OBJECTIVES : SSc is a rare disease with an estimated prevalence of 50 to 300 cases per million. The purpose of this study was to analyse the budget impact of nintedanib versus no treatment for SSc-ILD, and identify potential benefits of this new treatment entering the market from the Turkish healthcare authority’s perspective.

METHODS : An Excel model was developed to estimate the budget impact. Resource use data were obtained from the Social Security Institution’s and the Turkish Medicines and Medical Devices Agency’s official websites. The population data were taken from TUIK 2018 national statistics and the population growth rate was 14.7‰ simulated over 3 years prospectively. Prevalence for SSc, obtained from the literature, was 0.0158% and for SSc-ILD, obtained from DRG Patient Flow Analysis, was 30%.

RESULTS : Estimates showed that 78 patients from the overall SSc-ILD population could benefit from nintedanib in the first year, 120 patients in the second year and 189 patients in the third year. Prices were assumed to remain constant, as the change rate cannot be predicted for the next three years. Accordingly, if nintedanib was introduced, the net budget impact would be estimated at 3,769,841TRY (492,010€) in year 1, 5,837,165TRY (756,403€) in year 2 and 9,152,214TRY (1,185,981€) in year 3. On the other hand, nintedanib demonstrated budget savings of around 8-9% in idiopathic pulmonary fibrosis (IPF), which represented around 2.6 times the expected net impact of the SSc-ILD indication. Therefore, looking at all the indications, including the IPF savings, nintedanib is still expected to be cost-saving overall for the healthcare system.

CONCLUSIONS : Since SSc-ILD affects a very limited population, nintedanib’s impact on the current budget should be acceptable, while offering the first and only approved treatment for patients with lung involvement. This impact would represent less than 0.01% of the budget allocated to drug expenditure in Turkey.