ARTICLE | Regulation

The Provenge Messages

Provenge-Medicare points to routine challenges of FDA-approved uses of new drugs

November 22, 2010 8:00 AM UTC

The long-awaited Medicare Evidence Development & Coverage Advisory Committee meeting on Provenge sipuleucel-T from Dendreon Corp. makes it clear that Medicare is on course to routinely question labeled uses of expensive therapies and deny coverage of off-label uses for newly approved drugs.

For doctors and patients used to a system in which drugs are routinely used off label, especially in cancer, the coverage policy that is likely to emerge next year will leave two paths forward. They will have to wait until there are enough data to support inclusion of off-label uses in compendia or widely accepted treatment guidelines, or find a way to get access by other means. This could range from paying out of pocket to enrolling in clinical trials to enrolling in patient access schemes offered by drug companies...