HTA Decision Analysis Framework
Trench Rossi e Watanabe / Brazil
Join industry executives in staying informed on the market access and HTA process in Brazil.
1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?
In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies into the SUS, based on evidence of efficacy, safety and cost-benefits in relation to already existing technologies.
However, ANVISA and CMED also act as HTA assessment bodies: the first evaluating the efficacy and safety during the process for granting the drug market authorization, and the second also evaluating evidence of efficacy and comparing treatment costs and international market to set the price of a drug.
ANS is also an HTA assessment body, evaluating the mandatory coverage aspects.
2. Do regulators require HTA studies in your country?
Yes. For incorporation purposes, as mentioned in item V.1 above.
3. Do payers require HTA studies in your country?
As a rule, the entities that compose SUS only pay for technologies that have undergone HTA assessment by Conitec and that have been incorporated into the public health system.
Private institutions and health insurances companies have the autonomy to purchase technologies not incorporated into SUS. However, the health technology must have been approved by ANVISA (since this is a legal requirement for marketing in Brazil).
4. How are HTA assessments translated into pricing conditions in your country?
HTA is conducted after pricing is defined by CMED.
5. How are HTA assessments translated into reimbursement conditions in your country?
Only health technologies that have undergone HTA evaluation by Conitec will be eligible for reimbursement since they must be incorporated into SUS — besides be covered by health insurances, which is an analysis and implementation conducted by ANS.
6. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?
The evaluation criteria applied in HTS are efficacy, effectiveness, safety, risks, costs, cost-effectiveness, cost-benefit and cost-utility, equity, ethics, economic and environmental implications.
7. What is the methodology used in your country for HTA assessment?
There are four methodologies: Cost-Benefit, Cost-Minimization, Cost-Effectiveness and Cost-Utility. The most used approaches currently in the health sector are the last two. Cost-effectiveness analysis is a way of evaluating complete economic analysis in which both costs and consequences (outcomes) of health programs or treatments are examined. The result is expressed, for example, in cost per year of life gained. Cost-utility analysis is focused on the quality of the health outcome produced or avoided and introduces the QALY concept – quality-adjusted life years.
8. Which are the other decisions impacted by the assessed outcome in your country?
Drugs included in the public health system after HTA assessment and recommendation by Conitec are compulsorily added to the ANS list, which establishes the mandatory treatments for private health insurances, due to Law 14.307/2022.
9. Does your HTA review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?
Conitec requires that the assessment application be followed by international studies/articles on the technology to be evaluated.
