THE HEALTH ECONOMICS BLOG - Trends, Politics, Opinions etc. in biotech & pharma industry

Market Access Position with GSK

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 04 Nov 2009 09:50:00 +0000

GlaxoSmithKline
Director of Market Access, Dermatology
Research Triangle Park, NC

Company:
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company. GSK has leadership in four major therapeutic areas - anti-infectives, central nervous system, respiratory, and cardiovascular/metabolic and dermatology. In addition, it is a leader in the important area of vaccines, has a growing portfolio of oncology products, and is making significant investments in the area of immuno-inflammation.

Job Description:
Reporting to the Vice President Dermatology, the Director of Market Access is responsible for the development and implementation of strategies to establish the value proposition, global pricing and market access for Stiefel Rx/Aesthetics products. Stiefel was acquired by GlaxoSmithKline in 2009 for $3.9B, with revenues of $1.5B annually and a portfolio of over 12 commercial compounds and a robust development portfolio of 15 compounds.

Specific accountabilities:
• Internal expert and global strategist on value development, global pricing, HTA (Health Care Technology Assessment) and reimbursement for Rx/Aesthetic products;
• Extensive coordination with Global Clinical, Global Commercial and Regional Commercial Teams to coordinate/develop research studies to support data needs and establish value of portfolio of (new/existing) products for pricing, reimbursement and market access;
• • Establish/maintain effective professional relationships with key global opinion leaders in Health Economics, Pricing and Reimbursement.

Job Requirements:
• Bachelor's degree or similar degree/and or work experience required, PharmD/MBA preferred;
• 10 years experience in global pharmaceutical industry, with 3+ years leading international teams;
• 5 years experience in managed care and/or health economics teams in major pharmaceutical markets around the world;
• At least 5 years experience leading pricing, reimbursement and/or HEOR teams;
• Comprehensive understanding of Healthcare Technology Assessment (HTA).
.

Personal Attributes:
• Highly organized and able to work independently with excellent communication skills;
• Detail orientated with exceptional follow-up skills;
• Strong analytical and problem solving skills;
• Demonstrated success understanding the Health Care industry and it’s trends;
• Proven ability to anticipate problems or issues and respond accordingly.

For additional information please contact:
Emery Rowand
Partner, Savant Consulting
707-284-5400
emery@savant.com
www.savant.com

Brand new HE&OR and P&R Department - Multiple Locations

noreply@blogger.com (ustaginnus@hotmail.com) — Tue, 03 Nov 2009 11:37:00 +0000

Dear All,

this just came in. Please get in touch with Simon.
Cheers
Ulf

Hays Pharma are working exclusively with a top Pharma who looking to start a new department with multiple vacancies in different location.

The positions vacant are:

Director/Senior Manager – Health Economics and Outcomes Research
Region – PECANZ (Europe, Canada, Australia and New Zealand)
Location – London or Paris

Director/Senior Manager – Pricing and Reimbursement
Region – Global
Location – New York or London

For more information please look at http://www.hays.com/jobs/pfizer/marketaccess.html.

Either apply on-line or send your C.V. to simon.rose@hayspharma.com

If you want to know more detail about this position or any other please contact Simon Rose on +44 (0)207 922 7155.

Simon is a specialist recruiter in Health Economics and Outcomes Research so if these positions are not suitable for you but interested in hearing about others please contact him. Simon is open to give any career or recruiting advice to Candidates, Line Managers and Human Resources

Risk sharing workshop @ ISPOR

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 30 Oct 2009 08:27:00 +0000

Dear All,

back from Paris we just wanted to thank all participants for the very positive feedback on our workshop. People really liked the practical approach and the comprehensiveness of the issues to be considered when thinking of setting up a Risk Share agreement. We are also writing up a manuscript and I will keep you posted on its publication. As Oliviers' bag got lost during travel we did not have handouts at the presentation therefore please feel free to drop me a line and I will forward you a copy of the slides.

Best wishes
Ulf

European Court of Justice on tiered pricing for pharmaceuticals

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 09 Oct 2009 16:01:00 +0000

The highest court in Europe stood with the pharmaceutical manufacturers. The ECJs decision is related to a case filed by GSK, but this is important for the whole industry in dealing with the issue of parallel-trade. In the late 90's GlaxoSmithKline introduced differentiated prices with Spanish wholesalers according to whether they resold the products in question in Spain or other EU countries. The European Commission initially ruled that was a no-no, due to violation of antitrust rules. This week, the ECJ now upheld in large parts an earlier judgment of the European Court of First Instance and found that such an agreement - although in principle a breach of EU Competition law rules - may be subject to an exemption considering the potential wider benefits to economy, society and research, in particular on innovation.

Click hereto read the ECJ statement.

Market Access Seminar in Spain: "Access to market for new drugs. Present and future in our country." 5 and 6 November. Madrid

noreply@blogger.com (ustaginnus@hotmail.com) — Mon, 28 Sep 2009 14:47:00 +0000

PORIB is organizing a conference entitled "Market access of new drugs" to be held on 5 and 6 November 2009, in Madrid. The workshop objectives are to review the current status of the criteria and procedures in this area and to determine who will decide the market access of new drugs in different segments. Besides, health key issues for decision makers will be assessed. These seminars are aimed at professionals in the Pharmaceutical Industry and Health Authorities staff or decision makers of the National Autonomous Health System.

Here the link to the program.

100 Best Blogs for economics students

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 23 Sep 2009 06:58:00 +0000

Dear Readers,

I received the below article from the administrator of the site and thought that would be interesting to all - especially the students among of you.

"As an economics student, you have access to a great wealth of information online. One of the best places to find information online is in blogs, such as economics blogs written by educators, experts, and self-proclaimed know it alls. Here, you’ll find the 100 best blogs for economics students to read."

Regards
Ulf

UK to consult on automatic generic substitution

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 02 Sep 2009 11:19:00 +0000

01 September 2009

James Mills

The UK department of health is planning to hold a public consultation in the autumn on the automatic substitution of generics for branded drugs at pharmacy level.

Automatic generic substitution was included as a theme in the renegotiation of the pharmaceutical price regulation scheme (PPRS) between the department and the Association of the British Pharmaceutical Industry last year. Automatic substitution was to be introduced in January 2010, subject to consultation.

Norgine is campaigning against automatic substitution and funded a report that draws attention to potential risks ( scripnews.com, July 17th, 2009). An online petition on the UK government's number10.gov.uk website has collected almost 8,700 signatures.

