An update on Provenge and the FDA

Provenge, a vaccine to treat the recurrence of prostate cancer, has been approved by the Food and Drug Administration (FDA).   The vaccine is made from a patient’s own blood cells with cancer cells and an immune boosting substance.  A three dose course of the immunotherapy is estimated to cost $93,000.  According to the company producing the vaccine, that equals $23,000 per added month of life.

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

The Ovarian Cancer National Alliance supports access to drugs and therapies that can extend a patient’s life or improve quality of life.  We have been working with Members of Congress and the Administration to ensure that ovarian cancer patients have access to necessary drugs, including off-label anti-cancer therapies.  We have also joined the cancer community in calling for CMS reimbursement for Provenge, based on its FDA approval.