Daklinza and Sovaldi’s BC PharmaCare Decision

Daklinza and Sovaldi's PharmaCare DecisionBC PharmaCare has posted notice that it will not cover Daklinza (generic name daclatasvir) when it is combined with Sovaldi (generic name sofosbuvir) for the treatment of chronic hepatitis C genotype 3 infection, in their list of covered treatments.

BC PharmaCare listed the following three reasons for their decision:

  • “The available clinical evidence included only a small number of genotype 3 patients treated, and did not provide sufficient evidence to demonstrate efficacy compared to current sofosbuvir plus ribavirin (RBV) regimen. There are no comparative head-to head trials with sofosbuvir plus RBV or other combinations. Therefore, there is no evidence that daclatasvir plus sofosbuvir is more effective or safer than sofosbuvir plus RBV.” (BC PharmaCare)
  • “At the submitted confidential price, daclatasvir plus sofosbuvir 12-week regimen is less costly than the transparent price of a 24-week course of sofosbuvir plus RBV.” (BC PharmaCare)
  • “The Ministry of Health engaged in discussions with the manufacturer for daclatasvir through the pan-Canadian Pharmaceutical Alliance (pCPA), but the pCPA participating jurisdictions agreed that the parameters required for negotiations by both the manufacturer and the participating jurisdictions cannot be achieved through negotiations at this time.” (BC PharmaCare)

More information about this decision can be found in the treatment’s Drug Coverage Decision for B.C. PharmaCare.

Daklinza and Sovaldi

Daklinza and Sovaldi is a Health Canada approved treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment.

A sustained viral response (SVR12), or ”cure”, has been achieved by  ~90% of patients infected by hep C genotype 3 who have been treated with Daklinza and Sovaldi. The treatment has had higher success rates when treating hep C genotypes 1 or 2. (Health Canada)

More information about the treatment combination and its Health Canada approval can be found on Health Canada’s Summary Basis of Decision for Daklinza page.

Bristol-Myers Squibb Canada’s CLAIRE Program

Canadians and British Columbians prescribed the Health Canada approved treatment Daklinza and Sovaldi, with, in some cases, ribavirin, can still request to be enrolled in the CLAIRE patient support program. The CLAIRE patient support program was designed to help patients seek coverage and provide access to a customized list of services. It was designed so that one person will take care of each patient through the program’s duration. For more information, contact your doctor, nurse, or contact the program at: 1-844-HCV-2559 (phone number), 1-844-FAX-2559 (fax number), info@claireprogram.ca (email address).

*BMS has stated that this decision to not cover Daklinza included treatment for other hep C genotypes as well. It will not be covered by BC PharmaCare. We will continue to track Daklinza and report on any further news.