Brazil, the world's sixth largest pharmaceutical market, has joined the ranks of countries requiring a formal and transparent
assessment of a drug's cost-effectiveness, budgetary impact, and medical need to gain access to the public sector. The action
has wide-ranging effects: Brazil has a reputation as an innovator in global health policy, so it often serves as a precedent
for reform in other countries. It also carries important implications for commercial success in the domestic drug market,
which is growing at double digit annual rates. Public spending on health accounts for a significant share—46 percent—of total
health spending. Hence, lack of access to this market not only limits the growth potential for foreign drug makers, it is
poor public relations, because the majority of the population relies on the public system for healthcare.
Over the past few years, the government has made a significant effort to improve limited and unequal access to drugs through
expanded federal financing. The Ministry of Health recently announced plans to spend $17 billion on drugs between 2013 and
2016. Significantly, 40 percent of current federal spending on drugs is on innovative biologics. This not a race-to-the-bottom
pool comprised exclusively of cheap generics. For this reason alone, the actions of the government on this new strategic approach
to health technology assessment (HTA) should be followed closely in the industry c suite.
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Expanded agency review powers
The Comissão Nacional de Incorporação de Tecnologias (National Commission of Incorporation of Technologies—CONITEC) was established
in March 2012. All new technologies now require a positive recommendation from CONITEC for funding in the Brazilian public
healthcare system. The new HTA process is significantly more transparent than that of the former HTA body, CITEC, since it
is regulated by a federal law that requires assessments of technologies to be publicly disclosed.
An appraisal by CONITEC can be requested by the government, the manufacturer, or any other stakeholder after a drug receives
market authorization from ANVISA, the Brazilian equivalent of the FDA, and has its maximum price set by CMED, the federal
drug pricing body.
CONITEC has set a goal of conducting appraisals within 180 days of the request—and by and large it is meeting that target.
CONITEC publishes all its appraisals and has opened a public consultation process online, allowing for feedback from patients,
manufacturers, physician associations, and academia. Once there is a positive decision by CONITEC, the technology needs to
be made available in the public sector within 180 days. This is a substantial improvement over the previous approach, where
appraisals were not publicly disclosed, there were no clear timelines for review and no timelines for making a drug available
after a positive recommendation.