pharmaceutical innovation, offering substantial benefits for patients.

The study, "The Future Costs, Risks and Rewards of Drug Development: The Economics of Pharmacogenomics," was written by Joseph Cook and Graeme Hunter of NERA Economic Consulting and John Vernon of the University of North Carolina at Chapel Hill, and published in the July issue of PharmacoEconomics. According to the study, pharmacogenomics can provide more focused and targeted information to researchers during the R&D process, potentially reducing the number of patients needed for clinical trials as well as the cost and time required to complete the trials. Products could reach the market faster, providing a longer period of time over which the innovator companies could recoup the investment costs of developing products.

"We may see pharmacogenomics pushing us in the right direction of more investment in pharmaceuticals," said study author John Vernon. "The main features likely to drive this phenomenon are the ability of pharmacogenomics to drive adoption of drugs and lower costs of development and time to commercialization. Of course, we have yet to see how these factors are likely to play out, but pharmacogenomics has the makings of a powerful force for economic change and encouraging the financing of new drugs and treatments for patients."

For example, better information about the patients who are more likely to respond to a medication could increase the rate of use of that medicine. Biological markers also could help to identify patients for whom a drug may pose a significant risk of harm. Knowing which patients are not appropriate candidates for a certain drug may help increase the likelihood that a product that might otherwise have been dropped from development could make it to market and become available to treat those patients who could benefit. Thus, as companies make decisions about products to develop, the potential for a product to generate a positive return on investment could well be affected by the improved information that pharmacogenomics can offer. As the study notes, this could have important implications for patients in the U.S. through the improved availability of new pharmaceutical and biological innovations.

The authors caution, however, that because this is such a new field of study, "there is considerable uncertainty as to how the area will evolve, both clinically and economically." Although "the time horizon necessary for the science to develop and be adopted into clinical practice is not clear," the study does "shed some light on possible outcomes and provides researchers with a better understanding of the economics of pharmacogenomics."

"The ability to target medicines more specifically to patient groups is a significant change in the pharmaceutical landscape," said Dan Leonard, NPC President. "This study shows how pharmacogenomics can positively affect innovation and lead to increased benefits for patients."

NPC will continue to explore the issue of targeted, or personalized medicine, during an October 28 conference hosted in conjunction with the Personalized Medicine Coalition. Further information is available on NPC's website, www.npcnow.org.

To download a copy of the pharmacogenomics study, go to https://articleworks.cadmus.com/doc/dSoftcopy?o=807150&i=998589&c=1472827&atDownload=true

About the National Pharmaceutical Council
NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based biopharmaceutical companies. For more information, visit www.npcnow.org.

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NPC | Evidence. Value. Innovation.

NPCNow — Wed, 29 Jul 2009 17:37:05 GMT

Learn more about the National Pharmaceutical Council. This brochure highlights the mission and unique approach of NPC in the areas of evidence, innovation and value, and fosters a broader understanding of our robust research agenda.

Comparative Effectiveness Research (CER) Toolkit

NPCNow — Thu, 23 Jul 2009 17:26:38 GMT

Although the concepts of comparative effectiveness research (CER) and evidence-based medicine (EBM) are not new, it is important to establish a clear definition and understanding of why these are so prominent today and the many related issues and initiatives under consideration in Washington, DC.

To facilitate this understanding, the National Pharmaceutical Council (NPC) has developed a series of informational pieces, which taken together provide an overview of CER and EBM. Each of the following items outlines a specific aspect in a short, easy-to-read format.

Defining Evidence-Based Medicine and Comparative Effectiveness Research
A Brief History of Comparative Effectiveness Research and Evidence-Based Medicine
NPC's Key Considerations on Comparative Effectiveness Research
Legislative Proposals Regarding Comparative Effectiveness Research
Comparison of Comparative Effectiveness Research Legislative Activities in the Context of NPC's CER Recommendations to Institute of Medicine, Federal Coordinating Council on CER and the Agency for Healthcare Research and Quality
Additional Resources

NPC will�provide updates to the materials on an ongoing basis.

NPC Strengthens Its Evidence-based Medicine Research Team

NPCNow — Mon, 06 Jul 2009 15:38:32 GMT

Brings Jennifer Graff on Board as Research Director, Methods, Evidence, and Coverage

For Immediate Release

Contact: Andrea Hofelich, 703-715-2741

July 6, 2009, Washington, DC - The National Pharmaceutical Council (NPC) today announced that Jennifer Graff, PharmD, has joined the organization as Research Director, Methods, Evidence and Coverage. In this new position, Dr. Graff will be working with NPC Vice President for Clinical and Scientific Affairs Les Paul, MD, MS, to advance the numerous evidence-based medicine (EBM) and innovation research initiatives NPC has underway.

"Jennifer is joining us at a critical time as we move forward with new projects focusing on EBM and comparative effectiveness research," said Dr. Paul. "Her extensive research and pharmacoeconomics background make her especially well suited to the development of our growing portfolio of research."

Most recently, Dr. Graff served as Associate Director of Health Outcomes and Pharmacoeconomics at MedImmume, where she was responsible for health outcomes and pharmacoeconomics for 10 products in clinical development for the respiratory and inflammation therapy areas. She also developed strategic research and case studies to identify market challenges and enhance product differentiation. Prior to MedImmune, she held several positions at the Pfizer Pharmaceuticals Group, most recently as the Associate Director for Worldwide Outcomes Research. Dr. Graff holds a Doctorate of Pharmacy from the University of Nebraska Medical Center, and completed a Health Outcomes and Pharmacoeconomics fellowship at the University of Michigan.

"Since 2007, we have continued to expand NPC's contributions to the rigorous research and stakeholder dialogue on comparative effectiveness and evidence-based medicine," said NPC President Dan Leonard. "We're pleased that Jennifer has joined NPC to help us with those efforts."

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

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NPC Says Comparative Effectiveness Research Can Improve Patient Outcomes

NPCNow — Thu, 18 Jun 2009 13:14:48 GMT

For Immediate Release
Contact: Andrea Hofelich, 703-944-3137

National Pharmaceutical Council Says Comparative Effectiveness Research Can Improve Patient Outcomes
Requires Thoughtful Prioritization, Rigorous Research Methods, and Integration With Provider Decision Support

Issues Highlighted at NPC Symposium, "Entering a New Era of Evidence"

June 17, 2009, Washington, DC-Speaking at the National Pharmaceutical Council's (NPC) symposium today, NPC President Dan Leonard said it's critical for the federal government to "get comparative effectiveness research (CER) right" so that it will support the dialogue between health care providers and patients, and thus enhance the quality and value of patient care.

"Public and private health care stakeholders have recognized that the quality of patient care and health outcomes can be improved if there is more information available to help inform coverage decisions and treatment choices," said Leonard in his opening remarks.

In recent weeks, NPC submitted comments to the Institute of Medicine's CER Priority Setting Committee, the Agency for Healthcare Research and Quality and the Federal Coordinating Council for Comparative Effectiveness Research, which is in the process of developing a draft definition, criteria for research, and a strategic framework for CER. NPC said that CER should provide evidence to encourage good decision making by health care professionals and patients; encompass all health care services; be rigorous and transparent; consider the needs of subpopulations; utilize a full range of types and sources of evidence; and disseminate study results in a timely manner.

These issues also were highlighted today at NPC's symposium, "Entering a New Era of Evidence." The symposium featured presentations on CER in the United States and abroad, as well as perspectives from Capitol Hill, the administration, and stakeholder organizations. Speakers included

Kurt Schrader, U.S. Representative (D-OR), and sponsor of The Comparative Effectiveness Research Act of 2009;
Shawn Bishop, Professional Staff, U.S. Senate Finance Committee;
Jean Slutsky, PA, MSPH, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality;
Robert Kocher, MD, Special Assistant to the President, National Economic Council;
Adrian Levy, PhD, Director, Oxford Outcomes, who is working on NPC-sponsored research about health technology assessment organizations in other countries and what we can learn from them; and
A panel on CER in America, moderated by NPC Vice President for Clinical and Scientific Affairs Les Paul, MD, MS, and that featured Marc Berger, MD, Vice President, Global Health Outcomes, Eli Lilly and Company; Eugene Rich, MD, Scholar-in-Residence, Association of American Medical Colleges; Lindy Hinman, Vice President, America's Health Insurance Plans; and Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council.

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based biopharmaceutical companies. For more information, visit www.npcnow.org.

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NPC Submits Testimony on Draft CER Definition, Criteria and Framework

NPCNow — Tue, 09 Jun 2009 20:06:10 GMT

Written Testimony of Les Paul, MD, MS
Vice President, Clinical and Scientific Affairs
National Pharmaceutical Council

For the Federal Coordinating Council on Comparative Effectiveness Research
On the Draft Definition and Strategic Framework for Comparative Effectiveness Research

June 10, 2009

On behalf of the National Pharmaceutical Council (NPC), thank you for the opportunity to comment on the draft comparative effectiveness research (CER) definition, prioritization criteria, and the proposed strategic framework that was developed by the Federal Coordinating Council on Comparative Effectiveness Research (FCCCER). The definition, prioritization criteria, and the strategic framework for CER can play an important role in improving patient health outcomes, and we congratulate the FCCCER on this critical effort.

About the National Pharmaceutical Council

Briefly, the National Pharmaceutical Council sponsors and conducts scientific analyses on the appropriate use of pharmaceuticals and the clinical and economic value of improved health outcomes through pharmaceutical innovation. CER and its foundation of high quality scientific evidence are important areas of focus for NPC. It is our goal to ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies.

Draft Definition of CER

When the $1.1 billion in federal funding was first allocated for CER, there were many unanswered questions regarding which projects would be prioritized, what kind of strategic framework would be developed, and how the research would be conducted and disseminated. To address those questions, NPC and other healthcare stakeholders provided recommendations in previous testimony that priorities for CER should:

Focus on conditions with the greatest impact on morbidity and cost, such as chronic conditions like cardiovascular disease, chronic respiratory diseases, cancer, diabetes, arthritis, and serious mental health conditions.
Include all major therapeutic options used to treat those conditions such as drugs, medical and surgical procedures, diagnostics, and medical devices.
Take into account the needs of patient subgroups who may respond differently to therapeutic options based on demographic characteristics, genetic variation, and coexisting medical conditions; and
Express clear support for the development of new CER methodologies, such as analysis of non-randomized studies of treatment effects using secondary databases, practice-based clinical practice improvement studies, more accurate modeling and simulation techniques, and methodologies that ensure optimal interpretation and application of CER in a variety of patient care settings.

NPC is pleased that the draft definition of CER encompasses these important concepts in a broad and thoughtful manner.

Draft Prioritization Criteria

The general nature of the prioritization criteria allows for considerable flexibility in their interpretation. While they represent a good foundation, clarification is needed to ensure that CER funding decisions will be made in the best possible manner and result in useful information that improves clinical decision making for health care providers and patients.

In particular, NPC is concerned about the reference to the "time necessary for research," and whether this would preclude lengthy or more in-depth projects from consideration. Proposed prioritization of research topics and studies, their associated research time frames, final study outcomes, and related information should be made transparent to all stakeholders and should be disseminated in a timely manner To maximize this potential, the FCCCER should prioritize the funding of an assessment of strategies to ensure the continuous evaluation of new evidence related to specific health care technologies - for example, how best to determine when a health technology assessment should be revised based on new clinical information.

The criteria also suggest that CER "lays the foundation for future CER or generates additional investment." CER not only lays the foundation for future CER, but also the foundation for future innovation. How the agenda and conduct of CER develops has the potential to influence incentives for innovation and we would recommend that the study of this important question be an explicit interest of publicly funded CER.

Additional Factors for Consideration in Priority Setting Under the Strategic Framework

Moving forward, it also will be important to consider other key factors in the selection of the highest priority research.

First, it will be important to conduct research to define rigorous, high quality, and validated CER methodologies that are focused on providing timely, accurate and balanced information in order to assist clinical decision making.

These questions include, but are not limited to, defining how best to address the full range of health effects of a new technology including quality of life, functionality, and productivity, as well as how best to appropriately characterize the strengths, weaknesses, and limitations of various underlying health technology assessment analytic techniques.

In order to minimize the likelihood for inaccurate or inappropriate interpretation of CER, we suggest the inclusion of a transparent and readily accessible description of the strengths, weaknesses, limitations, and potential for generalizability of the findings of CER utilizing varied experimental and non-experimental research designs.

