What I didn't expect, but should have, was how quickly the Obama administration would make that decision and how it distanced itself from the FDA ODAC vote to revoke Avastin's indication. From Reuters:
"The FDA decision, when it comes, does not affect CMS," Don McLeod, a spokesman for the Centers for Medicare and Medicaid (CMS), said on Thursday."The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it," he said, adding that CMS often pays for off-label uses of drugs." www.reuters.com/article/2011/06/30/roche-avastin-cms-idUSN1E75T17U20110630
Gee, what happened to the effort to coordinate reimbursement decisions and FDA approvals in order to "bend the cost curve."
The comparative effectiveness crowd must be comparing in their pants..
And if that wasn't enough, Team Obama trotted out Donald Berwick to extol the virtues and value of Provenge, a drug it delayed paying for by 18 months. Here's what Berwick said in a prepared statement that sounded like a forced confession from the lover of Britain's single payer health system.
“We are optimistic that innovative strategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Dr. Donald M. Berwick. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”
www.latimes.com/health/boostershots/la-heb-prostate-cancer-provenge-medicare-20110701,0,7641053.story
Here's Berwick in 2009:
"We can make a sensible social decision and say, “Well, at this point, to have access to a particular additional benefit [new drug or medical intervention] is so expensive that our taxpayers have better use for those funds.” We make those decisions all the time. The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open. And right now, we are doing it blindly."
www.ncbi.nlm.nih.gov/pmc/articles/PMC2799075/
Every time a new cancer drug is approved in Britain, the NHS gets hammered for rationing care. But what happens in Britain is tee-balll compared to what CER types and the institutions that will produce or use CER will go through every time it tries to restrict or delay access to treatments that benefit a segment of the population.
Trying to go up against innovation in the US? It could be compared -- if the Avastin and Provenge sagas are any indication -- to trying to challenge St. Louis Cardinal pitcher Bob Gibson, know for his take no prisoner attitude against any hitter. What Hank Aaron said in that regard might explain Team O's response to the FDA decision:
'Don't dig in against Bob Gibson, he'll knock you down. He'd knock down his own grandmother if she dared to challenge him. Don't stare at him, don't smile at him, don't talk to him. He doesn't like it. If you happen to hit a home run, don't run too slow, don't run too fast. If you happen to want to celebrate, get in the tunnel first. And if he hits you, don't charge the mound, because he's a Gold Glove boxer.' I'm like, 'Damn, what about my 17-game hitting streak?' That was the night it ended."
Don't dig in against innovation.