OBJECTIVES: Mexico has a rapid obesity epidemic. Since 2018 the anti-Obesity Medicines (a-OM) were recommended by the mexican Guidelines of Clinical Practice. Nevertheless, all previous attempts to add any a-OM into de National Formulary (NF) had failed. After 2 rejections, we got the approval of our a-OM into the NF with a mixed-strategy generating new evidence and building innovative pathways.

METHODS: Previous requests fully met technical pharmacoeconomic requirements but, we were rejected. Innovative pathways were required. First step: identify relevant causes of rejections validating NF “official response” with Therapeutic Area Leaders. Authorities recognized our a-OM as valuable and necessary but, incosteable. Three main drivers were identified: large-treated population (37% of adults); budget impact and; the absence of strategies for guarantee a rational use of a-OM. Second step: find a specific population which benefits the most and would be “affordable”. We found it in obesity class 2 with cardiometabolic comorbidities; unfortunately, there were no official data to support it. Third step: build new evidence from a raw dataset of the national nutrition survey: we estimated 1.7% of target population. Forth step was to develop realistic and simple pharmacoenomic models. So, we excluded patients who abandoned the treatment and measure costly-relevant outcomes (macro and microcardiovascular complications) in short and long-term (bariatric surgeries and avoided deaths). Also, we made explicit the hidden cost-effectiveness of diet and exercise. Finally, to limit budget impacts and rationalize the use of the medicine only patients who attend to clinical services and get endocrinologist attention were considered. A pay for performance was agreed.

RESULTS: We run the faster approval process and got a-OM approval in 5 weeks.

CONCLUSIONS: Access of medicines is not a linear process. Guidelines are important to fulfill technical requirements and new evidence and realistic pathways are the root of success to expand access into reimbursement markets.