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.

Keywords::

• Delayed-release dimethyl fumarate
• Relapse-remitting multiple sclerosis
• Budget impact
• Canada

Transparency

Declaration of funding

Funding for this study was provided by Biogen Idec.

Declaration of financial/other relationships

ED and AK were employed at Evidera, a company that received funding to assist with the conduct of this analysis and the preparation of this manuscript. SS was employed at Biogen Idec, the financial sponsor of this study. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors gratefully acknowledge the contributions of Parexel (formerly Heron) to the model development.