The Evolution of HTA in Emerging Markets Health-Care ... - TREE

OHE Consulting Report for PhRMA
5 January 2011
A1.5 Incorporation of New Drugs in the Brazilian Health Care
System
When a new drug comes to Brazil, it must be submitted to ANVISA for registration. ANVISA
evaluates the safety and efficacy of treatment based on Phase III trials, and decides whether or not
to approve the indication in Brazil. After approval, the label of the drug for the approved indication
is registered. There is not an official deadline for each evaluation, but it usually takes between 12 to
18 months.
After the registration of the drug, CMED, which is a branch of ANVISA, defines the price of the drug.
This price is based on the category of the drug. It is considered category 1 if it has a valid patent in
Brazil and brings gains to treatment (defined as higher efficacy, same efficacy with fewer adverse
events, or same efficacy and safety with lower costs), and then the approved price is the lowest
price from 9 reference countries. If the drug is considered as Category 2 (either without a valid
patent or without gains to treatment), the maximum price is the equivalent price of the treatment
already registered in Brazil that provides equivalent efficacy. For innovative products, after the
initial price is set via external reference pricing, it is adjusted subsequently by SUS/CMED for
inflation, affordability, etc.) ,
When the drug has an approved price and label in Brazil, it can be bought by patients out of pocket
or reimbursed by private payers if administered in ambulatory care or in hospitalized patients. Prices
of drugs are updated every year to account for inflation and the percentage of price update is
defined yearly by CMED.
For a new drug, considered as high-­‐cost, to be included in the Component of Specialized
Pharmaceutical Assistance, it must be submitted to CITEC for evaluation. CITEC gives guidance in
favour or against the inclusion and the Ministry of Health decides about the final incorporation. In
practice, a favourable guidance is mandatory for implementation. When it is positive, there is
effectively national availability of the new technology. When it is negative or when there is no
answer, the access to the technology is restricted. Importantly, the government does not publish the
rationale behind the recommendations given (for positive and negative guidance). Thus, it is difficult
to learn from the previous recommendations, and to understand government priorities.
Since 2005, there have been 222 submissions to CITEC:
44 technologies incorporated by the Ministry of Health
24 proposals for incorporation with a negative answer
1 proposal for exclusion of technology with a negative answer (not excluded)
technologies excluded from SUS reimbursement list
12 technologies for genetic diseases with treatment protocols under development.
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