Second, and consistent with our comment on the prioritization of the study of the impact of CER on innovation, the strategic framework should implicitly assume that innovative technology is an external input to the CER framework. It should be encompassed within and considered integral to the framework.
Third, the agenda for CER should be driven by the condition and the "key unanswered questions" in the context of that condition. Answering these questions may require comparisons between different types of technologies, processes, or procedures that may be considered to treat the condition; for example, the framework should reflect the need for comparisons of drug vs. surgery, drug and diagnostic vs. procedure, procedure vs. surgery, or other combinations.
Fourth, comparisons should also include delivery system architecture options, insurance plan designs, methods for primary/secondary prevention, and approaches to provider incentives to effect improvements in health.

The National Pharmaceutical Council appreciates the opportunity to take part in this critical dialogue and stands ready to assist FCCCER as it moves forward with the development of the CER definition and criteria. Thank you.

NPC to Host Conference, "Entering a New Era of Evidence"

NPCNow — Mon, 08 Jun 2009 15:02:35 GMT

Focus on Unanswered Questions of Comparative Effectiveness Research in the U.S.

Washington, DC-- As the federal government moves forward with determining how the $1.1. billion for comparative effectiveness research (CER) will be allocated, it is important to understand which projects will be prioritized, what kind of framework will be developed, and how the research will be conducted and disseminated. The National Pharmaceutical Council's June 17 conference, "Entering a New Era of Evidence," will bring together key stakeholders to address those issues and examine the current CER landscape in the United States.

"The debate over comparative effectiveness research will not be settled overnight," said National Pharmaceutical Council President Dan Leonard. "It's critical to the health care system for policy makers to get this right by establishing an open and transparent process for the prioritization of CER topics for study to ensure that sound evidence leads to quality patient care."

The conference will feature presentations on CER in the United States and abroad, as well as perspectives from Capitol Hill, the administration, and stakeholder organizations. Confirmed speakers include

Hon. Kurt Schrader, U.S. Representative (D-OR)
Shawn Bishop, Professional Staff, U.S. Senate Finance Committee
Jean Slutsky, PA, MSPH, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
Robert Kocher, MD, Special Assistant to the President, National Economic Council
Adrian Levy, Ph.D., Director, Oxford Outcomes
Marc Berger, MD, Vice President, Global Health Outcomes, Eli Lilly and Company
Eugene Rich, MD, Scholar-in-Residence, Association of American Medical Colleges
Carmella Bocchino, Executive Vice President, Clinical Affairs and Strategic Planning, America's Health Insurance Plans
Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council

The conference will be held from 8:30 a.m. to 2 p.m. at the Park Hyatt Washington, 24th and M Streets, NW, in Washington, D.C. Public registration is available. There is no charge for credentialed media, who should contact Andrea Hofelich at 703-715-2741 or ahofelich@npcnow.org to register.

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

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Apples and Oranges? Assessing Comparative Effectiveness and Comparative Value in the US and Other Countries

NPCNow — Fri, 15 May 2009 14:01:00 GMT

Friday, May 15, 2009

Attendees at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting had an opportunity to participate in an all-day symposium on comparative effectiveness and comparative value and what the U.S. might learn from the experience in other countries. Co-sponsored by NPC, Shire, and Oxford Outcomes, the symposium began with an overview of the health technology assessment systems in the United Kingdom, Sweden, and Canada, followed by a panel discussion on the implications for U.S. comparative effectiveness efforts. The presenters emphasized the need for sound real world evidence on the effectiveness of health technologies and urged that the stakeholders involved in and affected by comparative effectiveness research should be involved in deciding what to study and what kind of evidence will be sufficient for making decisions. They also noted that the economics associated with these decisions should not be ignored, but comparative effectiveness, and even cost effectiveness, research should not be expected to save money. Other countries have adopted more severe measures that limit total spending for health care services as a means to reduce cost. The symposium concluded with a debate on the proposition that publicly funded estimates of comparative value in the United States should take into consideration only net clinical benefit and explicitly exclude cost-effectiveness.

To view presentations (in PDF format) from the symposium, click on a speaker's name.

SYMPOSIUM SCHEDULE

10:00AM-10:15AM
WELCOME & OVERVIEW
Moderator: Adrian Levy PhD, Associate Professor, University of British Columbia & Director, Oxford Outcomes, Vancouver, BC, Canada

10:15AM-10:35AM
COMPARATIVE EFFECTIVENESS IN THE UK
Ron Akehurst BSc, Hon MFPHM, Professor of Health Economics. Dean and Chair of Executive Board, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

10:35AM-10:55AM
COMPARATIVE EFFECTIVENESS IN SWEDEN
Egon Jonsson PhD, Executive Director and CEO, Institute of Health Economics, Alberta, Canada

10:55AM-11:15AM
COVERAGE WITH EVIDENCE DEVELOPMENT: THE ONTARIO EXPERIENCE
Ron Goeree BA, MA, Associate Professor, Department of Clinical Epidemiology & Biostatistics, McMaster University & Director, Program for Assessment of Technology in Health, Hamilton, ON, Canada

11:15AM-11:30AM
BREAK

11:30AM-11:50AM
COMPARATIVE ASSESSMENT FOR MEDICATIONS AND DEVICES: APPLES AND ORANGES?
Scott Ramsey MD, PhD, Professor, University of Washington, Member, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

11:50AM-12:15PM
LESSONS FOR THE USA
Moderator: Lou Garrison AB, PhD, Professor, School of Pharmacy, University of Washington, Seattle, WA, USA

12:15PM-12:45PM
PANEL DISCUSSION - QUESTIONS/COMMENT All AM Speakers

12:45PM-1:15PM
LUNCH

1:15PM-1:25PM
OPENING REMARKS
Moderator: Adrian Levy PhD, Associate Professor, University of British Columbia & Director, Oxford Outcomes, Vancouver, BC, Canada

1:25PM-1:45PM
CONTEMPORARY CHALLENGES IN DERIVING SUMMARY ESTIMATES OF COMPARATIVE EFFECTIVENESS USING META-ANALYSIS
Ed Mills MSc, PhD, LLM, Research Scientist, BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada

1:45PM-2:05PM
NETWORK META-ANALYSIS: THE NEXT STEP FOR COMPARATIVE EFFECTIVENESS?
Neil Hawkins PhD, MSc, Director, Oxford Outcomes, External Affiliate, York University, York, UK

2:05PM-2:25PM
REFLECTING HETEROGENEITY IN PATIENT BENEFITS: THE ROLE OF SUB-GROUP ANALYSIS WITH COMPARATIVE EFFECTIVENESS
Mark Sculpher PhD Professor of Health Economics and Director of the Programme on Economic Evaluation and Health Technology Assessment, University of York, Centre for Health Economics, York, UK

2:25PM-2:45PM
TRANSPORTABILITY BETWEEN COUNTRIES OF ESTIMATES OF COMPARATIVE EFFECTIVENESS
Andrew Briggs BA, MSc, DPhil, Lindsay Chair in Health Policy and Economic Evaluation, University of Glasgow, Glasgow, Scotland

2:45PM-3:05PM
EXPERIMENTAL AND OBSERVATIONAL DATA AND FORMULARY LISTING
Raulo S. Frear PharmD, Director, Pharmacy Services, The Regence Group, Portland, Oregon, USA

3:05PM-3:25PM
NET CLINICAL BENEFIT: THE ART AND SCIENCE OF JOINTLY ESTIMATING BENEFITS AND RISKS OF MEDICAL TREATMENT
Adrian Towse MA, MPhil, Director, Office of Health Economics, London, UK

DEBATE: PUBLICLY FUNDED ESTIMATES OF COMPARATIVE VALUE IN THE UNITED STATES SHOULD TAKE INTO CONSIDERATION ONLY NET CLINICAL BENEFIT AND EXPLICITLY EXCLUDE COST-EFFECTIVENESS
Moderator: Seema Sonnad PhD, Director of Outcomes Research for the Department of Surgery, University of Pennsylvania Health System, Pennsylvania, PA, USAPro: Kathy Buto BA, MPA, Vice President for Health Policy, Government Affairs, Johnson & Johnson, NJ, USACon: Mark Helfand MD, MPH, Director, Oregon Evidence-based Practice Center, Portland, Oregon, USA

4:45PM-5:00PM
QUESTIONS & DISCUSSION All Speakers

5:00PM-5:30PM
RECEPTION

Webcast on Value Based Benefit Design: Promoting Value, Quality and Access

NPCNow — Thu, 14 May 2009 15:11:36 GMT

On March 26, 2009, NPC co-sponsored a town hall on Value Based Benefit Design with the New York Business Group on Health (NYBGH). The meeting was hosted by sanofi-aventis and featured:

Dr. Mark Fendrick, co-director of the University of Michigan's Center for Value-based Insurance Design;
Mr. Andrew Webber, President and CEO of the National Business Coalition on Health;
Dr. Irene Fraser, Director of the Center for Delivery, Organization and Markets at the Agency for Healthcare Research and Quality;
Dr. Robert Kritzler, CMO of Johns Hopkins Health Plan; and
Ms. Jennifer Boehm, Principal, Health Management, Hewitt Associates, shared her perspective on how her client employers are considering and evaluating value based designs.

To view the webcast, click on the link below.

Health & Productivity as a Business Strategy

NPCNow — Mon, 13 Apr 2009 20:54:00 GMT

The study, published in the April issue of the Journal of Occupational and Environmental Medicine, explored methodological refinements in measuring health-related lost productivity and assessed the business implications of a full-cost approach to managing health. After measuring productivity loss among 10 employers with 51,648 employee respondents and analyzing 1.13 million medical and pharmacy claims, researchers found that health-related productivity costs significantly exceed medical and pharmacy costs - on average 2.3 to 1. In addition, depression, obesity, arthritis, back and neck pain and anxiety drive the majority of costs when looking at both productivity and medical and pharmacy costs. The study also found presenteeism to be a bigger drain on productivity than absenteeism.

http://journals.lww.com/joem/pages/articleviewer.aspx?year=2009&issue=04000&article=00004&type=abstract

Most Employers Underestimate Full Costs of Employee Health on Productivity

NPCNow — Mon, 13 Apr 2009 15:31:46 GMT

Large multi-employer study indicates that the costs of poor health are much greater for employers than medical and pharmaceutical spending alone

Contact:
Paul Larson 847-475-1283
Andrea Hofelich 703-715-2741

(Elk Grove Village, Ill., April 13, 2009) - Poor health among workers is far costlier to U.S. employers than they realize, impacting their profitability and undercutting the nation's overall productivity, according to a major study published this week in the Journal of Occupational and Environmental Medicine (JOEM).

The multi-year study of ten organizations employing more than 150,000 workers indicates that employers who focus only on medical and pharmacy costs in creating employee health strategies may misidentify the health conditions that most impact the productivity of their employees - while underestimating the impact of other factors.

One such factor, "presenteeism," occurs when employees with health conditions are present at their jobs but are unable to perform at full capacity. The study closely examined the effects of presenteeism, concluding that impaired employee-performance typically creates a greater drain on a company's productivity than employee absence - a finding which could come as a surprise to some employers.

The study also found that when considering medical and drug costs alone, the top five conditions driving costs are cancer (other than skin cancer), back/neck pain, coronary heart disease, chronic pain, and high cholesterol. But when health-related productivity costs are measured along with medical and pharmacy costs, the top five chronic health conditions driving these overall health costs shift significantly, to depression, obesity, arthritis, back/neck pain and anxiety.

The study suggests that many employers miss an opportunity to improve productivity and their bottom-line results by failing to recognize and prioritize these health conditions when they develop integrated employee-health strategies and related interventions.

The study, coordinated by the American College of Occupational and Environmental Medicine (ACOEM), the Integrated Benefits Institute (IBI), and Alere LLC (formerly Matria Healthcare, Inc.) is one of the largest of its kind to date. Research was conducted via the Alere Center for Health Intelligence and funding was provided by the National Pharmaceutical Council.

"The wake-up call for U.S employers is that simply looking at the costs of specific medical conditions by adding up medical and pharmacy claims costs alone won't give a true picture of the full impact of poor health on the much greater costs of lost productivity in the workforce," said Ronald Loeppke, MD, MPH, executive vice president of Health and Productivity Strategy for Alere� and one of the study's lead researchers. In addition to his role at Alere�, Dr. Loeppke serves on the board of directors of both IBI and ACOEM.

