Medicaid restrictions on access to a breakthrough treatment for viral hepatitis C infection hit the poorest and most underserved patients the hardest, suggests data from a new study published today in the Annals of Internal Medicine.
Researchers from the Kirby Institute at UNSW Australia, Brown University, Harvard Law School and Treatment Action Group in the United States looked at Medicaid policies for the treatment of hepatitis C virus (HCV) in all 50 US States and the District of Columbia, including reimbursement criteria for sofobuvir - a new and highly effective treatment for the virus. The new drug is expensive at $84,000 for one treatment course. However, there are few, if any, side effects and a cure rate of more than 95%.
“Although Federal Medicaid law requires states to cover drugs consistent with their Food and Drug Administration labels, we found 42 states with known sofosbuvir Medicaid reimbursement criteria that have restrictions on who receives the drug,” said Dr Lynn Taylor, director of The Miriam Hospital’s HIV/Viral Hepatitis Coinfection Program and lead author of the study.
In distinct contrast to the situation in the United States, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) have recently recommended two highly effective sofosbuvir-based regimens for Pharmaceutical Benefits Scheme (PBS) listing, without drug use or disease stage-related restrictions.
“Australia has been a world leader in the development of treatment strategies for hepatitis C virus and enhanced access for the most vulnerable citizens, including people who inject drugs,” said Professor Greg Dore from the Kirby Institute. “Assuming that price negotiations are completed and Federal Cabinet approval gained, Australia should soon have the broadest access to interferon-free therapy internationally, with PBS listing expected in December 2015 or April 2016.”
In the US Study, researchers found that restrictions based on drug and/or alcohol use were most common. Among the 42 State Medicaid Committees, 37 (88%) include drug and/or alcohol use or abuse in their eligibility criteria with 50% requiring a period of abstinence and 64% requiring negative urine drug screening.
“This is particularly concerning because the majority of new and existing cases of HCV in the Unites States exist among people who inject, or have injected drugs,” said Taylor. “Rather than excluding people who inject drugs from treatment, they should be a priority group due to potential HCV treatment as prevention benefit.”
Since 2002, National Institutes of Health HCV guidelines have supported HCV treatment regardless of injecting drug use. International guidelines from the American Association for the Study of Liver Disease/Infectious Diseases Society of America, the European Study for the Association of the Liver, the International Network for Hepatitis in Substance Users and the World Health Organisation, now all recommend treatment for HCV infection among people who use drugs.
“There is now compelling evidence that HCV treatment is safe and effective among people who inject drugs. The decisions on restrictions are not evidence based and appear to be based on budgetary concerns rather than individual or public health-based priorities,” said Taylor.
Researchers also discovered that 74% of states limit sofosbuvir access to people with advanced fibrosis or cirrhosis.
“Rates of advanced liver disease complications and associated healthcare costs are rising in the United States.” said Dr Taylor. “Although there is a high risk of progression to decompensated cirrhosis and liver cancer among patients with advanced fibrosis, limiting access to people who have already progressed to late-stage disease as compared to treating earlier to prevent these liver-related complications seems counter-intuitive as a public health strategy.”
“The Medicaid restrictions generally apply to the poorest and most underserved patients with HCV infection are highly stigmatising, and not evidence-based,” said Associate Professor Jason Grebely, co-author of the paper from the Kirby Institute. “The data suggest that state Medicaid policies for access to new HCV therapies should be reviewed and revised in line with national and international clinical recommendations. Decisions for prioritising patients for more immediate therapy need to be made based on clinical criteria.”