Problem Statement: The social engagement of patients in HTA processes in Brazil also takes place through public consultations. This case study analyzed how these patients contributions for the public consultation of two drugs for cystic fibrosis were considered by the evaluators during the decision-making process.

Description: Exploratory and quali-quantitative case study, based on the analysis of documents from the National Committee for Health Technology Incorporation (CONITEC) on the process of incorporating two drugs for cystic fibrosis treatment - lumacaftor/ivacaftor and ivacaftor, aiming to identify how the Committee used the real-life reports from patients in their respective public consultations, and whether they had an impact on decision-making.

Lessons Learned: In the public consultation on the drug lumacaftor/ivacaftor, 11,916 contributions were identified in the experience and opinion form, 374 of which were from patients, with 15 contributions with real life evidence of medication use. The presentation and use of these reports in the decision-making meeting was not observed. In the public consultation on the drug ivacaftor, 10,417 contributions were identified, 340 of which were from patients and 7 with reports with real life evidence of use, but none of these reports were presented in the respective meeting. Although the total number is expressive, the number of patients who claimed to have had experience with the technology is smaller, favoring the analysis and use in the decision process, where new data on the effects could have been considered.

Stakeholder perspective: As a patient, HTA researchers and patient advocacy groups representatives in Brazil, we recognize the evolution of social engagement mechanisms in the country. However, in addition to better qualify social engagement, it is necessary to improve the processes of analysis and transparency of the use of real-life data reports. Thus, they can contribute heavily to the decision-making process.