OBJECTIVES: Rheumatoid arthritis (RA) is a systemic, chronic, inflammatory autoimmune disease that affects mainly diarthrodial joints. Various treatment options exist making the therapeutic strategy complex. However, given the phenomena of inadequate response or intolerance to treatments, the medical unmet need remains high, especially in some subpopulations. In this context, a new biologic treatment, sarilumab, blocking both the membrane bound and free interleukin (IL)-6 receptor has been recently assessed by several Health Technology Assessment (HTA) bodies. Comparison of these opinions may help identify key decision drivers behind recommendations across countries/regions.

METHODS: A systematic scanning of HTA websites was performed to find appraisals issued after the European Medicines Agency (EMA) approval of sarilumab and before May 2018. The assessments were analysed to understand potential drivers leading to different recommendations of sarilumab in the different RA subpopulations for five EU payers and in Canada.

RESULTS: HTA assessments were found in France (HAS), Sweden (TLV), England (NICE), Germany (G-BA), Canada (CADTH) and Scotland (SMC). Three main subpopulations were identified: patients treated with sarilumab monotherapy in case of intolerance or inadequate response to methotrexate (MTX), patients treated with sarilumab in second line (with MTX) after use of conventional disease-modifying antirheumatic drugs (DMARDs) and in third line (with MTX) after biotherapies. All HTA bodies recommended reimbursement for all subpopulations, except TLV that recommended reimbursement only as a third line therapy. In a part of monotherapy subpopulation, the G-BA gave a hint of a considerable added benefit. NICE and SMC only recommended sarilumab for severe RA, thus limiting the reimbursement despite EMA approval.

CONCLUSIONS: While the different HTAs had access to the same clinical data for sarilumab, the results of the evaluations differ. Each country/region weighted differently the available clinical evaluation (e.g. subpopulation, endpoints, comparators, effect size).

The study was funded by Sanofi and Regeneron Pharmaceuticals, Inc.