DECISION DRIVERS FOR BRAZIL- AN ANALYSIS OF CONITEC RECOMMENDATIONS

Author(s)

Kreeftmeijer J1, Skaltsa K2, Palazzolo D3
1Quintiles Consulting, Hoofddorp, The Netherlands, 2Quintiles Consulting, Barcelona, Spain, 3Quintiles Consulting, Reading, UK

OBJECTIVES: Since its establishment in December 2011, Brazil’s HTA body CONITEC (National Commission on the Incorporation of Technologies), has published more than 90 assessments. The objective of the present study was to perform an analysis on CONITEC’s positive and negative decisions, in order to understand the main decision drivers. METHODS: All assessments published by CONITEC between December 2001 and April 2014 were included in our analysis. The rationale for the decisions was analyzed for both positive and negative recommendations. Reasons for recommending or rejecting a technology were summarized into categories. RESULTS: In total, 101 publications were identified: 67 of those assessed drugs, 12 a procedure or intervention and 11 a medical device. The remaining 11 were clinical guidelines (not included in the analysis). Overall, 46 recommendations were positive and 44 negative.  The main reasons for rejection were concerns about the economic evidence (23 reports) or lack to demonstrate significant additional clinical benefits (22). The main reasons for positive recommendations were demonstrated clinical efficacy benefit (21), low budget impact (19) and fulfillment of high unmet needs (15). In the majority of cases, the decision was based on multiple factors. CONCLUSIONS: Brazil has set the way for a more transparent process for technology assessment following a formal process including pharmacoeconomic guidelines. However, insufficient clinical benefits and methodological concerns about the economic evaluation as major rejection drivers reveals that manufacturers are not yet addressing CONITEC’s requirements. Full transparency on the evaluation of outcomes is still missing, providing additional complexity for manufacturers towards a positive recommendation. Our results demonstrated a positive relation between acceptance and demonstrated clinical efficacy, as well as a low budget impact. CONITEC seems to follow a specific pathway in their decision that should be leveraged by manufacturers in order to increase their likelihood of receiving a positive recommendation.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP209

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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