The department of health says: "This a complex issue with many interested stakeholders. We want to make sure we engage with all stakeholders in the best way possible and we therefore intend to formally consult in the autumn on our proposals for implementation."

Source: Scripnews

US health care reform - side by side comparison of major proposals

noreply@blogger.com (ustaginnus@hotmail.com) — Tue, 18 Aug 2009 06:59:00 +0000

Dear All,

there is an interesting link on the web site of the Kaiser Family Foundation that will help keep track of developments.
Cheers
Ulf

"This side-by-side compares the leading comprehensive reform proposals across a number of key characteristics and plan components. Included in this side-by-side are proposals for moving toward universal coverage that have been put forward by the President and Members of Congress. In an effort to capture the most important proposals, we have included those that have been formally introduced as legislation as well as those that have been offered as principles or in White Paper form. This side-by-side will be regularly updated to reflect changes in the proposals and to incorporate major new proposals as they are announced."

Consulting opportunity at Double Helix in Manhatten

noreply@blogger.com (ustaginnus@hotmail.com) — Mon, 17 Aug 2009 13:05:00 +0000

Dear All,

there is an interesting opportunity with Double Helix based in NYC, please see below job description and contact details for application.

Best regards
Ulf

Profile: Management Consultant—Biopharmaceutical Market Access, Pricing, and Reimbursement

Employer: Double Helix Consulting Location: New York City

Double Helix Consulting (DHC) US is the US-based healthcare consulting division of Double Helix Group, which has provided Market Access consulting and Market Research services to the biopharmaceutical and medical device industries for 15 years and has offices in London (Market Access and Market Research), New York (Market Access) and Greater Philadelphia (Market Research). We seek a highly motivated, entrepreneurial executive with experience and expertise in the area of market access, including pricing and reimbursement, to help continue the growth of an exciting and dynamic consulting organization.

Responsibilities: To work with clients and DHC colleagues to:
• Evaluate global reimbursement environment and strategies to enhance technology adoption and coverage policies among payers (e.g., MCOs, PBMs, CMS, international health authorities), HTA and quality assurance groups (e.g., AHRQ, NCQA, JCAHO, NICE, CADTH), professional societies, and other stakeholders
• Cultivate and execute critical business development efforts, including fostering new client relationships, communicating firm’s capabilities and value proposition to clients, and surpassing client expectations to ensure repeat business
• Contribute to establishing and maintaining a network including health economists, payers, payer advisors, clinical opinions leaders, policy makers and patient groups
• Undertake business development activities based on prior experience, or to be willing to become fully involved in this area, in order to demonstrate DHC capabilities to clients
• Evaluate target product profiles and develop commercialization strategies to guide clinical program design, including choice of target populations, duration, comparators and endpoints
• Integrate clinical, market, and payer data to prepare HTAs and product dossier in formats defined by payers and industry associations (e.g., AMCP, WellPoint)
• Develop programs and materials for use by account managers, government relations and field staff that integrate information on product value to support strategies for optimizing revenues, reimbursement, and formulary positioning across managed markets

Education and experience:
• Significant biopharma client-facing Market Access consulting experience
• Experience working with payers and decision-makers on evidence-based customer strategies
• Experience making substantial contributions to commercial assessment, licensing & development decisions, portfolio management and/or lifecycle planning are all a plus
• Advanced degree in a quantitative discipline, e.g., health services research, economics, epidemiology, statistics or business; life sciences training/experience (medicine, pharmacy, nursing) a plus
Other qualifications:
• Proven track record of excellence in written and oral communication of complex technical information
• Strong collaborative style and persuasion skills to build consensus, effectively manage project teams, and achieve objectives
• Ability to thrive in an entrepreneurial work environment, including: willingness to take on responsibilities outside one’s typical scope of work, resourcefulness in very lean team situations, and drive to work collaboratively with other divisions of the company to leverage internal expertise
• Commitment to the highest levels of work product quality and client service
• Ability and willingness to travel up to 20%, primarily domestic

What we offer:
• Compensation and benefits very competitive and commensurate with experience
• Job title is flexible and fully dependent on prior experience
• Generous benefits
• DHC US’s prestigious offices are located in midtown Manhattan at Madison Avenue and 41st Street
• Ability to influence the growth of the US division and interact with the UK DHC team
• Ability to work with our Greater Philadelphia-based US strategic market research team
• DHC US is an equal opportunity employer celebrating diversity throughout our organization. EOE/M/F/D/V

Risk sharing a strong topic @ ISPOR Paris Fall 2009

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 05 Aug 2009 13:48:00 +0000

Dear All,

first of all there will be a little bit of slow posting due to the summer season. I am finally on vaccation myself however I thought I post a quick note on the ISPOR agenda in Paris later this year ... A friend of mine, Olivier, and I will run a workshop on the Risk Sharing topic but there are many other sessions on the matter as well that very lately became of paramount importance to many payers and manufacturers, especially within the oncology business. Therefore we are looking foreward to an insightful ISPOR conference again since the usual cost-effectiveness topics started to become a little boring lately ;)

Topics around risk sharing at ISPOR:

- Plenary session (with G de Pouvourville & J Grueger & S Sullivan)
- Workshop on RS, Opportunities, Pitfalls, Modeling (O Ethgen, U Staginnus)
- Workshop from UBC (with J Caro)
- Issure Panel (with M Drummond)

Here is the link for the program. Hope to see many of you at our workshop.

Happy holidays!
cheers
Ulf

Uk - faster access to innovative drugs?

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 15 Jul 2009 15:49:00 +0000

from The Daily Telegraph

Drug industry keen on new NHS trials
Britain's drug industry has welcomed Government plans to trial new drugs ahead of approval by the regulatory body as having the potential to deliver "a truly transformational change".

By Graham Ruddick
Published: 6:31PM BST 14 Jul 2009

The Office for Life Sciences (OLS), led by Lord Drayson, is proposing an "Innovation Pass", which will make it easier for companies to get their products to market, especially those for illnesses that affect only a small number of people.

The three-year scheme will be piloted from 2010/2011 with a budget of £25m. It will see innovative drugs that have gone through the initial three phases of trial be used by the NHS before approval by the National Institute for Clinical Excellence (Nice), which decides what medicines the health service should purchase and for how much.

The proposals are part of a "Life Sciences Blueprint" designed to boost pharmaceutical groups and biotechnology companies. The scheme also includes a commitment to consider a "patent box" incentive, a lower rate of tax on profits derived from products with patents located in the UK.

