December 12, 2016
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HCV treatments valued under $100 per patient

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Researchers estimated that a generic direct-acting antiviral regimen for the treatment of hepatitis C virus infection could cost less than $100 per person in the United States, according to data presented at The Liver Meeting.

Andrew M. Hill, PhD, of St. Stephens AIDS Trust at Chelsea and Westminster Hospital, London, and colleagues calculated the production costs of direct-acting antivirals (DAAs) using information from an online database of export ledgers containing per-kilogram prices and volumes of active pharmaceutical ingredients (APIs) for DAAs exported from India. The projected per-pill API expense was combined with other production costs, such as formulation and packaging, and a 50% profit margin. Since velpatasvir (Gilead Sciences), the newest DAA included in the analysis, lacks export information, the researchers used data from an analysis of chemical synthesis processes detailed in originator patents to estimate the drug’s per-kg API cost.

Andrew Hill, PhD
Andrew M. Hill

According to the data, API volumes exported from India between January and June 2016 included 10,200 kg Sovaldi (sofosbuvir, Gilead Sciences) — equivalent to 303,000 12-week treatment courses; 5,433 kg of Daklinza (daclatasvir, Bristol-Myers Squibb) — equivalent to 1,080,000 treatment courses; and 240 kg of ledipasvir (Gilead Sciences) — equivalent to 32,000 treatment courses.

The researchers reported that average API prices decreased over time. On June 1, the estimated cost of one 12-week HCV treatment was:

  • $62 for sofosbuvir — current U.S. price is 1,355 times higher;
  • $14 for daclatasvir — current U.S. price is 4,500 times higher;
  • $96 for sofosbuvir-ledipasvir — current U.S. price is 984 times higher; and
  • $181 to $216 for sofosbuvir-velpatasvir — current U.S. price is 346 to 413 times higher. – by Stephanie Viguers

Reference:

Hill AM, et al. Abstract 955. Presented at: The Liver Meeting; Nov. 11-15, 2016; Boston.

Disclosure: Hill reports no relevant financial disclosures.