OBJECTIVES: To estimate the budget impact of tofacitinib inclusion in the treatment of rheumatoid arthritis as a new oral alternative in second-line treatment and more, for patients with at least one conventional DMARD treatment failure, in the French Healthcare system.

METHODS: A model was developed with a five-year time horizon (2018 – 2022). The comparators were anti-TNF alpha, anti-IL6, anti-CTLA4, anti-CD20 and anti-IL1 approved or to be shortly approved on the French market. Both biologics and biosimilars have been included in the model. These biological treatments were considered in monotherapy and in combination with methotrexate, with different adherence rates according to the route of administration. The analysis included only the following direct medical costs (€2017): acquisition, administration and follow-up costs. Market shares were estimated based on a 2016 observational French market study. Deterministic and scenario sensitivity analyses were performed to assess the uncertainty level of this analysis.

RESULTS: From the French payer’s perspective, tofacitinib is among the least expensive treatments. With approximately 10,000 patients treated with tofacitinib over 5 years, the French market introduction of tofacitinib would generate savings ranging from 15 to 16 million euros. Sensitivity analyses showed the robustness of this budget impact analysis. The base case findings remained stable under variation in a wide range of model inputs.

CONCLUSIONS: The impact of French market inclusion of tofacitinib would generate significant savings on the total expenditure currently spent on patients suffering from rheumatoid arthritis with at least one conventional DMARD treatment failure in France.