HTA PROCESS IN BRAZIL- HOW FAR THE SUBMITTERS ARE FROM THE INCLUSION IN THE SYSTEM?

Author(s)

Araújo GTB*1;Decimoni TC1;Etto H1;Sansone D1;Santos AM1, Fonseca M2 1Axia.Bio Consulting, São Paulo, Brazil, 2Federal University of São Paulo / Axia.Bio Consulting, São Paulo, Brazil

OBJECTIVES: In 2012 CONITEC (Brazilian National Commission of HTA) rules, information checklist and timelines, were officially established for medicines, procedures and devices. One year after the start of this new process, 132 processes were submitted to the commission. The objective of this research is to present a quantitative and qualitative analysis of this process. METHODS: Analysis of the CONITEC different reports until Dec 31 2012 in relation to the established public health care programs and the 2012-2015 Brazilian national health plan. RESULTS: Of the 132 submitted processes, 98 were analyzed until Dec 31 2012. 40 submissions were recused by non-conformity with the documentation checklist; 35 had a positive answer for inclusion in the public health care reimbursement system and of them 24 were submitted by the government itself, 10 by both the government and manufacturers and 1 by the manufacturer alone; 23 did not achieve a positive recommendation; 34 submissions are still under evaluation. Technologies that were incorporated have a public health care program. Inclusion occurred because the technology was considered to have enough clinical evidence, represent savings for the system or was considered effective and although not representing savings to the system the government considered it an investment in a strategic disease. The main reasons for not achieving a positive recommendation for inclusion were: insufficient clinical data, inadequate economic studies to the local scenario, negative evaluations from other commissions (NICE and Scottish medicines consortium, mainly) and inexistence of real world public data.  CONCLUSIONS: Considering these results, a well-established clinical data program, stakeholders mapping, understanding of the local needs and scenario, careful analysis of the implications for the system of the technology inclusion and a very well planed market access strategy are mandatory before submitting new health technology to the evaluation commission, which is the end process of a negotiation.  

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PHP54

Topic

Health Policy & Regulatory

Topic Subcategory

Health Disparities & Equity

Disease

Multiple Diseases

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