A Medicare First!

Posted: August 17, 2010 in Uncategorized

For the first time in history, an FDA approved anti-cancer therapy may not be covered by Medicare.

Provenge, a vaccine to treat the recurrence of prostate cancer, has been approved by the Food and Drug Administration (FDA)… Medicare usually covers the cost of FDA-approved anti-cancer therapies. However, the Centers for Medicare and Medicaid Services (CMS) is still reviewing whether it will cover Provenge, and at what rate.

The CMS statute states that Medicare must cover therapies that are reasonable and necessary, while the FDA is instructed to approve drugs that are safe and effective. Because of the conflicting Federal coverage and approval requirements, there are some non-FDA approved drugs (called off-label drugs) that are paid for by CMS. However, with respect to Provenge, it appears that CMS is arguing that while the treatment is safe and effective, it may not be reasonable and necessary.

In other news:

Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance (OCNA) today urged the U.S. Food and Drug Administration (FDA) to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn.

In a joint letter sent to the FDA and key Congressional lawmakers Thursday, Komen for the Cure and the OCNA wrote, “We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”

“We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer,” said Ambassador Nancy G. Brinker, Komen’s founder and CEO, in the joint letter to the FDA. “However, we do know that for some women, Avastin offers a greater than modest benefit. We hope that this decision will not restrict access to Avastin to all patients.”

The FDA is considering cost effectiveness in its deliberations to withdraw their previous approval of the drug.

Since when is cost effectiveness a criteria for FDA approval? Is this the “Panel” we were warned about? Is it cover (withdrawing their approval) for Berwick’s plans for your healthcare?

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