There NICE goes again. The (misnamed) National Institute for Health and Clinical Excellence—actually the UK’s health rationing agency—plans to turn down a breakthrough treatment for advanced stage melanoma. From the Oncology Report story:
A drug considered a breakthrough treatment for advanced melanoma has been turned down by England’s clinical and cost-effectiveness agency...Subjects who received ipilimumab alone or with a peptide vaccine saw a median survival of about 10 months, compared with 6.4 months for those receiving only the vaccine. At 1 year follow up, between 44% and 46% of subjects in the ipilimumab arms had survived, compared with 25% in the vaccine-only arm, and at 2 years, between 22% and 24% in the ipilimumab arOn the strength of these results, in patient groups for whom few effective treatments exist, the Food and Drug Administration fast-tracked its review of ipilimumab, approving it in March; the European Medicines Agency recommended it in May, and it has been available Europe-wide since July. ms had survived, compared with 14% in the vaccine-only arm.
Those results were enough for the USA and Europe:
On the strength of these results, in patient groups for whom few effective treatments exist, the Food and Drug Administration fast-tracked its review of ipilimumab, approving it in March; the European Medicines Agency recommended it in May, and it has been available Europe-wide since July.
Here’s the excuse:
Although the results, Mr. Dillon continued, “did show the drug could potentially be very effective for a small percentage of patients,” the follow up from the trial “was too short to determine how long this effect would last.” Clinical specialists have advised NICE that about 30% of people treated with ipilimumab would have improved survival, with an estimated 10% potentially experiencing long-term benefits.
So, four out of ten of advanced melanoma patients would benefit, and one in ten long term. That’s known as efficacy. But the NHS is melting down. We must save money where we can!
With Obamacare seizing control of deciding coverage issues nationally, we are on the way to our own verson of NICE. Indeed, Donald Berwick, the short timer head of Medicare has extolled the agency. Former Senator Tom Daschle, one of the most influential advisers to the president and Congress on Obamacare, also is on record wanting us to follow the path blazed by NICE. We are already witnessing a rise in support among the medical intelligentsia for rationing life-extending cancer treatments.
This much is sure: If a US health insurance company denied coverage based on NICE’s justification, it would be sued into the bottom of the sea and regulators would tie anchors to its waist. But if government, or its authorized agents, makes the same decision, there isn’t much that can be done.
HT: E. Chevlen