Andrew Witty, the chief executive of GlaxoSmithKline, said: "Delivery of the 'patent box', the evolution of Nice and the NHS as catalysts for innovation, and the development of world-class life science clusters will be critical to the Blueprint's success."

Richard Barker, director-general of the Association of British Pharmaceutical Industry, said: "The OLS blueprint charts a course of action which is both sound and welcome. When the ship is steered safely home, it will deliver a transformational change for the life sciences industry in the UK."

Upcoming EU Pricing and Market Access events

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 08 Jul 2009 17:32:00 +0000

Health Technology Assessment World Europe 2009
8 – 11 December 2009
Royal Garden Hotel, London, United Kingdom

Evidence based healthcare for pharmaceutical products
This is the 2nd annual policy forum for the industry where all the major HTA agencies across the world and leading pharmaceutical companies discuss the challenges in obtaining market access.
The first annual Health Technology Assessment World Europe 2008 was the most influential meeting on HTA for pharmaceutical products in 2008. Over the course of the 3 days over 100 participants from the world’s leading pharmaceutical and biotechnology product manufacturers plus government agencies, academic institutions, contract service organisations and consultancies attended Health Technology Assessment World.
For more information either visit www.healthnetworkcommunications.com/2009/hta or contact Julie Phillips on +44 (0) 207 608 7039.

Pharma Pricing & Market Access Outlook 2010
23 – 26 March 2010
Royal Horseguards, Once Whitehall Place, London, United Kingdom

The leading policy forum on international pricing & reimbursement

Pharma Pricing and Market Access Outlook is the world’s largest gatherings of pharmaceutical pricing and reimbursement professionals.
Pharma Pricing and Market Access Outlook 2009 continues to establish itself as the world’s best attended strategic market access event with unprecedented attendance from the global biopharmaceutical community. In 2009, the number of participants exceeded expectations with representatives from leading pharmaceutical and biotechnology organizations, HTA bodies and health agencies.
The 4th annual Pharma Pricing & Market Access Outlook will be bigger and better than ever before in terms of both attendance and content.
For more information either visit www.healthnetworkcommunications.com/2010/pricing or contact Julie Phillips on +44 (0) 207 608 7039.

New drug assessment tool introduced in Germany

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 19 Jun 2009 18:29:00 +0000

New drug assessment tool created in Germany - EVITA

In early June, EVITA (evaluation of pharmaceutical innovations with regard to therapeutic advantage) started to operate in Germany. The tool, funded by the German association of statutory health insurance funds (GKV Spitzenverband), intends to focus on delivering risk-benefit analysis based on an assessment of new drugs against existing treatments. It plans to perform such analysis in a period of time shorter than that currently needed by IQWiG (German drug assessment body).

The new tool received criticism from the VFA and individual companies who questioned the methodology used and the need for a supplementary assessment.

The Price of life

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 19 Jun 2009 02:42:00 +0000

from The Telegraph

Hi All,

there was a TV report on BBC about the work of NICE.. it has triggerd a huge debate in the UK and throughout Europe as this documentary reached first time people who had never paid attention to NICE.. unfortunately I wasn`t able to post the video link as it seems to works only in the UK if you want to download from BBC. Below a short review from The Telgraph..

TV review: The Price of Life (BBC Two)

Andrew Pettie reviews Adam Wishart's documentary on Nice, the NHS body that decides what the health service can and can't afford, plus Sky1's new glossy drama series The Take.

Published: 6:17PM BST 17 Jun 2009

The Price of Life: ‘Is it wise to spend £30,000 to get two extra months of life for one [cancer sufferer], or to have a health visitor working with some very disadvantaged families preventing the next Baby P?” It’s a tough question. Sophia Christie, the woman asking it, is the Chief Executive of NHS Birmingham East and North. Each year she has around £630 million to spend on “birth to death universal healthcare” for 440,000 people. Her daily quandary – which treatments will prove the most cost-effective? Whose lives most deserve saving? – was the controversial nub of The Price of Life (BBC Two).

To tackle a question as complex and emotive as how the NHS should best deploy its resources, it was important the film retained an open mind and a clinical grasp of the issues at hand. At first, the signs were promising. The documentary-maker, Adam Wishart, is a science writer and film-maker with experience in this field. His father died from cancer six years ago and the book Wishart wrote about the history and science of the disease as a result, One in Three, was nominated in 2007 for the Royal Society Prize for Science Books.

What’s more, Wishart had pulled off something of a coup: his documentary was the first to gain access to the National Institute for Health and Clinical Excellence, the controversial NHS rationing body known as Nice. Watching Nice at work – eavesdropping on its deliberations as a committee of doctors and lay people debated the cost and efficacy of new treatments – was fascinating. And listening to the compassionate yet clear-eyed insights of Professor David Barnett, a heart specialist and the chairman of the Nice appraisal committee, made a nonsense of the notion that Nice was little more than a panel of uncaring bureaucrats.

“If it was me, if it was my family, I’d feel the same way [as those people lobbying Nice to approve a specific drug],” said Professor Barnett. “But Nice has to stand outside that and look at everybody, not just at the individual.”

To help the committee to weigh the cost-effectiveness of expensive new treatments, Nice has put, in Wishart’s phrase, a “price on our heads”. That price is £30,000 per annum. If it costs more than £30,000 for each year a drug will add to a patient’s life (according to the available clinical projections), then Nice will not approve it to be prescribed on the NHS. This may sound callous but the committee, as Prof Barnett patiently explained, is financially compelled to see the bigger picture.

It was therefore extremely frustrating that for long periods Wishart’s film was unable to do the same. Instead of spending more time with Professor Barnett and NHS managers such as Sophia Christie, The Price of Life focused too heavily on a group of patients campaigning for Nice to approve the cancer drug Revlimid. Of course, these patients’ stories were affecting and their frustrations with Nice understandable.

But Wishart was guilty of some wishy-washy journalism in allowing the patients to voice their complaints against Nice (“They do not care. We’re just numbers to them”) without once asking them to consider the counter argument: that if Nice approved Revlimid other, perhaps equally needy areas of the NHS would necessarily go without.

At other times Wishart’s contributions were infuriatingly facile. “Surely,” he said to Prof Barnett, “decisions about life and death shouldn’t be about money.” In a world of finite resources – ie the real one – that sort of woolly platitude only confused the issue.

