HTA in Brazil: A Moving Target

Published Jan 27, 2022

Stephen Stefani, UNIMED Central RS, Porto Alegre, Brazil, ISPOR Brazil Chapter and Juliana Busch, Capesesp, Rio de Janeiro, Brazil, ISPOR Brazil Chapter

Brazil is the largest country in Latin America, with a population of approximately 216 million inhabitants and a per capita gross domestic product (GDP) of USD 15,600, according to 2017 data. Since 1988, the Constitution established that all Brazilian citizens have the right to comprehensive health care through Sistema Único de Saúde (SUS), which is unique in the continent. A complimentary system, private healthcare, exists for those who can pay. The country spends $1,318 USD per capita in healthcare, a little over 8% of its GDP, which is close to the regional average. However, SUS and private systems have sizable inequity gaps where 80% of the population rely exclusively on SUS and spend less than half of the total healthcare budget.

The Brazilian Health Regulatory Agency (ANVISA) oversees the country’s registration of health technologies. The incorporation of new technologies is subject to the approval of different agencies in the public and private systems. In SUS, the National Committee for Technology Incorporation (CONITEC) is the governmental agency responsible for assisting the Ministry of Health in incorporating or excluding health technologies. 

In the private system, all patients have access to the procedures included in a list (“rol”) published and revised by the Supplementary National Healthcare Agency (ANS). A multi-stakeholder committee (COSAÚDE) evaluates and advises the private system regarding incorporating new technologies, but this evaluation is subject to further approval processes by ANS. The list of procedures is applied to private health care plans for the so-called “new plans” (private health care plans marketed from 01/02/1999), and “old plans “adapted” (plans acquired before 01/02/1999, but which were adjusted to the legal regulations, according to art. 35, of Law No. 9,656, of 1998), respecting, in all cases, the segmentation services contracted. Insurance companies can extend their coverage beyond the procedures mentioned in the list, but it can affect annual premiums. It is under discussion by the Supreme Court whether this list, regulated in Normative Resolutions No. 428/2017 and 470/2021 of the ANS, has a restrictive or exemplary objective. Another recent debate was the obligation to include obligatory coverage to new oral chemotherapy to use at home immediately after ANVISA approval, without any analysis from ANS. The law project suggests that the drugs should be provided within 48 hours of the medical prescription. The law was approved by the Chamber of Deputy and Senate, but it was rejected by the Presidency, due to the lack of details regarding funding source, among other technical reasons.

There is no doubt that slow and incomplete evaluation models must be improved, but when a debate should open up on the pricing of drugs versus clinically relevant outcomes, it is still based on fast incorporation without clear strategy to implementation. Recently, the time to update the list for the private system was changed from 2 years to 6 months. We still have uncertainties about how the health system will respond to these new demands

Furthermore, efforts only translate into success if we move forward in transparency. This will inevitably bring scientific advancement closer to clinical care and require us to fundamental data ownership, privacy, fairness, and social responsibility. Brazil has a long and strong tradition in health systems. It is important to remember that the entire debate about accelerating HTA processes does not mention the public system. Debates and strategies on reducing the inequity between public and private healthcare systems continue to be timid and do not seem on any agenda shortly. The COVID19 pandemic increased the discussions about the problems in the health system, especially the public system. Although the pandemic punishes the country, it also demonstrates that health is not a cost but an investment in social, political and economic stability.

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