Thu, May 15 2014
Late Tuesday, Bianco’s doctor got word that the earlier denials had been reversed – an unusually fast turnaround for the agency.
“I am very pleased that Mr. Bianco received approval for the treatment he needs,” said Dr. Hugo Vargas of Mayo Clinic in Scottsdale, Ariz. “I hope all patients in similar (or more urgent) circumstances can be given a fair hearing.”
In a statement, Medicare officials indicate that the new policy will apply broadly to hepatitis C patients whose doctors prescribe the combined use of the two drugs because they meet certain criteria laid out in January by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Those guidelines recommend the combined use of the two drugs in patients with advanced liver disease who have failed to be cured by earlier drug regimens – even though the FDA has not yet approved the combination.
Medicare officials say that beneficiaries “are required to have access to needed therapies” if they have demonstrated “medical necessity” and have “medically accepted indications” for the treatment.
The agency is reportedly conferring with medical specialty groups on refining the guidelines about when patients should be treated with which regimens.
For now, Medicare’s Part D plans may decide on a case-by-case basis whether to approve payment for the costly drugs. But if the plans deny payment, consumer advocates say patients will now have a good chance of prevailing because of the new stance by federal officials.
There is little doubt that coverage of the drugs will be a substantial financial burden for the program.
Sean Cavanaugh, deputy Medicare administrator, recently told a U.S. Chamber of Commerce summit that the agency hopes to have a handle on potential costs later this year after it receives bids from Part D drug plans which will take the cost of the new treatments into account.