ABSTRACT
OBJECTIVES: The high costs generated by the current epidemiological profile and the introduction of new technologies, impact on public health systems, this situation is complicated when the health budget is low and causes the drug to be paid by the patient's pocket. In this situation it is necessary to design strategies that strengthen the approval of drugs that will be used in public health institutions in Mexico. To describe the results of the drug approval process for use in public health institutions to ensure the efficacy, safety, and efficiency of health technologies used in public health institutions in Mexico. METHODS: We conducted a cross-sectional drug approval process, from September 2011 to December 2012, with a descriptive analysis for each stage in the process considered. RESULTS: Of the 394 applications received for approval of health technology, 244 (62%) were for drugs; of these, 151 (62%) met the requirements for evaluation (32% and 68% were modifications inclusions), finally was approved of 42% (61% of the changes and 33% of inclusions). The 73% of the applications were for consensus approval, 12% were conditioned at low price and 6% were approved by majority vote. The main reasons for refusal were lack of clinical evidence (31%) and methodological problems in the economic evaluation (27%). CONCLUSIONS: The strengthening of the process was conducted with methodological rigor based on critical analysis of scientific evidence, with transparency and legitimacy under a legal framework to promote resource optimization. The highest percentage of requests was for drugs which are the most commonly used therapeutic technology; for this reason it requires a proper selection process to ensure greater health benefit that ensures efficient use of economic resources. The economic evaluation was a support tool to consider in addition to price, the value of health determined by the quality of evidence, establishing a GDP per capita as a threshold to define a drug as an efficient alternative.
