As reported in Inside Washington Publishers, on April 23 at a forum in Baltimore, cancer groups demanding coverage of off-label uses of oral cancer drugs, "criticized CMS (Centers for Medicare and Medicaid Services) criteria that exclude coverage of off-label uses of drugs, prompting CMS officials to say they were open to a workable standard that was short of FDA approval for a specific treatment.
"The International Myeloma Foundation and drug maker Celgene testified that although thalidomide is still undergoing FDA approval for treatment of multiple myeloma, a blood cancer, it should be included in the program at least once it is approved if not sooner. Greg Brozeit, a consultant for the foundation, said that an FDA decision is expected in the next few months but even if it is not approved, CMS should allow thalidomide for multiple myeloma into the program.
"Under questioning by a staffer for Sen. Kay Bailey Hutchinson (R-TX), a myeloma advocate, Sean Tunis, CMS' chief medical officer, said, 'We would potentially look at a fairly precise addition of a vital subset of not yet labeled indications'...such that CMS is given a 'relatively bright line' test of which off-label drug uses would and would not qualify for coverage.
This week, Brozeit said that the IMF representatives will discuss this legal justification for thalidomide coverage with CMS lawyers and hope to set up a meeting with Tunis soon."
A special Washington report from IMF Advocate Greg Brozeit: