More Velcade-Style Risk-Sharing in the UK?

via the IN VIVO Blog by Melanie Senior on 21/01/09

It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.
The Velcade Response Scheme (VRS) came about out of desperation: cost-effectiveness watchdog NICE had turned down the drug as too expensive, so Janssen-Cilag, to its credit, said to the UK’s state payer, the Department of Health, ok, well if we promise to charge only when the drug is effective (and refund you if not), then will you give this to patients? The answer was yes. And now, not only have all of the UK’s Primary Care Trusts have signed up to the VRS, according to a Janssen spokesperson, but this scheme “may now be a good example of how a performance-based scheme could be structured.” That’s not a statement from Janssen; it’s from a position document issued last year by the British Oncology Pharmacy Association on risk-sharing schemes.
Indeed, such schemes have, perhaps inevitably, become a rather more regular feature of the UK drug landscape—making Janssen feel more pioneering than desperate (though Janssen isn’t the first to guarantee performance; Pfizer tried with Lipitor too).

Most of the other recent flavors of risk-sharing programs around expensive cancer drugs emerged, like VRS did, as a result of a negative NICE appraisal. Merck-Serono offered the Cetuximab Cost-Share Program around Erbitux in metastatic colorectal cancer, which involved refunding primary care trusts the cost of any vials of the drug used for patients that fell into a pre-agreed ‘non-responder’ category at up to 6 weeks. Roche instigated the ‘Tarceva Access Program’ for its NSCLC drug erlotinib, offering a rebate, in the form of a credit note against any future Roche purchase, for the amount that the drug cost over and above the cost of the incumbent NSCLC treatment docetaxel (Sanofi-Aventis' Taxotere) for an average patient duration (with an upper limit on the total number of packs).

Now granted, Roche’s program was initially introduced as a means to claw market share off docetaxel, which it was struggling to do ahead of NICE guidance. But when NICE found Tarceva to be un-cost effective—with questions around the lack of comparative data with docetaxel in particular--the scheme was formally proposed to NICE as part of a re-review. In November 2008, NICE issued positive guidance—but only on condition that the overall treatment cost remained in line with that of docetaxel. Roche had to drop the price by about 7.5%.

Critics say such programs are simply a way for industry to coerce NICE into a ‘yes’. Maybe. But there’s no denying that such schemes represent a logical way to improve patient access without breaking the bank. Indeed, the new UK drug pricing contract, the PPRS, formalizes a bunch of patient access schemes, including risk-sharing programs. And NICE, as we heard from CEO Andrew Dillon last week, would prefer such schemes to be proposed up front, before a drug is submitted for review, rather than as a last-resort of the drug fails the cost-test.

Small wonder, then, that in the last three or four months since the PPRS was published, the department of health has been in contact with various companies about schemes around several “high profile” drugs, according to David Thomson, Lead Pharmacist at the Yorkshire Cancer Network and author of the BOPA position statement.

The big problem is administration. As it is, it’s complex to administer rebates and track outcomes. The more different schemes are available, the harder that becomes. “Anecdotal evidence suggests that the VRS [and a similar scheme around Sutent] aren’t necessarily bringing the expected levels of financial benefit to the National Health Service,” Thomson told The IN VIVO Blog.

Add to this the problem of patchy uptake or availability of some of the existing handful of programs across the country, and the possibility of multiple risk-programs across a single drug for different indications, and it’s easy to see why BOPA's pushing for some sort of risk-sharing plan template....and why we may not, after all, see a flood of VRS-followers soon.

image by flickr user fboosman used under a creative commons license

© Copyright 2008 Windhover Information Inc. www.windhover.com/blog

NICE to put QALY under examination

LONDON, Jan 27 (APM) - NICE on Tuesday announced an arms-length investigation into how it values health technology, potentially putting the quality-adjusted life year (QALY) under the microscope.
In a press release, the cost-effectiveness body said NICE chairman, Professor Mike Rawlins, has written to England's top health minister announcing a "short study of how value is taken into account when looking at new health technologies". The study will involve submissions and the use of a series of workshops involving the healthcare industries, patients and the wider public, together with representatives of the NHS to explore this issue, NICE said.
NICE also said the Professor of health law, ethics and policy at University College London, Ian Kennedy has agreed to lead the study. Quoted in the release, Rawlins said: "This study which will look at whether particular forms of value are more important than others; and will explore factors that should be taken into account in establishing the value of new health technologies."


