PNS230 CALL FOR EFFECTIVE GUIDANCE: ASSESSMENT OF PHARMACOTHERAPEUTIC GUIDELINES IMPLEMENTATION

The National Health Technology Assessment System (SiNATS) is defined by two cumulative assessment stages for the pharmacotherapeutic and economic value. In November 2016, INFARMED issued guidelines for the first stage, relating the quality of evidence to the level of therapeutic conclusion: absent (inferior or absence of proof), equivalent (ETV) or added therapeutic value (ATV). Within the latter, several degrees have been pre-specified: major, moderate, minor or non-quantifiable. This research aimed to assess the extent of implementation of the pharmacotherapeutic guidelines. All Health Technology Assessments (HTA) reports published by INFARMED up to June 2019 were reviewed. Multiple decisions within the same report were considered as individual observations. Exclusion criteria: generic or biosimilar drugs. Variables collected: decision outcome, therapeutic value assessment and degree. Only assessments with decision dates after November 2016 were included. Implementation assessment included frequencies, decision rates and time-trend profiling of ATV degrees as well as a qualitative analysis of decision reports versus the guidelines criteria. Final analysis sample comprised 180 pharmacotherapeutic assessments: 49.4% (n=89) ATV, 37.2% (n=67) ETV and 13.3% (n=24) absent value. Within the ATV, 55.1% (n=49) did not report its degree while 4.5% (n=4) reported a non-pre-specified degree. Non-quantifiable ATV was the most frequent pre-specified degree attributed (38.9%, n=14). Major, moderate and minor ATV decisions were evenly distributed: 19.4% (n=7), 22.2% (n=8) and 19.4% (n=7), respectively. Overall, the decision rate was considerably higher for non-quantifiable ATV (1.47 decisions/quarter), compared to major, moderate and minor ATV (0.62, 0.87 and 0.51 decisions/quarter, respectively). However, time-trend ATV profiles differ substantially between degrees: the first record of non-quantifiable ATV dates from December 2017, whereas the others occurred within the first year of guideline implementation. Pharmacotherapeutic guidelines are not being fully implemented, particularly due to the lack of compliance in reporting the degree of added therapeutic value.