Velcade Corleone

  • by: |
  • 10/11/2007
WSJ blogger Peter Loftus writes, “Meter Set to Run on J&J’s Cash-Back Deal” – but it’s the meter on physician empowerment and patient choice that is already ticking.

In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldn’t refuse – the “Velcade Response Scheme” -- a money-back guarantee for the cancer drug.

The scheme changed the equation. “For those who may get a full response or a partial response … it’s a cost-effective intervention for the National Health Service,” Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. “Narrowing down to patients getting the best response makes it worth it.” A government proposal formalizing the deal is expected to become final on Oct. 24.

But the measures of “success,” are debatable. A “response” 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, “The 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.”

Translation – “in the United States.”

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 don’t improve "sufficiently" after four cycles of treatment with medicine.

But just what does “sufficiently 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

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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