Background:In Canada, interferon-free, direct-acting antiviral hepatitis C virus (HCV) regimens are costly. This presents challenges for universal drug coverage of the estimated 220 000 people with chronic HCV infection nationwide. The study objective was to appraise criteria for reimbursement of 4 HCV direct-acting antivirals in Canada. Methods:We reviewed the reimbursement criteria for simeprevir, sofosbuvir, ledipasvir-sofosbuvir and paritaprevir-ritonavirombitasvir plus dasabuvir in the 10 provinces and 3 territories. Data were extracted from April 2015 to June 2016. The primary outcomes extracted from health ministerial websites were: 1) minimum fibrosis stage required, 2) drug and alcohol use restrictions, 3) HIV coinfection restrictions and 4) prescriber type restrictions. Results:Overall, 85%-92% of provinces/territories limited access to patients with moderate fibrosis (Meta-Analysis of Histologic Data in Viral Hepatitis stage F2 or greater, or equivalent). There were no drug and alcohol use restrictions; however, several criteria (e.g., active injection drug use) were left to the discretion of the physician. Quebec did not reimburse simeprevir and sofosbuvir for people coinfected with HIV; no restrictions were found in the remaining jurisdictions. Prescriber type was restricted to specialists in up to 42% of provinces/territories.Interpretation: This review of criteria of reimbursement of HCV direct-acting antivirals in Canada showed substantial interjurisdictional heterogeneity. The findings could inform health policy and support the development and adoption of a national HCV strategy. AbstractResearch Research CMAJ OPEN E606CMAJ OPEN, 4(4) data requested evidence of advanced fibrosis (Meta-Analysis of Histologic Data in Viral Hepatitis stage F3) or cirrhosis (stage F4). Furthermore, most states (88%) had restrictions on drug and alcohol use, with half requiring abstinence before the start of treatment. In one-quarter of the states, populations coinfected with HIV had to be treated with antiretroviral therapy or show suppressed HIV viral loads. Furthermore, one-third of the states limited prescriber type to specialists. These restrictions do not align with published and accepted clinical guidelines. [20][21][22] Additional research into Medicaid-managed care programs, federal and state corrections plans, private plans and other payer sources would provide greater context to therapy access in the US.In contrast to the multitiered, privately financed health care system in the US, Canada has a publicly funded national health insurance program that provides coverage to each resident. Although Canada's 10 provinces and 3 territories are collectively governed by the Canada Health Act, every jurisdiction administers its own health plan. Since 2010, the pan-Canadian Pharmaceutical Alliance, made up of provincial/territorial health minister representatives, has negotiated drug prices with manufacturers. 23 In February 2016, the federal government joined the alliance. 23,24 For these reasons, it was hypothe...
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