Direct acting antiviral agents (DAAs) are remarkably effective for hepatitis C virus (HCV) infection, relatively free of adverse effects, the preferred method for treating patients, and very very expensive. The cost of a 12-week course of therapy initially exceeded US$100,000 and now lies in the range of US$60,000 to US$80,000. Perhaps it’s not surprising, then, that private insurance companies and state Medicaid programs balked at providing these drugs to their insured customers.
Ongoing “Battle for Coverage”
Initially, the “battle for coverage” pitted health care professionals advocating for their patients against state Medicaid programs and the private insurance providers. Usually, the health care professionals lost. This was all the more frustrating given that many health care professionals had been advising their HCV-infected patients to delay initiating treatment for 2 years or more until the more effective DAAs became available.
Each state Medicaid program is allowed by law (with some very important exceptions) to choose its own formulary and develop guidelines for the use of these drugs. Private insurance providers typically take the same approach to limiting the availability of very expensive drugs, even though the plans they offer are required under the Affordable Care Act (ACA) to meet certain minimum standards.
In addition, the federal government mandates that state Medicaid programs offer treatments that are “medically necessary” or “life-saving” or both to those who qualify by income for Medicaid.
Furthermore, under the ACA, public insurance programs are prohibited against “discriminating against patients on the basis of health status or diagnosis.” Nevertheless, many state Medicaid programs effectively denied patients access to the DAAs. The same was true for the private insurance companies and even the state drug assistance programs (Ryan White–funded) for HIV-infected patients, which often took their lead from the state Medicaid programs.
The “Tide” May Have Turned
But it appears that the “tide” has turned within the past year in favor of substantially easier access to the DAAs. What happened to effect this change?
First, both the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases stated in their guidelines that all patients who have HCV should be treated with the most efficacious drugs available.
Second, in the fall of 2015, the Obama administration wrote to state Medicaid programs that they may be violating federal law by restricting access to HCV medications.
Then, in May 2016, a US Circuit Court judge, in a lawsuit brought by a patient against the State of Washington, ordered that state to lift restrictions on coverage for the DAAs.
This was the first time a federal court had declared that placing “widespread” restrictions on HCV medications in a state Medicaid program was illegal. Subsequently, similar lawsuits brought against other state Medicaid programs were settled, resulting in broadening of the coverage for the DAAs. The private insurance companies quietly changed their coverage as well. Nevertheless, restrictions on coverage of the DAAs persist across state Medicaid programs and private insurance companies.