German IQWIG: New Methods for Cost-benefit assessment of pharmaceuticals published

Now the new assessment methods are finally out. Everyone was waiting to find out what was going to happen in Germany with the additional mandate of IQWIG (Institute for qality and efficiency in the healthcare system) to assess the cost-benefit relation of new pharmaceuticals. The main points of the new methods are:
- cost-effectiveness/benefit assessments will only be disease-specific
- price (price cut-off point) is dependent on existing competitors and incremental "effect"
- there is apparently no discussion about thresholds, such as QALYs etc.
- assessment will be supplemented by budget-impact analysis

For an English version of the method paper, click here.

I am certain there will be lots of discussions among all stakeholders and it remains to be seen how that turns out in Germany. I will be posting the upcoming news on the matter, stay tuned!


Value based pricing in Oncology - presentation at the 19th annual Cancer Progress conference in New York

MattsonJack Vice President Lee Blansett addresses the issue of Value-Based Pricing for Oncology Drugs, Including the Role of Biomarkers in Pricing - Will They Help to Set Price Points, Affect Reimbursement?

Click here for more details on the program.


Best Practices in Global Oncology Clinical Trials - free event

Prologue is hosting a free event on Best Practices in Global Oncology Clinical Trials. More details on marketwire.


New book: Best practices in biotechnology business development

Yali Friedman's new book on biotechnology business development is coming out soon. We have contributed a chapter on applied pharmacoeconomics for biotech CEOs/executives. Watch this space for the chapter posting when the book is in the stores. See below the book description from Yali's blog.

First Edition, March 2008, Perfect Bound, 186 pages, US$67.95, ISBN: 978-09734676-0-4
Best Practices in Biotechnology Business Development

Valuation, Licensing, Cash Flow, Pharmacoeconomics, Market Selection, Communication, and Intellectual Property

Seeking to meet the need to understand how to practice the business of biotechnology, these best practices provide a framework upon which to understand critical issues in biotechnology business development. Experts from a wide range of disciplines have composed best practices based on their experiences and expertise, creating a vital toolbox covering a broad spectrum of topics. These best practices will enable you develop a better understanding of the key elements in these operations and empower you to better manage their implementation.

Better differentiation of oncology drugs will be required for market access

Today I came across a timely article from Graham Lewis, VP global strategy at IMS, on oncology drug development and related market acces and funding issues.


Outcomes Research Faculty Position at University of Utah College of Pharmacy

Dr. Diana Brixner from the university of Utah (Associate Professor and Chair Department of Pharmacotherapy) has asked me to post a new opening for an outcomes research faculty position at her department. For details and contact information see below post.

Tenure Track Outcomes Research Faculty Position
Associate/Professor Rank
Department of Pharmacotherapy
University of Utah College of Pharmacy
Salt Lake City, Utah

The Department of Pharmacotherapy is seeking to fill a 12-month, tenure track faculty position at the minimum rank of Associate/Professor within the disciplines of outcomes research including health economics, biostatistics, and clinical outcomes. Applicants must possess an earned doctorate in behavioral research, pharmacoeconomics, health economics, pharmacoepidemiology, or a health services research-related field. An undergraduate or professional degree in Pharmacy is desirable, but not required. The ideal candidate will possess an outstanding research record as well as a strong interest, competence and commitment to excellence in teaching in the professional and graduate programs.
The College of Pharmacy is situated in the foothills of the Wasatch Mountains in L.S. Skaggs Hall, which houses college and departmental offices. The College of Pharmacy is part of the Health Sciences Center which incorporates the University of Utah Hospital and Clinics, the School of Medicine, the Colleges of Health, Nursing, and Pharmacy, the Eccles Health Sciences Library and a state of the art Health Sciences Education Building. The Health Sciences Center offers an environment conducive for interdisciplinary and translational research. The University of Utah College of Pharmacy is consistently ranked in the top five pharmacy schools nationally receiving National Institutes of Health funding for research. The successful applicant is expected to complement the strong research program at the College of Pharmacy.
Qualified applicants should send by mail and email a letter of intent, current curriculum vitae, and the names and addresses of three references to:

