2.03.2010

Oncology Innovative Pricing deal with NICE on lung cancer drug

A new oncology patient access scheme is currently being proposed to NICE by Astra Zeneca in the UK. This is an interesting proposal of a flat fee coupled with a registry.

Key points:

- NICE is minded not to recommend gefitinib due to the lack of information provided in order to assess the most probable cost/QALY
- NICE has asked AZ to provide additional information
- A patient access scheme is envisioned, which proposes that a fixed cost is charged for each patient treated with gefitinib regardless of the length of treatment.
- AZ proposes setting up a gefitinib registry which will provide real life data. In 3years time, AZ commits to evaluating these data and renegotiating with NICE on the value of gefitinib

In summary, the Appraisal Committee could not assess whether gefitinib is a cost-effective treatment option because it did not have sufficient information to assess the most plausible ICER for gefitinib compared with standard platinum combination therapy or with pemetrexed and cisplatin. Therefore the Appraisal Committee is minded not to recommend gefitinb for the treatment of locally advanced or metastatic NSCLC. It is recommending that clarification should be sought from the manufacturerer, including analyses that use alternative survival extrapolations and application of hazard ratios, amended first-line chemotherapy costs and chemotherapy cycles, alternative prevalence rates of EGFR-TK mutations and alternative assumptions about the cost of the EGFR-TK mutation tests.

In more detail:

Appraisal Committee’s preliminary recommendations

1.1 The Committee is minded not to recommend gefitinib as a treatment option for people with locally advanced or metastatic non-small-cell lung cancer (NSCLC).

1.2 The Committee recommends that NICE requests further clarification on the clinical and cost effectiveness of gefitinib from the manufacturer as described in sections 1.3 to 1.5. This information should be made available for the next Appraisal Committee meeting.

1.3 NICE requests an exploration of alternative probability distributions for the extrapolation of progression-free survival and overall survival beyond the timeframe of the Iressa Pan Asian Study (IPASS). This should include the following.

1.4 Independent survival curves (overall survival and progression-free survival) for both gefitinib and paclitaxel/carboplatin based on the IPASS data and exploration of different approaches to applying the hazard ratio to incorporate other comparators (for example, pemetrexed and other platinum-based regimens). The different approaches to applying the hazard ratio should consider using either gefitinib or paclitaxel/carboplatin as the baseline.

1.5 Examination of alternative probability distributions and consideration of model fit to early trial data and the shape of the curves at the tail of the distribution.

1.6 Observational or epidemiological evidence on long-term survival in patients with locally advanced or metastatic NSCLC and how this relates to the most plausible model fit.

1.7 The provision of individual patient-level data from IPASS to enable the Evidence Review Group (ERG) to validate key aspects of the submitted model, including the modelling of overall survival and progression-free survival, the choice of parameter values, and structural assumptions.

1.8 NICE requests an analysis to determine the robustness of the incremental cost-effectiveness ratio (ICER) to alternative survival distributions for progression-free and overall survival, based on the independent survival curves for gefitinib and paclitaxel/carboplatin from the IPASS data. The analysis should also provide evidence on alternative approaches to applying the hazard ratio to link to other comparators. These cost-effectiveness analyses should include amended costs for first-line chemotherapy to account for a lower level of dosing in female patients and varying the number of first-line chemotherapy cycles between four and six.

1.9 NICE also requests further analyses to explore the sensitivity of the ICER to:

1.10 varying the prevalence of EGFR-TK mutations between 5% and 17%, taking into account different scenarios costs, comorbidities and the probability of obtaining a specimen suitable for testing (including possible repeat biopsy and the possibility of not obtaining a useful result)

1.11 alternative assumptions about the volume, and hence cost, of the EGFR-TK mutation tests carried out.

On the Patient access scheme:
The Committee noted that the patient access scheme involved a fixed cost being charged for each patient treated with gefitinib regardless of the length of treatment. The Committee agreed that such a scheme was probably relatively simple to administer in the NHS. However, the Committee was concerned that although such a scheme may be beneficial across the whole NHS, there could be some areas where patients receive short courses of treatment and the cost of gefitinib under such circumstances would be greater with the scheme than without it.

