OBJECTIVES

: To evaluate the cost-effectiveness of thrombolysis with alteplase to treat acute ischemic stroke until 4.5 hours of symptoms initiation compared with clinical treatment without thrombolysis (control) under the Brazilian Unified Health System (SUS) perspective.

METHODS

: A four-state Markov model of the primary ischemic stroke treatment was built to predict costs, life-years gained (LYG), quality-adjusted life years (QALYs), and respective incremental cost-effectiveness ratio (ICER) considering a life-time horizon. After the treatment, patients could develop fatal or non-fatal intracranial hemorrhage and would enter three states of disability (modified Rankin scale, mRS 0-1, 2-3, 4-5) or death. Transition to a greater disability/death would occur by recurrent stroke. Effectiveness and safety inputs were obtained in an individual patient-level meta-analysis for treatment until 3 hours and 3-4.5 hours. Acute and chronic costs were obtained in a reanalysis of micro-costing data from a cohort of ischemic Brazilian stroke patients treated in public hospitals. Deterministic and probabilistic sensitivity analysis (PSA, 1000 simulations) were performed. Discount rate of 5% was applied for costs and effectiveness.

RESULTS

: Treatment with alteplase compared with control resulted in 5.95 vs. 5.73 LYG, 3.59 vs. 3.24 QALY and total costs of R$ 36,606.30 vs. R$ 32,495.75, with ICER of R$18,403.41/LYG and R$11,942.61/QALY. The ICER/LYG was most sensitive to variation in alteplase effectiveness, acute stroke treatment and 90-day mortality. ICER/QALY was most sensitive to alteplase effectiveness, acute and chronic stroke costs, utility of mRS 0-1 state and fatal HIC risk. In PSA, the 95% confidence interval were R$ 11,395.00 to R$ 30,837.47/LYG and R$ 15,450.79 to R$ 16,983.76/QALY, with 70.7% and 93.1% being under a willingness-to-pay threshold of R$ 31,833.50 (2019 gross domestic product per capita of Brazil).

CONCLUSIONS

: Treatment of acute ischemic stroke with alteplase until 4.5 hours from onset is cost-effective in the perspective of the Brazilian public health system.