Thankfully, after a year of filming, Wishart had “come to realise… that if a drug costs too much money for too little benefit then the NHS must be allowed to deny it to patients.” To any intelligent viewer, though, this hard-won conclusion appeared self-evident. Despite Wishart’s courage in tackling a provocative issue, The Price of Life was primarily an opportunity missed.

NICE upholds restrictions on Alzheimer drugs

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 12 Jun 2009 07:07:00 +0000

June 11, 2009
NICE final appraisal upholds decision on Alzheimer's drugs
by Anna Bratulic

The National Institute for Health and Clinical Excellence issued a final appraisal determination Thursday which upheld an earlier decision by the agency to limit access to Pfizer's and Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine) and Shire's Reminyl (galantamine) on the NHS to patients with moderate forms of Alzheimer's disease.

NICE Chief Executive Andrew Dillon said that the decision was made after releasing for consultation "the executable version of the economic model used in this appraisal" and after the consideration of comments made by consultees. He explained that "although these comments resulted in minor changes to the model, our independent advisory committee concluded that these were not enough to make these treatments a cost-effective use of NHS resources in the mild stages of the disease." A legal challenge by Pfizer and Eisai had resulted in a UK Court of Appeal ruling last year that NICE's guidance process for the Alzheimer's drugs was "procedurally unfair," and the court suggested that the agency release details of its cost-effectiveness model.

The final appraisal also provides guidance for Lundbeck's Ebixa (memantine), which NICE noted "is not recommended as a treatment option for patients with moderately severe to severe Alzheimer's disease except as part of well-designed clinical studies." The companies have until July 1 to appeal the appraisal.

Market Access and Pricing Positions Europe

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 05 Jun 2009 11:40:00 +0000

Head Market Access Switzerland

A large global well respected Pharma is seeking a Senior Market Access professional to be based in this global Headquarters.

Job Description
To increase business by maximizing market access capabilities globally. The individual will need to develop a market access plan.

MAJOR ACCOUNTABILITIES
Lead cross-functional Market Access Team
Rollout/support global Market Access initiatives/tools
Work with the main markets to identify all the key stakeholders in the process of Market access
Develop/monitor local manufacturing strategy and capabilities to facilitate access
EXPERIENCE:
Experience in similar position
Track record of accomplishing goals
Extensive knowledge of the business
International experience

Pricing & Reimbursement / Market Access Director Belgium
I am looking for an entrepreneurial individual looking for a new challenge in their career. My client is a start up looking to create a Global Market Access Department who has a dream job for the right person.

Responsibilities
To developing frameworks and content enabling policy support and market access in EU and possibly further afield
To set up and maintain lead contacts and relationships at government authority level and develop plans to gain support and market access.
To develop pricing and reimbursement strategies to ensure a fair price and reimbursement on an on-going basis.
To develop and manage a junior Market Access / P&R employee with the intention to grow this MA/P&R to MA/P&R expert level in Europe.
Experiences:
Experience in pharmaceutical and/or healthcare industry with experience in reimbursement, health economics, public policy, strategy development.
Experience in managing large projects and contractors.
Excellent social skills, high-energy level, ability to write articles, can-do mentality, team worker.
.
Director Pricing and Reimbursement London
My client is a fast growing consultancy specialising in Pricing and Reimbursement. Due to rapid expansion they are looking for a Director to help develop and mentor the existing team and help with new business tenders. My clients are looking for someone who is well known in the industry and well connected.
Experience required:
Understanding of pharmaceutical pricing and reimbursement systems
Experience managing direct reports, and in staff mentoring
Advanced degree in relevant field
Feel free to contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com for more information. If this role does not suit you but you are interested in hearing about other positions Simon has positions across Europe at different levels.

Wanted Europe
I am looking to speak HE&OR professionals that are interested in a number of full time contract and Interim roles I have available at the moment in Belgium and Switzerland. I am also looking for a number of contractors who are able to take on projects part time for an up coming venture. Please contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com for more information.

Interacting with economic models through dashboards on the web

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 05 Jun 2009 11:31:00 +0000

release from BaseCase Software

Interacting with economic models through dashboards on the web

Summary

BaseCase Software, a company based in Switzerland, has invested 4 years of development and research to create a web-based platform that can host economic models on the web. The platform can import economic models of many types and formats, and allows the consultants of BaseCase to rapidly configure a user-friendly dashboard for the model that is easy to access online.
User-friendly dashboards for economic models can be used by the pharmaceutical industry to communicate value to decision makers such as hospital administrators, third party payers or clinicians. Another application is the use of a dashboard to communicate public health models to a broad audience of decision makers in developing nations.
As an example of the capabilities of the platform, BaseCase has just launched a public dashboard to a widely known ‘classic’ model on treatment strategies for erosive oesophagitis by Goeree, Briggs and colleagues. It can be found here:
https://interactive.basecase.com/anon.py?GERD_Dashboard

Relevance of this subject to the audience of healtheconomicsblog.com
Of major importance to many health economics professionals, whether they are working in the industry, in academia or as consultants, is to clearly communicate the outcome of complex economic model to decision makers. Interaction with economic models can play an important role in communicating health economic evidence. It can help transferring economic evaluations to other settings, and the (technological) barriers for non-experts to interact with economic models can be substantially lowered. This new approach can make an important contribution to increase the impact of health economics on decision making.

Background
In the field of health economic, decision makers don’t often interact directly with the economic model that underlies most economic evaluations, even though this interaction has important benefits. For example, it can explain relationships, it can allow decision makers to incorporate the latest evidence and transfer a model to their own setting, and it can help to build consensus among stakeholders.
The reason economic models are not usually accessible to decision makers, is because of the technical complexities associated with modelling technologies. To overcome these technical difficulties, BaseCase uses modern web technology to allow interaction with economic models on the internet.

