The Velcade Three
Cancerworld: Risk Sharing
One possible solution gaining in popularity is risk sharing, where reimbursement authorities reach a provisional agreement based on early evidence, with provision for revising that agreement according to longer-term evidence of how the therapy performs in practice. This option, which could allow for raising or lowering the reimbursement price and/or restricting or widening indications for use, is being weighed in a number of European countries.
Post-launch studies give a chance to see the effectiveness of a product in the real world: used in a normal clinical settings by normal doctors in an unselected group of patients with a normal age range, mix of comorbidities and normal adherence to their prescription.They could look at the most cost-effective dosage, as in the PHARE trial. They could also provide an opportunity to gather data that could help better identify which patients respond best, who is resistant to treatment and who is more liable to side-effects. This approach could give pharmaceutical companies an incentive to work with clinical practitioners and patient groups and payers to maximize the clinical benefit from their product - which has to be better than hurling accusations at one another.
The agreement reached this June between Janssen-Cilag (Ortho Biotech) and NICE over the reimbursement of Velcade (bortezomib) for myeloma patients shows what can be achieved in a collaborative approach.
Having had their application for reimbursement rejected by NICE at the end of last year, Janssen-Cilag came back witha proposal that all patients for whom Velcade is indicated be offered a maximum of four cycles of treatment. Those who respond fully or partially - determined by a 50% or greater reduction in serum M-protein - will be able to continue treatment with full reimbursement. Where this response is not achieved, treatment will be stopped and the manufacturer will refund the cost of the four cycles of treatment.
The agreement doesn't represent a blueprint that can be universally applied - many cancers and cancer drugs are less amenable to early measurement of benefit. However, Pfizer is negotiating a similar'response scheme' with local health authorities in England for Sutent [sunitinib] for use by GIST patients who have developed resistance to Glivec [imatinib].
Many health economists will nod approvingly at this creative approachto risk sharing, and the French may acknowledge it as a step in their direction - looking for ways to use the drug where it is most effective. The agreement also goes a long way to answer the objection tousing a single benefit measure for a highly differentiated group of patients.
What is does not do is allay all fears that some patients may be excluded, perhaps because they are slow to respond to the drug. This is a worry for myeloma advocacy groups such as Myeloma UK, although they have welcomed the agreement as “a creativeway to ensure that this important drug can be made available to patients”. Jacky Pickles, one of the 'Velcade 3' who had been campaigning for access to the drug, presented the decision as a victory for the principle that no myeloma patient shouldhave to die without first being given the chance to try Velcade. “It could keep us alive long enough for a cure to be found.”
Jesme Baird, board member of the European Cancer Patient Coalition and Medical Director of the Roy Castle Lung Cancer Foundation in the UK, believes that all patients should take heart from the Velcade agreement. “Ultimately I and anyone who represents patient organisations will be in favour of anything that will get drugs to people who respond. We all know that in the next 20 years there's going to be a huge number of these new targeted therapies coming down the line. The good thing about the Velcade announcement is that at least there are some people out there in industry and in the technology appraisal bodies who are talking to each other and looking at how we will be able to afford these things.”
Copyright © The Velcade Three, 2010.