No particular mention of the QALY was made in the release but the measure is at the centre of NICE's work and has been doggedly defended by the institute despite increasing hostility from industry. However, a shift may have taken place with the new UK pricing contract which outlined a greater role for NICE, bringing it to the centre of UK drug pricing.

The pharma industry is known to have pressed for a much wider examination of the benefits of medicines including keeping people in work, reducing the workload of carers and saving the National Health Service costs in reduced hospital admissions.
Rawlins noted a recent report on the future of the biotechnology industry stressed the importance of NICE and the pharmaceutical industry working towards a shared understanding of how to value innovative new health technologies, adding, "NICE supports that view."


[14027] 27/01/2009 11:02 GMT - INDUSTRY


Wales sidesteps NICE recommendation on kidney cancer drug access


Welsh patients will be able to receive four kidney cancer drugs that have not been
recommended by the National Institute for health and Clinical Excellence (NICE), the
Welsh health minister Edwina Hart has announced.
The decision will allow greater access to four drugs currently being reviewed by NICE
for advanced renal cancer - Pfizer's Sutent (sunitinib), Genentech's Avastin
(bevacizumab), Bayer's Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus). None
of the drugs was found cost-effective a draft NICE appraisal last August; the assessment
of the treatments has since been extended, with final guidance expected this month
(Scrip Online, October 21st, 2008). However, the health minister has instructed Local Health Boards (LHBs) to provide the drugs to end-of-life patients with kidney cancer, with immediate effect, choosing not to wait for NICE's decision. Although describing the move as a "temporary arrangement", the health minister added it was "unacceptable" for patients to be kept waiting for the treatments.
The decision follows a clinical audit of Sutent issued last December. Originally, NICE
and the All Wales Medicines Strategy Group (AWMSG) issued guidance that the drug
should not be funded by the NHS as it was too expensive (Scrip Online, August 8th,
2008), thus leaving funding decisions to LHBs for individual patients. However, a study undertaken by the Medical Director of NHS Wales Professor Mike Harmer found that of 73 requests for Sutent only 23 received the treatment in 2008, raising questions of consistency; the report revealed that all patients who were recommended the treatment in Neath, Port Talbot and Bridgend received it, while only one of 13 patients received the drug in Cardiff and none of the 14 patients recommended received the drug in Swansea.
The health minister has already shown she is prepared for Wales to make its own
decisions regarding drug availability; in July last year she made Novartis's Lucentis
(ranibizumab) for wet age-related macular degeneration (AMD) in both eyes available
on the Welsh NHS, a month before final guidance for England and Wales was confirmed
by NICE (Scrip Online, July 17th 2008 and August 27th, 2008).
NICE has proposed changing its cost-effectiveness parameters for end-of-life drugs,
partly in response to a public outcry over the initial draft of its assessment of the four
kidney anticancers.

SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 26 January 2009 COPYRIGHT Informa UK Ltd 2009
PHIND: Pharma & Healthcare Ind News - today only (PHID)


‘Comparator Report on Patient Access to Cancer Drugs in Europe’ reveals significant inequalities still remain

Brussels, 16th January 2009 – European patients still face unequal access to cancer treatment, depending on where they live. This was confirmed in a report published today by Dr Nils Wilking, clinical oncologist at the Karolinska Institutet in Stockholm, Sweden, and Prof Bengt Jönsson, Professor of Health Economics at the Stockholm School of Economics. These inequalities and gaps in survival of cancer patients are particularly noticeable when comparing Eastern Europe with Northern and Western Europe.

The report, based on findings from the 27 EU Member States (excluding Cyprus and Malta), Iceland, Norway and Switzerland, updates and improves on two earlier reports by the same authors in 2005 and 2007. This most recent report was supported by an unrestricted grant from EFPIA, the Federation of the research-based pharmaceutical industry in Europe. Analyses were conducted by i3 Innovus, a company specializing in health economics and outcomes research. “Appropriate access to new treatments is vital, and examining variations in patient access between countries is a positive way to stimulate discussions on the optimal use of new technologies and treatment,” said Brian Ager, Director General of EFPIA.

The report reveals that whereas cancer incidence is increasing, cancer mortality is decreasing, indicating the positive impact of screening programmes and improvements in treatments. “New treatments have made it possible to target diseases more effectively. For cancer patients, these newer therapies mean an improved quality of life, with less time spent in hospital and the chance to return to their day-to-day activities earlier”, said Dr Wilking.

