In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldnâ€™t refuse â€“ the â€œVelcade Response Schemeâ€ -- a money-back guarantee for the cancer drug.
The scheme changed the equation. â€œFor those who may get a full response or a partial response â€¦ itâ€™s a cost-effective intervention for the National Health Service,â€ Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. â€œNarrowing down to patients getting the best response makes it worth it.â€ A government proposal formalizing the deal is expected to become final on Oct. 24.
But the measures of â€œsuccess,â€ are debatable. A â€œresponseâ€ would be considered to be when a patient achieves a 50% or more overall reduction in their paraprotein after four cycles of Velcade. Only patients who achieve this 50% plus reduction in their paraprotein will continue on Velcade. No rebates will be issued for patients who achieve a full or partial response. Also, the drug is recommended only for people who are having their first relapse, who have received one prior therapy and who have undergone a bone marrow transplant or have been deemed unsuitable for a transplant.
Non-responders at 4 cycles will not have the option of continuing therapy because NICE does not consider that there is sufficient clinical evidence to show that those patients who have not responded well after four cycles, would gain any benefit by having four further cycles. Hmm.
Loftus write that, â€œThe Velcade rebate program is the first of its kind in the U.K. and may be a harbinger of things to come there and elsewhere.â€
Translation â€“ â€œin the United States.â€
In a matter of weeks, J&J is expected to be on the hook for the full cost of Velcade treatment for multiple myeloma patients who donâ€™t improve "sufficiently" after four cycles of treatment with medicine.
But just what does â€œsufficiently mean? What type of "evidence" should be used? And who defines it, physicians or the government? That question has been asked and answered in Great Britain.
There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.
When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it