November 10, 2014

Advantages of Gilead’s Harvoni over emerging hepatitis C treatments

10-11-2014

US surveyed specialists anticipate prescribing Gilead Sciences’ (Nasdaq: GILD) Harvoni to a high proportion of their genotype-1 infected hepatitis C virus (HCV) patients, including those with cirrhosis of the liver, even if it is listed on a non-preferred formulary tier (tier 3 or higher).

Harvoni, a fixed-dose combination of Gilead’s nucleotide polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir, is the first once-daily single tablet regimen for HCV infections. According to physicians surveyed for a news report from Decision Resources Group, Harvoni has advantages over other emerging treatment options on all efficacy, treatment duration, safety and tolerability attributes considered.

Surveyed MCOs have prioritized Sovaldi over Olysio

Furthermore, surveyed Managed Care Organization (MCO) pharmacy and medical directors have prioritized formulary inclusion of Gilead’s Sovaldi over (sofosbuvir) Janssen/Medivir’s Olysio (simeprevir), suggesting that Sovaldi’s broad label and excellent clinical profile have allowed it to defend its higher cost.

Other key findings from the US Physician & Payer Forum report, titled Hepatitis C Virus: How will More Efficacious Direct-Acting Antivirals Influence US Prescribing and Reimbursement for this Dynamic Indication, include:

  • Impact of new HCV treatment guidelines on MCO reimbursement: Among the almost two-thirds of surveyed MCO pharmacy and medical directors who are aware of the American Association for the Study of Liver Diseases’ treatment guidelines, more than two-thirds are aware of recommended treatments, and some indicated 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.
  • Concerns over increased risk of relapse following shortened course of therapy: Food and Drug Administration labeling recommends an eight-week course of Harvoni in treatment-naive, non-cirrhotic patients with lower baseline viral loads. Strikingly, nearly half of surveyed experts are concerned that short treatment duration increases risk of viral relapse following completion of HCV therapy with a high proportion indicating that durations of eight weeks or less are too short.

Decision Resources Group analyst Seamus Levine-Wilkinson commented: “Physicians report that discontinuation rates for Sovaldi and/or Olysio are higher than expected from clinical trials. Notably, the elevated “real world” discontinuation rates do not appear to stem from low efficacy or unexpected safety issues but are rather driven by high out-of-pocket cost associated with these therapies. Our findings may also have implications for the recently launched Harvoni as well as other novel therapies expected to enter the market in the near future. Approximately four out of five surveyed physicians have either already contacted or plan to reach out to patients regarding the newest HCV treatment options. As a result, uptake of novel HCV agents could surge as physicians treat the sizeable number of warehoused patients.”

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