UK cancer patients threaten to sue NHS for drug cost refunds

Patients 'demand refunds for expensive cancer drugs' on the NHS
Patients denied expensive cancer drugs on the NHS are threatening to sue their local healthcare trusts for refunds.

By Kate Devlin, Medical Correspondent
Last Updated: 3:28AM GMT 28 Oct 2008

from The Telegraph

Hundreds of patients have been told that the life extending medications are not "cost-effective" enough to be available on the National Health Service.
Many have chosen to pay to buy the drugs themselves, costing up to tens of thousands of pounds.
Now some are demanding refunds from their local Primary Care Trusts (PCTs).
One trust, Bromley in London, has already compensated a patient for the cost of privately bought cancer drugs, after an internal panel overturned the PCT's decision to refuse the drug.
At least three PCTs have faced calls for refunds from patients.
Later this year the Government is expected to announce that patients can pay for the drugs themselves without facing a bill for the rest of their NHS care, following widespread public anger over the issue of so-called "top ups".
Ian Reynolds, chairman of Wandsworth PCT, said patients were demanding refunds for the money they have spent. Patients can challenge a PCT's decision by applying to be treated as an "exceptional case" before a specially convened panel.
Mr Reynolds said: "We're being sent bills by people turned down by exceptional treatment panels and who have then gone private. "We're not liable to pay but the reality is that these claims will now end up in court."
Keith Farmer, assistant director of corporate affairs at Bromley PCT, said: "As a result of a case going through our normal appeals process we decided to pay back the money that this patient had spent.
"This was a one-off and to my knowledge we have not done anything similar for any other patient."
A spokesperson for the Department of Health said that the issue was a matter for PCTs. He said: "If an individual challenges a trust decision to refuse a drug on the NHS it is for the trust to judge whether or not to refund."
There was widespread outrage earlier this year when the National Institute for Health and Clinical Excellence (Nice), the Government's drugs rationing body, ruled that a kidney cancer drug, Sutent, was too expensive for the NHS.
Patients groups and charities accused the organisation of condemning sufferers to an "early death sentence" by not providing the £24,000-a-year drug.


Rising Diabetes cost in the US

From The Wall Street Journal

CHICAGO -- Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to $12.5 billion.

Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin -- an inexpensive generic used reliably for decades -- may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

In one, researchers from University of Chicago and Stanford University looked at which pills and insulin doctors prescribed and total medication costs. Diabetes drug spending rose from $6.7 billion in 2001 to $12.5 billion in 2007, a period when costs dropped for metformin.

More patients got multiple prescriptions as new classes of drugs came on the market. And more patients with diabetes were seeing doctors, increasing from 14 million patients in 2000 to 19 million in 2007.

"There's been a remarkable change in diabetes treatments and remarkable increases in the cost of treatments over the past several years," said study co-author Caleb Alexander, assistant professor of medicine at the University of Chicago. "We were surprised by the magnitude of the changes and the rapid increase in the cost of diabetes care."

Nearly 24 million Americans, 8% of the population, have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

Current guidelines say doctors should prescribe metformin (about $30 a month) to lower blood sugar in newly diagnosed patients and urge them to eat healthy food and get more exercise. Other drugs can be added later, on top of metformin, to help patients who don't meet blood sugar goals. The updated guidelines don't include Avandia, which costs about $225 a month.

Susan Spratt, an endocrinologist at Duke University Medical Center, said she prescribes whatever it takes to lower her patients' future risk of blindness and amputations. That can mean coupling more costly drugs with metformin to hit blood sugar goals.

"I think cost-analysis is important from a public health standpoint," Dr. Spratt said. "But when you're sitting across from a patient, you want to use whatever is going to help them get control of their diabetes."

In the other study, Johns Hopkins University researchers analyzed findings from 40 published trials of diabetes pills that measured heart risks. Compared to other diabetes drugs or placebo, metformin was linked to a lower risk of death from heart problems.

The findings hint that Avandia has a possible increased risk for heart disease death, but that increase wasn't statistically significant, meaning it could have been the result of chance.

Few of the studies lasted longer than six months. The researchers cited a "critical need" for long-term studies of diabetes pills and heart risks.

Last year, the Food and Drug Administration issued a safety alert on Avandia, made by British-based GlaxoSmithKline PLC, after another pooled analysis of studies found a risk of heart attacks. And in July of this year, FDA advisers said the agency should require drug makers to show new diabetes drugs don't increase heart risks.

GlaxoSmithKline spokeswoman Mary Anne Rhyne said FDA-approved labeling for Avandia says available data on the risk of heart attack are inconclusive. The medication, approved in 1999, has been used by well more than 7 million patients, she said.

