Two studies published online June 29 in the Annals of Internal Medicine examine how states are deciding which Medicaid patients will get sofosbuvir, the $1000-per-pill treatment for hepatitis C that has a 90% cure rate.
The authors of both studies find restrictions vary tremendously across states' Medicaid fee-for-service programs and often differ with guidelines set out by professional associations. One study says the restrictions violate the federal Medicaid law.
In the first study, Lauren A. Canary, MPH, from the Division of Viral Hepatitis, National Foundation for the Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues, found that Medicaid programs in 31 states had deemed sofosbuvir a "nonpreferred" drug, often meaning there is a less expensive drug available and clinicians have to provide evidence of medical necessity as defined by a state's law. Seventeen states designated it "preferred." Although providers do not necessarily have to demonstrate medical necessity in those states, all but two states required clinicians to get prior authorization.
Prior authorization criteria also varied widely but often require abstinence from alcohol, illicit drugs, or both, and the period varies from 1 to 12 months before treatment. However, that is in conflict with Infectious Diseases Society of America (IDSA)/American Association for the Study of Liver Diseases (AASLD) guidelines, which recommend patients abstain from drugs and alcohol before treatment but do not recommend withholding treatment. Instead, the guidelines say patients should get counseling and education and simpler treatments such as sofosbuvir therapies.
Severity of disease requirements under Medicaid programs also conflicted with the associations' guidelines. Most states required scoring of the level of fibrosis as part of the screening for sofosbuvir. IDSA/AASLD guidelines say treatment is of "highest priority" for those with METAVIR fibrosis scores of F3 or F4 and "high priority" for scores of F2. In 33 state Medicaid programs, the authors found, patients must have a score of F3 or F4 to receive sofosbuvir. Four states require biopsy to check fibrosis levels.
Authors Claim Methods Violate Law
In a second paper, Soumitri Barua, a researcher from Brown University in Providence, Rhode Island, and colleagues conclude that current restrictions violate federal Medicaid law, which requires that states cover drugs consistent with their US Food and Drug Administration labels.
Under the federal Medicaid statute, almost all drugs from drugmakers that have rebate agreements with the Secretary of Health and Human Services (which includes the maker of sofosbuvir) must be available under state Medicaid programs, with only limited restrictions on coverage.
"None of the restrictions on sofosbuvir coverage detailed here seem to meet the criteria for permissible restrictions," write Barua and colleagues.
The researchers found that 19 states (45%) require information about HIV status, and 10 of those states require that patients must be receiving antiretroviral therapy or have evidence of HIV virologic suppression.
Twenty-nine states have restrictions based on prescriber type, and in 14 of them, the prescriber has to be a specialist (gastroenterology, hepatology, infectious diseases, or liver transplantation); in the other 15, decisions can be made by a nonspecialist after consultation with a specialist.
Some states also allow prescribers to rate patients' likelihood of completing treatment, the authors found.
More than 3 million people in the United States are chronically infected with the hepatitis C virus (HCV), and Medicaid covers 25% of those who are hospitalized, but have limited budgets. That, combined with the high cost for a course of treatment, means there is pressure on the state programs to decide who can get the drug that is not only highly effective but also works for all genotypes, has fewer adverse effects than the interferon-based drugs, and is used for a shorter period.
Consequences Without Restrictions
Barua and colleagues acknowledge the concern that if everyone who needs sofosbuvir gets coverage, that could lead to reducing or eliminating coverage for other diseases.
They write: "It is unrealistic, however, to expect that all potential candidates will immediately seek HCV treatment. One example of this is Massachusetts. Despite relatively unrestricted sofosbuvir access in its Medicaid fee-for-service program, recent data indicate that only 14% of Massachusetts Medicaid enrollees known to be diagnosed with HCV are engaged in treatment."
Although only sofosbuvir was examined, the implications for future direct-acting antivirals is important, the authors say, and Medicaid may be setting a precedent.
Without consistent, ethical guidelines for prescribing, they argue, a person's chance of getting the most promising treatment may depend on where he or she lives.
Canary reports employment by Leidos Inc. during the study. The other authors have disclosed no relevant financial relationships. Barua was supported by the Lifespan/Tufts/Brown Center for AIDS Research Summer Student Internship program. Various coauthors report receiving support from the National Health and Medical Research Council; the Rhode Island Foundation, for the Rhode Island Defeats Hep C project; the National Institute of Allergy and Infectious Diseases; AbbVie; Merck; Bristol-Myers Squibb; Janssen; Roche; Gilead; GlaxoSmithKline; and the Health Practice Research Institute. The Kirby Institute is funded by the Australian Government Department of Health and Ageing.
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Cite this: States Vary Widely on Who Gets Hep C Drugs Under Medicaid - Medscape - Jul 01, 2015.