Reimbursement Status of Centrally Authorized Drugs in Spain per Therapeutic Area and Orphan Designation

OBJECTIVES: To assess the reimbursement status and time to reimbursement in Spain of drugs authorized by the European Medicines Agency (EMA).

METHODS: A list of human medicines centrally authorized from 01/2018-12/2021 was retrieved from the EMA website. Medicine name, therapeutic area, orphan designation, and marketing authorization date were collected. Minutes from the Spanish Interministerial Commission on Prices and Health Products (CIMP) meetings from 01/2018-06/2022 were extracted to analyze the reimbursement resolutions. National code, medicine name, resolution adopted, criteria stated for decision, and special funding conditions were collected for this purpose. A product was considered reimbursed once it was included in the national reimbursement list (Nomenclátor). The rate of reimbursement, measured by the number of medicines in the national reimbursement list as of 20^th June 2023 (including products with restricted indications), and the time since centralized marketing authorization to inclusion in the national reimbursement list were estimated for the total sample and for several subcategories.

RESULTS: A total of 168 new medicines were authorized by the EMA in the study period, of which 46 in oncology and 122 in other therapeutic areas. Approximately one-third were orphan drugs (61). Most (148, 88.1%) had a valid national code and were reimbursed (112, 66.7%). Specifically, 24.4% were fully reimbursed, 42.3% were partially reimbursed (restricted indication), 15.5% received a negative reimbursement resolution, 11.9% had no national code, and 6.0% were pending a reimbursement resolution. The rate of reimbursement was 69.6% for oncology drugs, 65.6% for non-oncology drugs, and 65.6% for orphan drugs. Mean time to reimbursement for all the medicines reviewed was 21.7 months, being 21.5 months for oncology drugs, 21.8 for non-oncology, and 26.8 for orphan drugs.

CONCLUSIONS: As of June 2023, Spain had reimbursed 2 in 3 medicines centrally authorized by the EMA from 01/2018-12/2021, with a 21.7-month gap since the centralized authorization.