PHARMACIST STEVE

More than a third of chronic hepatitis C (HCV) patients were denied access to direct-acting antiviral (DAA) treatment by their insurance provider, researchers found.

Among patients prescribed DAAs, 35.5% (95% CI 34.5%-36.5%) had their prescriptions denied by their insurer, reported Charitha Gowda, MD, of Ohio State University College of Medicine in Columbus, and colleagues.

Not only that, but the proportion of hepatitis C patients whose DAA prescriptions were denied by their insurance company increased over a period of 16 months, the authors wrote in the study online in Open Forum Infectious Diseases.

The authors noted that despite the benefits of HCV therapy, research in Clinical Infectious Diseases indicates that the high cost of DAAs has led public and private insurers to restrict access to these medications, and that insurers required “varying criteria for reimbursement” such as “evidence of advanced liver fibrosis, consultation with a specialist, and/or abstinence from alcohol or illicit drug use,” according to studies in Hepatology and Journal of Hepatology.

While advocacy efforts, threatened lawsuits, and greater price competition led some insurers to ease these restrictions, the Gowda and co-authors said their aim was to examine how access to DAAs has changed.

The team examined data from patients filling a prescription for DAAs from Diplomat Pharmacy Inc., which was described by the authors as providing “specialty pharmaceuticals” to patients across the U.S.

From January 2016 to April 2017, the system received prescriptions from 9,025 patients for DAAs — 4,702 covered by Medicaid, 2,502 covered by commercial insurance, and 1,812 covered by Medicare. Patients were a median 57 years old, and 38.4% were women. Over half were prescribed sofosbuvir/ledipasvir with or without ribavirin.

The authors noted that denial of treatment was more common among patients with commercial insurance (52.4%) compared with those with Medicaid (34.5%) or Medicare (14.7%, P<0.001 for both). The incidence of absolute denial increased across the study period, from 27.7% in the first quarter to 43.8% in the last quarter (test for trend, P<0.001).

Out of 45 examined states where a DAA prescription was submitted, eight states contributed 90% of prescriptions. Pennsylvania had the highest proportion (31.5%), followed by California (23.6%) and Michigan (14.3%). However, when the researchers examined the overall incidence of absolute DAA denial in these eight states, Maryland had the highest incidence (51.5%), followed by Delaware (49.1%), New Jersey (47.2%), and Pennsylvania (45.7%).

The authors emphasized the important clinical implications of the findings — namely that “persons denied access to HCV therapy remain at risk for the development of hepatic fibrosis, cirrhosis, liver decompensation, and hepatocellular carcinoma,” as well as ongoing HCV-associated inflammation that could lead to extrahepatic complications.

The team also pointed out the potential public health impact — i.e., that lack of access to DAAs could impede the goal of HCV elimination. The researchers cited a recent report from the National Academies of Sciences, Engineering, and Medicine that recommended that “public and private insurers should remove restrictions to DAAs that are not medically indicated and offer treatment to all chronic HCV-infected patients,” which is also consistent with guidelines from the American Association for the Study of Liver Diseases/Infectious Diseases Society of America.