Unlocking the Key to Public Funding in Brazil - Pharmaceutical Executive


Unlocking the Key to Public Funding in Brazil

Pharmaceutical Executive

A promising start...with some surprises

Figure 1: Clinical factors driving CONITEC decisions. Sum does not need to add up to 100 percent. Multiple factors per appraisal possible. Selection of most frequent factors shown.
Since its establishment in March 2012 through the end of February, CONITEC issued an impressive 32 appraisals, assessing 48 health technologies (85 percent of them drugs) for 26 therapeutic indications. This is almost twice the number of technologies the former HTA commission CITEC evaluated on average each year. Furthermore, 71 percent of the evaluated technologies received a positive funding recommendation from CONITEC. In comparison, the approval rate for the old CITEC commission was 55 percent.

Figure 2: Economic factors driving CONITEC decisions. Sum does not need to add up to 100 percent. Multiple factors per appraisal possible. Selection of most frequent factors shown.
The primary focus of the CONITEC evaluation is on efficacy and safety data, cost-effectiveness studies, and budget impact analysis. Nevertheless, there have been a few surprises, such as evaluation of net prices in countries not included in the official referencing basket set by the federal pricing chamber CMED, including the United Kingdom and Turkey.

Figure 3: CONITEC HTA decisions versus NICE.
CONITEC is open to recommend innovative technologies, supported by the fact that 59 percent of the drugs with a positive appraisal are still on-patent. Significantly, however, all innovative treatments obtaining a positive recommendation target have relatively small patient populations. There are tough trade-offs involved here, because on a per capita level, public payers in Brazil have smaller budgets than government payers in mature markets. The government prioritizes spending on high-cost drugs for severe diseases, which most patients cannot afford to buy, while devoting most resources to generic retail drugs. This has not changed with CONITEC, which did not make a positive recommendation for a single branded retail drug. Branded retail drugs are mostly priced at significant premium to alternatives purchased by the government and are largely paid out of pocket by patients from the upper class and the growing middle class.

More efficacy, please

CONITEC typically considers clinical factors first, so positive coverage decisions are usually driven by a strong therapeutic improvement relative to publically available health technologies and a high perceived unmet need in the indication. Technologies that meet these two criteria represent 76 percent and 57 percent of the positive decisions, respectively. Additionally, the stated priority level of the indication within public healthcare policies supported 24 percent of the inclusions.

Snapshot: How Boceprevir and Telaprevir Obtained a Positive Recommendation
CONITEC prioritizes technologies that clearly demonstrate large efficacy improvements. For example, boceprevir and telaprevir proved this in the context of the high unmet need of the hepatitis C patient population. Despite their potentially large budget impact, both drugs secured a positive funding recommendation less than a year after their launch.

Lack of efficacy was the determining factor for 45 percent of the negative appraisals. For example, CONITEC argued that the clinical studies of biologic treatments for psoriasis did not clearly define the target patient population, lacked an active clinical comparator, and only evaluated short-term efficacy outcomes.

However, sources in the Ministry of Health stated that CONITEC may also cover technologies with similar efficacy in indications where there is already public funding in order to broaden the physicians' treatment arsenal and to stimulate price competition. This could have motivated the extensive coverage of biologics for rheumatoid arthritis.

Technologies considered to have insufficient safety represented 55 percent of the funding denials. For example, certolizumab pegol in Crohn's disease was evaluated as lacking data on long-term safety, despite having been approved by ANVISA for use in the Brazilian market.

In total, CONITEC concluded that 73 percent of the technologies which received a negative funding recommendation failed to show sufficient clinical evidence to back up their efficacy claims and safety benefits. Studies considered "too short" represented 36 percent of the negative appraisals; those with an insufficient sample size and a lack of Phase III /IV studies represented 20 percent of the denials, respectively.


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