Presentation (CTI)

OBJECTIVES: The objective of this study is to analyse the reimbursement status of poly (ADP-ribose) polymerase inhibitors (PARPi), indicated for the treatment of ovarian cancer within the Spanish National Health System (SNHS), and to estimate their total annual cost.
METHODS: A review of PARPi authorized by the European Medicines Agency and the Spanish Agency for Medicines and Health Products was conducted in June 2025. Therapeutic indications were analysed, excluding PARPi authorized for other cancer types. Subsequently, their reimbursement status in the SNHS and the associated cost-control measures were reviewed. Finally, annual costs were constructed using list prices and dosage regimens specified in each drug’s the summary of product characteristics.
RESULTS: Since 2016, three PARPi have been authorized and reimbursed by the SNHS for the treatment of ovarian cancer, 33.3% (n=1) reimbursed for its full indication. The average time from national authorization to reimbursement approval was 369.7 days (standard deviation: 126.5 days; range: 267 days to 511 days). Currently all PARPi have special reimbursement conditions, with a mean of 1.7 (standard deviation: 0.6) per PARPi: additional discount (33.33%; n=1), sales threshold (33.33%; n=1), and mandatory monitoring through the Seguimed™ software (100%; n=3). The estimated annual cost per patient ranges from €64,962 to €97,443.
CONCLUSIONS: All authorised PARPi in ovarian cancer have been reimbursed in Spain, after a process that lasted between 0.5 and 2 years. Each drug is subject to one or two reimbursement conditions, mainly the monitoring of drug supply through the national Seguimed™ software. The high annual cost per patient reinforces the need for comprehensive economic evaluations and robust monitoring mechanisms to ensure the sustainability of public healthcare financing.