OBJECTIVES: Analyze the evolution of coverage of anti-hemophilic drug treatments into the Mexican Public Health System (MPHS) through the last 3 decades.

METHODS: All new medicines approvals and their Indications of Use (IoU) included into the MPHS from 1996 to May 2024 were identified. Total number of anti-hemophilic medicines were followed retrospectively by 29 years to characterize the inclusion or exclusion process of medicines and their IoU. A sub-analysis for the type of hemophilia A (HA) or hemophilia B (HB) was performed. The IoU were catalogued and counted as “general indication” if the approved indication was just “hemorrhage” and as “specific indication” if the approval was for a particular medical condition such as “surgical procedures”, use in “patients with inhibitors” or “severe”.

RESULTS: Three decades ago, there were only 2 medicines to cover the health needs of hemophilic patients: one for HA and one for HB. For 6 years, there were no additional alternatives. Since then, drug coverage has grown 7 times (n=14). Currently, 68.8% (n=11/16) of them attend HA and 18.7% HB (n=2). Three medicines attended both types of hemophilia. In 1996 there were 3 “general” IoU; for 2024 these number grew 5 times (n=16). Notably, although 73.6% of the approved new IoU were for “specific indications” (n=14/19), the approvals for “general indications” remained growing. Even in 2023, when 8 medicines already have the IoU for “hemorrhage treatment”, one additional drug was approved. Any medicine has been excluded.

CONCLUSIONS: The coverage of antihemophilic medicines has growth substantially in 30 years, especially for HA. But few options for HB were detected. Interestingly, the IoU amplified the coverage of both, general needs and specific indications. So, into the MPHS additional rationalizing criteria has driven approvals, besides coverage needs.