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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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July 1, 2011

Avastin and Medicare

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Posted by Derek

So, the FDA's advisors voted unanimously to remove Avastin's indication for metastatic breast cancer. Fine. But Medicare is saying that they'll continue to cover it? Really?

Now, as opposed to the other day, we're starting to talk about cost. Avastin is (famously) not cheap, and insurance companies often don't want to reimburse for off-label use of drugs. But if Medicare, well, doesn't care, then what? A number of insurance companies take their policies into account for their own coverage recommendations.

So this makes a person wonder what all the arguing over this issue has accomplished. Perhaps fewer oncologists will be willing to write off-label prescriptions after the FDA makes its call - there is that. But (on the one hand) this isn't looking quite like the consigning-people-to-death outcome that patient advocates were warning about. It also gives you an insight into health care costs, doesn't it? The FDA says "We don't recommend you use this. The clinical trial data don't support it." And Medicare says "Well, yeah, sure, but we'll pay for it, so what the hey". What, indeed, the hey?

Comments (13) + TrackBacks (0) | Category: Cancer | Drug Prices | Regulatory Affairs


1. Jonathan on July 1, 2011 11:11 AM writes...

It's a weird decision. Medicare can't make cost-based decisions (thanks, Congress!) but they can and should make them based on the science...

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2. murka on July 1, 2011 12:50 PM writes...

Indeed, the Medicare claim is super puzzling. Especially in such a public proclamation. But since this is other people money, the administrators should not care about cost/benefit at all. Now it looks like they don't have to care about science either.

In a few short years, the young people will work most of their time to support the aging baby boomers, spending whatever it takes. Then, when the time comes, there will be nobody to take care of those who are young at present. Where is cost/benefit in all of this?

I see that FDA will be a lot more stingy with the provisional approvals going forward. Roche could have started looking for markers in cases where the drug did help, instead they will just create more problems for themselves down the road with other (non-)approvals.

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3. alig on July 1, 2011 1:12 PM writes...

Maybe Medicare is waiting for the final FDA decision rather than just the advisory committe's decision.

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4. MTK on July 1, 2011 1:24 PM writes...

It's not just Medicare if you read the Reuters article it quoted a WellPoint spokesman as saying they'll continue to cover Avastin also.

Like I said, the protesters need to be in front of the HMO's and insurance companies, not the FDA. They can cover whatever they want to cover.

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5. Steven Walker on July 1, 2011 1:52 PM writes...

Come on Derek. CMS weighed in as quicKly as it did because no one who knows anything about metastatic breast cancer or the facts surrounding this FDA misadventure, agrees with the FDA. The FDA just functioned as precisely the kind of mindless, agenda-driven bureaucracy that opponents of the IPAB and the administration's obsolete approach to applying the results of simplistic Comparative Effectiveness Research to coverage decisions, claim will produce "death panels." Here's what happened to prompt te quick statement from CMS. The Presidents advisors, including Kathleen Sebelius, realized very quickly - based on the fact that no one was agreeing with the FDA on this (including practicing oncologists, patients and their advocates, the EMA and the NCCN, etc.) - that the FDA had just handed the Republicans proof that parts of the President's health care act would result in poorly supported rationing decisions. The actual MBC patients who showed up, and their advocates (which included advocates for other forms of terminal cancer as well), put a human face on it, and made it clear that some women would die prematurely if this drug was taken away from them. Ralph D'Agostino, an ODAC member who voted against the drug last July but didn't serve on the hearing panel, admitted in an NEJM editorial this week that the evidence indicates about of quarter of women do benefit from the drug, but the cost may override that benefit, since the other 75 percent may not (no question anymore that at least some members of ODAC were thinking about cost when they are actually prohibited by law and regulation from doing that). Wyndham Wilson, the chair of the panel that voted against the drug at the hearing, said the same thing after the hearing - quoted in a number of press articles yesterday. Here is what almost certainly happened. In the face of an obvious bungling of this decision by FDA, Sebelius was instructed to make this thing go away. The first step was the CMS statement. You should expect more. Geez, Derek, please get more engaged on this stuff. The FDA is wrong on this, and unfortunately, the wrongheadedness that got them to that point is still in place within OODP and still holding back progress against cancer, with other good cancer drugs tied up behind Pazdur's Decelerated Approval Inititative. Had the patients and advocates not been at the hearing (I was one of them), FDA would have pulled the drug, and CMS would have followed suit. Are you suggesting that the people affected by FDA decisions shouldn't show up to make themselves visible and tell the FDA what they think the agency should do? Really?

I am going to say this once, and you can all pounce as much as you want. I won't waste my time responding this time.

DO YOUR HOMEWORK FIRST, THEN POST. The FDA really screwed this one up, and now the White House has a huge mess to clean up. If they fail, it could cost Obama a second term.