"Employers need to move beyond solutions that focus only on specific medical conditions and toward the development of integrated personal health support strategies that deal with multiple health conditions and health risks by focusing on the whole person as well as the whole population," said Thomas Parry, PhD, president of the Integrated Benefits Institute. "This is especially important if American business is to remain competitive in the midst of a dire global economy."

Other highlights of the study:

Health-related productivity costs are significantly greater than medical and pharmacy costs alone. On average, every $1 of medical and pharmacy costs is matched to $2.3 of health-related productivity costs - and that figure is much greater for some conditions.
Co-morbidities - employees with multiple chronic health conditions - drive the largest effects on productivity loss. The study calls for further research to better evaluate the impacts of co-morbidities by conditions and combinations of conditions.
The impact of poor health on productivity impacts all levels of an enterprise. Executives/managers seem to suffer high presenteeism productivity-loss related to specific health conditions along with those in non-managerial jobs.

Researchers analyzed more than 1.1 million medical and pharmacy claims during the study. The ten corporations that participated ranged from an industrial chemical manufacturer and a computer hardware manufacturer to telecommunications and technology companies.

To fully gauge health-related productivity costs, researchers measured medical and pharmacy spending along with lost-productivity costs related to absence and presenteeism. The study notes that employers have not historically assessed costs in this way, limiting themselves instead to a "siloed" approach that seeks to manage single health-cost categories, such as medical visits or pharmaceuticals, through benefit-package design.

Researchers compared pharmacy and medical claims data to employee self-reported absence, presenteeism and health information collected through the Health and Work Performance Questionnaire (HPQ), developed by Harvard University researcher Ronald Kessler, PhD, and the World Health Organization. Information collected on employer business measures was combined with this database in modeling health-related lost productivity.

The analysis employed by the research team breaks down the silos typically used when examining the cost of health care for a company. "When medical costs are viewed in a silo, or without the broader context of the full health-related costs, the full impact of a given health condition may be seriously underestimated without accurately assessing the accompanying costs of lost productivity," Dr. Loeppke said.

"A healthy workforce is critical to an employer's ability to compete in today's economy," said Dan Leonard, president of the National Pharmaceutical Council. "This landmark study can help employers understand the importance of balancing health care costs with quality of care and wellness and prevention initiatives when designing benefits. By recognizing these issues, employers can take steps toward improving employee health, productivity, and retention, as well as spend their health care dollars more effectively."

"The transformational opportunity for employers is to look beyond healthcare benefits as a cost to be managed and rather to the benefits of good health as an investment to be leveraged. Ultimately, a healthier, more productive workforce can help drive a healthier economy for our nation," Dr. Loeppke said.

ACOEM, IBI and Alere� have all launched efforts that encourage employers to embrace the full-cost view of workplace health. ACOEM's Health and Productivity Management (HPM) Center, located at www.acoem.org/HealthandProductivity.aspx, offers resources to help assess full costs, as does IBI's HPQ-Select and other tools located at www.ibiweb.org, and Alere�, which is located at www.alere.com.

Study authors include Ronald Loeppke, MD, MPH; Michael Taitel, PhD.; Vince Haufle, MPH; Thomas Parry, PhD.; Ronald C. Kessler, PhD.; and Kimberly Jinnett, PhD.

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About ACOEM
The American College of Occupational and Environmental Medicine (ACOEM) represents nearly 5,000 physicians specializing in occupational and environmental medicine. Founded in 1916, ACOEM is the nation's largest medical society dedicated to promoting the health of workers through preventive medicine, clinical care, disability management, research, and education. For more information, visit www.acoem.org.

About Alere�
Alere, a member of the Inverness Medical Innovations (www.invernessmedical.com) family of companies, is a leading provider of health management services to health plans and employers. In collaboration with industry and academic thought leaders, the Alere Center for Health Intelligence is at the epicenter of leading, ground-breaking research on important healthcare issues, conducting research and analysis on business initiatives and strategies and publishing findings in leading peer-reviewed health publications. For more information, email alereinfo@alere.com or visit www.alere.com

About IBI
The Integrated Benefits Institute provides employers and their supplier partners with resources for proving the business value of health. A nonprofit supplier of health and productivity research, measurement and benchmarking, IBI's programs, resources, measurement tools and expert networks advance understanding about the link between - and the impact of - health-related productivity on corporate profitability. For more information, visit www.ibiweb.org.

About NPC
The National Pharmaceutical Council's overarching mission is to sponsor, participate in, and promote the scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of improved health outcomes through pharmaceutical innovation. Supported by research-based pharmaceutical member companies, NPC sponsors and conducts research and education projects showing how the appropriate use of pharmaceuticals improves both patient treatment and cost outcomes in the overall health care environment. For more information, visit www.npcnow.org.

SOURCE: American College of Occupational and Environmental Medicine, Alere�, Integrated Benefits Institute, National Pharmaceutical Council

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It's Critical to Get Comparative Effectiveness Research Right

NPCNow — Tue, 07 Apr 2009 21:01:59 GMT

Commentary by Dan Leonard, President, National Pharmaceutical Council

Tucked inside the economic stimulus bill signed into law by President Obama is $1.1 billion to fund comparative effectiveness research (CER) evaluating the effectiveness of competing medical treatments, technologies, drugs and devices.� The comparative effectiveness provisions in this bill also take steps toward the creation of an entity that would oversee this research, and there is already significant debate about the composition of such a council and its powers.

It's critical to the health care system for policy makers to get this right by establishing an open and transparent process for the prioritization of CER topics for study to ensure that sound evidence leads to quality patient care. To determine what kind of framework might - or might not�-�be feasible for a CER entity in the U.S., policy makers can look to a number of CER and health technology agencies around the world.� One example is the United Kingdom's National Institute for Health and Clinical Excellence (NICE), the organization that provides guidance to the U.K's National Health Service on the clinical and economic effects of various medical treatments.� There are a number of lessons to be learned from what NICE does, according to a recent study of NICE commissioned by the National Pharmaceutical Council and written by University of York Professor Michael Drummond, along with Corinna Sorenson, Panos Kanavos and Alistair McGuire of the London School of Economics and Political Science.

NICE has a standardized system for determining the services it will -or will not - cover.� First, NICE receives suggested topics for assessments and guidelines from the U.K.'s Department of Health, clinicians, and other healthcare stakeholders, although priorities are set by the government in the U.K. Following systematic reviews of existing literature and economic modeling, along with input from a "wide range of stakeholders," NICE prepares guidances and disseminates the information to the appropriate healthcare decision-makers. NICE is not without controversy, having come under fire from patients for its preliminary decision not to cover certain new drugs for the treatment of kidney cancer.

In their critical examination of NICE's practices, the study authors suggest that, in order to make the most impact, any comparative effectiveness research "should consider all health technologies, not just drugs." By reviewing all aspects of the healthcare delivery system, CER studies are more likely to improve health outcomes.

Second, CER should involve all major stakeholders, in a transparent manner, in the development of assessments, guidance, and commentary on the results of studies.� Third, CER should focus on making high quality assessments and should take a broad array of factors into account instead of focusing solely on clinical outcomes. Additionally, the National Pharmaceutical Council would point out that evidence should encourage and facilitate good decision-making by healthcare professionals and patients, recognizing and supporting the physician and the patient as the center of the decision-making process.

Given the complexity of the issues and the implications for our health care system, it's important to learn from the U.K. and other countries that have tackled these issues. To this end, the National Pharmaceutical Council is undertaking a second study focusing on CER organizations in Scotland, Australia, Canada, Sweden, and the Netherlands that will be completed this spring.�

As the CER process moves forward in the United States, there are several critical questions that policy makers must answer first:�1) How to deal with the role of rapidly advancing science in personalized medicine and the needs of patient subgroups who may respond differently to therapeutic options based on age, genetic variation, and other conditions; 2) How to rapidly adopt healthcare technology, which has been long proven to be effective in the management of chronic disease; 3) How to address the requirement that new CER be rigorous, transparent, and conducted with proven methodology; and�4)�How to ensure that CER helps to incent healthcare technology innovation focused on improving health outcomes, quality of life, and productivity.

It's clear that the debate over comparative effectiveness research will not be settled overnight, given the wide range of issues for policy makers and stakeholders to consider. While there is much to be learned from international CER systems, we need to maintain the strengths of the unique U.S. healthcare system while preserving quality innovation and patient focus.

NPC Testifies on Priorities for Comparative Effectiveness Research

NPCNow — Fri, 20 Mar 2009 13:05:00 GMT

Written Testimony of Les Paul, MD, MS
Vice President for Clinical and Scientific Affairs National Pharmaceutical Council

Before the Institute of Medicine
On Consideration of Priorities for Comparative Effectiveness Research

March 20, 2009

Good afternoon. My name is Dr. Les Paul, Vice President for Clinical and Scientific Affairs at the National Pharmaceutical Council (NPC). On behalf of NPC, I would like to thank you for inviting us to comment today on the setting of national priorities for comparative effectiveness research (CER). This is a critical discussion focused on providing health care decision makers with timely, balanced, and high quality clinical evidence to help inform their decisions and improve patient health outcomes.

About the National Pharmaceutical Council

Briefly, the National Pharmaceutical Council sponsors and conducts scientific analyses on the appropriate use of pharmaceuticals and the clinical and economic value of improved health outcomes through pharmaceutical innovation. CER and its foundation of high quality scientific evidence are important areas of focus for NPC. It is our goal to ensure that sound evidence is recognized by independent experts, considered appropriately by private and public payers, reflected adequately in benefit designs, and incorporated into clinical practice. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies.

Chronic Diseases Afford Greatest Impact

It is clear today that health care costs are rising at an unsustainable rate, making it reasonable for the Institute of Medicine (IOM) to recommend that the prioritization of CER be biased toward medical conditions with the greatest impact on morbidity and cost. These include chronic conditions such as cardiovascular disease, chronic respiratory diseases, cancer, diabetes, arthritis, and serious mental health conditions. CER should not be limited to the drugs used to treat those conditions, but rather, it should be extended to all relevant health care services including medical and surgical procedures, diagnostics, and medical devices. In addition, this research should include alternative health care delivery methods and insurance benefit designs. Proposed prioritization of research topics and studies in these areas of medicine, their associated research time frames, final study outcomes, and related information should be made transparent to all stakeholders and should be disseminated in a timely manner.

Key Additional Factors for Consideration

It also will be important for the IOM to consider other key factors in the selection of the highest priority research.

First, it should conduct an assessment of strategies to ensure the continuous evaluation of new evidence related to specific health care technologies - for example, how best to determine when a health technology assessment should be revised based on new clinical information.
Second, it is necessary to study how best to employ CER in a manner that preserves incentives for the continuous innovation of health care technologies in areas of unmet need.
Third, it should be a priority to study how CER at a broad population level can be balanced with the goals and rapid scientific advancements in the area of personalized and stratified medicine in order to encourage the development of targeted therapies for subpopulations.
Fourth, it will be important to conduct research to define rigorous, high quality, and validated CER methodologies that are focused on providing timely, accurate and balanced information in order to assist clinical decision making. These questions include, but are not limited to, defining how best to address the full range of health effects of a new technology including quality of life, functionality, and productivity, as well as how best to appropriately characterize the strengths, weaknesses, and limitations of various underlying health technology assessment analytic techniques.
Lastly, there should be clear support for the development of new CER methodologies, such as analysis of non-randomized studies of treatment effects using secondary databases, practice-based clinical practice improvement studies, more accurate modeling and simulation techniques, and methodologies that ensure optimal interpretation and application of CER in a variety of patient care settings.

The National Pharmaceutical Council welcomes the opportunity to bea part of this critical dialogue and stands ready to assist the Committee as it moves forward with its CER prioritization recommendations.

Thank you.

NPC Statement on Nomination of Gov. Sebelius as HHS Secretary

NPCNow — Mon, 02 Mar 2009 18:43:00 GMT

For Immediate Release

Contact:
Andrea Hofelich
ahofelich@npcnow.org
703-944-3137

National Pharmaceutical Council Statement on Nomination of Gov. Sebelius as HHS Secretary

Washington, D.C., March 1, 2009 - National Pharmaceutical Council (NPC) President Dan Leonard today commented on President Obama's anticipated nomination of Governor Kathleen Sebelius to be Secretary of the Department of Health and Human Services (HHS):

"We congratulate Governor Sebelius on her nomination to be HHS Secretary.

