Alison D Marshall1, Sahar Saeed1, Lisa Barrett1, Curtis L Cooper1, Carla Treloar1, Julie Bruneau1, Jordan J Feld1, Lesley Gallagher1, Marina B Klein1, Mel Krajden1, Naglaa H Shoukry1, Lynn E Taylor1, Jason Grebely1. 1. The Kirby Institute (Marshall, Grebely), UNSW Australia, Sydney, Australia; Department of Epidemiology, Biostatistics and Occupational Health (Saeed), McGill University, Montréal, Que.; Faculty of Medicine (Klein), McGill University, Montréal, Que.; Faculty of Medicine (Barrett), Dalhousie University, Halifax, NS; Department of Medicine (Cooper), University of Ottawa, Ottawa, Ont.; Centre for Social Research in Health (Treloar), UNSW Australia, Sydney, Australia; Centre de recherche du Centre hospitalier de l'Université de Montréal (Bruneau, Shoukry), Montréal, Que.; Liver Centre (Feld), Toronto Western Hospital, University Health Network/University of Toronto, Toronto, Ont.; Vancouver Coastal Health (Gallagher); BC Centre for Disease Control (Krajden), Vancouver, BC; Department of Medicine (Taylor), Brown University, Providence, RI.
Abstract
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-ritonavir-ombitasvir 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.
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-ritonavir-ombitasvir 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.
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