Joseph Biskupiak, Ph.D. or Nancy Nickman, Ph.D., Co-Chairs
Outcomes Research Faculty Search Department of Pharmacotherapy, University of Utah College of Pharmacy
30 South 2000 East – Room 25

Salt Lake City, UT 84112-5820

(801) 581-5984
joseph.biskupiak@pharm.utah.edu or mailto:porlando@pharm.utah.edu

The University of Utah is an EEO/AA employer and encourages applications from women and minorities.


Health Economic question of the week @ healtheconomics.com

Dr. Patti Peeples has posted a question about liason between health economics and pricing departments on her website. Some companies have health economics directly combined with strategic pricing while others have seperate P&R departments. In todays environment, to get the combined pricing/value demonstration strategy right is obviously a key business consideration and it would therefore be insightful to see how other people do get aligned. Take some time and provide feedback on her webpage.

Pharmaceutical pipeline in Europe

The Business week published an interesting article around EU pharma's drug development outlook to 2009.


Health Economics model wizard in Excel

Matthew Black has posted today the below message on the healthecon discuss list. I have not yet heared of his group but perhaps that model wizard is useful for inhouse and/or early analysis or more.... If someone should check it out, it would be nice to hear back about this tool.

matthewblack@healtheconomica.com wrote:
We have developed an Excel-based wizard which automatically generates health economic models such as Markov models and decision tree models- including patient level simulation and probabilistic sensitivity analysis. The wizard also automatically generates a report summarising the model including model figures, model design specification, input and output data, and graphical analysis including scatterplots. For a free trial version or more information please contact: info@healtheconomica.com Kind regards, Matthew
Matthew Black MSc. Senior Health Economist HealthEconomica

Journal of Commercial Biotechnology - free online January edition

Yali Friedman has published the January edition of the Journal of Commercial Biotechnology. Companies currently hiring may find the article around "being a better interviewer ..." useful. There is also an update on biogenerics and much more interesting stuff around the biotech industry.

10% drug price cut in the UK

By Andrew Jack and Nicholas Timmins

A cut of 10 per cent in the prices the NHS pays for prescription medicines is being sought by the government in a deal it plans to conclude with the pharmaceutical industry by the middle of the year.
Alan Johnson, the health minister, told the Financial Times that he planned to generate substantial savings in the drugs budget during talks to be completed by June on the Pharmaceutical Price Regulation Scheme, the agreement that covers the price to the NHS of branded drugs.
Government officials are believed to have staked out an initial position with industry to cut the £11bn annual medicines bill by at least 10 per cent, or about £1bn.
The demand is part of the health department’s efforts to make savings of 3 per cent a year, imposed by the Treasury as part of the comprehensive spending review announced last year.
Pharmaceutical industry negotiators have expressed surprise and frustration at the demand. They agreed to an average 7 per cent cut in medicine prices in 2005 as part of the last renegotiation of the PPRS, which was meant to run until 2010.
The industry says the five-year deal provides predictability and stability in pricing, encouraging investment in new drugs.
It is concerned that the department is interested only in the narrow issue of reducing medicine costs, without taking account of the savings drugs can provide in health and social care costs, and the damage that lower prices could do to investment in research and development in the UK.
The industry may endorse calls to remove “branded generics” – drugs that are already off patent – from the PPRS. But in return it will seek higher prices for innovative drugs and much quicker uptake by the NHS of new products, arguing that the UK lags behind other countries in adopting new pharmaceuticals.
Aside from Mr Johnson’s desire to save money, the PPRS is under pressure from two reports from the Office of Fair Trading. One called for the scheme to move from its present basis – where it largely controls profits – to an approach based on value, where the amount the NHS pays would be much more closely related to the benefit the drug produces. That would probably produce higher prices for some drugs, but lower ones for others. The other report criticised medicines distribution.
There have also been demands for a review after a legal judgment last year that ruled in favour of GlaxoSmithKline against the department, in arguing that the PPRS was not an informal agreement but a formal legal contract.
Mr Johnson told the House of Commons health select committee late last year that pharmaceuticals was one of the areas he was targeting for savings.
Stressing the requirement to secure efficiency savings of 3 per cent a year, he said: “We have reopened negotiations with the pharmaceutical industry on the PPRS” and, along with improved procurement and spreading best practice in the NHS, the PPRS was “a very big and important part” of achieving the savings.