"Given the increased prevalence of chronic conditions and the need for improved access to quality health care, she will have a challenging job in overseeing important agencies like the Centers for Medicare and Medicaid Services, the Food and Drug Administration, and the Agency for Healthcare Research and Quality, along with their many programs. As Secretary, she would have the opportunity to build upon the success of their work to date and help to ensure that Americans will have access to the medicines they need to improve their lives.

"She also faces the challenge of guiding agency efforts to make the most efficient use of the $1.1 billion allocated by the economic stimulus package to comparative effectiveness research. Funding for this research is a very important first step, but there are still many unanswered questions about the type of research that should be conducted, and how healthcare decision makers would use the information generated. We believe that these efforts should proceed with transparency and input from each stakeholder segment, including patients and their health care providers, payers, plans and manufacturers. We stand ready to help address these issues."

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

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NPC Statement on President Obama's Address to Congress

NPCNow — Wed, 25 Feb 2009 09:01:00 GMT

FOR IMMEDIATE RELEASE

Contact:
Andrea Hofelich
ahofelich@npcnow.org
703-715-2741 or 703-944-3137

Washington, D.C., February 24, 2009 - Following is a statement from National Pharmaceutical Council President Dan Leonard on the health care provisions highlighted in President Obama's address to Congress:

"We applaud President Obama's goal of improving the delivery of health care in this country. Health reforms that increase patient access to needed therapies and improve the quality of care they receive can help make America stronger. But getting it right will be a challenging task, given the complexity of the health care system, the rise in the prevalence of chronic conditions, and our aging population.

"Enhancing the quality of the evidence used in health care decision making can play a critical role in improving patient health outcomes. It's clear that evidence-based medicine and comparative effectiveness research will be key parts of any health care reform plan, and all stakeholders should be involved in that discussion.

"We look forward to contributing to the thoughtful examination of key issues and approaches that might be considered."

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

# # #

NPC on Economic Stimulus Package

NPCNow — Tue, 17 Feb 2009 20:30:30 GMT

Comparative Effectiveness Research Funding Should Target Improvements in Quality of Patient Care

Contact:
Andrea Hofelich
703-715-2741
ahofelich@npcnow.org

Washington, DC -- National Pharmaceutical Council President Dan Leonard today released the following statement on the economic stimulus package, which includes $1.1 billion for comparative effectiveness research (CER):

"By signing the economic stimulus package into law, President Obama has made a major investment in America's future. The $1.1 billion for comparative effectiveness research also is a major investment in ensuring quality, patient-centered health care in this country.

"This research is a key part of the practice of evidence-based medicine. It is intended to ensure that patients receive the most appropriate care based on their individual needs and conditions through medical decision-making that uses the best available scientific and clinical knowledge.

"However, as Congress moves forward with the framework for CER, it is critically important that funding be targeted to improve the overall quality of patient care and that the research conducted examines all aspects of health care, including drugs, devices, and other medical treatments. Establishing an open and transparent process for the prioritization of comparative effectiveness research topics will be the next critical step toward ensuring that sound evidence leads to quality care."

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies.

# # #

National Pharmaceutical Council Statement on Nomination of Gov. Sebelius as HHS Secretary

NPCNow — Fri, 16 Jan 2009 17:13:00 GMT

For Immediate Release

Contact:
Andrea Hofelich
ahofelich@npcnow.org
703-944-3137

National Pharmaceutical Council Statement on Nomination of Gov. Sebelius as HHS Secretary

Washington, D.C. - National Pharmaceutical Council (NPC) President Dan Leonard today commented on President Obama's nomination of Governor Kathleen Sebelius to be Secretary of the Department of Health and Human Services (HHS):

"We congratulate Governor Sebelius on her nomination to be HHS Secretary.

"Given the increased prevalence of chronic conditions and the need for improved access to quality health care, she will have a challenging job in overseeing important agencies like the Centers for Medicare and Medicaid Services, the Food and Drug Administration, and the Agency for Healthcare Research and Quality, along with their many programs. As Secretary, she would have the opportunity to build upon the success of their work to date and help to ensure that Americans will have access to the medicines they need to improve their lives.

"She also faces the challenge of guiding agency efforts to make the most efficient use of the $1.1 billion allocated by the economic stimulus package to comparative effectiveness research. Funding for this research is a very important first step, but there are still many unanswered questions about the type of research that should be conducted, and how healthcare decision makers would use the information generated. We believe that these efforts should proceed with transparency and input from each stakeholder segment, including patients and their health care providers, payers, plans and manufacturers. We stand ready to help address these issues."

NPC's overarching mission is to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of innovation. The organization's strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

# # #

Comparative Clinical Effectiveness: A Media Briefing

NPCNow — Wed, 11 Feb 2009 20:10:11 GMT

NPC hosted a media briefing on Tuesday, February 10, 2009, about comparative effectiveness research and important insights for the U.S. from the experiences of the United Kingdom's National Institute for Health and Clinical Excellence (NICE). NICE is the organization that provides guidance to the U.K's National Health Service on the clinical and economic effects of various medical treatments. Speakers included NPC President Dan Leonard, NPC Vice President for Clinical and Scientific Affairs Les Paul, M.D., and University of York Professor of Health Economics Michael Drummond.

What Evidence Do Payers Need?

NPCNow — Sun, 30 Nov 2008 23:05:00 GMT

On November 14, 2008, NPC convened its Annual Forum, during which Dr. Bryan Luce of United BioSource Corporation moderated a panel session entitled, "What Evidence to Payers Need?" Speakers on the panel included:

Brian Sweet, BS Pharm, MBA, Chief Pharmacy Officer, WellPoint
Tamara Syrek Jensen, Deputy Director for the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services (CMS)
Alberto Colombi, MD, MPH, Corporate Medical Director, PPG Industries

The panelists represented crucial stakeholders integrally involved as "consumers" of evidence, including the private sector, public sector, and an employer, respectively. The panelists were asked to speak about the evidence they need and use when making policy decisions, their efforts to improve the health outcomes of the policy decisions they make, and overarching issues and/or barriers that may exist that prevent the development or implementation of such evidence.

This session summary document reviews the evidence-based themes of all of the presentations and discusses relevant policy issues.

NPC Announces New Vice President of Clinical and Scientific Affairs

NPCNow — Mon, 05 Jan 2009 21:59:43 GMT

Dr. Les Paul Named to Head Evidence-Based Medicine Practice

Contact:
Andrea Hofelich
703-715-2741
ahofelich@npcnow.org

Tucker Warren
202-350-6665
tucker.warren@edelman.com

Reston , Va., January 5, 2009 - The National Pharmaceutical Council today announced that Les Paul, M.D., M.S., will be joining the organization as its new Vice President of Clinical and Scientific Affairs. As Vice President, Dr. Paul will be coordinating NPC's strategic focus on Evidence-based Medicine (EBM) for health care decision-making, helping to facilitate dialogue between the pharmaceutical industry and key stakeholders, and creating awareness and understanding of industry expertise and perspectives on EBM. In addition to EBM activities, Dr. Paul will provide clinical and scientific expertise for NPC's other research projects.

"Dr. Paul's experience within the pharmaceutical industry as well as his work in managed care and as practicing physician� are real assets for NPC and make him uniquely qualified to lead our new focus on evidence-based medicine," said NPC President Dan Leonard. "I am delighted that he will be joining us and helping to further NPC's mission to enhance the quality of evidence and its application to health care decision-making."

Dr. Paul, a Board Certified pulmonologist and internist, has more than 25 years of experience in health care. Most recently, he was Vice President for U.S. Medical Affairs at Novartis Pharmaceutical Corporation, where he was responsible for the coordination of the Phase IV Program and for the oversight of evidence dissemination to clinical and scientific customers by the Medical Science Liaison team, the Medical Information and Communication Group and the Publications Team.� In addition he provided leadership for the Novartis Office of Grants and Education, and in 2008 he provided interim leadership for the U.S. General Medicines EBM Group.� From 2004-2007, he was Vice President for Medical Affairs at AstraZeneca, where he had similar responsibilities, including leadership of the Field-based EBM Team.

Prior to AstraZeneca, he served as Vice President for Medical Policy and Programs/Medical Affairs at Medco Health Solutions. At Medco, he led efforts to improve online health care tools, develop disease management programs, enhance clinical quality initiatives, and establish a medical communications group.

Dr. Paul holds a Master's degree in Health Administration from the University of Wisconsin, a Doctor of Medicine from the University of Illinois, College of Medicine, and a B.S. from the University of Illinois.

"EBM is a critical part of improving patient health outcomes. That's why I'm looking forward to working with NPC's staff, members and key stakeholders to advance the discussion on this important issue," said Dr. Paul.

About the National Pharmaceutical Council (NPC)
NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. While NPC's overarching mission remains to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation, in 2007 NPC announced a new strategic focus on evidence-based medicine (EBM) for health care decision-making.

For more information, visit www.NPCnow.org.

NPC Announces New Director of Communications

NPCNow — Mon, 01 Dec 2008 08:01:00 GMT

FOR IMMEDIATE RELEASE

Contact:
Tucker Warren
202-350-6665
Tucker.Warren@Edelman.com

Reston, Va., December 1, 2008 - The National Pharmaceutical Council (NPC) announced today that Andrea Hofelich will be joining NPC as its Director of Communications. In her new role, Hofelich will actively guide the development and implementation of NPC's communications strategies.

Hofelich brings considerable knowledge and experience to her new role, having served as the Director of Media Relations at the Generic Pharmaceutical Association (GPhA) since 2004. Prior to joining GPhA, Hofelich was the communications director for the U.S. Senate Governmental Affairs Committee (now Governmental Affairs and Homeland Security) where she was responsible for developing the Committee's media plans and managing press relations for the chairman, Senator Susan Collins (R-ME). Hofelich also served in communications positions for the U.S. Chamber of Commerce and two members of the House of Representatives, and worked on a number of political campaigns in the state of New Jersey. Hofelich holds an M.B.A. in marketing from the University of Maryland and a B.A. in journalism and history/political science from Rutgers University.

"Over the past year, NPC has taken significant steps in a newly focused direction, and I look forward to helping further NPC's mission of improving and advancing the use of pharmaceuticals to better human health," said Hofelich.

In 2007, NPC announced a new strategic focus on evidence-based medicine (EBM) for health care decision making. NPC's new focus aims to help facilitate dialogue between the pharmaceutical industry and key stakeholders, and to create awareness and understanding of industry expertise and perspectives on EBM.

NPC President, Dan Leonard said, "We are excited to have Andrea on board and feel her strong background will help communicate and amplify our messages to a broad number of key stakeholders around the science of evidence based medicine and its critical role in ensuring that patients have access to high quality health care in this country."

About the National Pharmaceutical Council (NPC)
NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. While NPC's overarching mission remains to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation, in 2007 NPC announced a new strategic focus on evidence-based medicine (EBM) for health care decision making.

For more information, visit www.NPCnow.org.

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NPC Announces Newly Redesigned Web Site

NPCNow — Mon, 17 Nov 2008 11:04:00 GMT

Reston, Va., November 14, 2008 - The National Pharmaceutical Council (NPC) is pleased to announce the launch of our newly redesigned Web site at npcnow.org. You might find the following new sections particularly useful:

What's New - the latest, most relevant NPC news and information
Issues That Matter - key areas of interest and conversation
Dictionary - a repository of key terms, this feature will grow over time
Research & Media Library - an easy to search and share library of NPC research
Events - Webinars, videocasts, podcasts and more!

NPC is a research and education association supported by the nation's major pharmaceutical companies. Our overarching mission remains to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. Last year NPC's Board announced a new strategic focus on evidence-based medicine (EBM) for health care decision-making.

We invite you to visit the new Web site often and hope that you will add us as a bookmark and think of us as a helpful resource.

About the National Pharmaceutical Council (NPC)
NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. While NPC's overarching mission remains to sponsor, conduct and participate in scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation, in 2007 NPC announced a new strategic focus on evidence-based medicine (EBM) for health care decision-making.

