Canada’s first “interferon-free combo” for hepatitis C,
sofosbuvir+ledipasvir, now known by tradename HARVONI, was granted
a “Notice of Compliance” (NOC) by Health Canada on Oct. 16, 2014. The
NOC is basically an authorization to the combo’s maker, Gilead Sciences,
to market this treatment in the Canadian market. The pill, taken once a
day for 8, 12, or 24 weeks (depending on condition of liver and
previous treatment history), is only approved for use with genotype 1
patients with chronic hepatitis C. It can now be purchased in Canadian
pharmacies with a physician’s prescription.
Access product monograph at http://www.gilead.ca/pdf/ca/harvoni_pm_english.pdf .
Canadian patients can either pay out-of-pocket or through some
private insurance agencies. However HARVONI still is not yet covered
(reimbursed) by any of Canada’s Pharmacare public insurance agencies.
This step will entail several more months of investigations and reports
at the provincial level.
Labels: Canada, Harvoni approval