Additional information

BaseCase software
BaseCase GmbH develops software to make health economic models, such as cost-effectiveness and budget impact models, easy to use online. BaseCase has developed a web-based platform that allows our customers, from the pharmaceutical industry as well as non-profit organizations and academic institutions, to use and share health economic models online. This software makes complex models easy to understand, easy to use and easy to distribute.
Academic background in health economics
BaseCase Software was founded by Gijs Hubben in 2004. He has performed his PhD research under the supervision of Prof. Maarten Postma at the University of Groningen, the Netherlands. The subject was the exploration of the combination of web technology and economic modelling to support decision making. The PhD defence is scheduled for the 11th of May 2009. Hubben and colleagues conclude that (1) economic models of healthcare interventions can play a greater role to actively support decision making, if decision makers can directly interact with these models, (2) through the use of web technology, the technical complexities associated with the use of modelling technology can be overcome, and (3) web technology offers a convenient way to disseminate models to a broad audience of decision makers, both at the national and regional level.
Thesis Summary
Cost-effectiveness of infectious disease interventions combining economic modelling and web technology to support decision making
The ultimate goal of the economic evaluation of healthcare interventions is to inform decision makers how to optimally allocate healthcare resources. A commonly used type of economic evaluation is cost-effectiveness analysis. This method makes use of mathematical models to synthesize available evidence from a wide range of sources and project the future costs and effects of healthcare interventions. But the outcome of these models strongly depends on the regional setting and the number of relevant scenarios and strategies can be daunting. In this thesis we have explored the use of modern web technology to allow interaction with cost-effectiveness models via the internet, to enhance the role of economic models to actively and directly support decision makers, and to allow these models to be more easily adapted to other settings. We constructed web interfaces within several modelling studies of infectious diseases using different types of models: a decision analytical cohort model for a pneumococcal vaccination program (Chapter 2), two Markov models to study blood transfusion screening and HIV treatment (Chapters 5 and 7 respectively) and a discrete event simulation model to study screening strategies for methicillin-resistant Staphylococcus aureus (MRSA) at hospital admission (Chapter 4). This thesis was a ‘concept exploration’ rather than the evaluation of a method, because the requirements of web interfaces to economic models as well as the software to construct these interfaces had to be developed and tested first. Nevertheless, three important conclusions could be drawn related to the use of web technology to interact with economic models: (1) economic models of healthcare interventions can play a greater role to actively support decision making, if decision makers can directly interact with these models, (2) through the use of web technology, the technical complexities associated with the use of modelling technology can be overcome, and (3) web technology offers a convenient way to disseminate models to a broad audience of decision makers, both at the national and regional level.

Links
BaseCase Software
http://basecase.com

More example online economic models:
http://basecase.com/demo

Main publications
Web-interface supported transmission risk assessment and cost-effectiveness analysis of post donation screening – a global model applied to Ghana, Thailand and The Netherlands
Marinus van Hulst, Gijs A.A. Hubben, Kwamena W.C. Sagoe, Charupon Promwong, Parichart Permpikul, Ladda Fongsatikul, Diarmuid M. Glynn, Cees Th. Smit Sibinga, and Maarten J. Postma.
In press Transfusion 2009
Enhanced decision support for policy makers using a web interface to health-economic models–illustrated with a cost-effectiveness analysis of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine in the Netherlands
Hubben GAA, Bos JM, Glynn DM, van der Ende A, van Alphen L, Postma MJ.
Vaccine. 2007 May 4;25(18):3669-78

Inquiries and further information
Gijs Hubben
Health Economist / Founder
BaseCase GmbH
Steinhof 4.OG
Bahnhofstrasse 28
CH6300 Zug, Switzerland

M: +49 1522 305 6714
T: +41 41 560 4351
F: +41 43 456 9489
E: g.hubben@basecase.com

BaseCase software - http://basecase.com

Abacus International is launching a website summerizing NICE reviews

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 27 May 2009 07:07:00 +0000

Abacus International is delighted to announce the launch http://www.HTAinSite.com

HTAinSite contains a summary of the clinical and cost effectiveness evidence base reviewed by NICE along with headline recommendations. Quickly find previous guidance with a search engine, review statistical summary of approval rates and factors that affect them, print reports containing primary headline guidance for each TA and product and much, much more.

This project is the result of collaboration between Abacus International, OHE and City University.

HTAinSite:

1) Saves considerable time and effort. It has key data on each appraisal in one place making searching for information such as clinical data or cost effectiveness very fast, accessible and clear

2) Can compare your selected TAs. It can present the details of several appraisals alongside each other so that direct comparisons can be made quickly and easily

3) Has statistical reports. View statistics on recommendation by product, BNF category, assessment group, patient group and process, appeals by outcome and assessments by technology type

4) Can search for TAs using key words. It is not possible to search the NICE website for certain types of information using key words, for example appeal outcomes, whereas HTAinSite has this capability

5) Is published NICE technology appraisal specific. It has the direct advantage of only holding information on the technology appraisals NICE has published rather than information on all the work NICE is involved in. As a result, the search facility in HTAinSite is focused on the information contained within these appraisals and will give more relevant and accurate results

6) Holds information that is no longer available on the NICE website. For example, following a review of an appraisal (which is therefore replaced by a new piece of guidance) the documents relating to the original appraisal are removed from the NICE website. HTAinSite retains this information perhaps giving a more complete view of the issues for a particular disease area or product

Visit http://www.HTAinSite.com to view sample reports and subscribe.

Drug Deals Tie Prices to How Well Patients Do

noreply@blogger.com (ustaginnus@hotmail.com) — Mon, 27 Apr 2009 20:45:00 +0000

one more interesting article from the NY times...

ANDREW POLLACK
Published: April 22, 2009
Think of it as product guarantees by the drug industry.

Merck, via Bloomberg News
Januvia, by Merck, is part of a cost-control deal with Cigna.
Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health.
In a deal expected to be announced Thursday, Merck has agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar.
And last week, the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine.
“We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.”
Some experts hail such arrangements as a welcome step toward health care that rewards good outcomes for patients.
“We’re going to see a growth in outcomes guarantees for pharmaceuticals, and it’s very healthy,” said Robert Seidman, a consultant who was formerly the chief pharmacy officer for WellPoint, an insurance company.
Traditionally, discounts and rebates that drug companies offer insurers have been based on how much drug is used, not how well patients do. But the emerging, outcomes-based contracts would — in theory — better align the incentives of insurers, drug companies and the employers that provide health coverage toward improving people’s health.
Such pay-for-performance contracts started to take hold a few years ago in countries with national health systems, in which the government could effectively block a drug from being used if it was too costly.
Johnson & Johnson set what is considered the prototype deal in 2007 with Britain’s national health system, which had tentatively decided not to pay for the cancer drug Velcade. To avert that decision, the company offered essentially a money-back guarantee. If Velcade did not shrink a patient’s tumors after a trial treatment, the company would reimburse the health system for the cost of that patient’s drug.
In the United States, where insurance companies do not have national monopolies — and where Medicare, by law, is precluded from negotiating drug prices — insurers have less leverage with drug makers. Even so, they can give favorable treatment to certain drugs, by reducing the required co-payments, for example.
Under the Actonel deal, if a patient insured by Health Alliance suffers a nonspinal fracture despite faithfully taking Actonel, the drug makers will help pay for the medical care — spending $30,000 for a hip fracture, for instance, and $6,000 for a wrist fracture.
This clearly lowers the cost of the drug to Health Alliance, a small insurer in Illinois and Iowa. But Procter & Gamble and Sanofi-Aventis might benefit as well. The deal could reduce the pressure on the insurance company to move patients off Actonel, which costs about $100 a month, to less-expensive generic versions of Fosamax. And the insurer has kept Actonel in a tier of its drug list that requires a smaller co-payment than for a competing brand-name drug, Boniva.