National Pharmaceutical Council Announces New Board Chairman

NPCNow — Fri, 14 Nov 2008 11:29:00 GMT

Reston, Va., November 14, 2008 - The National Pharmaceutical Council (NPC) today announced that Anthony C. Hooper of Bristol-Myers Squibb has been elected 2009 chairman of the board. Hooper, a board member since 2005, will help guide the organization in its mission to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals, the clinical and economic value of pharmaceutical innovation and the increasingly critical role of evidence-based medicine.

"NPC has helped advance the science to inform a number of health care discussions taking place today, and I look forward to assuming this new role to help the organization continue to develop practical solutions that will benefit patients," said Hooper.

As president of U.S. Pharmaceuticals at Bristol-Myers Squibb, Hooper has led the company through the launch of seven new products, several serious business challenges (including patent expirations and external threats to existing patents) and rapid changes within the pharmaceutical industry. Bristol-Myers Squibb is a global leader in the research and development of innovative treatments for cancer, cardiovascular disease, diabetes, obesity, psychiatric disorders, Alzheimer's disease, hepatitis, HIV/AIDS, rheumatoid arthritis, and solid organ transplant rejection.

Hooper replaces Paul Fonteyne, executive vice president of Boehringer Ingelheim Pharmaceuticals Inc., who has served as NPC's 2008 board chairman. "It's been a privilege to work with the board and the NPC staff, and I'm proud of what we have accomplished in 2008, including our recent collaborations surrounding evidence-based medicine," said Fonteyne. "I will continue to serve as a member of the board and look forward to working with Tony in that capacity."

About the National Pharmaceutical Council (NPC)

NPC was established in 1953 and is supported by the nation's major research-based pharmaceutical companies. While NPC's overarching mission remains to sponsor and conduct scientific analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation, in 2007 NPC announced a new strategic focus on evidence-based medicine (EBM) for health care decision making.

For more information, visit www.npcnow.org.

Teva Neuroscience Joins National Pharmaceutical Council

NPCNow — Mon, 27 Oct 2008 16:37:00 GMT

Reston, VA, October 27, 2008 - The National Pharmaceutical Council (NPC) announced a new member today in Teva Neuroscience.

Teva Neuroscience is the branded neurological products franchise of Teva Pharmaceutical Industries Ltd. and is responsible for the development, registration and marketing for Teva's branded neurological products in North America. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Teva Neuroscience's innovative products are developed for specialized markets with the current focus on neurological disorders and auto-immune diseases.

Jon Congleton, Vice President and General Manager at Teva Neuroscience, will serve as an NPC board member effective October 1. "We are very happy to join the list of distinguished members of the National Pharmaceutical Council. With the goal of improving patient care, NPC works tirelessly to sponsor and conduct analyses of the value and use of pharmaceuticals," said Congleton. "NPC's recent decision to focus on evidenced-based coverage and access as priority areas moving forward makes this an especially exciting time to join."

Teva Neuroscience currently has two products on the market in the United States: COPAXONE� and Azilect�. Azilect�, the first once-daily treatment for people with Parkinson's disease, is indicated for the treatment of the signs and symptoms of Parkinson's disease. COPAXONE� is a unique immunomodulator therapy for the treatment of Relapsing- Remitting Multiple Sclerosis. It is the only non-interferon agent available for MS as well as the number one prescribed multiple sclerosis therapy in the United States. COPAXONE� is also the first innovative drug to be developed in Israel to receive FDA approval [1].

NPC's addition of Teva Neuroscience strengthens its already strong membership roster which includes Abbott Laboratories, Astra Zeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer, Procter & Gamble Pharmaceuticals, sanofi-aventis, Schering-Plough, Solvay Pharmaceuticals, Takeda Pharmaceuticals and Wyeth.

"Teva Neuroscience offers quality products to the marketplace, but it also offers innovative and effective patient education and advocacy programs, and strong partnerships with professional organizations dedicated to supporting and improving people's lives," said Paul Fonteyne, Executive Vice President, Boehringer Ingelheim Pharmaceuticals Inc. and NPC Board Chairman. "We are pleased to welcome Teva Neuroscience as a member of the Council, and we look forward to working together to advance the science of evidence-based medicine and contribute to practical solutions that will benefit patients."

For more information, visit www.NPCnow.org.

[1] Israeli Ministry of Foreign Affairs, October 15th 2007

Dan Leonard to Lead National Pharmaceutical Council

NPCNow — Mon, 24 Mar 2008 13:24:00 GMT

RESTON, VA (March 24, 2008) - The National Pharmaceutical Council (NPC) announced that Dan Leonard has been appointed as its new president. As the leader of NPC, he will guide the organization as it adopts evidence-based medicine (EBM) as a new priority within its existing mission of advancing research on the appropriate use of prescription medicines. Leonard replaces Karen Williams, who has served as president since 1996.

NPC collaborates with key stakeholders to develop the science base needed to inform key health care discussions. Under Leonard's leadership, NPC will leverage its distinctive position to grow its focus on evidence-based medicine, while continuing to sponsor and participate in other research and education about the clinical and economic value of pharmaceuticals. Leonard will also be responsible for recruiting staff with the clinical, scientific and methodological expertise necessary to advance evidence-based decision-making.

"The NPC Board is pleased to welcome Dan as the new leader of the organization," said Paul Fonteyne, executive vice president of Boehringer-Ingelheim Pharmaceuticals and current NPC board chairman. "He brings a depth and breadth of experience in association leadership, public affairs and strategic communications that are critical for advancing the organization's mission."

Leonard comes to NPC from America's Health Insurance Plans (AHIP), where he most recently served as the executive vice president of advocacy and professional services and ran the legislative affairs, strategic communications and professional education departments. Leonard also worked closely with the AHIP Board of Directors and senior management team to guide the organization through the dynamic changes associated with the merger between the American Association of Health Plans (AAHP) and the Health Insurance Association of America (HIAA) that created AHIP.

For more than 50 years, NPC has provided research and education to give key decision-makers reliable information on which to base policy decisions. "I am delighted and honored to have the opportunity to lead NPC in fulfilling its mission," said Leonard. "NPC's priority of helping enhance the quality of evidence and its application to health care decision-making is timely and important. I share the Board's commitment to a strong science base as a critical component in ensuring the best possible patient health outcomes. Through our work at NPC and our collaborations with others in the coming months, we hope to advance the science of evidence-based medicine and contribute to practical solutions that will benefit patients."

NPC's focus on evidence-based medicine builds on the organization's long history of working with researchers, patients, medical professionals and payers, including employers and government officials. Recent NPC work on EBM has included engagement with the Institute of Medicine Roundtable on Evidence-Based Medicine, the Agency for Healthcare Research and Quality (AHRQ) and the Health Industry Forum. In pursuing NPC's new focus on EBM, Leonard will lead the organization in bringing the pharmaceutical industry's technical expertise and applied scientific knowledge base to considerations of EBM, comparative effectiveness reviews, evaluation and application.

NPC was established in 1953 and is supported by approximately 20 of the nation's major research-based pharmaceutical companies. A prior press release from August 2007 about NPC's new strategic focus and search for new leadership is available at www.npcnow.org/newsroom/pressreleases/PR_NPCfocus.asp.

New Resource Shows Medicare Beneficiaries What To Do if Medicine Isn't Covered

NPCNow — Sat, 01 Dec 2007 19:16:00 GMT

(NAPS)-Medicare prescription drug coverage has given many seniors peace of mind that they will have access to the medicines they need. But occasionally, because of individual plan rules, seniors might find that the medicine prescribed by their doctor isn't always covered. Fortunately, seniors who encounter this situation have several options, and a new brochure can help them understand what they can do about it.

The new brochure, titled"Using Your Medicare Drug Plan:What to Do if Your Medicine Isn't Covered," is available through Your Pharmacy Benefit (YPB), a collaborative consumer education effort. The brochure outlines the specific steps people can take to get their medicines covered.

"Many Medicare beneficiaries don't realize that they can appeal if their medications are not covered,and can often get coverage for the medicines they need to stay healthy, while controlling their costs," said Rick Kellerman, M.D., president of the American Academy of Family Physicians,one of the organizations involved in YPB. "This brochure shows seniors what actions they can take if they are denied coverage for medication."

Patients have the right to request coverage for their medicines and to appeal Medicare's decision if that coverage is denied,but they must follow a specific process. The brochure includes information on that process,including:

Tips on deciding whether to start this process
Explanations of how the process works
Definitions of key terms
A sample appeal letter
A step-by-step table of the coverage request process
Additional resources such as links to Medicare's appeal forms.

The brochure is available in English and Spanish through the Federal Citizen Information Center.There are three easy ways torequest copies of the brochure(publication number 661P):

Send your name and address to Publication Number 661P, Pueblo, CO 81009.
Call toll-free (888) 8-PUEBLO (888-878-3256), weekdays 8 a.m. to 8 p.m. EST.
Visit www.pueblo.gsa.gov to place your order online or to read and print these and hundreds of other federal publications for free.

Other resources provided by Your Pharmacy Benefit focus on choosing, understanding and using prescription coverage.Through a Web site and free brochures, YPB offers suggestions on how to use prescription benefits to their full potential, hints on how to save money and tips on what to do when your prescription is denied for payment.For more information, visit www.YourPharmacyBenefit.org.

Resource Helps Seniors Manage the Medicare Drug Coverage Gap; Brochure Provides Tips for Medicare Recipients About "Donut Hole" Coverage Gap

NPCNow — Thu, 28 Jun 2007 14:05:00 GMT

WASHINGTON, D.C. - Some Medicare beneficiaries using the Part D prescription drug plan might find themselves in the coverage gap or "donut hole."

A brochure available through Your Pharmacy Benefit (YPB), a collaborative consumer education effort, can help Medicare beneficiaries manage the coverage gap. The gap - a component of some Medicare prescription drug plans in which Medicare temporarily stops paying for prescriptions and the entire cost must be paid by the beneficiary - is likely to affect about 8 percent of Medicare beneficiaries. While many people will see little or no impact from the coverage gap, it can require some preparation by those who will encounter it.

"It's important to help seniors understand the gap in some Medicare prescription drug plans and how the gap could apply to them," said Pat Adams, vice president of external affairs at the National Pharmaceutical Council, one of the organizations involved in YPB. "This new resource explains these issues as well as steps people can take to delay reaching the gap and for getting out once they are there."

The brochure gives information on the coverage gap, offers resources for getting help covering prescription costs during the coverage gap and offers tips and a sample expense log for keeping track of spending under Medicare prescription drug plans."It's important to keep track of the money you spend while you're in the coverage gap, because every dollar you spend will help you get back out of the coverage gap," added Ms. Adams.

The brochure is available in English and Spanish through the Federal Citizen Information Center. There are three easy ways to request copies of the brochure, titled "Resources for Medicare Beneficiaries: Navigating the Coverage Gap":

Send your name and address to Publication Number 653P, Pueblo, CO 81009.
Call toll-free 1-888-8-PUEBLO (1-888-878-3256), weekdays 8 a.m. to 8 p.m. EST.
Visit www.pueblo.gsa.gov to place your order online or to read and print these and hundreds of other Federal publications for free.

Other resources provided by Your Pharmacy Benefit focus on choosing, understanding and using prescription coverage. By acting as a one-stop-shop for clear, concise and helpful information on how to get the most out of prescription drug coverage, Your Pharmacy Benefit ensures that consumers -both with private insurance and Medicare Part D - have the information they need to make the best decisions about their coverage needs.

Your Pharmacy Benefit's Web site and free brochures provide a step-by-step guide for selecting the right prescription plan, information about how pharmacy benefits are typically structured and glossary terms that will help consumers translate "insurance-speak." In addition, the site and brochures contain suggestions on how to use prescription benefits to their full potential, hints on how to save money and tips on what to do when your prescription is denied for payment.

For more information, visit www.YourPharmacyBenefit.org.

About Your Pharmacy Benefit:

Your Pharmacy Benefit is an in-depth resource designed to help consumers and those who care for them understand the value and make better use of their prescription coverage - whether they are covered through private insurance or Medicare Part D. YPB is a collaborative effort between a growing number of diverse organizations dedicated to helping consumers choose and effectively use their prescription drug coverage. For a full list of YPB partners, visit www.yourpharmacybenefit.org/private/about.asp.