However the report highlights wide gaps in Europe in relative survival rates. For example, in Sweden 60.3 % of men and 61.7 % of women diagnosed with cancer survive compared to only 37.7 % of men and 49.3 % of women in the Czech Republic. EUROCARE 4 data also shows that for a similar incidence, cancer patients in Sweden have greater chances of survival than those in the UK. Healthcare systems in Europe are spending more on cancer, but this expenditure remains lower than the relative burden of cancer in comparison to other diseases.

Patients in Austria, France and Switzerland have the broadest access to newer cancer treatments while Poland, the Czech Republic and the UK continue to lag behind. Prof Jönsson emphasized “The inequalities –highlighted in our original report in 2005 – still remain. For patients and society this is a real concern, as expectations are that all patients in Europe should have equal opportunity to access these treatments, particularly when evidence shows that access to cancer treatment is linked to an improvement in outcome”.

The report authors urged policy-makers to take action - 1.2 million deaths were caused by cancer in Europe in 2006 - and proposed new policies to improve treatment access for patients in Europe:

- Adapt healthcare budgets generally and hospital budgets specifically to incorporate the introduction of new cancer drugs;
- Introduce separate funding for cancer drugs, with or without requirements of an additional gathering of data;
- Expedite (regulatory and economic) review times for innovative cancer drugs
- Promote a European collaborative approach to collecting available scientific information for Health Technology Assessment (HTA)

The report is available for download on www.comparatorreports.se


Oncology Market Access Conference, April 22nd-23rd Zurich

eyeforpharma hosts the 2009 Oncology Market Access conference on 22nd-23rd April in Zurich. I have been told by the organizer that the conference is looking to be very popular. The website and brochure for the conference have been updated, please take a look.

New rules on drugs will not increase access for terminally ill: expert

New rules issued by the NHS drugs rationing body to increase access to drugs for terminally ill people will not work, an expert has said.
by Rebecca Smith, Medical Editor, Telegraph

The National Institute for health and Clinical Excellence (Nice) has told its drugs appraisals committees to be more flexible and approve drugs that would not normally be considered cost effective because they are expensive and only extend life by a short period.
The new rules were praised by charities and patient groups who felt that, for some patients with rare terminal illnesses, it could mean they would get drugs that would otherwise be denied them.
But James Raftery, Professor of Health Technology Assessment at Southampton University, says that the new arrangements will do little to improve availability of expensive drugs and may result in other patient groups being denied treatment.
Writing in the British Medical Journal online he said during 1999-2008, NICE rejected 11 drugs on the grounds of cost effectiveness.
The new advice applies to treatments that affect small numbers of patients who are not expected to live more than 24 months, and that offer demonstrable survival benefits, at least an extra three months of life, compared with current NHS practice.
Professor Raftery examined the effect the new arrangements would have had on all cancer drugs that NICE has refused or proposed to refuse because of cost effectiveness.
He found that few of the rejected drugs would qualify under the new criteria, with most failing to meet the criterion that no alternative treatment with comparable benefits existed.
He also warns that making an exception for any group sets a precedent for other groups, and that allowing more expensive treatments for a small group of patients within a fixed overall budget would result in other patient groups being denied treatment.
Prof Raftery said: "My analysis suggests that NICE's new arrangements for appraising end of life drugs may do little to improve availability of expensive cancer treatments. Few of the rejected drugs would qualify under the new criteria, with much depending on the interpretation of the criterion that no alternative treatment with comparable benefit is available through the NHS.
"NICE will celebrate its 10th birthday in 2009 having had to make a major change in its methods. Its attempt to minimise the effects of these changes will no doubt be tested in future appeals against its findings."
A spokesman for Nice said: "The supplementary advice we are now providing our Independent Committees with enables them to explore the perception that society may place greater value on extensions to life in circumstances where life expectancy is shortened. We think it likely that some treatments will be recommended where in the past they might not. We can't predict which ones will be or how many, perhaps no more than a one or two a year, but it depends to a great extent of what treatments get licensed in the future.
"We recognise that the supplementary advice is controversial and acknowledge there could be concerns that other, equally deserving, patient groups could lose out. We will therefore be ensuring an evaluation is undertaken to investigate whether the scheme is achieving its intended purpose."


France to increase cost benefit assessments of new medicines

France's HAS three-year plan includes economic assessment


France's HAS, an agency set up three years ago to advise the government on healthcare
issues, has set out a three-year work programme for 2009-11 that emphasises its dual
economic and scientific roles. The agency was reorganised last year and set up a new medico-economic committee that is charged with devising rational reimbursement policies and otherwise guiding public spending on healthcare. HAS's aim is to have systems in place by 2011 that will provide a functioning, interdisciplinary evaluation service for the government and healthcare professionals.
Until now, the agency has limited its assessments to the medical benefits of different treatments, but its 2009-11 strategy puts the cost of treatments into the equation. It expects to conduct more postmarketing studies and to develop methods for comparing the relative effectiveness of different products and practices.
The government criticised the agency last year for working too slowly. It was struggling to cut costs from the national healthcare budget and was looking to the HAS for costeffectiveness guidance on several classes of drugs. Perhaps stung by this public rebuke,the agency has set a 2011 target of completing its evaluation of newly licensed drugs within 90 days, and a 12-month timeframe for any re-evaluation of an entire class of drugs, which might be extended to 18 months for particularly complex assessments.
The HAS also plans to examine how to set up a short-response procedure and to
determine the circumstances in which an accelerated assessment might be appropriate.
Improving the quality of the information given to healthcare professionals is also among the agency's objectives for the next three years. It notes that its responsibility to inform patients and prescribers about medicines is duplicated by Afssaps, the medicines regulator, and it hopes that the two agencies can work together. Both agencies publish guidance on the use of medicines.
The HAS is also looking at the way the industry communicates with doctors and it plans to publish a report later this year on the way doctors perceive the information they get from sales reps. It plans to establish best-practice guidance for pharmaceutical companies, but here again it recognises that this effort might overlap the responsibilities of other agencies.
Besides working more closely with French organisations, the HAS says that it will coordinate its efforts with similar agencies in other countries, including NICE in the UK, Germany's IQWIG, the Danish National Board of Health and the Health Quality Authority in Ireland. It plans to deepen its participation in the European
Network for Health Technology Assessment and the European Network for Patient

SCRIP - World Pharmaceutical News - www.scrippharma.com FILED 09
January 2009 COPYRIGHT Informa UK Ltd 2009


Opportunities @ Double Helix Consulting

Hello everyone & happy 2009! Interested candidates please see contact details below.
best wishes

Title: Consultant—Biopharmaceutical Market Access

Summary: Double Helix Consulting US (DHC US) is the newly formed US-based life sciences consulting division of London-based Double Helix Development group which has provided market research and market access consulting services to the biopharmaceutical and medical device industries for nearly 15 years. We seek a highly motivated entrepreneurial executive with experience and expertise in the area of market access, including pricing and reimbursement, to help build an exciting and dynamic consulting organization with offices in the greater NYC metro area. The ideal candidate will be able to leverage existing and foster new relationships with leading biopharma companies and win business in a highly competitive market. The Consultant will collaborate closely with DHC US senior management to (a) define service and solution offerings, (b) market and secure consulting engagements with target clients, and (c) manage project teams to complete consulting assignments on time and on budget. Compensation commensurate with experience. Generous benefits available. DHC US is an equal opportunity employer that celebrates diversity at all levels of our organization. EOE/M/F/D/V

The Consultant will work with clients and DHC US colleagues to:
• Evaluate reimbursement environment and design strategies to enhance technology adoption and coverage policies among payers, HTA and quality assurance groups (e.g., AHRQ, NCQA, JCAHO), professional societies, and other stakeholders
• Contribute to establishing and maintaining a Market Access Advisory Network including health economists, clinical opinions leaders, patient groups and policy makers
• Develop market building and expansion strategies, including programs to educate customers regarding product value
• Evaluate target product profiles and commercialization scenarios to guide clinical program and trial 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/materials for use by field staff that integrate information on product value to support strategies for optimizing revenues, reimbursement, and formulary positioning across all managed markets

Education and Experience:
• MD or PharmD; or Masters or PhD/ScD in a quantitative, health-related field—health services research, economics, epidemiology, statistics or business
• Minimum 8 years’ client- and/or consultant-side biopharmaceutical industry experience, including substantial experience supporting Phase III, peri-launch and launch strategy
• Experience working with payers and decision-makers on evidence-based customer strategies
• Experience demonstrating product value, including preparing AMCP dossiers and/or submissions to HTA agencies
• Experience making substantial contributions to commercial assessment, licensing & development, portfolio management, lifecycle planning, M&A evaluation and/or alliance management desirable

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 and willingness to travel up to 40%, primarily domestic

Contact Information: Interested candidates should forward resume and cover note to hr@dhelixc.com