Copyright © 2008 Associated Press


New Health Economics & Market Access Opportunities

Dear All,

all new positions just came in. Interested folks please contact Peter Fortune at Eames.Jones.Judge.Hawkings, 29 High Street, Welwyn, Herts AL6 9EE. Telephone: +44 [0]1438 840984 or email your to: Peter.Fortune@EJJH.CO.UK



Health Economics and Market Access Manager
Field based
outstanding package + car

Our client is the UK and Ireland affiliate of a US based, $multibillion global healthcare company with a reputation for developing advanced technologies and innovation in the service of patients and physicians. With a very strong product portfolio and a rich programme of development, their growth is set to continue and their high-value products to provide fascinating professional challenges.

Joining a highly-skilled team, you’ll be the product champion and responsible for managing the HTA processes for your particular cluster. Drafting submissions and consulting with key healthcare decision makers and critical influencers, you’ll be developing robust budget impact models for the sales teams to use, and mapping and targeting areas where the post code lottery is at its worst. You will also represent the UK affiliate at European and global level.

With an MSc in HEOR or similar and experience of modelling and comprehensively managing three full NICE submissions, your proven track record of working with all levels of the NHS is complemented by a formidable results orientation and interpersonal and team working talents.


Health Economics & Market Access Manager c.£55,000 + car/allowance & benefits

West London

Established for over a decade, this biopharmaceutical company has pursued discovering, developing and commercialising original, small-molecule drugs to serve high unmet medical needs by following innovation where it leads. And, it’s led to some great things. By combining the entrepreneurial spirit and flexibility of a biotech with the disciplines of a pharma company, they have demonstrated their ability to discover and swiftly move products to commercialisation. Their rapidly-expanding pipeline - that includes five compounds in the final stages of clinical development - contains a first-in-class candidate. With strong values of innovation, trust and teamwork, they operate in an enthusiastic and stimulating environment that underpins their drive for results. To continue their progress they now need to make this new appointment – a HEALTH ECONOMICS & MARKET ACCESS MANAGER.

You will be responsible for the HTA process and the development of economic proposals at local and national levels, for both in market and pipeline products. As the UK and Eire affiliate’s expert on HEOR issues, you will provide strategic advice to management, and liaise with the European based global Economics, Pricing and Reimbursement team. With the small field based team of Market Access Managers, you will develop market access strategies ensuring alignment with the broader product plans. A key player in the delivery of market access plans, your contribution will help to ensure access to funds for company products.

With an MSc in HEOR or similar and experience in HEOR, Pricing and Reimbursement or Market Access, your detailed knowledge of the UK/Ireland healthcare environment is, ideally, in the specialised services arena and your ability to resolve complex and ill-defined problems is proven. You are results focussed, analytical, highly IT literate, astute and good with people. Naturally your organisation and communication skills (both written and oral) are impressive.

And now for something completely different!

Global Market Access Manager
West London
Very competitive and attractive package

Are you:

• ready to establish a core capability ?
• constrained by only working in health economics, market access or pricing and
• fed up of operating in a risk averse, slow decision making environment?
• able to manage a thriving portfolio, a strong pipeline and global challenges?

Our client is a specialist pharmaceutical company that offers you solutions to all of the above. This growing company, with sales of over €220m, has reached the point where it needs to establish a market access capability to ensure its products [pipeline, in market and off patent] are properly supported from an HEOR and pricing and reimbursement point of view, and are accessible to prescribers.

In this brand new role, you’ll have the freedom to establish the capability in the way you know it should be. With an appropriate higher degree, you must have a successful track record of at least one of the P&R, market access or HEOR disciplines - and have an interest and an appreciation of the others – ideally along with some international experience. Your influencing and interpersonal skills enable you to build effective relationships with colleagues right across the business, from R&D to the commercial function and at all levels.

Cost-benefit assessment in Germany: IQWiG publishes revised version of the methods draft

An editorially revised version of the methods draft on the assessment of the cost-benefit relations of drugs was published by the German Institute for Quality and Efficiency in Health Care (IQWiG) on 14 October 2008. Version 1.1 primarily clarifies misunderstandings and reacts to questions raised by the draft presented in January 2008 (Version 1.0). All comments on Version 1.0 submitted to the Institute, the scientific reply, as well as three technical appendices highlighting key aspects of the practical implementation of the efficiency frontier methodology are now completely available online. With the publication, IQWiG intends to constructively support the ongoing lively discussion among experts and in the media about the appropriateness of the costs of medical services.