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6. RickW on July 1, 2011 2:12 PM writes...

#3, I was wondering about something like that. The statement from the CMS person could be interpreted as "we're not ending coverage, *yet*."

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7. pete on July 1, 2011 4:50 PM writes...

@5 S. Walker (who claims he won't entertain replies)
"The FDA is wrong on this, and unfortunately, the wrongheadedness that got them to that point is still in place within OODP and still holding back progress against cancer, with other good cancer drugs tied up behind Pazdur's Decelerated Approval Inititative."

Do tell which drugs you have in mind. Not unike my counterparts on the CDER committee, I'd like to see some data to support the bold statements.

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8. Anonymous on July 1, 2011 5:09 PM writes...

Steven Walker@5: The actual MBC patients who showed up, and their advocates put a human face on it, and made it clear that some women would die prematurely if this drug was taken away from them.

This is what makes me uneasy about these discussions. Did they really make it clear that statistically more women would die prematurely without access to the drug, or did they make it clear they *thought* some women would die prematurely? Certainly, in a perfect-knowledge, post-hoc analysis you'll be able to identify people who lived longer under Avastin versus without it. But the question is can you identify them a priori - or if you can't, does the survival benefit if it works outweigh the severe side effects and potential life reduction (either from adverse reactions or opportunity costs from using Avastin instead of another treatment) of when it doesn't?

I just read an article which gives a great analogy for the mental fallacy we tend to get into when looking at specific examples. Climbing aboard a landing craft before the invasion of Normandy, so the story went, Bob's sergeant told the men that by the end of the day, nine out of 10 would be dead. Said Bob, on hearing that news: "Each one of us looked around and felt so sorry for those other nine poor sonsabitches." Sure, Avastin may be great if it works for you, but going in you don't know if you're the lucky one, or one of the poor sonabitch for which it's less than useless.

I'm with Derek - FDA approval should be based on dispassionate analysis of the facts, not on a Panglossian/Pollyanna viewpoint of "well, it might not work for them, but it's *gonna* work for me."

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9. luigi on July 1, 2011 9:37 PM writes...

Same type of thing happened with iloperidone. Huge comparative effectiveness trials concluded that newer antipsychotics were no better than first generation compounds, so not worth more than a generic. Iloperidone had a very lacklustre profile HERG etc. e.g., it was a dog. Yet the FDA still approved it and as Derek has noted - sales in 2010 were around $12MM a year. Real blockbuster - why make comparative effectiveness trials an integral component of Obamacare and then ignore them????

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10. HFM on July 1, 2011 10:58 PM writes...

I think #5 has the politics right, at least - the science was equivocal, Europe called it the other way, and the last thing the current administration wants is another round of "death panels" hysteria.

But if Avastin is statistically worse than useless, the FDA made the right damn call. Even if it does help some people, if you can't pick the right people, it's still worse than useless. This doesn't mean the drug won't come back once we've actually figured out who should get it.

It's very common for targeted therapies to be useful only in some cases (and actively harmful in others). Apparently, if the difference between responders and non-responders is big enough, you can get away with running your own n=1 trial...if the responders are obvious within a week or two, you can take the non-responders off before it hurts them, so it's not absolutely critical that you know the difference beforehand. I'm sure they're looking for that kind of thing with Avastin - but if it was there we'd have heard about it.

Nobody's rooting for the cancer here, and I don't blame terminal patients for wanting to take a chance (even if the drug averages out to be worse than useless). But if we're talking an occasional minor benefit versus the nearly-certain side effects...there's some rethinking that ought to happen first.

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11. Just another Joe on July 2, 2011 6:38 PM writes...

Please. This was pure pandering to women (with the most "favored" disease). Had this been any other disease (especially one affecting males) no one would be talking about it and the Medi-decision would have gone the other way. Just calling it like I see it.

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12. Anthony on July 2, 2011 8:23 PM writes...

While it doesn't make sense logically, it's complicated because the drug *is* approved for other uses. Also, as was pointed out over on Marginal Revolution:

Orange14 July 1, 2011 at 11:06 am

There is no issue here. A regulation was put in place about two decades ago (I was working at a trade association at the time and filed comments on it) that says drugs that are generally accepted into practice as outlined in a compendium (at the time there were three major ones but I think this has changed over time) it must be reimbursed at the Federal level. This is why a lot of off-label cancer drugs (this is really not limited to Avastin!) are reimbursed by Medicare.

So in the specific situation with Avastin, Medicare is following the general rule. Whether the rule as a whole makes sense, I'm not sure, but the case of off-label uses makes it a difficult call.

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13. PharmaHeretic on July 4, 2011 9:06 PM writes...

So Chantix (varencline) is worse for your arteries than nicotine AND it makes you go nuts.

Study Links Smoking Drug to Cardiovascular Problems

Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on Monday.

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