Best bang for the buck
Although CONITEC has not mentioned high budget impact as an explicit reason for a negative appraisal, low budget impact played
a role in 33 percent of positive appraisals, such as clobetasol for the treatment of psoriasis. Furthermore, 27 percent of
applications were denied because budget impact calculations did not include the perspective of the public healthcare system.
Solid cost-effectiveness studies versus technologies already covered by the public system are a mandatory component of an
application for an appraisal. In 62 percent of the positive coverage decisions, this was considered a decisive factor for
a positive appraisal; examples include lanreotide acetate, palivizumab, and vaccines for MMRV (measles, mumps, rubella, varicella)
and hepatitis A. Important is that CONITEC prefers cost-effectiveness studies based on incremental cost per life year or per
avoided event, not incremental cost per QALY.
Clear evidence on future cost reductions benefiting the public healthcare system, achieved for example through a reduction
in hospitalizations, were considered in 24 percent of appraisals.
CONITEC advisors emphasize that while cost effectiveness is important, budget impact is even more important given the fiscal
restraints. Budget impact should be assessed by a pharmacoeconomic model detailing all costs associated to the technology
in the Brazilian public healthcare system.
To that end, gaining support from key stakeholders within the Ministry of Health to advocate for the funding of a new drug
significantly increases the likelihood of a positive appraisal. None of the appraisals requested by the Ministry of Health
were rejected, while almost all the rejected appraisals are from pharmaceutical companies.
Calling card of choice: technology transfer
Another pathway to obtain Ministry support is through technology transfers agreements. The Brazilian government is keen on
these deals to encourage domestic development and production of pharmaceuticals. In these agreements, know how on production
is transferred from the original manufacturer to domestic manufacturers supported by the government. The original manufacturers
are rewarded by preferential access (e.g., by waiving the requirement to conduct tenders or price volume agreements with more
favorable conditions for the manufacturer).
So far 64 technology transfer agreements have been signed. Drug with technology transfers represent 32 percent of the positive
appraisals from CONITEC, such as rituximab and the vaccines for MMRV and hepatitis A.
A fine point is that this is still a learning process for industry in Brazil. Forty three HTA requests were denied prior to
assessment by CONITEC due to non-compliance with the required documentation.
A tropical NICE?
Even though CONITEC has similar functions to that premier HTA body, the United Kingdom's National Institute for Health and
Clinical Excellence (NICE), in advising the government on funding decisions and the development of treatment guidelines, the
decision criteria used by the two institutions differ. Cost-effectiveness is only one of several criteria considered for CONITEC
recommendations, and there is no official incremental cost-effectiveness ratio threshold.
Positive NICE appraisals don't necessarily guarantee a recommendation from CONITEC. The Brazilian HTA body denied funding
for technologies that had received positive appraisals from NICE in 35 percent of cases, including biologic treatments for
psoriasis. For those reports where CONITEC reached a different conclusion than NICE, both HTA bodies criticized similar aspects
of the data presented such as inadequate data or the lack of an active comparator.