Beneficio económico de los ensayos clínicos controlados patrocinados: El gasto evitable en medicamentos para el tratamiento de la artritis reumatoidea.

OBJECTIVES: To estimate the following: (1) the avoidable cost of biologic (bDMARDs) and conventional synthetic Rheumatoid Arthritis (RA) modifying antirheumatic drugs (csDMARDs) during controlled clinical trials (CCTs), their extension period, and for bDMARDs in post study drug programs; and (2) to evaluate the impact on health insurances.

METHODS: We analyzed 13 CCTs (233 patients) that evaluated bDMARDs. Avoidable cost was what the health insurance should have paid if the patient had not received the medication from the CCT sponsor and was estimated with a micro-costing approach (bottom-up method). Results were expressed as mean ± standard deviation (SD) or percentages. Approved by the Ethics Committee.

RESULTS: Mean age was 50.62 SD 11.8 years, 84% were women, 72% (n = 166) had health insurance. The mean annual cost of bDMARDs was US$ 30 567.40 while the cost for csDMARDs was US$ 104.90 during the CCTs. The mean annual cost in extension periods and post study drug programs for bDMARDs was US$ 36 016.20 and for csDMARs during the extension period was US$ 81.70. The avoidable cost for public health insurances exceeded one million dollars per year.

CONCLUSION: This work describes for the first time in Argentina the significant economic benefit that may represent for RA patients' health insurances the participation in CCTs with bDMARDs. It shows that during the execution of the CCT, its extension periods, or post study access programs, while medication provision is guaranteed, the economic burden imposed by the treatment of the RA is relieved.