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NPC in Key Leadership Role in CER Discussions at the 15th Annual International ISPOR Meeting

NPCNow — Mon, 24 May 2010 15:32:47 GMT

The National Pharmaceutical Council's Vice President for Clinical and Scientific Affairs, Dr. Les Paul, spoke to large audiences about the evaluation, dissemination and interpretation of comparative effectiveness research (CER) at the International Society for Pharmacoeconomics and Outcomes Research's (ISPOR) 15th Annual International Meeting. Hundreds of health outcomes researchers, physicians, pharmacists, scientists, health care decision-makers, and others attended the meeting, which was held May 15-19 in Atlanta, GA.

During the course of the meeting, Dr. Paul was a panel speaker in two symposia and a workshop that all focused on CER. At the first symposium, sponsored by IMS Health, "Will Comparative Effectiveness Research Survive Health Reform?" Dr. Paul took a closer look at the timeline and issues involved with the implementation of the new public-private CER entity, the Patient-Centered Outcomes Research Institute (PCORI). He pointed out that operational details, such as the structure and setup of the board of governors and committees, the scientific standards and research methods that will be followed, the role of AHRQ's Office of Communications and Knowledge Transfer, and the guidance for the use of CER, among other issues, must still be addressed.

During this discussion, Dr. Paul was joined by Penny Mohr, MA, Vice President of Programs at the Center for Medical Technology Policy; Daniel A. Ollendorf, MPH, ARM, Chief Review Officer at the Institute for Clinical and Economic Review; and moderator Vernon Schabert, PhD, Principal for Health Economics and Outcomes Research at IMS Health.

Research sponsored by NPC and conducted by Cerner LifeSciences, "Demystifying Comparative Effectiveness Research: A Case Study Learning Guide," served as the basis for a workshop, "Your Role in Interpreting and Appropriately Communicating CER Results in a Highly Charged Environment." Dr. Paul participated in this workshop, which took a closer look at how to evaluate CER results through three consecutive steps: 1) Consider for whom the findings are applicable; 2) Consider whether any aspects of the study design might affect the results; and 3) Consider whether the findings may change with new research. In particular, Dr. Paul focused on what constitutes "good" evidence and how it could be interpreted and disseminated.

In addition to Dr. Paul, Jean Slutsky, Director of the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, and Brian Sweet, RPh, Chief Pharmacy Officer at WellPoint, Inc., took part in this discussion that was moderated by Dr. Robert DuBois, Chief Medical Officer at Cerner LifeSciences.

Copies of the NPC-sponsored report were distributed widely at the meeting.

Finally, Dr. Paul delivered remarks during a discussion, "Comparative Effectiveness and Standards of Evidence: The Intersection of Science, Policy, Regulation and Business," sponsored by United BioSource Corporation. During this discussion, Dr. Paul delved into the importance of "harmonizing" high-quality CER standards to create a more predictable environment for adoption and diffusion of CER results in order to inform health care decisions and improve health outcomes. Speakers included Dr. Paul; Brian Sweet of WellPoint, Inc.; Laurie Burke, RPh, Director of Study Endpoint and Label Development at the FDA's Center for Drug Evaluation and Research; and Dr. Bryan Luce, Senior Vice President of United BioSource Corporation, who moderated the discussion.

Time for PCORI's Implementation

NPCNow — Mon, 03 May 2010 20:57:09 GMT

By Dan Leonard

Now that the dust has settled and health care reform has been signed into law, many health care stakeholders are wondering what happens next. With more than 2,000 pages in the law, I wanted to focus on one aspect of it-comparative effectiveness research and the timelines associated with the implementation of the new private/public, non-profit entity, the Patient-Centered Outcomes Research Institute (PCORI). Building the Institute literally from the ground up will be a large task, given the number of details that must be worked out before it can begin its primary mission of spearheading and overseeing millions of dollars in new comparative effectiveness research.

