The existing clinical data on Dendreon’s prostate cancer vaccine Provenge (sipuleucel-T) cannot be "generalizable" to off-label uses, most members of the Medicare Evidence Development & Coverage Advisory Committee agreed at a Nov. 17 meeting.
The meeting was called by the Centers for Medicare and Medicaid Services to consider whether Provenge is a "reasonable and necessary" therapy and thus eligible for Medicare coverage. The treatment is approved for treating asymptomatic or minimally symptomatic prostate cancer that is metastatic and resistant to standard hormone treatment.
The committee’s review is part of a national coverage analysis on Provenge and may be followed by a national coverage determination. Off-label use is one significant issue for the agency. A proposed decision on the agency’s analysis is scheduled to be released by March 3, 2011, and a final decision will be released in June 2011.
The committee voted on a number of questions designed to probe the strength of the available evidence for both off-label and on-label use. In answering questions posed by CMS, members were asked to rate their confidence in the data on a scale ranging from "low" to "high."
The majority of members signaled that the data could not support use of the therapy in patients whose prostate cancer has not metastasized; in patients who have metastatic, castrate-resistant disease but whose symptoms are more severe than minimally symptomatic; or in patients who have metastatic prostate cancer but who have not failed hormonal therapy.
The committee was more confident about the data supporting on-label uses. The majority voted that the data are reasonably adequate to conclude Provenge improves overall patient survival and can help to avoid the "burdens," including side effects, associated with chemotherapy. The committee expressed less confidence that the data conclusively show Provenge improves the control of disease-related symptoms.
MEDCAC members felt the clinical trial data can be extrapolated to use of Provenge in community-based settings and were moderately confident that the research findings were generalizable to demographic groups underrepresented by the patients participating in the studies, including Medicare beneficiaries and minorities, such as African Americans.
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