ANALYSIS OF REAL-WORLD EVIDENCE AND REAL-WORLD DATA BY CONITEC, BRAZILIAN HTA AGENCY
Author(s)
Nita ME1, Riveros BS2, Vaz P3, Mussolino F3
1IECS, HAOC, and FIPE, Sao Paulo, Brazil, 2Federal University of Parana, Curitiba, Brazil, 3HEADS, Sao Paulo, Brazil
            OBJECTIVES:  Very little information is available about the demand from CONITEC, the Brazilian HTA agency, for real-world evidence (RWE), moreover, few real-world data (RWD) sources are available. The objective of this study was to examine reports from CONITEC to identify patters of RWE and sources being used.  METHODS:  The reports from CONITEC are publicly available at the Ministry of Health (MoH). All reports from January to September of 2015 were reviewed for RWE and RWD information. In total, 37 seven reports were analyzed in this research. The assessed variables included type of technology, therapeutic area (TA), source of demand, final decision, RWE and RWD sources.  RESULTS:  In total, there were 33 inclusion demand and 4 were exclusion. The most frequently technology requested were drugs, 31 out of 37. Infectious disease (8), immunobiologics (6), and cancer (4) were the most frequent TAs. A total of 24 demands were from organizations within MoH. Among external demands the majority were from pharmaceutical industries. Brazilian Unified Health System (SUS) database, the DATASUS, was the RWD source most frequently quoted in the final reports (19), and epidemiology, resources used and treatment patterns were the most used RWE. Drug costs were more frequently quoted (17) from the official MoH Journal (DOU).  Observational studies were quoted in 12 reports, including chart reviews, and non-randomized interventional trials were used to support the decisions. Surveys were used in two reports to identify treatment patterns.  CONCLUSIONS:  CONITEC is increasingly demanding RWE in the reports.  By expanding the use of existing RWD, as DATASUS, a new concern arises with the way RWE are being retrieved and statistically adjusted in the reports. It is noticeable the concentration of RWE in MoH demands compared to other claimants. From demands without RWE, estimations and assumptions were taken into account.
        
    Conference/Value in Health Info
                        2016-05, ISPOR 2016, Washington DC, USA
                    
                Value in Health, Vol. 19, No. 3 (May 2016)
Code
PHP167
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases