Funding attached with a string
The suggestion that CONITEC is more even handed than might be assumed must be balanced by evidence that pricing for positive
recommendations is may be much lower than in most mature market countries. For high-cost drugs with a positive recommendation,
CONITEC often recommends funding subject to usage restrictions, including observational studies. CONITEC may also demand economic
concessions in exchange for recommending the funding of high-cost drugs, such as discounts of up to 50 percent below the maximum
ex-manufacturer price set by CMED.
Final government prices may therefore reach levels lower than in developed markets. Compared to international prices, the
government prices demanded by CONITEC for two recently approved high-cost drugs are, respectively, 50 percent and 42 percent
lower than in Italy, which already has one of the lowest ex-manufacturer prices in the European Union. However, it can be
said that there is less worry about the spillover impact of low net prices on other markets. Prices in Brazil do not affect
mature markets. Smaller markets such as Colombia or Saudi Arabia may reference Brazil, but do not reference net prices.
In any case, demands for low prices from CONITEC may still leave some room for negotiation. The government purchasing contract
for one of aforementioned drugs in 2013 features a net price which is almost 30 percent higher than the price demanded by
Seven steps to success
CONITEC should not arbitrarily be seen as a barrier to public funding in Brazil—the number of new technologies funded has
never been higher. CONITEC can be an ally to obtain public funding, if manufacturers are prepared to do the following:
» Dedicate sufficient resources to evaluate opportunities in different market segments. Before even planning to apply for public funding, manufacturers must find out whether this is likely and desirable for the
targeted indication. CONITEC is much more likely to recommend specialized care drugs in smaller patient population with high
unmet need than retail drugs for blockbuster indications. The Brazilian marketplace is complex, with great differences between
therapeutic areas and many relevant stakeholders. Therefore, every single drug to be launched merits an individual assessment
» Provide scientifically sound evidence on added value in terms of efficacy or safety. CONITEC prefers direct comparisons against an active comparator used in the public healthcare system. Trial length needs to
consider the natural course of the disease. The sample size needs to be representative of targeted patient population.
» Target a well-defined patient population. Even if a drug shows significant benefit and is cost effective, the government has more limited resources per capita versus
mature markets. Targeting a well-defined patient population from the outset and identifying potential subgroups that benefit
more from the treatment will address budget impact concerns and increase the likelihood of a positive recommendation.
» Present solid budget impact studies adapted to the reality of the Brazilian public healthcare system. Showing cost effectiveness is useful, but presenting a budget impact model detailing all costs incurred by the technology
in the public healthcare system is most important.
» Identify and engage with key stakeholders in the Ministry of Health. An HTA requested by stakeholders related to the government is much more likely to receive a positive recommendation versus
an HTA requested by a manufacturer.
» Be flexible and explore opportunities for win-win solutions. Given the limited government budget, be prepared to make concessions—but also ask for a quid pro quo. Low net prices versus
mature markets or technology transfer agreements can be accepted in exchange for locking in high volumes or preferential access.
Don't worry about implications of low net prices in other markets.
» Prepare a realistic implementation plan to overcome treatment access and patient monitoring hurdles in the public system.
Even if there is funding for a new drug, there is unequal access to quality healthcare including crucial elements such as
diagnostic devices and access to specialist physicians, which ultimately limits access to the drug.
Ken Genenz is based in Madrid and leads Simon-Kucher & Partners Latin America Life Science practice. He can be reached at email@example.com
. Andrea Dominguez is a Senior Consultant, Rafael Alencar is a Consultant, both within Simon-Kucher & Partners' Brazil Life Sciences team. They can be reached at firstname.lastname@example.org
. Beatris Januário was an Associate Consultant for Simon-Kucher & Partners and is currently finalizing a degree in Business Administration at
the Instituto de Empresa in Madrid.