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

OHE Consulting Report for PhRMA
5 January 2011
proposals considered out of the scope of CITEC
In total, there are 89 results (40%) from submissions with a result. There remain 133 technologies
for evaluation.
Also, at CITEC, there are 74 studies under development supported by the Ministry of Health.
Twenty-­‐four chemotherapeutic agents are under evaluation. Currently, SUS pays a different
diagnosis-­‐related group (DRG) payment for each type of cancer but not the drugs separately. Eighty-­six
therapeutic protocols are under review: 53 for update and 33 being developed. Fifteen
academic institutions are involved in the studies.
Manufacturers may request directly for the MS to evaluate their technologies, but unlike NICE, they
cannot participate or give opinions to the process of analysis. There are public consultations about
some points of the Policy for Management of Health Technologies and about the clinical protocols
and therapeutic guidelines, when manufacturers can give their opinion, as well as any other
institution or individual.
In practice, most of the time, manufacturers define which new technologies should be evaluated by
the government since the government has not clearly defined its priorities and what will or will not
be evaluated. However, public bodies, medical associations and patient groups may also request for
the evaluation of new technologies.
New technologies not considered as high-­‐cost may also be incorporated by states or municipalities
in their own Lists of Essential Medicines. Besides pharmaceutical assistance, new procedures and
exams may be also incorporated in the medium and high complexity program for ambulatory and
inpatient care. These processes do not go through CITEC for evaluation.
In summary, the health technology assessment of medicines in Brazil is a complex process. First,
marketing authorization of new drugs is tied to pricing, carried out by two separate units in ANVISA.
After the first unit establishes that drug has sufficient efficacy, safety, and production quality, the
pricing unit (CMED) assesses the innovative status of the drug. This assessment will normally include
a submission of evidence from the manufacturer. If the new drug is deemed to be innovative
(Category 1), then the price will be established based on international reference pricing.
If the drug is similar to other drugs (Category 2), then price will be based on internal reference
pricing, relying on the prices of those similar drugs in Brazil. This marketing authorization puts the
drug in the marketplace at that price, and there are no guarantees that private insurance
(Supplementary Healthcare) will cover these drugs...
The drug will not necessarily be covered in the public system (SUS) until the drug’s clinical impact,
cost-­‐effectiveness, and budget impact are reviewed by CITEC.
In the private system, the process is further complicated by different treatment of intravenous and
non-­‐intravenous drugs. The private insurance system is required to cover intravenous drugs, but
important oral oncology drugs can be excluded.
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