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.
MEDCAC, as well as CMS' own internal technology review, found little evidence one way or the other on the efficacy of off-label Provenge. The company selling the treatment, Dendreon, has indicated it has no data to support its use for unapproved indications.
Nevertheless, in the proposed decision memo, the agency said it would leave coverage of Provenge for off-label uses to the judgment of its local administrative contractors.
"If future evidence demonstrates improvement in patient health outcomes as a result of incremental improvement(s) to the current labeled process, we want our administrative contractors to have the flexibility to determine local coverage without the need to reconsider an NCD [National Coverage Decision]," the memo indicated.