OBJECTIVES: To compare the cost effectiveness of fingolimod and interferon (IFN)-β1a as first-line therapies in the management of pediatric-onset multiple sclerosis (PoMS).

METHODS: We used the simplified version of a previously developed Markov model, adapted to the Mexican public health care setting. The model considers 11 health states based on the Expanded Disability Status Scale (EDSS): 0‒9 for relapsing PoMS and Death. Annualized relapse rates were extracted from the PARADIGMS study and mortality was estimated using Mexican local data. For disability progression, the adult natural course of the disease was transformed to properly reflect the pediatric population, while relative treatment effects were obtained from the PARADIGMS trial and published mixed treatment comparisons. Costs and resource use were extracted from a Delphi panel, and Mexican price sources. Costs and benefits were discounted at 5%, with a time horizon of 8 years. The primary outcome was incremental cost-effectiveness ratio (ICER) measured in Mexican pesos (MXN) per relapse avoided. Sensitivity analyses were performed to assess the robustness of the model estimations. Budget impact analysis was also estimated for the social security system in Mexico.

RESULTS: In comparison with IFN-β1a, fingolimd was associated with a reduction of 5.6 relapses over 8 years with an associated incremental cost of MXN 190,805, corresponding to an ICER of MXN 33,998 per relapse avoided. Probabilistic sensitivity analysis demonstrated fingolimod was cost-effective in 100% of the simulations, assuming a willingness-to-pay threshold of MXN 188,974 per relapse avoided (1 GDP per capita). The inclusion of fingolimod resulted in cumulative additional expenditures of MXN 5.3 million, over a 5-year period, for the social security system in Mexico.

CONCLUSIONS: Fingolimod is cost-effective for the treatment of PoMS, compared to IFN-β1a, in the Mexican public health care context, given that it registered one of the highest relapse reductions in the MS clinical literature.