PD33 Incorporation Of New Medicines In Brazil: A Descriptive Analysis

Abstract

Introduction:

Health Technology Assessment (HTA) is important to the rational decision in healthcare systems. In Brazil, HTA is carried out by the national commission for the incorporation of technologies in the public system (Conitec), which issues reports with recommendations. This work aims to describe these recommendations and the factors influencing them.

Methods:

A descriptive analysis was conducted on Conitec's reports of incorporation of medicines between 2012 and 2016. The medicines were classified according to the Anatomical Therapeutic Chemical system (ATC).

Results:

One hundred and twenty-eight reports were assessed. Most requests were issued by the pharmaceutical industry (n=72; 47 percent), followed by the Ministry of Health (n=63; 41 percent). More reports issued by the Ministry of Health had positive recommendations compared to manufacturers (n=22 vs. n=50; χ2=30.231, df=1, p<0.001). Other antivirals were the most common class with requisitions (n=16), followed by TNF-α inhibitors (n=14) and selective immunosuppressants (n=12). Other antivirals had the most positive recommendations (n=12; 75 percent), followed by TNF-α inhibitors (n=7; 50 percent) and selective immunosuppressants (n=7; 58 percent). The difference was significant (χ2=88.65, df=63, p=0.02). TNF-α inhibitors was the class with the most negative recommendations (n=7; 50 percent), followed by monoclonal antibodies (n=6; 67 percent). Sixty-two reports contained economic assessments. Fifty-four presented incremental cost-effectiveness ratio (ICER) data and 57 presented the budget impact. Twenty-three reports showed data indicating dominance of the medicine, but only five of these were recommended for incorporation. Drugs for cancer have been recommended despite high ICER values. Decision makers accepted all the recommendations issued by Conitec.

Conclusions:

Data suggest that the economic evaluation is secondary to the decision of incorporation. The pharmaceutical industry is the largest applicant for the incorporation of medicines, but these requests are significantly less accepted than those made by the Ministry of Health. Conitec's recommendations are well-accepted by policy-makers. It was not possible to determine an implicit cost-effectiveness threshold.