Basic statements remain unchanged

A total of 46 comments on the methods draft on efficiency frontiers (Version 1.0), published on 24 January 2008, were received on time by the end of March. Parties submitting comments included associations of the pharmaceutical industry as well as companies, medical organizations, scientific societies, hospitals, patients, and other private persons. About 20% of the comments originated from abroad and were written in English. In addition, the German Federal Ministry of Health, as well as the IQWiG Board of Trustees, provided comments outside the framework of the formal commenting procedure.

Compared with Version 1.0, the basic statements of Version 1.1 remain unchanged. However, the new version now presented formulates individual statements more clearly and is therefore more precise. The Institute thereby also reacts to queries and misunderstandings addressed in the comments. In a separate document ("Scientific Reply”), IQWiG and its international expert panel respond to the arguments and objections frequently presented in the comments.

Model calculations are necessary for the cost side

Three technical appendices presented simultaneously aim to contribute to an understanding of the proposed methodology. They specify three important aspects for the implementation of the methodology: modelling, cost estimation, and uncertainty.

When considering costs and benefits, the time period investigated should reflect the course of disease appropriately. However, clinical trials are often considerably shorter, which is why model calculations may be necessary for the cost side. However, as with every prediction, model calculations are extremely uncertain, as specific assumptions have to be made. The technical appendix "Modelling” therefore describes, among other things, principles for the development of models and their implementation in health care. The technical appendix "Cost estimation” addresses the issue of how costs are made up and how they can be determined from different perspectives, for example, that of statutory health insurance (SHI) or society as a whole. In the technical appendix "Uncertainty”, it is primarily discussed how information on the degree of bias can be gained in the estimation of efficiency frontiers.

With the publication of Version 1.1 together with the comments, the scientific reply, and the technical appendices, the Institute aims to ensure the greatest possible transparency in the methods development and involve a large circle of experts, in particular health economists. As all documents are available both in the English and German languages, international experts can also participate in the scientific discussion, or at least follow it.

Final version of the methods should be available in the summer of 2009

In the first stage of the methods development, the Institute commissioned a group of well-known health economists from eight countries. In this way, the Institute aimed to ensure that the methodology complied with internationally accepted standards, which are also required by law. From now on, IQWiG's Scientific Advisory Board will be even more closely involved in the consultations. For this purpose, the Scientific Advisory Board has formed its own working group. In order to ensure continuity and the involvement of international expertise on the one hand, and to add weight to health economics of German character on the other, the Scientific Advisory Board also appointed external researchers. These researchers are members of the Working Group: Methods of Health Economic Evaluation (AG MEG) of the German Society for Social Medicine and Prevention (DGSMP); the Panel for Health Economics in the Society for Social Policy; and IQWiG's international health economic expert panel.

This working group will advise IQWiG's Scientific Advisory Board, and its advice will be incorporated in the methods draft 2.0, which will also be open to comments. In parallel, IQWiG will test the practicability of the method for the German setting in several dry runs. If this process runs in an optimal manner, the future final methods 1.0 could be available in the second quarter of 2009 and be the binding basis for the assessment of the relations of the costs and benefits of drugs. However, only the general procedure will be described. For each assessment, the specific project-related methodology will be discussed initially with all interested parties on the basis of a preliminary report plan, and will then be specified in a binding manner in the final report plan.


The Pharmaevolution

It is a challenging time for the pharmaceutical industry, with recent announcements of more job cuts at GSK R&D and the latest news of Pfizer abandoning research on key areas of the past, such as cardiovascular, bone health and obesity. In addition, strategic actions are now being taken in order to overcome the in sustainability of the old business model coupled with an increasing pressure on the cost of drugs through government health technology assessment agencies and payers.

Concentration of high need areas and adding new skills to the organizations – “market access” – are fashionable at the moment. In the end, whatever you want to call it, the matter comes down to evidence development and creation of convincing data to payers, which will have a remarkable impact on how successful business is done in future years and who will gain a competitive advantage. As a result, skills and experiences that are related to understanding this new environment are now in high demand. In particular, those individuals who comprehend not only payer business models but also how the decisions of these organizations are affected by outside influencers will be invaluable in determining the future pricing and positioning of drugs.

The gradual shift by payers to an “outcomes-based” analysis or “risk-sharing” agreements as recently proposed by the UK NHS is further complicating the cost/benefit analysis of R&D investments. This shift will increase pharmaceutical company risk because it will make it much more difficult to exactly forecast the expected revenues generated from the drug portfolio under development. Payers do not yet have sufficient data to conduct such analyses on a wide-scale basis, nor is it easy for the industry to provide such data at the time of launch, at least not comprehensively in most cases. Maybe in the near future, as physicians and hospitals shift to electronic medical records, it will be easier to collect the required data.

