2SPD-014 Evaluating the methodological quality of pivotal clinical trial publications for orphan drugs authorised in 2018. Are they reliable?

Abstract

The estimated annual cost was calculated based on the dosage of omalizumab and compared with the estimated annual cost applying the protocol, which indicated that for treatment of IgE mediated SA and eosinophilia >300 cells/mL, the drug used would be selected according to efficiency criteria. The variables collected were weight, dosage and level of IgE and eosinophils at the start of treatment. The SAP application was used for data extraction. Costs were calculated from the sales price of the laboratory (PVL) applying the Spanish Royal Decree discount (À7.5%) and the discount offered to the hospital. Results A total of 65 patients were analysed, 71% (46) of whom met the criteria for IgE mediated SA and eosinophilia >300 cells/mL. Median patient weight was 74.5 kg (45-120), median IgE was 219.5 IU/mL (46-1500) and median eosinophils were 630 cells/mL (310-1783). The estimated annual cost according to the dosage for omalizumab was 582 541.95C ¼ while the cost applying the treatment protocol by efficiency criteria was 384 945.81C ¼ , an annual saving of 197 596.14C ¼. Conclusion and relevance Multidisciplinary protocols allow strengthening of partnerships between hospital departments, improve best health outcomes and maintain economic sustainability.