Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
FDA Approves Vosevi for treatment of hepatitis C
Though most patients with hepatitis C virus have seen success with the new oral antiviral agents, the treatment has not proved effective in all cases. In response to treatment failures, the FDA has approved Gilead’s Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg), a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 and who have been previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
There are 6 major HCV genotypes (strains) that cause infection.
- Genotype 1 is the most common strain in the United States (nearly 75% of all HCV infections
- Genotypes 1, 2, and 3 are found worldwide (20-25%)
- Genotype 4 is found throughout Northern Africa (rare 4-6 account for 1-2%)
- Genotype 5 commonly is found in South Africa
- Genotype 6 is commonly found in Asia
Gilead said Vosevi will be available in about a week at a wholesale acquisition cost (WAC) of $24,920 for a 28-day bottle. Patients in studies received the combo for a 12-week course of Vosevi, which would cost $74,760.
Why does it matter: employers should have PA guidelines in place to verify appropriate criteria for patients while approving eligibility for coverage of Vosevi.
Opana ER to be removed from the US Market
Endo Pharmaceuticals will pull its opioid painkiller, Opana ER, off the market due to increased abuse of the drug. The FDA has requested that the manufacturer voluntarily remove the reformulated version of, oxymorphone hydrochloride, from the U.S. market.
The Opana ER reformulation was approved in 2012, with the intent to become more abuse-deterrent. However, postmarketing data has shown a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with outbreaks of HIV and hepatitis C, as well as cases of a serious blood disorder.
Endo International PLC said it will voluntarily stop selling the pills, approved for use in patients with severe, constant pain, after consulting with the U.S. Food and Drug Administration. It’s the first opioid drug that the FDA has sought to remove from the market due to abuse.
Why does it matter: it is extremely important for employers to consider this when formulating their Controlled Drug Management Program/Opioid Management Program.
Senior Product ManagerIrina holds a Bachelor Degree in Pharmacy from Temple University, and brings over 17 years of experience bringing healthcare solutions to payers. Irina started her pharmacy career at a leading PBM in 1999, and has held a variety of management roles in mail service pharmacy operations, pharmacy compliance, clinical pharmacy, and clinical support. Irina’s focus at Truveris is to oversee current product offerings with a focus on improving clinical outcomes and managing costs. In the past, Irina held roles at OptumRx and Express Scripts.