Tamachiro Susanna Tawata, Gonçalves Fabio Augusto Rodrigues, Simone Adriane Lopes Medeiros, Aguiar Patricia Melo
Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brasil.
Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brasil.
Cad Saude Publica. 2022 Jul 25;38(7):e00233321. doi: 10.1590/0102-311XPT233321. eCollection 2022.
The objective is to analyze the contribution of the pharmaceutical industry to the sustainability of the Brazilian Unified National Health System (SUS), based on the pressure for the incorporation of medicines. For this purpose, a descriptive study was conducted on requests for the incorporation of medicines sent to Commission for Incorporation of Technologies in the SUS (CONITEC) from 2012 to 2020. Characteristics such as technology indication, economic evaluation, financing component, public consultation, and CONITEC decision were analyzed. The results were compared according to the type of solicitor using statistical tests. 514 requests were analyzed, of which 438 related to incorporation. The pharmaceutical industry accounted for 37% of the requests and 33.5% of the incorporations. Differences were observed between the solicitors regarding the type of economic evaluation and incremental cost-utility ratio value, with half of the industry's demands above the threshold of 3 PIB per capita/QALY. The pharmaceutical industry obtained more contributions in public consultations of its requests and presented concentration of requests for antineoplastic and immunomodulatory agents and for anti-infectious, especially for hepatitis C and HIV. There was also a lower number of demands from the pharmaceutical industry in the Basic and Strategic Components of Pharmaceutical Assistance. Our findings point to the tension between the significant participation of the industry as an applicant, the high mobilization of public consultations, the emphasis on Specialized Component drugs, and CONITEC's resistance to this pressure, with a tendency of greater refusal and greater participation of other solicitors in requests for expansion of use, exclusion, and incorporation of drugs that are less requested by the pharmaceutical industry.
目的是基于药品纳入的压力，分析制药行业对巴西统一国家卫生系统（SUS）可持续性的贡献。为此，对2012年至2020年发送至SUS技术纳入委员会（CONITEC）的药品纳入申请进行了描述性研究。分析了技术适应症、经济评估、融资组成部分、公众咨询和CONITEC决定等特征。使用统计测试根据申请方类型对结果进行了比较。共分析了514份申请，其中438份与纳入有关。制药行业占申请的37%，占纳入的33.5%。在经济评估类型和增量成本效用比值方面，申请方之间存在差异，该行业一半的需求高于人均3倍国内生产总值/质量调整生命年的阈值。制药行业在其申请的公众咨询中获得了更多支持，且申请集中在抗肿瘤和免疫调节药物以及抗感染药物，尤其是丙型肝炎和艾滋病毒药物。在药品援助的基本和战略组成部分中，制药行业的需求也较少。我们的研究结果表明，作为申请方，该行业的大量参与、公众咨询的高度动员、对专科组成部分药物的重视以及CONITEC对这种压力的抵制之间存在紧张关系，其他申请方在扩大药物使用、排除和纳入制药行业较少申请的药物方面有更大的拒绝倾向和更大的参与度。
