title: Restrictions for reimbursement of direct-acting antiviral treatment for hepatitis C virus infection in Canada: a descriptive study.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Alison D
authors.initials: AD
authors.lastname: Marshall
authors.affiliation: 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.
authors.forename: Sahar
authors.initials: S
authors.lastname: Saeed
authors.affiliation: 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.
authors.forename: Lisa
authors.initials: L
authors.lastname: Barrett
authors.affiliation: 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.
authors.forename: Curtis L
authors.initials: CL
authors.lastname: Cooper
authors.affiliation: 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.
authors.forename: Carla
authors.initials: C
authors.lastname: Treloar
authors.affiliation: 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.
authors.forename: Julie
authors.initials: J
authors.lastname: Bruneau
authors.affiliation: 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.
authors.forename: Jordan J
authors.initials: JJ
authors.lastname: Feld
authors.affiliation: 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.
authors.forename: Lesley
authors.initials: L
authors.lastname: Gallagher
authors.affiliation: 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.
authors.forename: Marina B
authors.initials: MB
authors.lastname: Klein
authors.affiliation: 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.
authors.forename: Mel
authors.initials: M
authors.lastname: Krajden
authors.affiliation: 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.
authors.forename: Naglaa H
authors.initials: NH
authors.lastname: Shoukry
authors.affiliation: 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.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Taylor
authors.affiliation: 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.
authors.forename: Jason
authors.initials: J
authors.lastname: Grebely