The Institute and its activities would be governed by an independent, 19-member Board of Governors that includes the director of the Agency for Healthcare Research and Quality (AHRQ) and the director of the National Institutes of Health, with the remaining members appointed by the U.S. Comptroller General. Among these appointed stakeholders, there are three representing patients and health care consumers; five representing physicians and providers; three representing private payers; three members representing pharmaceutical, device, and diagnostic manufacturers or developers; one representing quality improvement or independent health service researchers; and two representing the federal government or the states. The members are to be appointed no later than six months after enactment of the law, or September 23, 2010.

PCORI also would have guidance from a standing methodology committee, permanent or ad-hoc expert panels, expert panels for clinical trials, and an expert advisory panel for rare diseases. Within the expert advisory panels, "the Institute may include a technical expert of each manufacturer or each medical technology that is included under the relevant topic, project, or category for which the panel is established."

Eighteen months after PCORI is established, the methodology committee must issue methodology guidelines on how CER should be conducted. Embedded in the law is very specific language pertaining to transparency and the importance of opening the process for comment by patient groups, health care stakeholders, and the public. PCORI is required to have a public comment period of 45-60 days prior to the adoption of proposed methods, and PCORI also must have public comment periods prior to the adoption of national priorities and the research project agenda. The National Pharmaceutical Council will weigh in, when appropriate, during those comment periods.

Once PCORI is up and running, 90 days after receiving research findings, they must make these findings available to "clinicians, patients and the general public," working through the Office of Communication and Knowledge Transfer at AHRQ. The public comment period for findings of various research will be 45-60 days from the release of these drafts.

PCORI also is required to submit several reports to Congress and the Administration, and to make these publicly available. One of these is an annual report. Another, required at least every five years, is a report on the "extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on reducing practice variation and disparities in health care and the effect of the research conducted and disseminated on innovation and the health care economy of the United States."

Other required reports would review the "dissemination and training activities and data networks" established by the law, as well as in 2018, a review the "adequacy and funding for the Institute and activities."

Other clear timelines are set for PCORI's funding, which kicks in this year. PCORI will be funded by the Patient-Centered Outcomes Research Trust Fund through 2019, which has been allocated $10 million for 2010, $50 million for 2011, and $150 million for 2012. In future years, the Trust Fund will comprise general revenues, an annual $2 fee per Medicare beneficiary transferred from the Medicare Trust Fund, and an annual $2 fee per-covered-life assessed on private health plans adjusted for health expenditure inflation. Taken together, total sustained annual funding for PCORI could be more than $650 million.

The next few months will be busy as the Board of Governors is appointed and the initial work to set up PCORI and coordinate activities begins. As with any new undertaking, it will take some time and thoughtful input from health care stakeholders to fully implement PCORI. We look forward to being part of that effort.

NPC Pleased With Establishment of Patient Centered Outcomes Research Institute

NPCNow — Thu, 25 Mar 2010 15:58:07 GMT

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

Washington, DC (March 25, 2010) - The National Pharmaceutical Council (NPC) today said it was pleased with the establishment of the Patient Centered Outcomes Research Institute (PCORI), a private, non-profit corporation that would develop and fund comparative effectiveness research (CER). PCORI was a key provision in the "Patient Protection and Affordable Care Act" that President Obama signed into law this week.

"Helping to inform health care decision making through CER is an important goal in this legislation and has the potential for positively impacting patient health. To accomplish this goal, CER must be conducted and applied appropriately. That means starting with good, relevant data; using appropriate methods to analyze that data; and translating those results in a way that is useful, understandable and actionable for health care decision makers. The establishment of the new Institute is an important step toward assuring quality in CER," said NPC President Dan Leonard.

The outline for PCORI is consistent with the principles for CER that NPC championed last year in its testimony before 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. The CER sponsored by PCORI 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, PCORI would provide evidence to encourage good decision making by health care professionals and patients, and work with other bodies to disseminate study results in a timely manner. The law also would establish a standing methodology committee to ensure that rigorous scientific methods are utilized, and PCORI would be governed by a multi-stakeholder Board of Governors. All of these concepts were espoused in NPC's comments.