Knowing the Rules: Consumers Must Understand Health Plan Rules to Ensure Uninterrupted Access to Needed Medications

NPCNow — Thu, 02 Feb 2006 15:12:00 GMT

Advice to Help Consumers Get What They Need from their Prescription Drug Benefit

WASHINGTON, D.C. (February 2, 2006) - The new plan year often brings a change to health insurance plans and the rules that go along with them. For consumers becoming familiar with new plans and seniors starting to use their Medicare prescription drug benefit, this may mean trouble when filling prescriptions for the first time.

But even those who are continuing on with the same plan as last year may experience some of the same frustrations. Rules can vary from health insurance plan to health insurance plan and even from one pharmacy visit to the next because plans are allowed to make changes throughout the year. And consumers may not be aware of issues that may impact copayments and lists of preferred medicines, thus causing problems when trying to fill a prescription.

In an effort to help consumers to become educated and prepared, eleven groups representing consumers, pharmacy, physicians, patients and pharmaceutical companies have teamed up to provide free tips and resources to help consumers understand how prescription drug benefits work and find out what to do if coverage for their medicine is denied. The program offers guidance for navigating drug coverage, tips for troubleshooting problems, and a sample appeal letter and a glossary of important terms, available at www.YourPharmacyBenefit.org.

"Pharmacists can be a patient's greatest ally in navigating new drug coverage programs," said Mary Ann Wagner, the senior vice-president for pharmacy, policy and regulatory affairs at the National Association of Chain Drug Stores. "They are highly trained and thoroughly familiar with patients and their medicines. The resources offered by www.YourPharmacyBenefit.org are more valuable tools for helping patients make sure their healthcare needs are met."

The program offers several tips to help consumers who encounter problems filling a prescription, including situations where:

The information your pharmacy has about your plan doesn't match what is on your pharmacy benefit ID card.
It's too early to refill the prescription.
A particular medication may react badly with another medication you're on or with another medical condition you have.
The medicine your doctor prescribed requires your plan's prior approval.
The medication is not covered by your health plan, or is not on the "formulary," the list of medicines covered by the plan.

The Web resource explains all of these situations and provides tips on how to resolve these problems. It also provides other important information including how to understand "insurance-speak," and who to contact when questions arise. It also explains to consumers how to file an appeal if the plan refuses to cover a medicine the patient needs.

"Consumers will find this site helpful in giving them information about how prescription drug coverage works so they can ensure their medicines are accessible and affordable," said Gary A. Puckrein, PhD, Executive Director, National Minority Health Month Foundation. "Nobody wants to be surprised by having to pay out of pocket for a prescription they thought their insurance would cover."

For more information and for a list of current partners, please see www.YourPharmacyBenefit.org.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

New Online Resource Helps Consumers Get Medicines in Hand

NPCNow — Tue, 13 Sep 2005 14:22:00 GMT

Growing Number of Healthcare Organizations Join Together to Help Consumers Navigate System

WASHINGTON, DC (September 13, 2005) - This fall many Americans will make changes to their health insurance coverage. Some may sign up for a new health insurance plan at work; others may be eligible for the new Medicare prescription drug benefit. But both groups now have the opportunity for new guidance on how to assess their pharmacy benefit to ensure they have the best access to the medicines they need.

The process of choosing and effectively using the best health insurance coverage can be overwhelming. For consumers, it often means frustration when a prescription can't be filled. "Consumers may be taking their frustration out on their doctor or pharmacist, when the more likely source of the problem is that the request doesn't meet the requirements of their health insurance plan," says Sandra Leal, Pharm.D., CDE, president of the Association of Clinicians for the Underserved.

In an effort to encourage consumers to understand their pharmacy benefit and make sure they have access to the medicines their doctors prescribe, a growing number of healthcare groups have joined together to introduce YourPharmacyBenefit.org. This free Web site is a problem-solving resource for consumers, whether privately insured or covered through Medicare.

"Navigating complex health programs can be a daunting task for anyone," said Michael Faenza, president and CEO of the National Mental Health Association. "However, for people with chronic health conditions, like mental health disorders, it can be particularly challenging. YourPharmacyBenefit.org can help make sure people can get the treatments they need by acting as a one-stop-shop for clear, helpful information on how to get the most out their pharmacy benefit."

The site provides a step-by-step guide for selecting the right prescription plan, information about how pharmacy benefits are typically structured, and glossary terms that will help consumers translate the "insurance-speak." In addition, the site contains suggestions on how to use prescription benefits to their full potential, hints on how to save money, and tips on what to do when your prescription is denied for payment.

"Consumers pay a lot of money for their families' health benefits, and they deserve to get as much out of the coverage as possible,' says Linda Golodner, president of the National Consumers League. " The information available on YourPharmacyBenefit.org will give consumers an important edge when making decisions about their coverage and when they go to use the new Medicare drug plan in January."

The site is a collaborative effort between a growing number of organizations, including the Association of Clinicians for the Underserved, the Asthma and Allergy Foundation of America, the National Alliance on Mental Illness, the National Association of Chain Drug Stores, the National Community Pharmacists Association, the National Consumers League, the National Mental Health Association, the National Minority Health Month Foundation and the National Pharmaceutical Council.

For more information, consumers can visit www.YourPharmacyBenefit.org today.

###

Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

Drug Advertising Leading to New Treatments, Lifestyle Changes in Addition to Prescriptions for Advertised Pharmaceuticals

NPCNow — Wed, 28 Apr 2004 14:34:00 GMT

New Survey Reveals Physicians' Prescribing Habits-Few Doctors Prescribe Drugs Solely To Accommodate Patients' Wishes

BETHESDA, MD-Physicians prescribed a drug that is advertised directly to consumers 39 percent of the time when patients asked specifically for that drug, but were just as likely to recommend that patients change their lifestyle to treat a medical condition, according to a new survey published today on the Health Affairs Web site.

Those encounters led to new treatment for conditions more than half the time, suggesting that while direct-to-consumer advertising (DTCA) may lead to increased drug consumption, it also may have positive effects for patients "that transcend merely prescribing a DTCA drug," according to the survey conducted by a team of researchers led by Joel Weissman, an associate professor at Harvard Medical School.

Weissman's survey is one of seven articles published today that examine issues surrounding direct-to-consumer advertising. A second survey, by Steven Woloshin and colleagues, tests whether a "prescription drug benefit box" would clearly communicate the chances of various outcomes with and without the drug being advertised.

Weissman and colleagues asked 643 physicians about how DTCA affected their practices and about the results of their most recent experience in which a patient specifically asked for an advertised drug.

While nearly three-quarters agreed "strongly" or "somewhat" that DTCA helps educate and inform patients about treatments available to them, a greater number, about four in five, agreed "strongly" or "somewhat" that DTCA also encourages patients to seek treatment they don't need, and more than four in five agreed "strongly" or "somewhat" that DTCA does not provide information on risks and benefits in a balanced manner.

Physicians said male impotence (10.9 percent) led the conditions about which patients asked in the most recent DTCA-related encounter, followed closely by arthritis (10.5 percent), allergies (9.6 percent), and high cholesterol (8.7 percent). Twenty-five percent of DTCA-related visits resulted in a new diagnosis. About 41 percent of conditions initially discussed during the visit and 30 percent of new diagnoses were considered high-priority conditions.

Physicians prescribed the requested DTCA drug in 39.1 percent of the cases, but were just as likely to recommend a lifestyle change (39.1 percent). Other actions included prescribing another drug (22.4 percent), referring to a specialist (5.8 percent), recommending an over-the-counter drug (12.2 percent), and recommending a diagnostic test (9.3 percent).

In the cases when the DTCA drug was prescribed, 46.1 percent of physicians said it was the most effective drug, while 48.4 percent said it was as effective as other medications and wanted to accommodate their patient's request.

In only 5.5 percent of cases did physicians prescribe the requested drug to accommodate patients' wishes even if another drug or treatment option would be better. By specialty, only 1 percent of primary care doctors did that, but 10 percent of surgeons and 6.8 percent of other medical specialties had done that, although that may reflect their belief that surgery or other more invasive procedures are superior to drugs in those encounters, the survey said.

When asked about the impact of prescribing a requested DTCA drug on patients' overall health, 22.6 percent of physicians said it would be a "large positive," and 53.8 percent said it would be "somewhat positive." Few said it would be "somewhat" or "large negative" (1.5 percent). Those percentages were largely true no matter if the physicians believed the DTCA drug was the most effective, as effective as, or less effective than other drugs or treatment regimens.

"When evidence exists on appropriateness, drug advertising may produce a social good by reducing underuse," Weissman says. "On the other hand, in different circumstances drug advertising may encourage overuse of higher-cost drugs among patients who have little to gain. Our research provides further insight into the health and health care effects of DTCA, suggesting possible benefits, although it is by no means conclusive."

You can read the survey at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.219.

In addition to the Woloshin survey, the package includes perspectives by Pat Kelly, president of U.S. Pharmaceuticals at Pfizer Inc.'s Pfizer Pharmaceuticals Group; David Riggs, a senior regulatory associate at Eli Lilly and Co., and two colleagues; U.S. Sen. James M. Jeffords (I-VT); U.S. Rep. Henry A. Waxman (D-CA); and Peter Pitts, associate commissioner at the Food and Drug Administration.

The accompanying articles can be read at the following addresses:

Woloshin: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.234.
Kelly: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.246.
Riggs: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.249.
Jeffords: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.253.
Waxman: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.256.
Pitts: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.259.

Health Affairs, published by Project HOPE, is a bimonthly multidisciplinary journal devoted to publishing the leading edge in health policy thought and research.

Hispanics Face Significant Disparities In Pharmaceutical Treatment

NPCNow — Mon, 08 Mar 2004 20:38:00 GMT

Study shows Hispanics have less access to state-of-the-art medications; Genetic and environmental factors demonstrate need for prescribing tailored to the individual

WASHINGTON, DC (March 8, 2004) - Hispanics are less likely to receive or use medications for asthma, cardiovascular disease, HIV/AIDS, mental illness, and pain, according to a new study. These disparities in pharmaceutical treatment are substantial and often persist even after adjustment for differences in income, age, insurance coverage, and coexisting medical conditions.

The study, Genes, Culture, and Medicines: Bridging Gaps in Treatment for Hispanic Americans, was co-authored by Dr. Carolina Reyes, Adolph P. Falc�n, Texas State Senator Leticia Van de Putte, and Dr. Richard A. Levy. It encourages physicians to tailor prescribing for Hispanics based on age, coexisting conditions, responsiveness to medications, and cultural perceptions of disease and treatment.

According to Senator Van De Putte, study co-author and practicing pharmacist, "This study brings together for the first time emerging research demonstrating that genetic and environmental factors have a significant impact on the effectiveness of medicines for Hispanic patients. Eventually advances in genetics will allow us to tailor pharmaceutical therapy to individual needs."

The study shows that differences among racial and ethnic groups in how medicines are metabolized have been observed, and may be due to variation in genes regulating drug metabolism, environmental factors, or their interaction. These differences can result in higher or lower levels of drugs in the bloodstream.

Based on preliminary evidence, the study pointed to several classes of medicines that particularly warrant extra attention:

Some Hispanic groups may require lower doses of antidepressants and some antipsychotic medications and may be more prone to increased side effects at normal doses of these medicines. In one study, the average therapeutic dose for Hispanics was half the dose commonly given to Caucasians or African Americans.
Mexican Americans metabolize drugs regulated by the CYP2D6 gene faster than whites, impacting 30 percent of therapeutically important medications, including many cardiovascular drugs.

The study found that language barriers and differences in cultural values can have an impact on the quality of care delivered and can negatively influence medication compliance, self-management of chronic disease, and overall health outcomes for many Hispanic patients.

"Patients and physicians need to be on the lookout for unexpected responses to medications," said Dr. Carolina Reyes, Assistant Clinical Professor at the UCLA School of Medicine and the study's lead author. "Physicians must help their patients identify what to look for in determining whether a prescribed medicine might be too weak or too strong of a dose and health providers must be aware of environmental factors such as a patient's diet and environmental pollutants in the community. Good communication and awareness between patients and their doctors will ensure the best access and care for Hispanic populations."

