Epclusa (generic name: sofosbuvir/velpatasvir), developed by Gilead Sciences Canada, Inc., just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.
Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This recommendations report is then sent to the provinces and territories to help them decide on coverage.
The Canadian Drug Expert Committee’s Final Recommendation Advocates for Epclusa to be Reimbursed as a Treatment for Chronic Hepatitis C if the Following Conditions are Met:
- Treatment should be started by physicians experienced managing patients w chronic hep C.
The Canadian Drug Expert Committee’s Reasons for their Epclusa Recommendations
- Very good SVR/cure rates seen for all genotypes and among treatment-naive and patients who have already, unsuccessfully, tried treatment. The ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4 clinical trials showed that treatment with Epclusa achieved high rates of SVR12 (cure at 12 weeks) for all types of hep C patients, including those who have been considered hard to treat.
“There is insufficient evidence that the new treatment is superiorto the least costly alternative.”
“The true incremental cost-effectiveness of SOF/VEL versus other interferon (IFN)-free regimens is uncertain in the various patient populations considered.”
Other Noted Discussion Points
“The drug plan cost of treatment with the drug under review should not exceed the drug plan cost of treatment with the least costly alternative interferon-free option.”
Reported Research Gaps
Research should look into the following as a high priority:
- Patients who were activity using drugs and co-infected with HIV or hepatitis B were excluded from the trials submitted to this review.
- Resistance-associated variants (RAVs) should be examined more as they may influence future coverage criteria.
Epclusa (generic name sofosbuvir / velpatasvir) is the first pan-genotypic hepatitis C treatment, treatment for all 6 hep C virus types, to be approved for use in Canada against all 6 hep C virus types.
Epclusa is made up of 2 direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir is a nucleotide NS5B polymerase inhibitor that directly targets the hep C virus to stop it from making copies of itself in the liver. They attach themselves onto the genetic information, called RNA, to block the virus from multiplying. Velpatasvir is a NS5A inhibitor that blocks a virus protein, NS5A, that the virus needs for reproducing and various stages of infection.
“We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history.” ~Dr. Jordan Feld