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Medicare to cover prostate cancer vaccine.

The Centers for Medicare and Medicaid Services has determined that the evidence supports the conclusion that the prostate cancer vaccine sipuleucel-T, better known as Provenge, is an effective therapy and should be covered for Medicare beneficiaries.

The national coverage decision in favor of the autologous cellular therapy is an important one for sipuleucel-T's maker, Dendreon, and for patients. The CMS said that prostate cancer is the most common noncutaneous cancer in American men, leading to some 192,000 new cases each year and 27,000 deaths.

But the decision is also controversial. The estimated cost per three-dose, 4-week treatment is $93,000, according to the Santa Monica, Calif-based Prostate Cancer Foundation, which funded some of the investigators who were involved in the pivotal phase III approval study of Provenge. That study, published in the New England Journal of Medicine, estimated that sipuleucel-T therapy resulted in a median 4 months' additional overall survival (N. Engl. J. Med. 2010; 3 63:41 1-422).

Based on that trial and two others, the Food and Drug Administration approved sipuleucel-T in April 2010 for castration-resistant, metastatic prostate cancer. Subsequently, a Medicare Evidence Development & Coverage Advisory Committee met in November 2010 to consider whether the federal health program should cover sipuleucel-T. The panelists expressed middling confidence that the immunotherapy was safe and effective for its labeled indication, but a low level of confidence in general; the panel found intermediate confidence on the evidence for labeled use, and very low confidence on off-label use.

When the CMS issued its initial proposal in June 2010, it received 657 comments. In all, 94% were in favor of coverage. The agency said that only 67 (10%) were submitted by physicians, 23 (3%) by other health care providers, 55 (8%) by patients, 44 (8%) by professional groups or advocacy organizations, 18 (3%) by researchers or investigators, 10 (1%) by attorneys, and 15 (2.3%) by industry representatives or investors.

The vast majority of comments, 455 (69%), were submitted by the general public. The CMS noted the unusual aspect of the comments; some were "submitted via a legal representative to preserve anonymity in light of alleged death threats. Others alleged that there were efforts afoot to manipulate Dendreon's stock price. Some commenters assumed false identities. One - J. Mengala MD/PHD/VDRL/STD/ AWOL - appeared to be patently phony.

Because of these issues, the CMS said it was in doubt "about the evidentiary weight that may reasonably be assigned to certain of the public comments."

When it issued its proposed decision in March 2011, the agency received 590 comments, again with the vast majority in favor of coverage. And, once again, most were submitted by members of the general public.

After the FDA approval in 2010, Dendreon said it would most likely not be able to meet demand for the vaccine because of manufacturing capacity issues. The day that the CMS announced its decision to cover the therapy, Dendreon issued a statement that it had recently received FDA approval of a manufacturing facility in Los Angeles, giving it expanded capacity.

Dendreon CEO Mitchell H. Gold said in the statement, "The increased capacity and positive National Coverage Decision by CMS in conjunction with the patient assistance programs will ensure patients who may benefit from treatment with Provenge have increased access to it."
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Title Annotation:ONCOLOGY
Author:Ault, Alicia
Publication:Internal Medicine News
Date:Aug 1, 2011
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