The authors make several recommendations:

Improve access to pharmaceutical therapy. Health care financing and reimbursement practices should be broad and flexible enough to enable rational choices of drugs, dosages, and formulations for Hispanic patients based on their genetic, medical, and cultural needs. Choice of the best pharmaceutical therapy should be between patient and provider.
Prescribe based on individual needs. Hispanic populations require prescribing that considers the many biological, environmental, and cultural factors that can influence drug effectiveness and patient adherence to treatment regimens.
Treat coexisting conditions. Pharmaceutical treatment must take into account coexisting conditions common in this population, including depression paired with asthma, diabetes or cardiovascular disease, and diabetes paired with depression.
Meet quality standards of cultural proficiency and communication. Communication barriers and cultural differences between health care providers and Hispanic patients can reduce treatment adherence and compromise overall disease management. Implementation of existing federal and professional standards for cultural and linguistic proficiency is a priority.

About the National Alliance for Hispanic Health

The mission of the Alliance is to improve the health and well-being of Hispanics. The Alliance is the nation's oldest and largest network of Hispanic health and human services providers. Alliance members deliver quality services to over 12 million persons annually. As the nation's action forum for Hispanic health and well-being, the programs of the Alliance strive to:

Inform and mobilize consumers;
Support providers in the delivery of quality care;
Promote appropriate use of technology;
Improve the science base for accurate decision making; and
Promote philanthropy.

The Alliance provides key leadership and advocacy to ensure accountability in these priority areas with the result of improving health for all throughout the Americas. The constituents of the Alliance are its members, Hispanic consumers, and the greater society that benefits from the health and well-being of all its people.

About the National Pharmaceutical Council

Since 1953, NPC has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovations. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers, and policy-makers. More than 20 research-based pharmaceutical companies are members of NPC.

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Please direct all media inquires to Pat Adams, phone (703) 620-6390.

New Study: Health Benefits Worth up to Three Times More than Money Invested

NPCNow — Wed, 28 Jan 2004 21:21:00 GMT

WASHINGTON, DC (January 28, 2004) - Over the past 20 years, each additional dollar spent on health care services has produced $2.40 to $3.00 in tangible gains in health care, according to a landmark new study released today by The Value Group, a coalition of seven of the nation's leading health organizations.

The report, titled The Value of Investment in Health Care: Better Care, Better Lives, reveals that without this investment, in the year 2000 alone, there would have been 470,000 more deaths, 2.3 million more people with disabilities, and 206 million more days spent in the hospital.

"This unprecedented study provides strong evidence that the value generated by investments in health care greatly outweighs the costs," said Bryan Luce, MEDTAP International Chairman and director of the study.

As lawmakers address rising health care costs, this groundbreaking study provides evidence on a critical issue frequently missing from the discussion: the value of our increasing investment in health care.

"The continuing debate in Congress and the states over spending on health care must consider the important benefits to society and the value of each dollar spent," noted Luce at a press conference today at the National Press Club. "Policymakers, payers, and other health care providers must work together to ensure that discussions focus on the value of investment in health care, not simply the cost."

Study Results

The report - a compilation of published findings from the top peer-reviewed journals in health and medicine supplemented with original analysis of national data - looks at the value of investment from multiple angles. It documents the dynamic advances in health, lifespan and quality of life due to investments in health care. Specifically, since 1980:

Annual death rates declined 16%
Life expectancy from birth increased by more than three years
Disability rates for seniors fell 25%
Number of days Americans spent in the hospital fell 56%

The study also indicates that the improvements in outcomes for specific diseases have been even more striking:

Mortality from heart attacks has been cut nearly in half
Stroke mortality has been cut by more than a third
Diabetes can now be managed to dramatically reduce complications such as blindness, kidney failure, stroke, and death
Breast cancer mortality has been cut by more than 20%

The report was compiled for The Value Group by MEDTAP International, Inc. in collaboration with researchers at Research Triangle Institute and Duke University. It marks the first collaboration by members of the group, which consists of senior-level representatives from:

Advanced Medical Technology Association (AdvaMed)
American College of Cardiology (ACC)
American Hospital Association (AHA)
Federation of American Hospitals (FAH)
Healthcare Leadership Council (HLC)
National Pharmaceutical Council (NPC)
Pharmaceutical Research and Manufacturers of America (PhRMA)

Copies of the report are available online at http://www.medtap.com

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

International Prescription Drug Price Differentials Roughly Track Income Differences, Health Affairs Article Says

NPCNow — Wed, 29 Oct 2003 07:01:00 GMT

Overall Average Price Variation May Not Be As Large As Widely Perceived,According To New Analysis That Accounts For Purchasing Power

WASHINGTON, D.C.-While pharmaceutical manufacturers have been criticized forovercharging U.S. consumers, the differences in prescription drug prices between countries roughlyreflect differences in average national incomes, according to a new analysis published today on theHealth Affairs Web site.

Patricia Danzon, a professor in the Wharton School's health care department at the Universityof Pennsylvania, and Michael Furukawa, a doctoral candidate at Wharton, compare prescription drugprices in the United States with those in eight other countries-Canada, Chile, France, Germany, Italy,Japan, Mexico, and the United Kingdom. Their analysis of prices incorporates on-patent brand drugsand generics and finds that overall average price differences may not be as large as widely perceived.

Gingrich Speaks on Medicare Reform, Health Care Trends

The Danzon-Furukawa analysis is one of two articles being published today on the HealthAffairs Web site addressing issues that Congress is debating as it nears a final vote on a Medicareprescription drug benefit.

The second article is an interview of former House Speaker Newt Gingrich by health carefuturist Jeff Goldsmith. Gingrich warns that House and Senate leaders need to view their respectiveversions of the benefit package as "building blocks, not as boundaries. If they allow themselves to seethe House and Senate bills as boundaries and negotiate a compromise between those two bills, theywill have created a mess."

Exchange Rates and Purchasing Power Contribute To Price Differentials

With seniors purchasing drugs from Canada to get lower prices, the price differentials analyzedby Danzon and Furukawa have played an important role in the debate over adding prescription drugs tothe Medicare benefit package and whether to authorize "reimportation" of U.S.-made drugs sold inCanada.

Unlike other analyses of pharmaceutical prices, the Danzon-Furukawa paper based itscomparison on manufacturer-level prices, rather than retail prices, because the latter include pharmacymarkups and taxes, which vary among the countries.

The most comprehensive indexes show Japan's prices to be higher than U.S. prices, with theother countries' prices ranging 6-33 percent less than U.S. prices, according to the analysis. Canadianprices were the lowest.

Changes in exchange rates contribute greatly to the decline in Canadian prices relative to U.S.prices over the past decade, and to the rise in U.K. prices relative to U.S. prices.

Comparing prices using purchasing power changes some of the price differentials, according toDanzon and Furukawa. When using a purchasing power index based on prices in the broad economy,which standardize for cost-of-living differences, the authors find that the differential between U.S. andJapanese prices virtually disappears and the difference between Canadian and U.S. prices shrinks from33 percent to 14 percent. The U.S.-foreign price differentials are actually smaller for drug prices thanfor prices of other medical services, although this conclusion is tentative because the available pricemeasures for other medical services are rough.

"Our finding that drug price differentials between countries roughly reflect income differences(except for Chile and Mexico) plausibly reflects the interaction of drug manufacturers' pricingstrategies, using income as a rough proxy, and regulation," they write. Using income would be"inappropriate" for products in a truly competitive market in which trade is unrestricted. But in amarket like pharmaceuticals, in which research and development benefits all consumers but representsa major fixed cost, recouping those costs through markups based on ability to pay is a way to"maximize social welfare," the authors say.

Price comparisons across countries also differ greatly for brand-name drugs that are still underpatent protection, as well as for generic drugs. Market shares for those drugs also differ betweencountries. The relatively unregulated, more competitive structure of the U.S. market "seems to result inrelatively high prices" for patented drugs and "relatively high use of new products, but strong genericcompetition, high generic shares, and low generic prices once patents expire." The U.S. market alsoresults in a relatively large share of the total price that goes to manufacturers rather than intermediaries,and appears to be more favorable to innovation. By comparison, the more regulated, price-controlledmarkets have lower prices for patented drugs but also have more sales of the formerly patented brandnamedrug once the patent expires and less competition from generic drugs.

"Our study shows that comparing prices for prescription drugs across countries is complex.Using a larger and more representative sample than has been used by most previous studies, we foundthat prices on average are roughly in line with each country's broader economic context," said Danzon.The article can be read at http://www.healthaffairs.org/WebExclusives/Danzon_Web_Excl_102903.htm.Health Affairs, published by Project HOPE, is a bimonthly multidisciplinary journal devoted topublishing the leading edge in health policy thought and research.

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Highlights of 2003 NPC Member Forum

NPCNow — Wed, 05 Mar 2003 16:01:00 GMT

The National Pharmaceutical Council celebrated its50th Anniversary at its 2003 Member Forum, heldMarch 5-7. Members had the opportunity to hearfrom a wide array of industry experts, including topresearchers, the Food & Drug Administration (FDA)Commissioner Mark McClellan, employers, academicsfrom some of the most prestigious educational institutionsin the U.S. and other health policy experts.

The following are excerpts from what was said aboutpharmaceuticals, the rising costs of health care andwhat is in store for the future. Three sections include:

The latest from the research community
Perspectives from the employer community
Input from Mark McClellan, FDA Commissioner

View the PDF for the entire article

Study Shows that Genetic Differences in Minorities May Cause Varied Reactions to Medicines

NPCNow — Wed, 25 Sep 2002 19:27:00 GMT

Study Underscores Need for Individualized Care

WASHINGTON, DC (September 25, 2002) - Genetic differences among minorities may explain why some medicines are more effective in some patients than others, a new study finds. The study advises physicians and managed care plans to be aware of the need to tailor drug regimens for individuals considering their ethnic or racial group, and to be on alert for uncommon responses or side effects from medicines used by minority patients.

The study, to be published as a supplement to the October Journal of the National Medical Association, shows that responses to medications among minority patients can vary based on genetic, cultural and environmental factors. The researchers advise that such factors must be considered by health plans and providers in order to ensure access by minority patients to clinically appropriate prescription drugs and to prevent further widening of disparities in the healthcare that minority populations receive.

"A 'one-drug-fits-all' approach to therapy does not take into account individual patient responses to medicines," said L. Natalie Carroll, M.D., president of the National Medical Association. "New science is helping to identify differences in the ways individuals react to drug therapy. Any attempt to control spending should take such differences into account."

The study, Racial and Ethnic Differences in Response to Medicines: Towards Individualized Treatment, was co-authored by the National Medical Association (NMA) and the National Pharmaceutical Council (NPC). It shows that genetic variations can affect how the body processes a drug and its overall effect on the body, and that certain genetic variations are more prevalent among specific population groups. Although race and ethnicity are imprecise indicators of genetic differences, they can be helpful in anticipating variations in response to a medicine. For example:

There are general differences in the underlying characteristics of high blood pressure for black and Caucasian patients. For instance, because black patients tend to retain more salt and have a higher incidence of salt-sensitive high blood pressure, diuretics used in combination with other blood pressure medications may be necessary to achieve targeted blood pressure levels among black patients.
Medicines used to treat pain, such as codeine, have been shown to affect Caucasians and East Asians differently. Because many East Asians metabolize codeine differently than Caucasians, East Asians often require higher dosages for effective pain relief.
Ashkenazi Jews are significantly more susceptible to a potentially life-threatening blood disorder that can develop as a result of therapy with the drug clozapine used to treat schizophrenia. The specific set of genes thought to be associated with this disorder is found in 10 to 12 percent of the Jewish population in Israel and the U.S., but in less than one percent of the total Caucasian population of the U.S.

In addition to genetic factors, cultural factors (such as attitudes towards medicines, health beliefs, and family influence) common to members of different ethnic groups, and environmental factors (such as pollutants, smoking and climate) can affect how patients respond to drugs and compliance with prescribed treatments.

Varying cultural beliefs lead to actions that may increase health risk; for example, self-treatment with herbal and folk remedies may not effectively treat the disease or may interact with other treatments. Communication barriers are also common obstacles to optimum care.

"Multiple factors affect a patient's response to a given drug and thus the effectiveness of therapy," said Dr. Carroll. "Physicians, who work in a clinical setting, know this. Problems can arise if clinical decisions, which must be based on the individual's specific health needs, are constrained by techniques designed to control costs."