The Ideas and Influence of Alan Williams

A new book published in association with the office of health economics...

Edited by Anne Mason and Adrian Towse, Respectively Research Fellow, University of York; Director, Office of Health Economics, London
BE REASONABLE: DO IT MY WAY!The sign on Alan Williams’ desk revealed his sense of humour, a man who invited and relished debate, but always recognising that intellectual pursuits were a means to a practical end. Perhaps best known for his work within cost-benefit analysis, Alan Williams was a man of principles who developed guiding values in healthcare economics that embraced and encouraged active intellectual engagement and progression. He was concerned with the philosophical and ethical issues that underpin decision making and his courageous intellectual battles bore new ideas and revised ideology. This compilation of papers and further discussions arising from the Alan Williams tribute conference provides an analysis of the evolution and current status of key concepts in the field. It is highly recommended for health economics professionals and students.

‘To recognise and appreciate Alan’s legacy, the task falls to the health economics community to ensure that we do not shirk our responsibilities: the need to be intellectually rigorous without being rigid; to keep in sight the practical implications of our work; to acknowledge the shortcomings within our discipline; and to move forward in the spirit of the Williams way.’
Anne Mason and Adrian Towse, in the Preface

The value of a QALY

Someone sent me this morning a refreshing editorial on the QALY/Threshold discussion. Its funny, well written and to the point. Definitely worth a read!

Pharmacoeconomics 2008; 26 (1): 1-4


Speciality pharmaceuticals on the upswing

First of all Happy New Year to everyone! Let's see what surprises brings 2008 for our industry. The press is full of speculations around the upcomming pipeline issues for many large companies.. see the latest post below:

December 30, 2007Associated Press Newswires
WASHINGTON (AP) - There is no quick remedy for what ails the pharmaceutical industry: a tougher environment for drug approvals and a dwindling pipeline of new medications.
But these twin challenges -- evidence that the heyday of blockbuster drug-development is over -- are forcing the industry to ponder big changes in the laboratory. The biggest, analysts say, is likely to be a shift toward finding treatments for patients with rare diseases, or unusual strains of common afflictions.
By focusing on boutique medications, analysts say, drug makers will arouse less scrutiny from regulators, who have become extra sensitive to the potentially fatal side effects of widely prescribed medications for ailments such as arthritis and diabetes. The growing need to market niche treatments is also dictated by the reality of the business, in that there are fewer widespread maladies for which a popular pill doesn't already exist.
A lot is riding on the industry's ability to navigate this transition. For years, drug makers such as Pfizer Inc. and Merck & Co. could count on new blockbuster drugs to deliver double-digit profit growth. In the last two years, however, patents expired on Pfizer's blood pressure treatment Norvasc, Merck's cholesterol drug Zocor and more than $40 billion worth of other drugs. Meantime, the Food and Drug Administration delayed or denied would-be blockbuster therapies made by Sanofi-Aventis SA, Wyeth and others.
With profit growth slowing across the pharmaceutical industry, Pfizer and GlaxoSmithKline PLC -- the world's first- and second-largest drug makers -- each announced plans in 2007 to lay off thousands of employees.
"The hurdle has been raised, there's no question about it," GlaxoSmithKline Chief Executive Jean-Pierre Garnier said during a conference call to discuss third-quarter earnings. "What is unclear is exactly how we should modify our drug development plans to meet this higher hurdle."
Garnier and other executives say the FDA has become an increasingly cautious gatekeeper for new drugs, especially those to treat widespread ailments that aren't necessarily life-threatening. And the regulatory environment will only get tougher in 2008, when new rules kick in that allow FDA to limit how widely drugs are promoted and distributed to patients and physicians.
Drug companies griping about an overbearing FDA is a familiar refrain, but data backs up their contention that the agency is quicker to issue warning labels.
The FDA announced nearly 70 new or updated black box warnings on previously approved drugs in 2007, more than twice as many as in 2004, according to government data compiled by Joyce Generali, director of the Drug Information Center at Kansas University Medical Center. The warnings are the most serious a drug can carry.
In the past year, the agency also balked at approving Sanofi-Aventis' highly anticipated obesity drug Zimulti and sent Novartis AG and Wyeth back to the lab for more safety studies on their treatments for diabetes and menopause. The FDA also flatly rejected Merck's arthritis drug Arcoxia, a follow-up to Vioxx, the best-selling pain medication pulled from the market in 2004 after links to heart attack and stroke were found.
The withdrawal of Vioxx triggered a flurry of congressional hearings, during which the agency's ability to resolve drug-safety problems came under fire.
Former FDA Commissioner Mark McClellan, who left the post in early 2004, said the pressure to hold drugs to a higher standard of safety has increased dramatically since Vioxx.
FDA staff reject the bar-raising theory, pointing out that the percentage of drugs approved to those submitted has held steady in recent years.
But the agency has approved just 16 first-of-a-kind drug applications this year, a 20-year low that is 36 percent below the annual average over the last decade. FDA approved 18 first-of-a-kind drugs in 2005 and 2006, down from 31 in 2004.
Those who track pharmaceutical trends say companies share responsibility for the new-drug drought.
The number of applications for innovative drugs submitted to FDA has steadily declined since the mid 1990s, falling from a high point of nearly 60 submissions in 1995 to figures in the low 20s for recent years.
Operating under a "just say no to risk," mantra, companies have chosen to tweak drugs already on the market rather than invest in the unknown, said Steve Brozak, an analyst with WBB Securities.
"No pharmaceutical executive has ever lost his job for saying no to a new drug project," Brozak said. "And no FDA employee has ever lost his job for saying no to a new drug application."
Most recent biopharmaceutical breakthroughs have been for drugs to treat smaller patient groups.
Biotech powerhouse Genentech Inc. has successfully developed cancer treatments tailored to patients' specific genetic makeup. Meanwhile, Cambridge, Mass-based Genzyme Corp. has built a multibillion-dollar business around expensive treatments for rare diseases.
Several major pharmaceutical companies are already spending more on innovative biotechnology.
In the last year, Roche Holding Ltd. and Merck separately agreed to pay $1 billion for the rights to research drugs designed to silence genes that trigger certain diseases. The companies are banking on the research yielding personalized medicines with fewer side effects.
Investment in experimental technology, however, isn't as widespread a reaction as Wall Street expected.
Biotech drug maker Biogen Idec Inc. surprised investors earlier this month, saying it could not find a buyer two months after putting itself up for sale. Analysts had speculated that Pfizer, GlaxoSmithKline and Novartis AG might be interested in the company.
There are some industry observers who, counterintuitively, believe the FDA will become more willing to approve experimental drugs when the new regulations go into effect because they will be able to react with greater force when safety issues arise.
But most see that as wishful thinking.
"The pendulum at FDA is going to be stuck at the conservative end," said Christopher Milne, of the Tufts Center for the Study of Drug Development. Eventually, Milne believes, drug companies will learn to deal with a more cautious FDA, but only because they won't have any other choice.
(c) 2007. The Associated Press. All Rights Reserved. .