O Acordo de Compartilhamento de Risco do Zolgensma no SUS

Objectives: to analyze the Zolgensma risk-sharing agreement in the SUS and its capacity to reconcile access to gene therapy with budgetary sustainability. Methods: qualitative, bibliographic and documentary research analyzing Ministry of Health acts, the contract, STF Themes 6 and 1,234, and literature on performance-based agreements. Results: the model links installments to motor outcomes and survival, transferring part of the clinical uncertainty to the manufacturer. Limitation: long-term results are not yet consolidated. Conclusions: the agreement is promising, but its effectiveness depends on independent monitoring, reliable data and transparency.