Pharmacoeconomic Impact of Purchasing Off-Label Drugs in Tunisia: Case Study of Pembrolizumab (Keytruda®).

[PURPOSE] Access to medicines is a universal right guaranteed by Tunisian law and is ensured through 2 pathways: Marketing Authorization (MA) for products approved for national commercialization, or the off-label drug purchase procedure, which allows the importation of medicines not authorized on the Tunisian market. The aim of this study was to assess the current situation of these purchases and their pharmaco-economic impact through a case study of pembrolizumab (Keytruda).

[METHODS] This retrospective descriptive study analyzed all off-label drug purchases recorded between 2021 and 2023 using data obtained from the National Agency for Medicines and Health Products' (NAMHP) internal software called "SIAMED". The budget impact analysis of Keytruda (pembrolizumab) was conducted in accordance with the methodological steps recommended by the National Authority for Health Evaluation and Accreditation's guideline and using data of only 2023 from the Central Pharmacy of Tunisia (PCT).

[FINDINGS] The number of purchases rose steadily over the study period by 25.8%, with a predominance of anticancer drugs, particularly immunotherapies with a percentage of 43.76%, at the expense of conventional chemotherapies whose percentage fell to 23.48%. The distribution of therapeutic areas in the public and private sectors showed an interest in anticancer drugs for the public sector, and in drugs for the genito-urinary system for the private sector. The budgetary analysis of Keytruda revealed a marked increase in prescriptions from 42 in 2021 to 266 prescriptions in 2023, generating costs more than 20 million Tunisian dinars (MTND), and showed that granting MA could generate savings of 17,2 MTND.

[IMPLICATIONS] Although this purchasing procedure facilitates access to medicines, its regulatory framework needs to be reviewed. Budget impact analysis is a key tool for optimizing resource management and encouraging the issuance of MA, thereby helping to limit the costs generated by this procedure.