NOC granted to Canada’s first “interferon-free” combo, sofosbuvir/ledipasvir!

This page is an archive. Its content may no longer be accurate and was last updated on the original publication date. It is intended for reference and as a historical record only. For hep C questions, call Help4Hep BC at 1-888-411-7578.

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.

Those having trouble paying for this drug can consult with Gilead Science’s MOMENTUM Patient Assistance program (phone no. below) which attempts to make the treatment affordable to Canadians; note that ‘eligibility’ of patients is defined by Gilead, and is subject to change over time:

“To assist eligible hepatitis C patients in Canada with access to Harvoni, Gilead Sciences Canada, Inc. has added the medicine to the Gilead Momentum Support Program™, which provides an integrated offering of support services for patients and healthcare providers. The program provides access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying their coverage options through either private insurance or publicly funded programs. In addition, the program provides financial assistance for eligible patients who need help paying for out-of-pocket medication costs.

For more information regarding the Momentum Program in Canada, please call 1-855-447-7977.”

One of the two components of the combo, sofosbuvir (tradename SOVALDI), was previously granted an NOC to be used with several genotypes (see http://hepcbc.bchep.org/2013/12/sovaldi-sofosbuvir-approved-by-health-canada/), but only if given in conjunction with interferon and/or ribavirin.

Read complete Oct. 16, 2014 press release at http://www.businesswire.com/news/home/20141016006163/en/Health-Canada-Issues-Notice-Compliance-Gilead%E2%80%99s-Harvoni%E2%84%A2#.VEACYIvF_WQ .

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