(Editor's note: This article contains two corrections.)
Florida's Medicaid agency has set up guidelines for use of hepatitis C drugs that will limit their required use to only the most severe cases, sparing health plans from some expense during the rollout of the Statewide Managed Assistance Program.
The Agency for Health Care Administration notified plans of the limits -- called "prior authorization criteria" -- on the drugs Sovaldi and Olysio last week. (Correction: An earlier version of this article said the AHCA action overruled an advisory committee recommendation; it did not.)
The Pharmaceutical and Treatment Committee had urged that the drugs be added to the list despite their expense of $1,000 a pill, as Health News Florida reported last month.
State Medicaid plans typically get a modest discount from manufacturers, but their contracts with both private and public programs require them to keep the price a secret, AHCA officials say. Gilead Sciences Inc. manufactures Sovaldi; Olysio is made by Janssen Therapeutics. (Correction: An earlier version misstated the manufacturer of Olysio.)
Under the prior authorization requirements, the drug must be prescribed by a specialist in liver diseases and the patient must meet certain medical and behavioral criteria. The medical criteria include: stage 3 or 4 disease (with 4 being the highest); a particular genotype for the virus, since not all respond to the medication; and a minimum viral load.
In addition, the patient must be free of drugs and alcohol for at least a month, as demonstrated by urine or blood tests, or must be receiving counseling for substance or alcohol abuse at the time of the hepatitis treatment.
Hepatitis C, which in its most serious forms can destroy the liver, is transmitted by body fluids. Some of those who are infected were drug abusers who shared needles, although some got the virus from blood transfusions decades ago or were infected at birth.
Presumably the requirement for drug-free behavior was inspired by a concern -- expressed by advisory committee members -- that patients might be given the expensive drugs and be cured of disease, only to resume drug use and get it again.
Use of alcohol is presumably listed because it causes further damage to a liver that is already ravaged by the virus.
AHCA spokeswoman Shelisha Coleman said that about 20,600 Florida Medicaid recipients had a diagnosis of Hepatitis C last year. Only about one-third of them were in managed-care plans, but that is changing; almost all Medicaid beneficiaries are required to enroll in an HMO or similar doctor-led plan called a PSN (provider-service network) this summer.
Coleman said "it is impossible to tell" from the data how many of the diagnosed patients will be candidates for treatment with Sovaldi, Olysio, or both under the prior authorization criteria. She said AHCA actuaries will be working on cost estimates as the agency receives them, but at this point it has no plans to seek a supplemental budget request for the drugs.