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U.S. Specialists Applaud Harvoni, First Single-Tablet Regimen for HCV Infections
U.S. specialists expect to prescribe Harvoni (Gilead Sciences) to a high proportion of their genotype-1–infected hepatitis C virus (HCV) patients, including those with cirrhosis of the liver — even if the drug is listed on a non-preferred formulary tier (tier 3 or higher), according to a survey by Decision Resources Group, a health care research firm.
Harvoni, a fixed-dose combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir, is the first once-daily single-tablet regimen for HCV infections. According to surveyed physicians, Harvoni has advantages over other emerging treatment options on all efficacy, treatment-duration, safety, and tolerability attributes considered.
“Approximately four out of five surveyed physicians have either already contacted or plan to reach out to patients regarding the newest HCV treatment options,” said analyst Seamus Levine-Wilkinson, PhD. “As a result, uptake of novel HCV agents could surge as physicians treat the sizeable number of warehoused patients.”
Further, surveyed managed care organization (MCO) pharmacy and medical directors indicated that they have prioritized formulary inclusion of Sovaldi (sofosbuvir, Gilead) over Olysio (simeprevir, Janssen/Medivir), suggesting that Sovaldi’s broad label and excellent clinical profile have allowed it to defend its higher cost.
“Physicians report that discontinuation rates for Sovaldi and/or Olysio are higher than expected from clinical trials,” Levine-Wilkinson said. “Notably, the elevated ‘real world’ discontinuation rates do not appear to stem from low efficacy or unexpected safety issues but are rather driven by the high out-of-pocket cost associated with these therapies. Our findings may also have implications for the recently launched Harvoni, as well as for other novel therapies expected to enter the market in the near future.”
Among surveyed MCO pharmacy and medical directors who were aware of the American Association for the Study of Liver Diseases’ treatment guidelines, more than two-thirds were aware of recommended treatments, and some advocated reducing formulary restrictions and streamlining prior-authorization approvals for prescribed regimens recommended in the guidelines. These findings underscore the critical importance of treatment guidelines in favorable positioning of HCV therapies for reimbursement by MCOs, the report says.
FDA labeling recommends an 8-week course of Harvoni in treatment-naïve, noncirrhotic patients with lower baseline viral loads. However, nearly half of surveyed experts were concerned that a short treatment duration increases the risk of viral relapse after completion of HCV therapy, with a high proportion indicating that durations of 8 weeks or less are too short.
Source: Decision Resources Group; November 6, 2014.