June 30, 2015 — State Medicaid programs may be placing illegal restrictions on access to new but expensive treatments for hepatitis C, according to a new study published in the Annals of Internal Medicine.
The new drugs include Sovaldi (sofosubir) and Harvoni, which have only been on the market since last year. They cure over 90% of patients with hepatitis C and cause few side effects, but cost nearly $100,000 for a standard 12-week treatment.
Without treatment, hepatitis C can cause fibrosis, cirrhosis, liver cancer, liver failure, and death. The longer the disease goes untreated, the higher the risk it will spread to other people.
Federal laws requires state Medicaid services to cover FDA-approved medications, and those services are prohibited from discriminating on the diagnosis, type of illness, or condition.
However, researchers found that 42 state Medicaid programs had imposed restrictions aimed at reducing the number of people who qualify for coverage. Of those programs, 74% limited the drugs to patients with severe fibrosis or cirrhosis of the liver. Many private health insurers have imposed similar restrictions.
Common reasons for restricting access included:
- The level of fibrosis (scarring of the liver)
- Substance abuse and abstinence from alcohol and drug use
- Provider limitations on prescribing physicians
Dr. Lynn E. Taylor, lead author of the study, said:
“Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access. The denial of treatment by most states violates the spirit of the law. In our analysis, we found that most states with known sofosbuvir Medicaid reimbursement requirements impose undue restrictions on eligible recipients.”