The NHS and the cost-benefit dilemma

New research by health economists at the University of York has raised concerns over any move to broaden the range of costs and economic benefits considered in the analysis of new NHS treatments. A study by the University’s Centre for Health Economics suggests that widening the perspective used by the National Institute for Health and Clinical Excellence (NICE) to assess the cost-effectiveness of new technologies may not benefit either the NHS or the wider economy.

The research examined a range of possible policies and a number of case studies from past NICE appraisals.

The new study suggested that taking into account effects outside the NHS would require trade-offs to be made between the overall impact on the health of NHS patients, other social concerns and wider costs and economic benefits.

Extending the NICE perspective for drug assessment beyond the NHS raises questions of how to measure and value a range of wider economic effects, requiring controversial judgments about social values.

The research found that maintaining an NHS perspective would, in many circumstances, reflect overall economic effects because technologies which are regarded as cost-effective and offer overall health improvement for patients would also be expected to result in overall net economic benefits.

In addition, extending the perspective for all technologies appraised by NICE would impose additional costs on NICE’s appraisal process and introduce the possibility of a biased assessment if the economic benefits associated with other NHS care which may be displaced are more difficult to identify.

Consideration could be restricted to exceptional cases where the external economic benefits are likely to be substantially greater or less than current NHS activities which may be displaced.

This more focused approach would require greater clarity on how wider effects will be considered by NICE, as well as criteria to identify exceptional cases, possibly based on the nature of the technology, the type of disease and the patient population. But the researchers warn that repeated application of this policy will ultimately lead to significant impacts on the NHS and a positive bias in favour of new technologies.

The independent study, which was commissioned through the Department of Health’s Policy Research Programme, will be discussed at a workshop this Spring.

ENDS

Notes to editors:
The research is available at www.york.ac.uk/inst/che/publications/publicationsbyyear.htm

This is an independent report commissioned and funded by the Policy Research programme in the Department of Health. The views expressed are not necessarily those of the Department.

The Centre for Health Economics is widely recognised as a leading research centre in its field. Operating across all areas of the discipline, with a particular emphasis on methodological thinking and high policy impact, CHE is known especially for its work in health technology assessment, health status measurement, performance measurement and productivity, health care financing, and econometric methodology. The University was ranked joint first for health services research in the 2008 Research Assessment Exercise.

Contact details
David Garner
Senior Press Officer
UK

Tel: work +44 (0)1904 432153
dcg501@york.ac.ukKeep up to date

2.02.2010

UK and Denmark are dropped from the reference country basket for price revisions in Spain

It´s good to see that some countries health authorities finally wake up to the issues caused by the declining British pound and other non Euro currencies on pharmaceutical prices through international reference pricing, at launch or during regular revisions. In a public meeting last week a member of the pricing comission of the Spanish ministry of health stated that the UK and Denmark will from now on be excluded from that process, however the small caveat is that potentially Greek prices will get more attention.

Some more comments can be found at this weeks edition of El Global.

Cheers
Ulf

1.27.2010

2010 first Risk Sharing deal with NICE

National Institute for Health and Clinical Excellence

January 2010

Final appraisal determination
Certolizumab pegol for the treatment of rheumatoid arthritis

1 Guidance
1.1 Certolizumab pegol is recommended as an option for the treatment of people with rheumatoid arthritis only if:
certolizumab pegol is used as described for other tumour necrosis factor (TNF)-inhibitor treatments in ‘Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis’ (NICE technology appraisal guidance 130) and
the manufacturer provides the first 12 weeks of certolizumab pegol (10 pre-loaded 200-mg syringes) free of charge to all patients starting treatment.

This is an approximate $4,000 reduction from the first year access cost of Cimzia.

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.

9.22.2009

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

8.17.2009

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."

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