Risk sharing workshop @ ISPOR

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

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

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

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

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

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

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

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?

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

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

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

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

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

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

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