Evaluación económica del informe GENESIS-SEFH de olaratumab con doxorrubicina en el sarcoma de tejidos blandos en estadios avanzados

Objective: The economic evaluation of the drug olaratumab is carried out in the treatment of soft tissue sarcoma. Method: The data were analyzed following the recommendations contained in the MADRE program of the GENESIS-SEFH report model. Results: Progression free survival and overall survival results published in the pivotal clinical trial; Tap WD et al. (2016) were improvement of 2.5 months in median progression free survival (primary endpoint) HR=0.672; 1095% (0.442-1.021) and gain of 11.8 months in median OS (secondary endpoint) HR=0.463; IC95% (0.301-0.710). A cost-effectiveness analyses was performed considering 2 scenarios; scenario 1: with use of whole vials and scenario 2: use of whole vials and associating non-pharmacological costs (day hospital visits, mucositis, neutropenia and dexrazoxane use). In both cases we considered the cost of drugs and the efficacy data of the pivotal clinical trial. In Scenario 1, we would have an Incremental-Cost-Effectiveness-Ratio of (sic)28,443.81/month of progression-free survival and (sic)72,560.74 per year of life gained and in scenario 2 we would have an incremental-cost-effectiveness ratio of (sic)30,879.79/progression-free survival and (sic)78,774.99/year of life gained. The budgetary impact of this drug would range from (sic)61,759,592 to (sic)92,639,388 estimated to be 800 to 1,200 patients likely to receive treatment in Spain. Conclusions: Olaratumab is a drug that provides a significant benefit in overall survival but not in progression free survival. To be used in soft tissue sarcoma and to be cost-effective, the acquisition cost of the 500 mg vial should be between (sic)101.91 and (sic)506.54 and that of the 190 mg vial between (sic)39.31 and (sic)195.37.