The deal between Cigna and Merck is more complex.

Rather than getting paid more for good results, Merck will actually give Cigna bigger discounts on Januvia and Janumet. Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.
Moreover, in an unusual move, Merck will offer even greater discounts to Cigna on Januvia and Janumet if patients’ blood sugar is better controlled — regardless of whether the improvement comes through Merck’s drugs or other medications.
In effect, though, Merck is betting not only that its drugs prove superior but that Cigna’s incentives to reap the benefits of the deeper Januvia and Janumet discounts will prompt the insurer to try to keep patients on those drugs.
As part of the agreement, too, Merck will get better placement for Januvia and Janumet on Cigna’s formulary, meaning a lower co-payment for patients than for some other branded drugs. The deal was made with the pharmacy benefit management division of Cigna, which manages prescriptions for 7.1 million people.
Merck declined a request for an interview. In a statement the company said it was “committed to finding new approaches to demonstrate the value of our products to patients, physicians and payers.”
Januvia, approved in 2006, costs about $150 a month. Janumet, approved a year later, is a combination of Januvia and metformin, a widely used generic drug.
Eric Elliott, the president of Cigna Pharmacy Management, said his company was negotiating similar contracts with other drug makers.

“We wanted a contract that drives performance,” he said. “Getting this one out will provide more momentum.”

Cost-sharing arithmetic

noreply@blogger.com (ustaginnus@hotmail.com) — Mon, 27 Apr 2009 13:37:00 +0000

Hello Everyone,

comming back from the Zurich Oncology market access conference I received a couple of mails from readers regarding the entire risk sharing topic - many thanks for that.

For those of you having a subscription to BioCentury there was a very good review article on that matter (just posting the abstract):

• Cover Story - Cost-Sharing Arithmetic - NICE has added Celgene's Revlimid to its approved set of cost-sharing deals. But it has also shown it can walk away from these schemes if it doesn't like the numbers. In the long run, pricing specialists say it will be better to compile data showing superior clinical outcomes.

Also, I also received an interesting article from the US on new risk sharing deals.

Certainly a hot topic at the moment, I'll keep you posted on developments.

Cheers
Ulf

Payers view on risk sharing and outcomes based agreements...?

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 15 Apr 2009 08:11:00 +0000

Dear All,

in order to prepare for a conference talk that I will be giving next week in Zurich I asked the network via linkedin: "I would be interested in hearing your thoughts/comments on how payers view risk sharing and outcomes based agreements?"

Over the last week I have received a lot and valuable comments and therefore would like to thank all of you who provided an answer! Since this is a hot topic and many of you wrote me that you are actually wondering about the same issue, I post all answers below for the broader audience.

best wishes
Ulf

"I would be interested in hearing your thoughts/comments on how payers view risk sharing and outcomes based agreements?"

Answers received (for privacy reasons all names have been erased)

Payers may react positively if they disagree with your value hypothesis and wish proof in daily practice. They may react negatively if they feel no need e.g. one has always reimbursed non responders. Administrative burden is another important element that has to be traded off versus why not just a lower price?

My experience is that it very much depends on the therapy area/drug in question. Risk sharing agreements are very good for expensive drugs that has been approved by early data that has not yet shown its full potential. New oncology drugs are a good example of this I agree with xxx above that the burden of administration should be taken into consideration.

We have found in our work in this area that these schemes are only meant for a small minority of situations, and that over-emphasis on innovative risk sharing pre-launch may distract from basic focus on clinical value shaping and appropriate planning for traditional payer agreements.

In Spain I have tried to settle an agreement with one of our regions. We managed to reach a consensus about the value proposition, but it was impossible to agree on: 1.- Which Health Authority has to sign the agreement: the manager of the hospital, the Regional Health Authority, the National Health Authority. The payor or the provider? 2.- What to measure: subrogate or final variables, clinical or patient reported outcomes 3.- What subpopulation of patients: as SmPC, other. Should the contract be the same in all populations. 4.- Length of the agreement: first years to market or all. 5.- Who will measure the results of the drug?, a CRO, they or us? 6.- Should the agreement be public?

Ulf I have experience of both outcome guarantee and free access period based programs in the UK market. As xxx states, one of the big challenges with outcome based approaches is the ability of healthcare systems to capture the necessary data and also the costs of administration. Despite the challenges outcome based approaches are I believe inherently more appealing to payors as they mitigate risk to a greater extent than free access periods and sponsors have an inbuilt interest in ensuring patients maximize received benefits. In addition, outcome based approaches enable capture of additional, observational data which may support broader market access. If one is going down the road of simple, free access approaches I fully concur with xxx comments about what payors are looking for,ie.: - best cost savings - minimal administerial workload - transparency - aligned with clinical pathways kind regards xxx"

Ulf A couple of additional thoughts on the practicalities: - involve representatives from payor organizations in the development of any schemes - academic involvement can add significantly to the quality and acceptability of schemes, especially outcome based types kind regards xxx

I am seeing a more proactive request for this type of agreements from Spanish Regional Government payers, mainly when talking about very expensive drugs and with a cost-containment exercise in mind. There are already some examples in some regions, although details are kept confidential. However, as it has been mentioned, in my experience, they do not really know how to go about it: they can and do protocolisation of treatment regimens in certain subpopulation groups but do not know what or how to measure outcomes, clinical and economic. I regard this as a big opportunity for industry and payers. Personalized medicines offers a new, easier ground also.

Generally I think payers would like to see them happen more frequently but it is a treacherous pathway to take because of the measurement difficulties over the agreement (the outcomes part if you like) - the area is certainly evolving.