"It is crucial to 'get CER right,' because it impacts all stakeholders in the health care system. Health care professionals and patients need timely and relevant information to make decisions that support quality patient health outcomes," said Leonard.

"As with any new undertaking, it will take some time and thoughtful input from health care stakeholders to fully implement PCORI. We look forward to being part of that collaboration," he concluded.�

NPC's previous comments on CER and related research are available at www.npcnow.org. In addition, NPC has several studies currently underway looking at CER's impact on innovation and patient access, and at the differences in standards for generating evidence among government health agencies.

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Employers Are Focusing on Improving Health Outcomes

NPCNow — Thu, 04 Mar 2010 23:33:15 GMT

Employers Are Focusing on Improving Health Outcomes
By Dan Leonard, NPC President
February 2010

Employers across the nation increasingly recognize that one of the best ways to improve productivity is to ensure the health and well-being of their employees. That's why leading edge employers are focusing their attention on health outcomes, rather than individual health care service costs, in order to ensure they will get the most employee health, and associated productivity gains, out of the health care dollars they spend.

Simply adding up medical and pharmacy claims costs for specific medical conditions doesn't provide a true picture of the full impact of poor health on the much greater costs of lost productivity in the workforce. In fact, according to an NPC-funded study, employers who focus only on medical and pharmacy costs in creating employee health strategies may be missing the mark by misidentifying the health conditions that most impact the productivity of their employees and underestimating the impact of other factors.

According to the same study, there are high costs associated with lost productivity: on average, every $1 of medical and pharmacy costs is matched to $2.30 of health-related productivity costs. And 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.

When employers know which conditions are impacting their workers, they can take meaningful steps to address those issues through health and wellness programs, modified health care plan designs, and other focused tactics. One approach that is growing in popularity has been value-based insurance design, or VBID. VBID takes into account the bigger picture, beyond just medical and pharmacy costs, and uses approaches that recognize the full benefit of having healthy employees and the full costs of having unhealthy employees. VBID builds specific consumer incentives into plan design, benefits or premium contribution structures to steer consumers to make high-value decisions. Incentives often encourage the use of those interventions that have been shown to have a positive impact on health outcomes, such as specific medical services or medications, adoption of healthy lifestyles, or use of high-performance providers.

Medication compliance, sometimes referred to as adherence, is a key element to achieving health goals and is often an intrinsic part of VBID. Following a medicine treatment plan developed by an individual's health care provider, filling prescriptions, and taking medications as prescribed are foundational to reaping the benefit of therapy. According to a recent survey sponsored by NPC, 89% of employers acknowledge that medication compliance is a top health management objective, and a large percentage of those surveyed are taking steps to analyze health data and implement compliance programs.

This recognition that compliance can stave off more serious and costly health consequences has led employers to drive the creation of VBID programs that lower barriers to necessary and high-impact medications that help employees manage chronic and costly conditions. With the right approach, employers can incent the right utilization for the right reasons, and promote value and better health and productivity in their employees.

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Health Care Reform and a CER Entity: Will It Happen?

NPCNow — Fri, 29 Jan 2010 20:20:14 GMT

By Dr. Les Paul, NPC VP for Clinical and Scientific Affairs

In January 2009, it appeared to be nearly certain that Congress would approve a health care reform bill that included provisions to establish a comparative effectiveness research (CER) entity. It's now one year later, and health care reform is looking more uncertain, with the House and Senate mired in debate over differences between their bills and challenged by a newly elected Republican Senator who has pledged to vote against the current reform bill. If an agreement is reached, it is still likely that a new CER entity will remain a key element - alternatively, if an agreement is not reached on comprehensive reform, CER legislation may move forward separately. The bigger questions, then, are how would the entity be structured and how would the research and information be disseminated?

