12.22.2009

NHS watchdog is winning the price war with drug companies

Dear Readers,

I would like to close posting for this year with yet another interesting article around NICE and patient access schemes. 2009 has certainly been "The" year of Risk Sharing and alternate pricing discussions.
This is also a good opportunity to thank you all for the many messages I have received and the overwhelmingly positive feedback on the blog (although posting has been slow at times due to my crazy schedule) and the workshop on Risk Sharing that Olivier and I have facilitated at ISPOR in Paris. Many thanks also to all of you who pointed out interesting articles and issues; please keep it up. Guest post are equally welcome, if you have written an interesting piece of discussion and/or any opinion you may have on our day to day business please send it along.

With my very best wishes for the holiday season!
Merry Christmas
Cheers
Ulf


from The Independent
By Jeremy Laurance, Health Editor
Monday, 21 December 2009

Manufacturers forced to negotiate cost deals to gain approval for cancer medicine

Pharmaceutical companies are being forced to cut the price of high cost cancer drugs for the first time as a result of a tough new approach by the NHS medicines watchdog, the National Institute for Clinical Excellence (Nice).
In the latest example, Nice has today announced approval of trabectedin, a drug for soft tissue sarcoma, a rare cancer that can occur anywhere in the body, after the Spanish manufacturer, PharmaMar, agreed a deal which could halve the cost to the NHS.
It is the third time in the past year that companies have lowered the price of cancer drugs in order to get them approved by Nice. Similar deals were done in August with the makers of a drug for kidney cancer and in June for multiple myeloma.
One drugs expert said: "Whereas in the past companies went off in a huff when Nice refused to approve their drugs because of their high cost, now they are returning to the negotiating table to work out an acceptable deal."
The drug, trabectedin, is the first new treatment for soft tissue sarcoma in 20 years. Clinical trials show it can extend life in patients with advanced sarcoma from an average of eight to nine months to 12 to 13 months.
About 2,000 people a year develop the cancer in the UK, of whom 500 to 600 have an advanced form.
Trabectedin costs £3,500 to £5,000 per infusion, which is given every three weeks to one month. Nice initially rejected the drug as being too expensive for the benefit it brings.
That forced PharmaMar to resume negotiations with the Department of Health over the price. The company subsequently agreed to cover the costs of the drug for any patient who needed it beyond five treatment cycles, effectively limiting the cost to the NHS to £17,500 to £25,000 per patient, compared with £40,000 to £60,000 for patients who survive the average 12 months.
Carole Longson, director of the Health Technology Evaluation Centre at Nice, said the reduction in the overall cost of trabectedin had meant Nice was now able to recommend the drug.
"We are delighted the independent appraisal committee has been able to recommend trabectedin. Treatment options for this type of cancer are limited. [This] represents a step forward in the care of this group of patients," she said.
"Sometimes [the price of new drugs] is just too high for the degree of benefit they demonstrate. In these circumstances, companies can consider and present a new value proposition if they wish to. We would certainly encourage companies to help make their products cost-effective for the benefit of individual patients and the NHS as a whole."
For much of its decade-long existence Nice has been held to ransom by the drug industry, which has relied on patients, charities and medical organisations to lambast it each time it rejected a drug because of its excessive cost. Nice is prevented from negotiating with drug companies on price by its constitution.
In January the Government reached a new deal with the drug industry under the Pharmaceutical Price Regulation Scheme, which gave it the right to negotiate "patient access" arrangements to cut the cost of drugs to the NHS.
At the same time, Nice was ordered to increase its cost limits for new drugs for end-of-life conditions, from an estimated £30,000 per quality-adjusted life year (qaly) to £40,000-£45,000 per qaly.
Roger Wilson, director of Sarcoma UK, said: "Nice is now essentially an NHS price control mechanism. What we are seeing now is every technology appraisal of a new drug being refused at the first stage. Nice presents an open invitation to the company to go to the Department of Health and say we want to negotiate on a patient access scheme."
In August, Pfizer agreed a similar deal to win Nice approval for its kidney cancer drug, sunitinib (brand name Sutent). Under the deal, Pfizer said it would pay for the first cycle of treatment, worth around £3,100, for all patients.
In a separate case, Celgene, the manufacturers of lenalidomide (Revlimid) for multiple myeloma, agreed a price-limiting deal to win Nice approval under which the company will cover the cost after two years of treatment.
Andrew Wilson Webb, head of the Rarer Cancers Forum, said the new strategy was "a naked government ploy" to reduce the cost of drugs by squeezing pharmaceutical company profits.
He added: "In that sense I am all behind it. But the impact on drug company profits could lead to the withdrawal of research from the UK. If we got to the situation where clinical trials were no longer run in the UK, patients could suffer."

12.04.2009

MS drugs scheme fails to deliver results

The MS scheme was the first implemented Risk Sharing scheme in the UK, the article highlights nicely the difficulties with perforance based schemes in difficult disease areas..

from the Financial Times

By Andrew Jack
Published: December 3 2009 01:56 | Last updated: December 3 2009 01:56

A pioneering scheme designed by the government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched.
In an article published on Wednesday in the British Medical Journal, a team of medical academics concluded there was no evidence to date that five drugs given since 2002 to multiple sclerosis patients were cost-effective.
The long-awaited study was the first public analysis of a “risk-sharing” programme established by the Department of Health and a series of pharmaceutical companies after the government’s medicines watchdog advised against use of their products by the National Health Service.
The findings of the research, led by Mike Boggild, a consultant neurologist from the Walton Centre in Liverpool, raise questions about the growing number of other pharmaceutical risk-sharing schemes subsequently agreed between drug companies and government.
They also stirred further criticism of the National Institute for Health and Clinical Excellence , which assesses the cost effectiveness of new drugs, and the willingness of the NHS to follow its recommendations.
After Nice rejected the drugs Avonex, Betaferon, Rebif and Copaxone as poor value for money in 2002, the drug companies discounted their products to between £5,800 and £8,000 ($9,600 and $13,326) on condition that the price could change again after as little as two years if results were 20 per cent more or less effective than claimed.
However, it took until 2005 before the 5,500 multiple sclerosis patients necessary to assess the drugs had been recruited, and the data was only finally released this week, more than two years after the first evaluation period ended in 2007.
Echoing criticisms raised when the scheme was first launched, Dr Boggild said it was hard to assess the cost-effectiveness of multiple sclerosis drugs because of the difficulties in comparison with lack of treatment and because their effect can only be observed over long periods.
“There would have been easier diseases to study with this sort of study,” he said.
The Multiple Sclerosis Society, a patient group, criticised the “belated” publication of the data, called the scheme “ineffective” and highlighted that the ability to gain access to the drugs varied widely across the UK, and was among the lowest levels in Europe.
“This is a deeply frustrating situation,” said Simon Gillespie, chief executive.

12.03.2009

New report on big pharmas' reputation

Dear All,

just came across a report announcement from firstword.

With all what is going on in the industry it sounds like an interesting piece of work looking at the various aspects in a somewhat different and holistic fashion.

Cheers
Ulf

11.04.2009

Market Access Position with GSK

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

11.03.2009

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

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

10.30.2009

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

10.09.2009

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.

9.28.2009

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.

9.23.2009

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

9.02.2009

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

8.18.2009

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."

8.17.2009

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

8.05.2009

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

7.15.2009

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."

7.08.2009

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.