From previous discussion with payers on risk sharing, payers have often told me that they would like to see the true cost savings and/or benefit of getting involved in such a scheme. If the administrative burden and cost outweigh the savings then it is unlikely to generate any interest

…but I'm seeing an increasing number of job specs looking for "risk sharing / pay for performance" type roles.

We know NICE are all for it - in the revised STA submission form, there is even a place for such proposals. Also, in the new process, a risk-share has to be introduced at the time of submission. To date, people would wait to receive a negative ACD before suggesting a risk-share now they have to do it at the start.

...this is highly variable depending on the market. Some markets, such as France, already have financial based schemes in place (payback agreements), and therefore have little interest in outcomes based agreements. Others, are more open to the concept. However, a very important challenge is whether or not the payer has access to the necessary data to execute a risk sharing agreement - do they have the patient level information to be able to adjudicate the agreement later on? Payers, like everyone, are interested in agreements that: 1) Save them the most amount of money 2) Are very transparent (low risk) 3) Involve the least amount of administrative work

…Risk sharing agreements are very good for expensive drugs that has been approved by early data that has not yet shown its full potential. New oncology drugs are a good example of this….

don't have the answer but having the same question…For the time being, we have had a variety of failure and success building those kind of agreements with EU payers …

…..My views on usage of outcomes based agreement would depend very much on the nature of services contracted and market dynamics.

Latest edition of Spanish Journal for health economics online

noreply@blogger.com (ustaginnus@hotmail.com) — Sun, 12 Apr 2009 16:28:00 +0000

Hello everyone,

the latest edition of the Spanish journal for health economics is out. The journal is enjoying increasing readership within the Spanish speaking community although there are also publications in English. I contributed en editorial "The Pharmaevolution" speculating a little on the latest developments - consolidation is increasing again and new business and organizational models are being tested and deployed. Would be interesting to hear your thoughts on the sectors' evolution...?

Cheers
Ulf

UK allows private top-ups, privately

noreply@blogger.com (ustaginnus@hotmail.com) — Fri, 27 Mar 2009 07:45:00 +0000

Scrip

The UK department of health has published guidance for the national health service on
how to handle patients who want to pay out-of-pocket for licensed drugs that are not
funded by their local health authorities.
Private top-ups to publicly funded healthcare became the subject of heated political
debate after the health technology assessment agency for England and Wales, NICE,
refused to recommend several expensive anticancers for routine use in the NHS on the
grounds of cost.
Patients in some hospitals were allowed to purchase drugs privately and have them
administered at public expense, but other hospitals refused to combine public and private
treatments, insisting that patients choose one system or the other for all of their care.
Some public figures objected to these uneven policies - a postcode lottery, they said -
while others denounced top-ups as the beginning of a two-tier healthcare system. Still
others called for NICE to be abolished, arguing that no patient should be denied
treatment on the grounds of cost.
Professor Mike Richards, the national cancer director, studied the problem and
recommended last year that private payments should be allowed within the health
service. After a consultation period, the government accepted his proposals; the new
policy took effect on March 23rd.
The main principles of the department's guidance are that NHS care should not be
withdrawn from patients who choose to buy additional private care, and that the NHS
should continue to provide free of charge all care that the patient would have been
entitled to had he or she not chosen to have additional private care. But it says the NHS
should never subsidise private care with public money.
It calls for a strict separation of private and public healthcare. "Private care should be
carried out in a different place to NHS care, as separate from other NHS patients as
possible," it advises. By "a different place", it means private facilities or part of an NHS
organisation that has been "permanently or temporarily designated for private care, such
as a private wing, amenity beds or a private room."
Among several illustrations, the department's guidance describes a cataract patient who
wants to pay for a multifocal replacement lens rather than have the NHS standard single
focus lens inserted during surgery. The patient should be informed "that it is not possible
to pay for the multifocal lens while carrying out the surgery on the NHS as it is not
possible to separate the private element from the NHS element of care". SCRIP - World
Pharmaceutical News - www.scrippharma.com FILED 26 March 2009 COPYRIGHT
PHIND: Pharma & Healthcare Ind News - today only (PHID)
Page 23
Informa UK Ltd 2009
COPYRIGHT BY T&F Informa UK Ltd

Drug-Industry Shakeout Hits Small Firms Hard

noreply@blogger.com (ustaginnus@hotmail.com) — Mon, 23 Mar 2009 19:35:00 +0000

Another Wave of Acquisitions Is Likely as Companies Worry About Their Drug Pipelines and Health-Care Change – March 10, 2009