The main, and perhaps most important, difference between the current House and Senate bills is the location of the CER entity. The Senate bill would establish a non-profit corporation, called the "Patient-Centered Outcomes Research Institute," outside of the federal government. Oversight of the Institute would be conducted by an independent, 19-member multi-stakeholder Board of Governors that includes the director of Agency for Healthcare Research and Quality (AHRQ) and director of the National Institutes of Health (NIH), with the remaining members appointed by the U.S. Comptroller General. By contrast, the House proposal would establish a "Center for Comparative Effectiveness Research" within AHRQ. An advisory commission would oversee and evaluate the Center's activities. Both bills, however, would fund the CER entity through mandatory, multi-year funding from public and private sources and would create a trust fund to receive public and private payer contributions.

Under both bills, the entity could contract with private and governmental entities to conduct research and the research would be required to take into account the potential for various treatments to have different degrees of effectiveness among subpopulations. The research supported or conducted by the entity must be transparent, credible, and accessible to the public.

Whether the CER entity is public or private, AHRQ can be expected to continue to play a major role, particularly in setting standards and developing appropriate methods for CER, as well as in its dissemination to the public. Under the House scenario, research dissemination and methods and procedures would be developed by AHRQ; under the Senate version, the responsibility for translation and dissemination of findings is transferred to the Office of Communication and Knowledge Transfer in AHRQ, in consultation with the National Institutes of Health. The explanation of findings would include a description of considerations for specific subpopulations, the research methodology used, and the limitations of the research.

Outside of the entity's location, the two bills are not that far apart on CER, which should make it easier for House and Senate negotiators to find common ground on this particular issue. But if legislation is scuttled, it's unclear what will happen with CER after the $1.1 billion allocated by the American Recovery and Reinvestment Act (ARRA) is exhausted. Certainly, AHRQ will continue to take the lead on ARRA-funded studies, as well as CER conducted in the "Effective Healthcare Program" that was developed under authority granted to AHRQ under Sec. 1013 of the Medicare Modernization Act in 2003. Without either comprehensive health care reform legislation or standalone enactment of a new Comparative Effectiveness Research "Institute," it is unclear if Congress will appropriate funds beyond AHRQ's existing budget for CER. Despite the uncertainty in how government will move forward, it is important to note that there remains considerable interest in CER in both the public and private sector. It will, therefore be important to continue to support well-designed CER, which can greatly benefit patients and help to "inform" health care providers as they, together with their patients, use evidence to make decisions regarding the best treatment choices.

National Pharmaceutical Council Welcomes New Member, Otsuka America Pharmaceutical, Inc.

NPCNow — Mon, 21 Dec 2009 19:46:32 GMT

Contact: Andrea Hofelich, (703) 715-2741, ahofelich@ncpcnow.org

Washington, DC (December 21, 2009) - The National Pharmaceutical Council (NPC) today announced that Otsuka America Pharmaceutical, Inc. has joined the health policy research organization as a member.

Otsuka America Pharmaceutical, Inc. (OAPI) is a fast-growing specialty healthcare company that commercializes Otsuka-discovered product opportunities in North America, with a strong focus on and commitment to neuroscience, oncologic, and hospital products. OAPI is dedicated to improving patients' health and the quality of human life. OAPI is part of the Otsuka Pharmaceutical Group, and was established in 1989 by Otsuka America, Inc. (OAI), which is wholly owned by Otsuka Pharmaceutical Co., Ltd. (OPC).

In joining NPC, OAPI President and Chief Executive Officer Mark Altmeyer said, "I'm impressed with NPC's focus and achievements in the areas of comparative effectiveness research and evidence-based medicine. These are important issues that could affect not only research and development, but more importantly, patient health care."

Mr. Altmeyer will serve on NPC's Board of Directors, which includes top executives from the leading research-based pharmaceutical companies, including Abbott Laboratories, Astra Zeneca LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Inc., Eisai inc., Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc, sanofi-aventis, Takeda Pharmaceuticals North America, Inc., and Teva Neuroscience.

