Details

Autor(en) / Beteiligte

• Goozner, Merrill

Titel

Concerns about Provenge simmer as CMS ponders coverage

Ist Teil von

• JNCI : Journal of the National Cancer Institute, 2011-02, Vol.103 (4), p.288-289

Ort / Verlag

United States: Oxford Publishing Limited (England)

Erscheinungsjahr

2011

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• A Medicare advisory committee in mid-November expressed mild support for the evidence behind the use of sipuleucel-T (Provenge), approved by the FDA for asymptomatic, metastatic, castration (hormone)-resistant prostate cancer. The 14-member Medical Evidence Development and Coverage Advisory Committee rated the quality of evidence supporting the vaccine at 3.6 of a possible 5 for its FDA on-label use and at 1.2 of 5 for off-label use. But in an unusual move, committee members also suggested that the Centers for Medicare and Medicaid Services collect postapproval outcomes data through its coverage-with-evidence-development program. That could help physicians and patients identify which patients are most likely to benefit from the therapy. Medicare has previously used registries to track use of procedures such as imaging, but never drugs. An expanded registry for sipuleucel-T could monitor outcomes such as mortality, time to progression, and side effects.