PHARMA/POLICY/QUALITY: Cost-effectiveness in drug approval

I’ve been hanging with the libertarian Canada-bashers from PRI! They and the California Health Institute (the Cal biotech and drug company industry group) invited me to a very, very nice dinner last night. I assume that they used the drug companies’ money rather than the Scaife’s so I can keep my lefty credentials! Then they had a meeting Friday morning, intended to scare the world about the prospect of an Australian-type cost-benefit analysis requirement for drugs coming here.

IMS put out a report saying that access to drugs in the US would be massively restricted if an Aussie style system was imported here; Randy Frankel from IMS gave the talk (although I sat next to him at dinner and he has a varied and interesting background including setting up disease management at Medco and he basically agreed that we were out of easy targets for drugs and had to decide what to do about biotech drugs that cost $100K for an extra year of life).

Ruth Lopert, adviser to the Australian system gave it a somewhat vigorous, but also defensive defence. She said a few things

  • Government doesn’t set prices…price is proposed by the drug co, but then accepted if it makes it under the cost-benefit analysis (i.e. better come into line!) so prices for me-too drugs are lower than for first movers
  • She says prices for innovative drugs are higher in Australia than they are here! (Gleevac, Embrel)
  • She says it’s not a mechanism for cost containment, Australia’s drug costs are going up 12% a year. (to which I should almost asked, but didn’t, why bother at all then!)
  • And if it’s not reimbursed by the state, you can pay out of pocket! And for most patients in Australia paying out of pocket costs less than the average payment me for drugs by a typical patient on Medicare Part D!

Marjorie Ginsburg, from Sacramento Healthcare Decisions, talked very entertainingly about their report in which they found that people where in general happy to say no to funding certain technologies (including Aricept for Alzheimer’s).  There is a subset of people who believe that if it saves one life (such as an implantable defibbilator) it’s worth it, but once you get past direct life saving technology, they don’t care. Only 12% said cost effectiveness should never be considered. 50% said it should always be. Other things they want — 67% wanted price controls, 56% wanted cost benefit analysis, 49% want more oversight. Her message is that this is acceptable—but don’t do it just by itself. It will have to be part of a whole package of how to deal with health- are. The way to get this done, she says, is to present as getting it best value, not cost savings.

Meryl Comer who’s been caring for her husband with Alzheimer’s for 12 years gave a harrowing talk about the impact that’s coming from that disease. She said that there’ll be 13.9m Americans with Alheimers by 2010. 650K are diagnosed while still under 65. Make it to 65 and there’s a 1 in 10 chance that you’ll get it; by 85 it’s 1 in 2. Still no cure, even though the disease was discovered in 1906. She wants to make sure that the access to successful cures is not prevented, because it’ll save so much.

Kwabena Adubofour, a diabetes care clinic director from Stockton gave a long talk about how EBM analysis for drugs is largely irrelevant while care is generally problematic, and that there’s massively unequal treatment based on ethnic origin, poverty, et al. His concern is that limiting pharmaceuticals via cost containment in this environment is a double hit on minority health care. He points out that there’s a huge gap in care for blacks compared to whites (much fewer rates of referral) women only got 60% of the referrals that men did, blacks only got 60% that whites did. He thinks formulary redesign is irrelevant—there’s lots more to do first. His long list of stuff included DM, pay for Improvement, reducing unnecessary care, etc, etc). He thinks that no one (as far as he can tell) is against rational thinking about how to tackle pharmaceutical costs (Can’t say that I agree with him about that!) But we should only be doing that in the context of this other stuff.

Peter Pitts, ex-PRI, ex-FDA, claims that the problem is that one size doesn’t fit all in health care (or anything else) because EBM is a regression to the mean. And the studies ignore the massive patient based variation. (and he’s right….) So his answer is no formualries. He says that restrictive formularies cause higher costs later. Genomics/personal medicine will fix all this. At least I think that’s what he’s saying. He’s saying we need innovation? (Are we opposed to that over on the EBM supporting side….I’d guess he’d say we are!)

BTW if you’re a former governor, you still have to show up at things like this. At least Pete Wilson is here. Another disincentive to run for public office!

The Q&A pretty much was a fight between Pitts and Lopert.

The audience was very amusing. 2 doctors asked random questions. One said “why is the government establishing these guidelines, shouldn’t a 100 flowers bloom”. Another decried cookbook medicine and said that “Evidence-based medicine is creating Alzheimers in doctors brains…” (i.e. it’s stopping doctors from thinking). Randy Frankel smacked them both down by explaining the variability in medical practice, and showed that it takes 17 years for a guideline to come into being.

Peter Pitts answered my long long rambling question/comment trying to figure out what the panel was about by (essentially) saying that he’s opposed to formularies, and that third party payers should pay for whatever the doctor wants to prescribe. Kwabena Adubofour says that in cost containment with pharmaceuticals, it’s always the cheapest drug that gets pushed—not the best “value” overall.

From the audience The medical director of Safeway (didn’t catch his name) and Anthony Barrueta VP of government relations at Kaiser Permanente both essentially said that EBM is about changing physician behavior and we need to do that. Because, for example, per capita we do 19 times the rate of back fusions than they do in Denmark. That’s some practice variation for you! That’s what happens when there are no guidelines…the Safeway med director says that when Australia is spending 9% of GDP and we’re spending 17% it’s crazy to think that we don’t have a problem.

An interesting session, but I don’t really know what it was about! We’re going to get some level of practice guidelines and EBM incentives via P4P, they’ll be fought tooth and nail, and cost-effectiveness analysis will be part of that process. But it ought to be done in the context of wider health care reform, because this is not the biggest problem in our health care system. And you know what is, with more evidence just last week

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