title: The budget impact of introducing delayed-release dimethyl fumarate for treatment of relapse-remitting multiple sclerosis in Canada.
abstract: OBJECTIVE
  Multiple sclerosis (MS) causes significant disability globally and is especially prevalent in Canada. Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) is an orally administered disease-modifying treatment (DMT) for patients with relapsing-remitting MS (RRMS) that is currently on the market in the US, Australia, Canada, and Europe. A budget impact model (BIM) was developed to assess the financial consequences of introducing DMF for treatment of RRMS in Canada.
  
  
  METHODS
  A BIM calculated the financial consequences of introducing DMF in Canada over 3 years based on RRMS prevalence, treatment market share, and clinical effects. RRMS prevalence in Canada was derived from published literature and natural relapse rates, and disease state distribution from clinical trial data. It was conservatively assumed that 100% of RRMS patients were treated with a DMT. DMF was assumed to absorb market share proportionally from the following current treatments: interferon beta-1a-IM, interferon beta-1a-SC, interferon beta-1b, and glatiramer acetate. Treatment efficacy, in terms of relapse rate reductions and treatment discontinuation rates, was determined from mixed treatment comparison. Treatment costs (including costs of acquisition, monitoring, and administration) and cost of relapse were considered. Deterministic one-way sensitivity analyses were conducted to assess the most sensitive input parameters.
  
  
  RESULTS
  Over 3 years, the introduction of DMF resulted in an average annual increase of CAD417 per treated patient per year, with reductions in costs associated with relapses (CAD192/patient/year) partially offsetting increased drug acquisition costs (CAD602/patient/year). On a population level, the average annual cost increase was CAD24,654,237, a CAD 0.68 increase per population covered by the Canadian healthcare system. The main drivers of budget impact were drop-out rates, proportion of RRMS patients treated, and market share assumptions.
  
  
  CONCLUSIONS
  The acquisition costs of DMF for treatment of RRMS are predicted to be partially offset by reduced costs of relapses in the Canadian healthcare system.
authors.affiliation: a a Evidera , Bethesda , MD , USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Dorman
authors.affiliation: a a Evidera , Bethesda , MD , USA.
authors.forename: Anuraag R
authors.initials: AR
authors.lastname: Kansal
authors.affiliation: b b Biogen Idec , Cambridge , MA , USA.
authors.forename: Sujata
authors.initials: S
authors.lastname: Sarda
mesh_terms: D002170:Canada / Q000453:epidemiology; D003365:Costs and Cost Analysis; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D000069462:Dimethyl Fumarate / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D004185:Disability Evaluation; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D018803:Models, Economic; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology; D015995:Prevalence; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D000069462:Dimethyl Fumarate
keywords: Budget impact; Canada; Delayed-release dimethyl fumarate; Relapse-remitting multiple sclerosis