"We are pleased to welcome Mr. Altmeyer and Otsuka to NPC and we look forward to their active participation on our Board and research committees. As a leader in neuroscience, oncology and hospital therapies, Otsuka brings additional, valuable perspectives and expertise to NPC's scientific analyses and education to inform the health care policy debate," said NPC President Dan Leonard.

Demystifying Comparative Effectiveness Research: A Case Study Learning Guide

NPCNow — Thu, 10 Dec 2009 08:02:00 GMT

This report, "Demystifying Comparative Effectiveness Research: A Case Study Learning Guide," written by Robert W. Dubois, MD, PhD, chief medical officer of Cerner LifeSciences, and Sylvia L. Kindermann, MPH, Cerner LifeSciences senior research associate, discusses the three most prominent types of CER:

Randomized controlled trials (RCTs), wherein subjects in a population are randomly allocated into study and control groups to receive or not to receive an experimental intervention, such as a new therapeutic biopharmaceutical or medical device;
Meta-analysis, which synthesizes data across a series of similar studies, generally RCTs; and
Observational studies, which follow participants over a period of time to examine the potential associations between patients' exposure to treatment and health outcomes.

The report details a guide on how to best evaluate each kind of study, and it discusses case studies in each of the three types of CER.

An executive summary of this report is also available.

Demystifying Comparative Effectiveness Research: A Case Study Learning Guide (Executive Summary)

NPCNow — Thu, 10 Dec 2009 08:01:00 GMT

This 16-page executive summary of the report, "Demystifying Comparative Effectiveness Research: A Case Study Learning Guide," written by Robert W. Dubois, MD, PhD, chief medical officer of Cerner LifeSciences, and Sylvia L. Kindermann, MPH, Cerner LifeSciences senior research associate, discusses the three most prominent types of CER:

Randomized controlled trials (RCTs), wherein subjects in a population are randomly allocated into study and control groups to receive or not to receive an experimental intervention, such as a new therapeutic biopharmaceutical or medical device;
Meta-analysis, which synthesizes data across a series of similar studies, generally RCTs; and
Observational studies, which follow participants over a period of time to examine the potential associations between patients' exposure to treatment and health outcomes.

The report provides a reference guide on how to best evaluate each kind of study, and it briefly discusses case studies in each of the three types of CER.

The full report is also available on NPC's website.

New NPC Report Provides Guidance on Evaluating and Interpreting Comparative Effectiveness Studies

NPCNow — Thu, 10 Dec 2009 08:04:00 GMT

Contact: Andrea Hofelich, (703) 715-2741, ahofelich@ncpcnow.org

WASHINGTON, D.C. (December 10, 2009) - A new report released today by the National Pharmaceutical Council (NPC) provides guidance in the evaluation of comparative effectiveness research (CER), including easy-to-use "checklists" that help make sure such studies can be used to improve the dialogue between health care providers and patients, as well as better inform health care decision-making.

The report, "Demystifying Comparative Effectiveness Research: A Case Study Learning Guide," written by Robert W. Dubois, MD, PhD, chief medical officer of Cerner LifeSciences, and Sylvia L. Kindermann, MPH, Cerner LifeSciences senior research associate, discusses the three most prominent types of CER:

Randomized controlled trials (RCTs), wherein subjects in a population are randomly allocated into study and control groups to receive or not to receive an experimental intervention, such as a new therapeutic biopharmaceutical or medical device;
Meta-analysis, which synthesizes data across a series of similar studies, generally RCTs; and
Observational studies, which follow participants over a period of time to examine the potential associations between patients' exposure to treatment and health outcomes.

The report details a guide on how to best evaluate each kind of study, and it discusses case studies in each of the three types of CER.

"If conducted and interpreted correctly, these types of research can help to inform health care decision-making. If, however, such studies are conducted or interpreted incorrectly, the comparative answers from these studies may be inaccurate, or worse, misleading," Dubois and Kindermann note.

