TIME TO REIMBURSEMENT OF MULTIPLE SCLEROSIS THERAPIES IN POLAND ANALYSIS OF HTA SUBMISSION AND REIMBURSEMENT DECISIONS
Author(s)
Michal Seweryn, PhD1, Aleksandra Chromiec, MSc2, Karolina Skóra, MPH, MSc3, Joanna Augustynska, MSc4.
1Faculty of Health Sciences, Andrzej Frycz Modrzewski University, Krakow, Poland, 2Independent Researcher, Krakow, Poland, 3EconMed Europe, Wola Zachariaszowska, Poland, 4EconMed Europe, Krakow, Poland.
1Faculty of Health Sciences, Andrzej Frycz Modrzewski University, Krakow, Poland, 2Independent Researcher, Krakow, Poland, 3EconMed Europe, Wola Zachariaszowska, Poland, 4EconMed Europe, Krakow, Poland.
OBJECTIVES: To evaluate reimbursement timelines for innovative multiple sclerosis (MS) therapies in Poland by examining intervals between initiation of the Health Technology Assessment (HTA) process and reimbursement availability, in the context of European Medicines Agency (EMA) marketing authorization dates.
METHODS: A retrospective analysis was conducted for 19 MS therapies authorized by EMA and subsequently assessed for reimbursement in Poland between 2006 and 2025. Dates of EMA authorization, initiation of the reimbursement process (defined as AOTMiT referral date, used as a proxy for submission by the marketing authorization holder), and reimbursement implementation were collected from publicly available sources (EMA, AOTMiT public information bulletin, Ministry of Health reimbursement announcements). Time intervals between HTA initiation and reimbursement availability were calculated for individual therapies. One therapy (diroximel fumarate) was excluded due to withdrawal of the HTA referral.
RESULTS: Substantial variability in reimbursement timelines was observed across therapies. Time from HTA initiation (AOTMiT referral) to reimbursement ranged from 132 days for ponesimod to 935 days for subcutaneous natalizumab. Among recently reimbursed therapies, intervals were 194 days for ublituximab, 231 days for subcutaneous ocrelizumab, 357 days for ofatumumab, 437 days for ocrelizumab, 497 days for cladribine, 505 days for ozanimod, and 797 days for siponimod. Considerable differences were also observed in the interval between EMA authorization and HTA submission across therapies.
CONCLUSIONS: Reimbursement timelines for MS therapies in Poland varied substantially, ranging from several months to over two years from HTA initiation to reimbursement. Variability in the interval between EMA authorization and HTA submission suggests that manufacturer decisions regarding application timing contribute to differences in patient access. These findings may inform discussions on streamlining reimbursement pathways for neurological therapies in Central and Eastern Europe.
METHODS: A retrospective analysis was conducted for 19 MS therapies authorized by EMA and subsequently assessed for reimbursement in Poland between 2006 and 2025. Dates of EMA authorization, initiation of the reimbursement process (defined as AOTMiT referral date, used as a proxy for submission by the marketing authorization holder), and reimbursement implementation were collected from publicly available sources (EMA, AOTMiT public information bulletin, Ministry of Health reimbursement announcements). Time intervals between HTA initiation and reimbursement availability were calculated for individual therapies. One therapy (diroximel fumarate) was excluded due to withdrawal of the HTA referral.
RESULTS: Substantial variability in reimbursement timelines was observed across therapies. Time from HTA initiation (AOTMiT referral) to reimbursement ranged from 132 days for ponesimod to 935 days for subcutaneous natalizumab. Among recently reimbursed therapies, intervals were 194 days for ublituximab, 231 days for subcutaneous ocrelizumab, 357 days for ofatumumab, 437 days for ocrelizumab, 497 days for cladribine, 505 days for ozanimod, and 797 days for siponimod. Considerable differences were also observed in the interval between EMA authorization and HTA submission across therapies.
CONCLUSIONS: Reimbursement timelines for MS therapies in Poland varied substantially, ranging from several months to over two years from HTA initiation to reimbursement. Variability in the interval between EMA authorization and HTA submission suggests that manufacturer decisions regarding application timing contribute to differences in patient access. These findings may inform discussions on streamlining reimbursement pathways for neurological therapies in Central and Eastern Europe.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR15
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
Neurological Disorders