OBJECTIVES: The disease modifying therapies (DMTs) for multiple sclerosis (MS) are expensive and a burden on healthcare systems. Decisions driving the reimbursement of currently available DMTs can help prepare appropriate strategies for pricing and reimbursement submissions in future. The objective of this analysis was to understand recent health technology assessments (HTAs) for MS therapies in EU-5 nations and identify the factors driving their reimbursement decisions.

METHODS: European Commission (EC)-approved drugs for MS were identified via European public assessment reports. A surveillance of recent HTA decisions in the EU-5 regions, namely UK (NICE, SMC, AWMSG), France (HAS), Italy (AIFA), Spain (AEMPS, AETSA) and Germany (G-BA, IQWiG) was done using IQVIA™ ’s proprietary platform ‘HTA Accelerator’ from 01/Jan/2015 to 01/06/2019.

RESULTS: Fourteen MS-specific DMTs have received EC approvals to date, with daclizumab being voluntary withdrawn post-approval for various safety reasons by the innovator. Forty-nine single drug assessments (SDAs) were carried out for these 14 drugs since 2015. Of these, the highest number of SDAs were for fingolimod (22.4%; n= 11) and ocrelizumab (20.4%; n= 10). Among the recently published 49 HTA decisions (SDAs), it was found that five negative recommendations were received for three DMTs in EU-5 [fingolimod (1 for G-BA), cladribine (1 for HAS and 1 for G-BA) and fampridine (1 for SMC and 1 for AWMSG)] owing to insufficient evidence justifying high cost or inability to demonstrate sufficient clinical effectiveness against the comparators.

CONCLUSIONS: Despite approval of several DMTs for MS in the EU-5 region, DMTs have confronted negative recommendations from HTA agencies for not being able to justify their high cost against comparators. Hence, further emphasis on robust economic analyses justifying price vis-à-vis clinical benefits are warranted to drive positive HTA recommendations.