Just as the R&D areas of pharmaceutical and biotech companies must undergo significant changes, so too will marketing and commercialization. A shift from the “physician-prescriber” to a “stakeholder-payer” model will make the ability to influence payers of paramount importance to drug manufacturers. Consequently, these companies will need fewer people whose primary added value is being able to access physicians. Instead, they will seek individuals who are very sophisticated in working with payers to position and price their products. The industry is in for a big change and that may also open up great opportunities for those companies that manage to concentrate their development on unmet needs areas coupled with a different approach to product commercialization and pricing. It will therefore be very interesting to see how the industry shapes up over time and some significant adaptation is still to be done, however the very good news is that a similar meltdown like in the banking sector is more than unlikely.


Health Economics Opportunities in North America


please see below a few new jobs on offer in the US and Canada. Please contact Darren Kruszynski.

Global Project Leader Oncology HE/Outcomes/Reimbursement - 130+ New Jersey
Deputy Director, US Health Economics, Outcomes & Reimbursement (HEOR), Women's Healthcare - 150+ New Jersey
Associate Director, Medical Outcomes Research - 150+ Connecticut
Health Economics Manager - 110+ Toronto Canada
Director Pricing/Reimbursement - 130+ Montreal Canada

Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
M5V 1X1
416-581-1445 ext 225


UK is negotiating with drugmakers to lower NHS prices

October 07, 2008
by Anna Bratulic

The UK government is negotiating with pharmaceutical companies to offer lower prices for new drugs on the understanding that the NHS will pay more for the treatments if "later evidence proves greater effectiveness." Government officials see the move as "an answer to whether patients should be allowed to "top up" NHS" treatments that are deemed clinically effective but not cost-effective by the National Institute for Clinical Excellence.

Negotiations between government officials and ABPI are underway to arrive at a "risk-sharing" agreement as part of a new pharmaceutical price regulation system that will be launched in 2009. Under the scheme, companies would reduce the price of a drug sufficiently to allow the product to be approved by NICE, and the drug's price would subsequently raise as proof of clinical effectiveness grows.


New Vacancies Health Economics & Pricing

Hi everyone,

all positions below just came in. Please get in touch with Simon Rose.

- Health Economy Liaison Manager – Field Based, Multiple locations – UK
- Health Economist, Berks – UK
- Senior Health Economist, Home Counties – UK
- Senior Contracts & Pricing Manager, Switzerland
- Senior Project Manager International Health Economics, Switzerland
- Health Economist, Northern Home Counties, UK
- HTA Manager, Northern Home Counties, UK
- HE&OR Manager (Global), Switzerland
- Senior Health Outcomes Analyst/Manager, Surrey,UK
- Health Economist, Ireland
- Health Outcomes Manager, Netherlands

If none or these are suitable please get in contact with me regard other positions. Any queries please contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com. I am a specialist recruiter in HEOR and an available for careers advice or a general discussion. for online Information: http://www.hayspharma.com. If interested please send your CV to the above address. At Hays Pharma we have Health Economic and Outcomes Research positions at all level throughout Europe and now in Asia/Pac.


New HTA and Pricing events organized by Health Network Communications

Health Technology Assessment World Europe 2008

9 – 11 December 2008, The Grosvenor Hotel, London United Kingdom

Health Network Communications, in association with the London School of Economics is organising the first annual policy forum for the industry where all the major international HTA agencies and leading pharmaceutical companies will be able to discuss the challenges in obtaining market access. Health Technology Assessment World Europe 2008 will provide delegates with a comprehensive overview of HTA standards and practices across the world. It will also look at the relationship between HTA and health policy making. Through a number of case studies, advice will be given on the tools and methodologies that can be used to demonstrate cost effectiveness.

Contact us to find out more!

Prithibah Irving
+44 (0)20 7608 7055

Pharma Pricing and Market Access Outlook 2009

28 April – 1 May 2009, London, United Kingdom

Health Network Communications in association with the London School of Economics will be running the 3rd annual Pharma Pricing & Market Access Outlook. This is the world’s largest pricing, reimbursement and market access event. It is where the pharmaceutical and biotech community will hear from leading industry practitioners on how to develop and implement the optimal pricing and market access strategy. The programme will give delegates the unique opportunity to hear from all the major international health agencies on pricing policy and the role of health technology assessment. This meeting is the focal meeting point for all leaders working within pricing, reimbursement, market access and health economics.

Contact us to find out more!

Prithibah Irving
+44 (0)20 7608 7055

Health Network Communications

Health Network Communications is an international events company dedicated to providing conferences, training courses and seminars for the life science community. Through our network of advisors in industry, academia and the regulatory authorities, we are able to develop quality events that discuss and find solutions to some of the most pressing issues in the life science sector today.