By AVERY JOHNSON and RON WINSLOW
Drug makers have begun a frenzied consolidation drive that is redrawing the industry landscape.
Merck & Co.'s $41.1 billion agreement to acquire Schering-Plough Corp., announced Monday, follows Pfizer Inc.'s $68 billion January takeover deal for Wyeth. Roche Holding AG's seven-month pursuit of Genentech Inc. was also nearing an agreement Monday, according to people familiar with the situation.
The push to consolidate is being driven by the knowledge that the big companies' pipelines aren't producing enough new moneymakers to keep growth going when major products lose patent protection over the next couple of years. As a result, the drug giants are looking to consolidations that will cut costs by combining research and sales efforts and eliminating other overlaps.
What will be left is an industry dominated by behemoths, raising questions about the fates of smaller drug companies, as well as the countless small biotechs hungry for suitors. Even though their labs aren't what they used to be, the major pharmaceutical companies have product lineups that still command fat margins, giving most of them the cash to pursue deals.
"There are too many companies chasing smaller revenue opportunities, so there's got to be a shakeout," says analyst Tim Anderson at Sanford C. Bernstein & Co. "If you've got cash and the value of the companies you want to buy is lower, it's the perfect setup."
Johnson & Johnson seems most likely to be involved in the next wave of consolidation in the drug industry, analysts say.
There could also be pressure tied to moves in Washington, where health-care reform could eat into margins. Bigger drug companies might be in a better position to bundle their products and negotiate with the government, analysts say.
The wreckage on Wall Street is also a factor: The health-care sector is traditionally viewed as a relatively safe bet, making it easier for drug companies to get financing than other industries.
But megadeals haven't cured industry problems in the past. Pfizer paid $116 billion for Warner-Lambert in 2000 and an additional $54 billion for Pharmacia in 2003, yet still needed to acquire Wyeth this year to help replenish an anemic pipeline.
As the dust settles, Eli Lilly & Co., Bristol-Myers Squibb Co., AstraZeneca PLC, Sanofi-Aventis SA and Johnson & Johnson seem most likely to be involved in the next wave of consolidation, analysts say. Factors including existing partnerships, the timing of patent expirations and how well drug makers can absorb multiple acquisitions could affect who will be a buyer and who will be a seller.
"Bristol and Lilly stand out in terms of size versus the rest of the industry," says Les Funtleyder, an industry analyst at Miller Tabak. "They'll have to do something, because it's a consolidating industry."
Lilly, based in Indianapolis with a market capitalization of $32 billion, will lose patent protection on its bestselling antipsychotic Zyprexa in 2011. It just bought ImClone for $6.5 billion. Mr. Anderson suggests it could merge with Bristol-Myers, whose chief executive, James Cornelius, came from Lilly.
Lilly, which has strong ties to Indiana and an undesirable series of patent losses coming up, would be more likely to buy than sell. "There's no way Lilly's a takeout," says Mr. Anderson.
Mark Taylor, a Lilly spokesman, says, "We're not interested in large-scale M&A activity in pharma and believe small and medium scale acquisitions, licensing and internal development" are the best way forward for Lilly.
Bristol-Myers faces a similar dilemma, because Plavix, the bloodthinner it sells with Sanofi-Aventis, faces generic competition in 2011. A merger with Lilly could face antitrust hurdles because both companies have clotting drugs and antipsychotics. A tie-up with Sanofi-Aventis is frequently rumored because of Plavix.
Bristol-Myers sold its ConvaTec wound-care business last May for $4.1 billion and offered a $720 million partial initial public offering for its nutritional business last month -- divestitures that could either add to its war chest for deals or make it a more attractive takeover target. Bristol-Myers declined to comment.
Sanofi-Aventis's new chief executive, Christopher Viehbacher, said in an interview last week that he isn't seeking a megamerger but would consider deals of under $19 billion. Some analysts say that could leave Sanofi-Aventis open to buying the U.S. biotech company Biogen Idec Inc., which has a market value of $13.3 billion. Both companies have declined to comment.
Another possibility for Bristol-Myers could be a deal with Britain's AstraZeneca because the companies are co-developing a drug for diabetes called saxagliptin. One rationale for the combination of Merck and Schering-Plough is to run the companies' joint venture selling the cholesterol medicines Vytorin and Zetia under one roof. AstraZeneca declined to comment, but has said in the past it's not interested in big deals.
Catherine Arnold, a drug-industry analyst at Credit Suisse, says that hasn't stopped companies in the past. "Sanofi, Glaxo and Novartis have said they're not interested in big deals, but Jeff Kindler said that nine months ago," she said, referring to a statement in March 2008 by Pfizer's chief executive that he did not see a megamerger on the horizon.
Meantime, 180, or 45%, of publicly traded biotech companies have less than a year of cash on hand, and about half are trading below $1 a share, according to BIO, the trade group for the biotechnology industry based in Washington.
But biotech acquisitions aren't a panacea. One reason is that small companies offer little opportunity for cost savings. Another is the worry that founders and scientists will leave if their companies are taken over.
In the interview last week, Mr. Viehbacher indicated his preferred strategy would be to enter partnerships with biotech companies rather than acquire them. "You don't want to bring them in to the mother ship because then you ruin it," he said.
The severe funding crunch facing small biotech companies is prompting worries that important new drugs won't make it to market, impeding the progress of medicine. "Innovation has been on the biotech side, but now the money is gone," says Edward Saltzman, president of industry consultant DefinedHealth. "We're in a pickle."
Meanwhile, the next target could actually be Schering-Plough. Johnson & Johnson, an historically acquisitive company, could throw a wrench in Merck's plan by making a more attractive offer for Schering. J&J sells Remicade, an anti-inflammatory drug, with Schering-Plough, and a deal for the company could give it full rights to the drug.
--Jeanne Whalen contributed to this article.
Write to Avery Johnson at avery.johnson@WSJ.com and Ron Winslow at ron.winslow@wsj.com
Printed in The Wall Street Journal, page A12

Drugs to be approved for NHS use within six months, ministers announce

noreply@blogger.com (ustaginnus@hotmail.com) — Wed, 04 Mar 2009 07:36:00 +0000

Patients will get approved drugs on the NHS within six months instead of waiting up to two years, as ministers announce plans to speed up the National Institute for Health and Clinical Excellence.

by Rebecca Smith, Medical Editor, The Daily Telegraph
Last Updated: 2:12PM GMT 03 Mar 2009

The drug rationing body, Nice, has been accused of being too slow in its appraisals of drugs meaning patients are forced to wait years for medicines which may prolong their lives.

Ministers have announced a package of measures to speed up the process including adding another committee of experts to consider the drugs and 'horizon scanning' earlier in the drug development programme for medicines that will need to be referred to Nice.

The move comes after Nice ordered its committees to put extra weight on the final months of life when appraising drugs for terminal patients with rare conditions.

This followed public outcry over draft guidance which did not approve four kidney cancer drugs, including Sutent, which can extend the lives of sufferers by months.

Guidance is being issued to primary care trusts which decide whether to fund drugs where Nice has not appraised the drug or has not yet come to a decision.

PCTs have their own panels which consider individual patients for 'exceptional case' funding but this has led to a postcode lottery where all people in one area may be funded but none in a neighbouring area. The guidance is aimed at making the decisions more consistent and training will be provided to help.

Health Minister, Lord Darzi, said: "Last year in High Quality Care for All I set out our commitment to speed up the Nice process. Together, the measures set out today build on this commitment and will help provide faster and fairer access to new drugs and treatments – great news for patients.

"We are delighted to be working in partnership with Nice to ensure that new drugs and treatments are assessed sooner and more quickly in future, leading to improved and higher quality care for patients.

"The guidance for PCTs will help the NHS to ensure that local decisions are robust and transparent, leading to more consistency in those exceptional cases where there is no existing NICE guidance."

Andrew Dillon, Chief Executive of Nice, said: "This is an important consultation on the way that topics are chosen and referred for Nice's world-leading appraisals of new drugs and treatments. We are very keen to ensure that our guidance is produced as quickly as possible to benefit patients and the NHS.

"Speeding up non-cancer appraisals by at least three months to come in to line with the cancer appraisals, and increasing transparency by clarifying topic selection criteria, are just some of the potential improvements we and the Department of Health are suggesting.

"The views of patients, the public, health professionals and other stakeholders on the proposed changes to the topic selection process will be very helpful, and we look forward to receiving their comments."

A consultation on the proposals will run for three months.