Abstract
In Italy, Long-acting (LA) injectable therapy with cabotegravir (CAB) and rilpivirine (RPV) is currently used as maintenance treatment for HIV-1 and may increase patient satisfaction and facilitate adherence. The cost-effectiveness incremental ratio has not been calculated in Italy since the market authorization. The Authors use data from the registration trials of cabotegravir-rilpivirine: FLAIR+ATLAS at 48 weeks, and SOLAR at 48 weeks for efficacy and adverse events (AE). Moreover, the treatment price of the therapy in the Lombardy Region HIV+ clinical pathways is included to attain the 48 weeks Incremental Cost Effectiveness Ratio (ICER). Despite the nature of the short-term evaluation in a chronic condition disease, results can address the acceptability of the treatment in the Italian context. In FLAIR+ATLAS, the CAB+RPV LA efficacy is 93,10% and 94,40% for the comparator, the utility achieves 0,7922 for CAB+RPV LA and 0,7889 for the comparator, according to the CD4 counts. In the SOLAR trial the CAB+RPV LA efficacy is 90,16% and 92,83% for the comparator, the utility achieves 0,6823 and 0,6945, respectively. According to the results of FLAIR + ATLAS, the amount of costs for treatment, and grades 3 and 4 of AE is €7.538,80 for CAB+RPV LA, and €7.681,19 for CAR. In the SOLAR trial, the costs are €7.029,83 for CAB+RPV LA and €7.040,93 for CAR. In FLAIR+ATLAS trials, the ICER is equal to €10.953,11, and the ICUR to €19.896,80; in the SOLAR trial, the ICER = €376,31, and the ICUR = €415,96. All the results are under the threshold, generally indicated in Europe as €50.000 for chronic and acute diseases, different from rare and oncologic diseases. The ICER and ICUR ratios in both studies show a strong indication of use. However, it is important to highlight that the enrollment criteria for LA therapy, and the adherence and preference data distinctly indicate that the present analysis is comparing different health technologies indicated for the same treatment.