NPC released the report during a "Town Hall" meeting at AstraZeneca's Wilmington, Del., U.S. headquarters that was designed to help participants learn more about CER and explore how it can be designed to inform health care decision-making while sustaining innovation and patient access to needed medicines.

"There's so much written about CER, but very little written about how to properly evaluate a CER analysis. This report will help health care providers, patients and the media better understand what to look for so they can be better informed," said NPC President Dan Leonard.

In the "checklists," the authors suggest various questions, including:

For assessing a study's overall validity: "Is the study conducted in a 'real-world' setting?"
For randomized clinical trials: "Are study limitations discussed?"
For meta-analysis: "Were all relevant studies included?"
For observational studies: "Did the authors adequately describe and defend the statistical methods they used for analysis?"

The full report is available on NPC's website at www.npcnow.org. An executive summary is also available.

In addition to the new report, 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. For more information, visit www.npcnow.org.

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Health Plan Capabilities to Support Value Based Benefit Design

NPCNow — Mon, 30 Nov 2009 16:15:58 GMT

To assist employers in understanding how to more effectively work with their health plans to implement programs to lower costs, the non-profit National Business Coalition on Health (NBCH), with funding support from the National Pharmaceutical Council, developed a guide around health plan capabilities to support Value Based Benefit Design (VBBD). VBBD is a purchaser strategy which incorporates focused consumer incentives into health plan and related benefits to steer consumers to better health and lifestyle decisions.

This report highlights data reported by health plans that participate in eValue8^TM. NBCH's eValue8 is the nation's leading standardized Request for Information (RFI) tool used by employers and coalitions to gather health care data from more than 70 HMO and PPO health plans. More than 96 million Americans, or about two-thirds of those insured by employers, are members of health plans that respond to eValue8.

NBCH eValue8T Report Reveals Health Plans' Ability to Align Employee Incentives to Improve Health

NPCNow — Mon, 30 Nov 2009 16:03:47 GMT

As health care costs rise and workforces shrink, purchasers are looking for innovative ways to curb increases while keeping employees healthy

Contact:
Andrea Hofelich, ahofelich@npcnow.org, 703.715.2741
Cary Conway, cary@conwaycommunication.com, 972.731.9242

Washington, DC (November 30, 2009) - The current rate of health care cost increases are unsustainable and health care purchasers are increasingly recognizing the impact of lifestyle choices and management of chronic conditions to contain costs. To assist employers in understanding how to more effectively work with their health plans to implement programs to lower costs, the non-profit National Business Coalition on Health (NBCH) developed a new guide around health plan capabilities to support Value Based Benefit Design (VBBD). VBBD is a purchaser strategy which incorporates focused consumer incentives into health plan and related benefits to steer consumers to better health and lifestyle decisions.

The publicly available report, "Health Plan Capabilities to Support Value Based Benefit Design," highlights data reported by health plans that participate in eValue8^TM. NBCH's eValue8 is the nation's leading standardized Request for Information (RFI) tool used by employers and coalitions to gather health care data from more than 70 HMO and PPO health plans. More than 96 million Americans, or about two-thirds of those insured by employers, are members of health plans that respond to eValue8.

"Purchasers have pointed the finger at health plans, providers and technology to explain the rise in health care costs," said Dennis White, senior vice president, Value Based Purchasing at NBCH. "They are correct to do so, but they often fail to recognize and leverage the influence that employee incentives can have as a driver of health status and cost. Value Based Benefit Design is not just about health and wellness programming that too often is separated from other benefits, including the health plan. Employers should explore the breadth and depth of VBBD options, many of which are challenging administratively and this report helps identify all of the moving parts and profiles the ability of health plan to support this growing area for employers."

