An interesting signal from CMS as “the good guy”


As many in the prostate cancer community will be aware, there has been a major battle ongoing over whether the drug bevacizumab (Avastin) should continue to be approved by the U.S. Food & Drug Administration (FDA) for the treatment of women with metastatic breast cancer.

We have no desire to get into the details of the debate. There are excellent arguments to be made on both sides of this battle. Suffice it to say that earlier this week, for the second time, an advisory committee to the FDA voted that the approval should be withdrawn on the grounds that the risks to patients associated with the use of bevacizumab in this particular indication outweighed the benefits. The Commissioner of the FDA will have to make a final decision.

However, the Centers for Medicare and Medicaid Services (CMS) announced yesterday that, even if the FDA did withdraw approval of bevacizumab for treatment of breast cancer, Medicare would continue to cover the costs of this drug in combination with chemotherapy for the treatment of women with metastatic breast cancer. (See this article on the New York Times web site.) Not only is this going to come as a great relief to those women on Medicare who have been taking bevacizumab for treatment of late stage breast cancer, it is also going to be a strong signal to commercial insurers that they should also cover this use regardless of the decision of the FDA.

So why would CMS make this decision, which at first sight appears to be a slap in the face to the FDA?

Actually this decision makes perfect sense. Regardless of the FDA’s decision, there is extensive data in the peer-reviewed literature and in the recognized “compendia” (such as the NCCN Drugs & Biologics Compendium) suggesting that bevacizumab is active in the treatment of metastatic breast cancer. CMS is legally obliged to cover the costs of the use of all drugs that are recognized in established compendia to be active and reasonably safe in the treatment of cancer — on or off label. Therefore they will cover the costs of bevacizumab even if the FDA removes the approved indication.

Not only is this a good decision on the part of CMS. It is a signal that physicians and their patients retain the right — together — to make clinical decisions that they believe to be in the best interests of individual patients with cancer, and that Medicare will cover appropriate costs resulting from such decisions. Let’s hope that the commercial insurers will also take a similar position — as they historically have for the off-label use of other cancer drugs. According to the above-reference article in the New York Times, United Healthcare — one of the largest commercial insurance companies — apparently will follow the same policy as CMS

The interesting question now is going to be whether the FDA and Roche/Genentech (the developer of bevacizumab) can find some common ground that will allow a repeat of the original trial (comparing paclitaxel + bevacizumab to paclitaxel + a placebo) that showed a 5-month progression-free survival benefit in the treatment of metastatic breast cancer so that they can re-establish approval of bevacizumab for this indication. The principles of good science would suggest that this is the right thing to do, regardless of the FDA’s final decision about the approval of bevacizumab in the short term.

Why does any of this matter to the prostate cancer community? Because it is a strong signal that Medicare will continue to follow well-established practice and cover the costs of the off-label use of any form of treatment that is clearly well documented in the peer-reviewed literature and (ideally) supported by documentation in the legally approved compendia. With the rapidly expanding range of agents coming available for the treatment of progressive forms of prostate cancer — on and off label — confirmation of this principle may well become very important to patients with (or at risk for) progressive forms of prostate cancer and their families

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