- The U.S. District Court has ruled in favor of a group of plaintiffs with hepatitis C in Washington state who were denied coverage for oral hepatitis C treatments from Gilead, AbbVie and Merck, according to Stat.
- The defendant, the Washington State Health Care Authority (WHCA), argued that only the sickest hep C patients should receive the medications because of the cost burden. The average list price for hepatitis C regimens ranges from $54,600 to $94,500.
- U.S. District Court Judge John Coughenour determined that WHCA's refusal to cover hepatitis C drug violates federal law and issued a preliminary injunction requiring the WHCA to provide coverage regardless of disease severity.
The preliminary ruling in this case could set a precedent calling into question the ability of a state Medicaid program or a commercial payer to define "medically necessary" in such a way as to automatically exclude large parts of the population of individuals with hepatitis C. The WHCA had deemed treatment not "medically necessary" for all but the sickest patients.
The term "medically necessary" is especially important in this case, because the plaintiffs "alleged that the WHCA failed to provide medically necessary treatment as required by the Medicaid Act," according to Judge Coughenour's written opinion.
This case was filed as a class action suit in January and quickly worked its way through the legal system. In November 2015, concerns about restricted access to hepatitis C medications led the Department of Health and Human Services to send state Medicaid directors a notice warning them against blocking patient access to pricey hepatitis C drugs, notes Stat.
According to the injunction, the WHCA is required to coverage hep C drugs regardless of fibrosis score and must submit a status report to the court within 60 days providing an update on implementation.
Limiting coverage for the new hepatitis C antivirals has become a point of contention recently. In April, seven New York health insurers agreed to broaden their coverage of the drugs after reaching a deal with the New York Attorney General's office. Five of the seven had previously limited coverage to only those patients with the most advanced forms of the disease.
The Department of Veterans Affairs also decided this year to lift its restrictions on reimbursement for the new drugs.
While the drugs remain pricey, their ability to "cure" nearly all patients of the liver condition has been a powerful argument in favor of broader coverage.