Key findings in this report from the eValue8 survey related to VBBD programs include:

Cash and cash-equivalent rewards for preventive activities like filling out personal health assessments and tobacco cessation are well established and commonplace as is elimination of co-pays and deductibles for preventive services like cancer screening.
For chronic care services, over half of the responding plans (54%) are now able to adjust co-pays and deductibles contingent upon program participation (e.g. coaching) with a higher proportion of national plans reporting this capability than regional plans (88% versus 24%).
Acute care incentives are still in their infancy with only 26% of responding plans reporting offering plans that provide incentives for choosing more cost effective treatment alternatives.
The report also considers incentives for choice of better performing doctors and hospitals and the availability of tools to support consumer choice beyond financial incentives.

The report was authored by Margaret Houy, JD, MBA, senior consultant, Bailit Health Purchasing, LLC, with contributions from Michael Joseph, senior consultant with Bailit, and Laura Jacobus-Kantor, PhD, assistant research professor, Center for Integrated Behavioral Health Policy, George Washington University Medical Center. NBCH gratefully acknowledges the support of the National Pharmaceutical Council (NPC) for development of this information.

"Value based benefit design is helping to promote a healthier workforce, with reductions in absenteeism, medical disability, and productivity losses associated with health conditions," said NPC President Dan Leonard. "That's why it's important to gain a better understanding of the health plan infrastructure that is necessary to support value based benefit design and maximize its benefits for employees."

The report can be found on both NBCH and NPC's websites.

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 National Business Coalition on Health and eValue8
NBCH is a national, non-profit, membership organization of 60 business and health coalitions, representing over 7,000 employers and 25 million employees and their dependents across the United States. NBCH and its members are dedicated to value-based purchasing of health care services through the collective action of public and private purchasers. eValue8T is a product of the National Business Coalition on Health and is the nation's leading evidence-based request for information (RFI) tool used by coalitions and major employers to assess and manage the quality of their health care vendors. For additional information visit: www.nbch.org.

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Employer Medication Compliance Initiatives

NPCNow — Thu, 19 Nov 2009 23:33:46 GMT

Medication compliance has long been acknowledged as a serious problem for the American health care system, costing billions of dollars in lost productivity, additional doctor visits, preventable hospitalizations and nursing home admissions, and even premature death. This NPC-sponsored study, "Employer Medication Compliance Initiatives," which for the first time surveyed employers' views and strategies on medication compliance, says 89% of employers acknowledge its importance to employee health.

The research included a web-based survey of 75 employers, supplemented by 13 in-depth interviews. The survey targeted employee benefit directors, medical directors and other health management professionals with health management and pharmacy benefit decision-making authority or influence in large, self-insured corporations. An accompanying slide deck is available.

Medication Compliance Is Top of Employers' Minds, According to New Survey

NPCNow — Thu, 19 Nov 2009 23:31:18 GMT

Unique Survey Takes First-Time Look at Employers' Views and Strategies to Improve Compliance

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

Washington, DC (November 19, 2009) - More employers are taking steps to improve their employees' health by making sure they take their medicines as prescribed, a move that could stave off more serious and costly health consequences, according to a new report sponsored by the National Pharmaceutical Council (NPC).

Medication compliance, sometimes referred to as medication adherence, is simply following a medicine treatment plan developed by an individual's health care provider, filling prescriptions, and taking medications as prescribed.

And the NPC report, "Employer Medication Compliance Initiatives," which for the first time surveyed employers' views and strategies on compliance, says 89% of employers acknowledge its importance to employee health. Only preventive care and lifestyle behaviors were rated more highly.

"It's well documented that people with chronic diseases who take their medications as prescribed are healthier and more productive," said NPC President Dan Leonard. "This study shows that employers are actively taking steps to encourage medication compliance to help improve the health and well-being of employees and their families."

Medication compliance has long been acknowledged as a serious problem for the American health care system, costing billions of dollars in lost productivity, additional doctor visits, preventable hospitalizations and nursing home admissions, and even premature death.

The NPC report shows that diabetes is a key focus of medication compliance initiatives. Other conditions that warrant employer attention are high cholesterol, blood pressure, cardiovascular disease, congestive heart failure, and chronic obstructive pulmonary disease.

