Penn Researchers, Diplomat study shows: Nearly 50% Medicaid hepatitis C patients denied therapies as not considered “a medical necessity”

A recently released study on differences in medication coverage for the treatment of hepatitis C in patients with proven disease has shown an overall 86% approval rate, with large differences among the populations studied.

The study was undertaken by Burman’s Specialty Pharmacy, a Diplomat company, with Penn Medicine. The study was reported at the American Association for the Study of Liver Diseases 2015 Liver Meeting, and as explained on Tuesday, the results were statistically significant.

According to the study, it was discovered that nearly 50 percent of Medicaid patients infected with chronic hepatitis C virus (HCV) whose doctors had prescribed newer, life-saving antiviral drugs were denied coverage to the therapies because they were not considered “a medical necessity,” among other reasons. In contrast, only 5 percent of Medicare patients and 10 percent of commercial patients were ultimately denied. The data was revealed through a prospective analysis of prescriptions submitted to Burman’s Specialty Pharmacy for patients in Pennsylvania, New Jersey, Delaware and Maryland.

“Burman’s is a provider of individualized patient care with a primary focus on the challenging condition of hepatitis C,” said Phil Hagerman, Diplomat CEO and chairman.

“We couldn’t be any prouder to be a part of this study with Penn Medicine and look forward to future collaboration to improve patient care.”

According to the study, among chronic HCV-infected patients prescribed direct-acting antiviral therapy (DAA), certain specific factors were strong predictors of denial. These include insurance type and lack of cirrhosis.

Vincent Lo Re III, MD, MSCE, an assistant professor of Medicine and Epidemiology in the division of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania and the Center for Clinical Biostatistics and Epidemiology, said that the it were high costs of those agents to treat—and in most cases, cure—those infections and barriers to coverage that have resulted in denials and delays for the therapies.

As Diplomat has explained, to determine the number and cause of denials, the team analyzed prescriptions from 2,342 patients between Nov. 1, 2014, and April 20, 2015, submitted to Burman’s Specialty Pharmacybranches throughout the four states. Among those patients, 517 were covered by Medicaid, 800 by Medicare and 1,025 by commercial insurers.

Paul N. Urick, RPh, an author on the study and the vice president of industry relations and pharmaceutical account management at Diplomat said: “While nearly one in two Medicaid patients were denied medication, 90 percent or greater of all commercial and Medicare patients were approved. These results also motivate our focus toward drug adherence, rather than drug denials. The study also provides information for health plans to lower administrative costs, since a vast majority of commercial and Medicare prescriptions for direct-acting antivirals are ultimately approved.”

Diplomat’s press release noted that, the most common reasons for denial by Medicaid were “insufficient information to assess medical need” (48 percent), “lack of medical necessity” (31 percent) and positive alcohol/drug screen (4 percent). It was also found that those who did receive therapy through Medicaid had to wait 10 days longer to have prescriptions filled, compared to privately insured and Medicare patients.

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