• Avastin

    On Dec. 15th, the FDA recommended amending the label for Avastin (bevacizumab), removing the indication for metastatic HER2-negative breast cancer.  Here’s the conclusion:

    The modest benefit observed with Avastin together with the substantial adverse reactions observed in breast cancer trials to date fail to provide a favorable risk-benefit profile to support continued marketing of Avastin for a first-line metastatic breast cancer indication.  It is the conclusion of OND that the breast cancer indication for Avastin be withdrawn.

    The drug remains approved for various colon, kidney, brain and lung cancers.

    The WSJ’s editorial reaction was harsh, calling the decision ”reprehensible” and a “tragedy for desperately ill women.”

    The reprehensible tragedy is that the WSJ would write this editorial.  Some facts:

    • The decision doesn’t pull Avastin from the market.  Genetech can still sell it for anyone with a prescription from their doctor.
    • The decision doesn’t prohibit physicians from prescribing Avastin for breast cancer. If your doctor thinks it can help, they can still prescribe it off-label.

    The primary result of this FDA recommendation – if it withstands the political attack on science – will be a hearing in which Genentech can dispute the FDA’s analysis.  If the FDA prevails, Genentech will have to change the label and from that point forward cannot market Avastin off-label for metastatic breast cancer.

    Marketing a $88,000 drug on an unproven hope of a cure?  That’s what I call a tragedy for desperately ill women.

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    • It’s my understanding that Medicare will not reimburse for medications deemed by the FDA to be ‘less than effective’ which is certainly the intent of withdrawing approval.

      In most cases, as goes Medicare, so go the private insurances.

      I’m not, in this case, disputing whether or not this is the right thing to do. I think that $88,000 is a hell of a lot of money for the meager gains to be had.

      I also think that this sends the wrong message to the innovators of cancer drugs, and biologics in general. What happens to the price of Avastin now that the FDA has cut this portion of the market? It certainly doesn’t go down, which is generally the preferred direction. What happens to the next promising cancer drug that can’t promise much more than a couple of months? Is it worth the price of bringing it to market if the FDA gets to decide by fiat after approval that, absent any data other than cost and limited life extension, a drug should no longer be approved (I’m discounting the ‘adverse reactions’ because it’s chemotherapy, plus they can be treated with Tylenol and Benadryl)?

      This is more indicative of a fundamental problem in drug approval, one that I don’t think gets enough attention. There’s no real skin in the game if FDA gets one wrong, they can just rescind approval. Pharma/Biotech is still liable for any ills, and must price that risk into the agent.

      • @Some guy- I talked about reimbursement in some detail above. You’re still on PhRMA talking points.

        “Sends the wrong message” – no, actually this sends the right message to drug developers:

        • Drugs won’t be approved unless the science is proven; and
        • Drugs can’t be marketed for unapproved uses.

        Even better – we should pay for value in drug reimbursement.

    • What’s the relationship between decisions on Medicare reimbursement and FDA recommendations? I understand that, at the moment, the drug is still reimbursed under Medicare. Assuming Genetech loses the hearing, how likely is it that Medicare will stop reimbursement? Do they tend to follow FDA recommendations, or does Medicare just do it’s own thing?

    • Saying that you addressed something and actually addressing it are, you’ll find, two different things.

      Medicare WILL NOT pay for drugs that the FDA has ruled to be “less than effective”. The FDA approves/denies drugs based on effectiveness, Rescinding approval means that Medicare won’t pay for it. Just because they didn’t get around to updating the website yet doesn’t change the policy.

      I’m not quoting PhRMA talking points because I have no affiliation with them, and know nothing of their talking points. Your attempt to demonize my position by associating it with an organization you disagree with is illustrative.

      I think that sending the message that the FDA will approve a drug, then rescind that approval at no liability to the FDA, discourages the risk of applying for drug approval. Additional risk will be priced into new drugs, driving prices upward even more.

      Also: Citing yourself?

    • @ Scott & Some guy – Medicare and Medicaid pay for tens of billions of dollars of drugs prescribed off-label. If an approved drug is found to be dangerous and withdrawn from the market, then of course Medicare won’t pay, but that’s not the case with Avandia.

      We’ll have to see if Avandia is removed from all of the private compendia as a treatment choice for metastatic breast cancer. I would say that’s very unlikely, and in any event, these are private organizations beyond the control of CMS.

      It is theoretically possible that HHS could try to affirmatively exclude payment for Avandia for metastatic breast cancer, but nothing has been said on that yet (and it is a different process from what the FDA just did). Last time HHS messed with Part B reimbursement of this drug, all hell broke loose.

    • I tend to agree with Some Guy – if this stands it will eventually mean that CMS will not pay for Avastin for patients with HER-2 negative breast cancer (assuming they are able to identify such patients).

      The thing is, I would fully agree with that. Why in the world should CMS pay for extremely expensive drugs that its sister agency says produce net negative benefits? Does CMS have to pay for everything, no matter how expensive, no matter the evidence for its clinical benefits, if the patient and doctor want it? If not, how would you argue that it ought to pay for Avastin?

    • The real “tragedy” is that this drug probably does work in some women but not at all in others and right now we have no idea who will respond and who won’t. To find this out requires doing more research which requires $$$ as well as a willingness by patients to subject themselves to additional blood draws or biopsies. You’d be surprised how many people refuse. It’s a complicated problem without an easy answer.

    • Some guy:

      You are completely wrong about the FDA. They gave conditional approval to this medication so it could be used prior to it being shown effective. Normally the company would have to do this study before being allowed to sell the medication at all. However, if the study data shows that the drug is ineffective then the approval is removed. This is an example of the FDA working.

    • My wife just started on Avastin (12/2010) for recurrence of a grade 3 brain tumor (anaplastic oligodendralglioma). She had been on Temodar for a year, but it lost its magic and her tumor has tripled in size since August.. The total charges for her first treatment were $9,920 which annualizes to $258,000 per year. Wow. Thank goodness for insurance.