From Clinical Assessment to Drug Reimbursement in Spain: Current Timelines and Potential Impact From the Joint Clinical Assessment

OBJECTIVES: Assess the time to reimbursement in Spain for centrally authorized drugs and explore the impact of the new European Joint Clinical Assessment (JCA).

METHODS: JCA timelines were mapped using regulatory data. Since Spain lacks predefined reimbursement timelines, average timelines since EU marketing authorization (MA) were calculated for authorizations issued from 01/2019-12/2022. The time to national code (NC) served as a proxy for the submission of the value dossier and the beginning of the pricing and reimbursement assessment. Time to first reimbursement resolution was determined from the Spanish Interministerial Commission on Prices and Health Products meeting minutes from 01/2019-04/2024. Reimbursement was official upon inclusion in the Nomenclátor. Reimbursement rate was measured by the number of authorized medicines in the Nomenclátor as of 26/06/2024.

RESULTS: During the study period, 166 new medicines were centrally authorized, of which 47 were in oncology. Of these, 90.4% (150) had a valid NC, 81.9% (136) had a CIPM resolution, and 69.9% (116) were reimbursed. The reimbursement rate varied for oncology (74.5%), non-oncology (68.1%), and orphan (62.9%) drugs. The average time from centralized MA to NC was 5.7 months. Additionally, it took 16.7 months to reach the first CIPM resolution and 22.2 months for full reimbursement. The time to NC varied across oncology (4.4), non-oncology (6.2), and orphan (6.6) drugs. The time to the first CIPM resolution varied across oncology (14.9), non-oncology (17.5), and orphan (18.2) drugs. The time to reimbursement varied across oncology (24.2), non-oncology (21.4), and orphan (24.3) drugs. With the new process, the JCA report will be published 30 days after MA.

CONCLUSIONS: By June 2024, Spain had reimbursed two-thirds of EMA-authorized medicines (01/2019-12/2022) in an average of 22.2 months. By providing clinical assessment results within one month, the JCA offers the possibility to reduce local timelines for value dossier submission and assessment.