To improve compliance, 95% of employers surveyed for the report say they are taking action, and the trend is toward more sophisticated interventions including employee education and additional prescription reminders by e-mail. Employers are often using their vendors to play a key role in analysis and intervention, with pharmacy benefit managers (PBMs) and employee benefit consultants (EBCs) were most often cited.

Employers believe that focused and more sophisticated interventions from vendors are the most effective, with the highest ratings coming from those that focused on individuals with compliance issues and Value-Based Benefit Designs, which lower compliance barriers for high-value services.

The survey, conducted for NPC by the Benfield Group, had 75 responses along with 13 in-depth interviews. The survey targeted employee benefit directors, medical directors and other health management professionals with health management and pharmacy benefit decision-making authority or influence in large, self-insured corporations. An accompanying slide deck is available.

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.

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Avalere Explores Impact of Comparative Effectiveness Research on Healthcare Innovation

NPCNow — Tue, 17 Nov 2009 17:07:22 GMT

Contact: Andrea Hofelich, 703.715.2741, ahofelich@npcnow.org

November 17, 2009, Washington, DC - A new Avalere Health report presents an analytic framework for evaluating the impact of comparative effectiveness research (CER) on healthcare innovation. The research - presented at Avalere's symposium, "Bridge the Gap / Proving the Value of Healthcare Innovation" - comes amid intensifying interest in how deeper federal investment in CER will affect healthcare delivery, access, and costs. Against a backdrop of many new available therapeutic treatments and increased concern about how to pay for them, there has been growing demand for comparative research that determines which interventions are most effective.

Investment in CER - including $1.1 billion of new federal funding appropriated in the American Reinvestment and Recovery Act - has sparked interest from a range of stakeholders on how this research will be structured, disseminated, and used. At the core of this debate is the important question of how CER investments will shape incentives for bringing new therapies to market-the effect on medical innovation. To address this issue, Avalere researchers convened a roundtable of public and private payers, clinicians, and academic researchers. Avalere then integrated that expert insight into its own market research and constructed a framework of topics and questions that policymakers and stakeholders must consider in anticipating the full impact of CER on innovation:

CER Generation: How does the way in which CER is generated affect the knowledge and attitudes of payers, providers, and patients toward using the information in decision-making?
CER Application: What is the role of CER findings on public and private payer coverage decisions? What types of CER do physicians currently use when making treatment choices? Is the availability of CER in key therapeutic areas associated with further specificity and differentiation in the type of recommendations presented in clinical guidelines?
Pharmaceutical Development and Societal Health Outcomes: How does the integration of CER into clinical practice affect the types and timing of product development investment decisions made in the development and commercialization of medical products? Do different policy constructs shaping clinical practice lead to different product investment decisions?

"The relationship between CER and healthcare innovation is critically important within the context of achieving a balance between prudent purchasing and strategic investment," said Tanisha Carino, a vice president of Avalere Health and co-author of the report. "When policymakers change how government evaluates medical products, they will change the kinds of studies that are developed to support registration and marketing. Our framework is a guide to help guide policy and commercial decision-making to achieve an appropriate balance."

"A CER framework should encourage innovation as well as improve health outcomes for patients," said Les Paul, MD, MS, vice president for Clinical and Scientific Affairs at the National Pharmaceutical Council. "To ensure those goals, we need to address how CER will be generated, disseminated, and integrated by key healthcare stakeholders."

The report, "Framing the Debate / Untangling the Role of Comparative Effectiveness Research on Innovation," was authored by Riaz Ali, Jennifer Bowman, Tanisha Carino, Jon Glaudemans, and Elaine Purcell, all of Avalere Health. Participants in the roundtable are listed in the full report. The paper was written on behalf of the National Pharmaceutical Council, which provided funding for this research. Avalere maintained editorial control and the conclusions expressed in its research are solely those of the authors.

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

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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

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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

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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

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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

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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.

**************************************************************************

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

###

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.

###

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.