One-third of Patients Denied New Hepatitis C Drugs

Diana Swift

June 07, 2018

More than a third of patients with hepatitis C (HCV) submitting prescriptions for direct-acting antivirals (DAAs) are denied coverage by private and public insurers, according to data published online today in Open Forum Infectious Diseases.

These barriers to curative treatment persist despite a 2017 report from the National Academies of Sciences, Engineering, and Medicine calling for eradication of HCV in the United States by 2030 through the use of these highly effective but expensive drugs.

"To achieve the goal of HCV elimination, access to antiviral treatment must be improved," write Charitha Gowda, MD, MPH, MSCE, from the Department of Pediatrics at Ohio State University College of Medicine in Columbus, and colleagues in the newly published study.

The prospective cohort study included data from 9025 patients with chronic HCV who submitted a DAA prescription to Diplomat Pharmacy Inc, a national provider of HCV medications, between January 2016 and April 2017. Participants had a median age of 57 years and resided in one of 45 states.

Of these patients, 4702 were covered by Medicaid, 1821 by Medicare, and 2502 by commercial carriers. Among nine different DAA regimens, the most frequently prescribed was sofosbuvir/ledipasvir, with or without ribavirin (4662 patients, 51.7%).

The investigators were surprised to find that 3200 patients overall (35.5%; 95% CI, 34.5% - 36.5%) were absolutely denied treatment approval, including 52.4% of those with private insurance, 34.5% of those with Medicaid, and 14.7% of those insured by Medicare.

Furthermore, the absolute denial rate rose in each quarter of the 16-month study period, increasing from 27.7% in first quarter to 43.8% in last (test for trend P <.001), and it also rose for each of the three insurance types (test for trend P <.001 for each type).

Asked to comment on the findings for Medscape Medical News, Andrew I. Aronsohn, MD, an associate professor of medicine at the University of Chicago Medical Center in Illinois, said, "We are never going to reach any of our HCV elimination goals with denials this high."

Aronsohn, who was not involved in the study, expressed surprise especially at the persistent denial for Medicaid beneficiaries. "My impression is that Medicaid denial rates are still really unacceptably high," he said. "I think that cost is the cornerstone of this, although certainly Medicaid is not technically allowed to restrict use of medications based on cost. But since many people feel these are very safe and highly effective medications, there's really no other reason besides cost for why these would be so heavily restricted."

Abundant data have shown these regimens reduce overall healthcare costs by improving survival and quality of life, he added.

Also surprising to Aronsohn is the high denial rate among private insurers. "It was previously thought that commercial plans had a very high acceptance rate, but this study is showing otherwise," he said.

Eight of the 45 states in the study accounted for 90% of prescriptions. Among these, the highest rate of absolute denial was in Maryland at 51.5%, followed by Delaware (49.1%), New Jersey (47.2%), and Pennsylvania (45.7%).

The study results run counter to the investigators' working hypothesis that access would likely have increased in the previous 2 years, thanks to advocacy efforts, threatened lawsuits, more options, greater price competition, and some relaxation of reimbursement requirements. Although DAA therapy has a cure rate of at least 94% and reduces healthcare and economic costs overall, its high price had led to tough criteria for coverage, including advanced hepatic fibrosis, specialist consultation, and/or abstinence from alcohol and illicit drugs.

"The reason for this higher-than-expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist," the researchers write.

Whatever the reasons, the adverse consequences are many. "From a clinical standpoint, patients who are denied access to hepatitis C treatment are going to remain at risk for the development of liver complications like cirrhosis, hepatic decompensation, and liver cancer," said senior author Vincent Lo Re III, MD, MSCE, an associate professor of infectious disease and epidemiology in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia in a news release. "The denial of this treatment can also lead to ongoing hepatitis C-associated liver and systemic inflammation, which could increase the risk of other extra-hepatic complications, like cardiovascular disease, bone and joint disease, and kidney disease."

Interestingly, the study found a notably lower overall incidence of absolute denial of DAAs for Medicaid beneficiaries than in previous research reported by Medscape Medical News, in which Lo Re and colleagues found an incidence as high as 46.3%.

The authors attribute this decrease to the 2017 drug rebate notice from the Centers for Medicare & Medicaid Services stating that rationing DAA access on cost-containment grounds violates federal law.

In Aronsohn's view, studies such as this should be a call to arms to get rid of restrictions across the board. "The entire planet is working toward an elimination [of viral hepatitis] by 2030 based on the World Health Assembly recommendations, and the United States is very far behind many other countries that are well on their way with elimination strategies. It's embarrassing," he said.

"If you're thinking about strategies for eliminating a disease and you're restricting treatment, you're not even going to come close." He advises advocates to lobby diligently to remove all treatment restrictions.

This study was funded by the Penn Center for AIDS Research (a National Institutes of Health–funded program), and the National Institutes of Health. Two coauthors are employees of EnvoyHealth. One coauthor reports receiving research support from Gilead Sciences and has served on Gilead advisory boards. Another coauthor has served on an advisory board for Gilead Sciences. All other authors and Aronsohn have disclosed no relevant financial relationships.

Open Forum Infect Dis. Published online June 7, 2018. Full text

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