Private health insurance companies in the United States denied nearly one in four requests for Harvoni (sofosbuvir/ledipasvir) as hepatitis C virus (HCV) treatment in 2015, according to a new report published in PLoS One. However, experts at the Yale Liver Center also point out that most people who were turned down in 2015 ultimately gained access after they appealed, aidsmap reports.
For the report, university researchers designed a retrospective study involving 129 people prescribed the new treatment, which is produced by Gilead Sciences, at the Yale medical center between October and December 2014. Their mean age was 57 years, 61 percent of them were male and 61 percent had liver cirrhosis.
More than three-quarters, or 77.5 percent, received initial approval for the $1,125-per-pill treatment. A further 14 percent later gained access to the drug after appealing to their insurance company, though with significant delays. In the end, fewer than 10 percent of people at the center failed to obtain the new hep C treatment.
According to liver experts, this is the first study assessing the real-world access to new interferon-free direct-acting antiviral (DAA) regimens in people with HCV. They noted that high costs—Harvoni is priced at more than $94,000 per patient for a standard 12-week course of treatment—were a major barrier to treatment access.
Investigators also found that people with advanced liver disease and Medicare/Medicaid insurance coverage actually had earlier decision and approval times than the rest of the study population. Those with Medicare/Medicaid approval were also more likely to be initially approved.
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