Medicare Reverses Denial Of Costly Treatment For Hepatitis C Patient

Walter Bianco, an Arizona man denied access to new drugs to cure his hepatitis C infection, will get the costly medications after all.

Walter Bianco (Photo by Alexandra Olgin for KHN)

After Kaiser Health News and NPR his plight in a story that aired Monday, federal Medicare officials said they would look into the case. Bianco鈥檚 appeal of an earlier denial had been rejected by WellCare, a private insurer that contracts with the federal program to provide drug coverage.聽 The insurer rejected coverage saying the combined use of the聽costly new drugs has not yet been approved by the Food and Drug Administration — even though two doctors’ groups had recommended the protocol in cases like Bianco’s.

Late Tuesday, Bianco鈥檚 doctor got word that the earlier denials had been reversed 鈥 an unusually fast turnaround for the agency.

鈥淚 am very pleased that Mr. Bianco received approval for the treatment he needs,鈥 said Dr. of Mayo Clinic in Scottsdale, Ariz. 鈥淚 hope all patients in similar (or more urgent) circumstances can be given a fair hearing.鈥

Bianco, whose liver has been severely damaged by the hepatitis C virus, said Medicare鈥檚 reversal 鈥渋s great news for me, and hopefully for many others, since a precedent has been set now.鈥

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聽meet certain criteria laid out聽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 鈥 even though the FDA has not yet approved the combination.

Medicare聽officials say that beneficiaries 鈥渁re required to have access to needed therapies鈥 if they have demonstrated 鈥渕edical necessity鈥 and have 鈥渕edically accepted indications鈥 for the treatment.

The agency is reportedly conferring with medical specialty groups on refining the聽guidelines about when patients should be treated with which regimens.

For now, Medicare鈥檚 Part D聽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聽doubt that coverage of the drugs will be a substantial financial burden for the program.

, deputy Medicare administrator, 聽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.

One of them, called , costs $84,000 for a typical 12-week course of treatment, although some patients will need to take the drugs for 24 weeks. The other, , costs about $66,000,聽but is approved for fewer types of patients. Other drugs must often be used with the two new products, adding to the cost.

The issue of paying for the expensive new drugs 鈥 which may cure upwards of 90 percent of patients — is being closely watched by patient advocates, federal health and budget officials, state , the Department of Veterans Affairs, and corrections officials across the country. All face billions of dollars in potential obligations to treat the three to five million Americans infected by the deadly virus.

The publication Inside CMS has reported that Gilead Sciences, maker of Sovaldi, gained 90 percent of the $2.1 billion first-quarter sales of the drug 鈥 a record for any new drug 鈥 from Medicare and private health insurers. Another 7 percent of sales came from Medicaid.

Medicare officials鈥 fast response in the Bianco case is an indication of the political sensitivity of rejecting聽potentially life-saving coverage based at least in part on the drugs鈥 costs. 鈥淲e want to try to be as helpful as we can to get beneficiaries the drugs that they need,鈥 a Medicare spokesman said earlier this week.

Or to put it the other way around, no one wants to be the first to say that patients who need the drugs can鈥檛 get them鈥 in other words, that hepatitis C has pushed the nation into explicit rationing of life-saving care.

This article was produced by Kaiser Health News with support from .

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