Medicare to Cover Pricey Prostate Cancer Treatment
Provenge immunotherapy has a price tag of about $93,000
March 31, 2011— -- Medicare plans to pay for Provenge -- an immunotherapy for prostate cancer -- following a determination that it is genuinely effective in metastatic hormone-refractory disease, according to the Centers for Medicare and Medicaid Services.
"The evidence is adequate to conclude that the use of ... [Provenge] improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication," the agency said in a proposed decision memo.
Moreover, in an unusual move, CMS declined to either endorse or prohibit off-label coverage nationwide. Instead, the agency will allow its individual local contractors to cover Provenge for certain off-label uses at their discretion.
A final decision is scheduled to be issued by June 30 after CMS evaluates public comments on the memo.
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The treatment consists of a patient's own peripheral mononuclear cells exposed ex vivo to a prostate cancer antigen and a recombinant growth factor, and then returned to the patient. The procedure primes the cells to recognize tumor cells and direct an immune-system attack on them.
Provenge won FDA approval in April 2010, after a long and arduous series of clinical tests and data submissions. Then, in November, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) found that the evidence was reasonably good -- with a score of 3.7 out of a possible 5 -- that the treatment significantly improved survival in patients with metastatic hormone-refractory prostate cancer.
The proposed decision memo, published Wednesday, essentially ratifies the MEDCAC finding.
However, CMS punted on a second issue, which was whether Medicare should also pay for off-label use of Provenge in patients with prostate cancer that is not metastatic or hormone-refractory or that is more than minimally symptomatic.
Medicare sometimes pays for off-label treatments, and there has been considerable interest in Provenge for treating prostate cancers other than those specified in the FDA-approved indications.
