PND51 Cladribine Tablets (CT) Versus Other Disease-Modifying Therapies in the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) - Cost-Effectiveness Analysis.

Abstract

To assess the cost-effectiveness of CT (Mavenclad®) as a treatment of high disease activity (HDA) RRMS, compared with alternative 1st line therapies in Poland: interferon beta-1a (IFN-b1a), interferon beta-1b (IFN-b1b), peginterferon beta-1a (pegIFN), dimethyl fumarate (DMF), glatiramer acetate (GA) and teriflunomide (TER). CT is a distinctive therapy in RRMS, mainly due to its unique dosage scheme. It is administered in 2 courses – 5-day cycles in 2 consecutive months at the beginning of each of 2 years of therapy. Patients have a good chance to be relieved from any regular MS treatment even over 4 years since the start of CT therapy. A global Markov model was adapted to reflect healthcare system in Poland. During lifetime horizon, in each subsequent 12-month cycle the cohort was at risk of experiencing disability progression, remission, no EDSS change, one or more relapses, or death. Clinical data was based on CLARITY and respective trials for comparators. Utilities were derived from literature. Direct medical costs from the public payer’s perspective were calculated. Assuming the CE threshold of 147,024 PLN/QALY, CT in the HDA RRMS population was the cost-effective strategy compared to most alternatives (ICUR values in relation to the threshold ranging from -14,6% to +0,9%). Only when CT vs GA or vs pegIFN were considered, the ICUR value slightly exceeded the threshold, but of less than 1%. Uncertainty was explored via deterministic and probabilistic sensitivity analyses, which confirmed robustness of the primary results. CT appears as cost-effective MS therapy in Poland, offering good value for money in the Polish healthcare system. Therefore the recent positive reimbursement decision for Mavenclad® issued for restricted population should be reconsidered in the future, so that more patients with HDA RRMS could benefit from CT use, that is firmly grounded in clinical evidence and supported by the financial estimates.