The authors make several recommendations:

Patients from diverse racial and ethnic groups must receive care tailored to their specific needs so that disparities in health care do not become even greater than those identified by the IOM report.
Health plans should not restrict access to specific drugs based on cost alone or impose drug preferences that preclude individual patients from accessing medicines that are safe and effective for them.
When treating minority patients, physicians and other health care providers must be mindful of uncommon responses or unexpected side effects from medicines. Dosage adjustments may also be necessary.
Efforts to include greater numbers of diverse populations in clinical trials and outcomes studies should be strongly encouraged in order to further understand the clinical implications of drug therapies among racial and ethnic groups.
Health care providers should stay abreast of developments in pharmacogenomics, the growing field that studies the genetic basis of differences in patients' response to drugs. Such studies will increasingly enable physicians to customize care for patients and should be used by health plans to refine strategies that manage drug spending.

About the National Medical Association
The National Medical Association (NMA) is the collective voice of African American physicians and the leading force for parity and justice in medicine and the elimination of disparities in health. The National Medical Association is a 501(c)(3) national professional and scientific organization representing the interests of more than 25,000 physicians and their patients. Established in 1895, NMA is committed to 1) preventing the diseases, disabilities and adverse health conditions that disproportionately or differentially impact African American and underserved populations, 2) supporting efforts that improve the quality and availability of health care to poor and underserved populations, and 3) increasing the representation and contribution of African Americans in medicine.

About the National Pharmaceutical Council
Since 1953, the National Pharmaceutical Council (NPC) has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovations. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

Experts Say Overall Benefits of Investment in Pharmaceuticals Outweigh Spending

NPCNow — Tue, 29 Jan 2002 21:20:00 GMT

New Analysis of Literature Released at Briefing Today

WASHINGTON, DC (January 29, 2002) - Consumers and the health care system overall are reaping big benefits because of investment in new pharmaceuticals, according to a body of recent economic studies presented today at a briefing at the National Press Club.

The briefing, hosted by the American Enterprise Institute (AEI) and the National Pharmaceutical Council (NPC), marked the release of a new economic analysis of the literature, titled Assessing the Impact of Pharmaceutical Innovation: A Comprehensive Framework, by Jack Meyer of New Directions for Policy. Also being released is a Health Affairs Primer on "The Value of Rx Innovation," compiling relevant work featured in the journal over the past two years.

"The findings of these researchers really go against the 'conventional wisdom' on how we can control health care spending" said Meyer, one of the panelists. "Critics have often pointed their fingers at drug spending as an inappropriate driver of health care costs, but this research shows that even though pharmaceuticals can be expensive, they are an effective way to keep people healthy, productive and out of the hospital in the long run."

Meyer's analysis revealed a consistent theme - that the benefits of new drugs outweigh the costs, often in dollar savings as well as in improved health and quality of life.

"We can now quantify the payoff from new drugs, and it's huge," said Meyer.

According to Frank Lichtenberg of Columbia University, another presenter at the briefing whose work was reviewed in Meyer's analysis, Americans born in 1995 can be expected to live 22 years - or 41 percent - longer than those born in 1920. Reductions in premature death are over five times greater in diseases with many new drugs available to treat them than for those with fewer new drug treatment options.

"Anyone who is serious about controlling health care spending should pay careful attention to the emerging research on the benefits of pharmaceuticals," said Dr. Jack Calfee of AEI.

A study sponsored by the Agency for Healthcare Research and Quality, also reviewed in the Meyer analysis, found that greater use of a blood-thinning agent could prevent 40,000 strokes each year, saving $600 million annually in health care costs. The average annual cost of the drug and monitoring was $1,025, compared to the $100,000 lifetime cost of stroke treatment.

"There is increasing evidence that newer medicines provide significant benefits to patient health, worker productivity and the overall economy," said Karen Williams, president of NPC. "Those wishing to get the most health for their health care dollar should view new therapies as a sound investment."

Since 1953, NPC has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

Pharmaceutical Innovation is Paying Off for Consumers

NPCNow — Thu, 06 Sep 2001 20:30:00 GMT

Study Shows Use of Newer Rx Drugs Linked to Economic Gain, Improved Quality of Life

WASHINGTON, DC (September 6, 2001) - According to research published today in Health Affairs, pharmaceutical innovation is paying off for American consumers by improving the quality of their lives, and for payers by lowering total health care expenditures.

A study by Columbia University economist Frank R. Lichtenberg, Ph. D., concludes savings in other medical spending significantly offsets spending on newer prescription drugs among American consumers. This is the first study to examine the value of newer drugs in the aggregate. The conclusions are based on analysis of the 1996 Medical Expenditure Panel Survey, the most current nationally representative database on the use of health care services and spending.

In his study, Are the Benefits of Newer Drugs Worth Their Cost? Evidence From the 1996 MEPS, Lichtenberg found that people who used newer prescription drugs were less likely to die or to lose time at work, and they spent fewer days in the hospital.

As a result, consumers of newer prescription drugs tended to spend significantly less on other health care services, thereby reducing overall expenditures. According to Lichtenberg, the cost of newer drugs was offset by an estimated four-fold reduction in non-drug spending.

According to the National Pharmaceutical Council, which funded the study, Lichtenberg's work is part of a growing body of research that examines the value of pharmaceuticals and other medical innovations. Several new studies appear in the September/October issue of Health Affairs.

"The art of good medical care involves treating the whole patient. Likewise, we must take a broader look at health care spending to understand both the direct and indirect effects of how we spend our health care dollars in order to determine where we are experiencing the greatest benefits," said Karen Williams, president of the NPC. "This new data by Dr. Lichtenberg shows the importance of understanding the overall value of pharmaceuticals, not only to individual patients, but to society as a whole," she said.

Since 1953, NPC has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

Small Improvements in Pharmaceuticals Have Large Positive Impact on Patient Care and Health Care Spending, Study Finds

NPCNow — Tue, 10 Jul 2001 20:35:00 GMT

Choice in Prescribing Especially Important to Elderly Patients and Others with Chronic Illness

PHILADELPHIA, PA (July 10, 2001) - The small incremental improvements to existing drugs that make up the majority of the new drug approvals by the FDA each year provide important health benefits to patients, especially elderly patients, according to a study released today by the Center for Pharmaceutical Health Services Research at Temple University.

Newer drugs in a therapeutic class often have fewer side effects, improved drug safety and effectiveness, and are used more easily, which facilitates compliance with prescribed treatments. A wide variety of product alternatives permit treatments to be better tailored to individual patient needs.

"By giving physicians a broad range of medicines we provide them with a 'tool chest' to treat each patient with precision and provide options when particular agents have less than optimal effectiveness or are poorly tolerated," said Dr. Albert Wertheimer, director of the Center for Pharmaceutical Health Services Research at Temple University and the lead researcher on the study. "Even choices in dosage form-tablets versus liquids, or once versus twice daily dosing-can benefit elderly patients who may have special needs or preferences regarding chewing, swallowing, or remembering to take their medications."

In addition to improving health outcomes, products entering the market that represent incremental innovations over their predecessors are often less expensive than existing agents in a therapeutic class. The result is less expensive alternatives long before generic products are available.

New uses for medicines are often discovered as a result of extensive clinical experience, often many years after introduction. For example, tissue plasminogen activator (tPA) was originally developed to treat heart attacks but is now used in stroke victims. Some incremental innovations have been demonstrated to save overall health care costs as well. For example, a study by the National Institute for Neurological Diseases and Stroke found that patients treated with tPA had shorter hospital stays than other patients and were more often discharged to home rather than to institutional care. Although hospital costs for treated patients increased by $1,700 per patient, rehabilitation and nursing home costs were reduced by $6,200, a net savings of $4,500.

"The process of incremental innovation in the pharmaceutical industry mirrors how product development is done in most manufacturing and high tech industries," said Wertheimer. "In fact, most of the top 10 prescription drugs sold in the United States in 1999 were incremental improvements on existing products. Policies that foster incremental innovations stimulate research, broaden access to important therapies and help to promote a competitive market."

According to a recent Johns Hopkins University study, 125 million Americans suffered from chronic illnesses in 2000, and that figure is expected to reach 157 million in 2020, at which time 25 percent of all Americans will be living with multiple chronic conditions, many common results of aging. Most of these conditions are treated by one or more drugs that have seen incremental improvement.

"Individual physical and medical differences increase as people age," said Wertheimer. "As a result, multiple drug options are necessary for safe effective, and individualized therapy, especially for the fastest growing portion of our elderly population, those 86-years-old and older." Dr. Wertheimer points out that "in the current debate over the details of drug programs for the elderly, it is important to keep focused on one key concept-the need to provide a range of incremental drug therapies necessary for appropriate care."

The study was conducted by the Center for Pharmaceutical Health Services Research of Temple University School of Pharmacy, in cooperation with the National Pharmaceutical Council (NPC). The Center conducts externally funded and academic research in treatment outcomes, pharmacoeconomics, and health policy analysis.

Since 1953, NPC has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

The report The Value of Incremental Pharmaceutical Innovation for Older Americans is available online.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.

NPC Partners with NCCN to Expand Breast Cancer Database

NPCNow — Wed, 27 Dec 2000 21:37:00 GMT

Data on Use of New Pharmaceuticals in Community Cancer Centers to be Included

RESTON, VA (December 27, 2000) - A research collaboration between the National Pharmaceutical Council (NPC) and the National Comprehensive Cancer Network (NCCN) will expand the NCCN Breast Cancer Outcomes Database to facilitate the participation of community-based cancer centers in this national database. Tracking the pattern of use of pharmaceuticals and the feedback of such information to facilitate the appropriate use of chemotherapies, especially new, promising agents, is among the primary objectives of the NCCN Database.

The collaborative effort will analyze of the introduction and diffusion of new pharmaceuticals in the NCCN centers and in affiliate community centers. The data gathered will be used to better understand how pharmaceuticals are being used and will provide information regarding utilization patterns of pharmaceuticals by thought leaders at the NCCN centers to participating community centers and to the oncology community at large.

"We are very excited about this opportunity to expand on the research into appropriate cancer care that both NPC and NCCN are actively engaged in and to educate those in the field about state-of-the-art treatments," said Dr. Jeann Lee Gillespie, director of scientific affairs for NPC.

The data will be gathered from major academic medical centers and community cancer centers around the country. Academic medical centers participating in the NCCN Database include: Dana-Farber Cancer Institute, Roswell Park Cancer Institute, Fox Chase Cancer Center, City of Hope National Medical Center, H. Lee Moffitt Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University, Memorial Sloan-Kettering Cancer Center, Stanford Hospital and Clinics, University of Michigan Comprehensive Cancer Center, the UNMC/Eppley Cancer Center at the University of Nebraska Medical Center, the University of Texas M. D. Anderson Cancer Center. The community cancer centers involved will be selected in the near future.

"The NCCN is very pleased to join the NPC in a major national effort to advance the state-of-the-art in cancer care," said Dr. William McGivney, NCCN's Chief Executive Officer. "The NCCN Oncology Outcomes Database is the most comprehensive of all existing databases on breast cancer patients. Chemotherapy plays a critical role in improving the outcomes for cancer patients. By advancing the data and information available on the application of important new therapies, we will work to improve the quality of care available to the patients whom we serve."

The NCCN is an alliance of 18 of the world's leading cancer centers, established in 1995 to provide the state-of-the-art in cancer care to the greatest number of patients in need. The NCCN member institutions are: The Arthur G. James Cancer Hospital & Solove Research Institute at Ohio State University, Columbus; City of Hope National Medical Center, Los Angeles; Dana-Farber Cancer Institute, Boston; Fox Chase Cancer Center, Philadelphia; Fred Hutchinson Cancer Research Center, Seattle; H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida, Tampa; Huntsman Cancer Institute at the University of Utah, Salt Lake City; Johns Hopkins Oncology Center, Baltimore; Memorial Sloan-Kettering Cancer Center, New York; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago; Roswell Park Cancer Institute, Buffalo; St. Jude Children's Research Hospital, Memphis; Stanford Health Care, Stanford; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham; UCSF Comprehensive Cancer Center, San Francisco; University of Michigan Comprehensive Cancer Center, Ann Arbor; UNMC/Eppley Cancer Center at the University of Nebraska Medical Center, Omaha; and University of Texas M. D. Anderson Cancer Center, Houston. For more information about NCCN, please visit www.nccn.org.

Since 1953, NPC has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

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Please direct all media inquiries to Pat Adams, phone (703) 620-6390.