Article type
Abstract
Background: Clinical Protocols and Therapeutic Guidelines (CPTG) are documents that regulate access to health technologies within the Brazilian National Health System (SUS). Issued by the Brazilian Ministry of Health (MoH) since 2000, these documents serve as guidelines and normative documents for non-neoplastic diseases. Since 2011, the National Committee for Health Technology Incorporation (Conitec) has advised the MoH on the incorporation or disinvestment of health technologies and in the development and updating of CPTG. Currently, there are 121 published documents.
Objectives: To map the diseases for which drugs are available in Brazil but lack corresponding CPTG published by the MoH.
Methods: A list of drugs approved in Brazil between 2010 and 2020 was compiled, including new drugs, biologicals, and advanced therapy medicinal products, and excluding oncology drugs. Regulatory registration data and indications were gathered from the Brazilian Health Regulatory Agency (Anvisa) website. For each drug, all indications listed on the label were extracted. Subsequently, it was identified corresponding published CPTG by the MoH for each identified disease. Additionally, it was mapped whether the drugs were assessed by Conitec.
Results: During the period, Anvisa approved 141 drugs, covering 115 distinct indications and forming 206 pairs of drug-indication. Sixty-five (56.5% of 115 diseases) had corresponding CPTG available. For 50 indications (43.5%), no health guidance was found, indicating an unmet need for these diseases within the SUS. Notably, for 41 diseases (82% of the 50 diseases without CPTG), Conitec has not conducted a technology appraisal for any selected drugs.
Conclusion: Conitec represents progress in the health technology assessment (HTA) in Brazil. However, many health conditions with medicines authorized for sale have not been assessed yet, and the lack of protocols and guidelines is evident. Brazil also lacks transparent prioritization for HTA. Monitoring technologies entering the country to prioritize Conitec assessments could improve the scenario. A comprehensive examination is required to explore the extent of the unmet needs for conditions without health guidance currently, as state and local levels have autonomy to supplement national policies.
Objectives: To map the diseases for which drugs are available in Brazil but lack corresponding CPTG published by the MoH.
Methods: A list of drugs approved in Brazil between 2010 and 2020 was compiled, including new drugs, biologicals, and advanced therapy medicinal products, and excluding oncology drugs. Regulatory registration data and indications were gathered from the Brazilian Health Regulatory Agency (Anvisa) website. For each drug, all indications listed on the label were extracted. Subsequently, it was identified corresponding published CPTG by the MoH for each identified disease. Additionally, it was mapped whether the drugs were assessed by Conitec.
Results: During the period, Anvisa approved 141 drugs, covering 115 distinct indications and forming 206 pairs of drug-indication. Sixty-five (56.5% of 115 diseases) had corresponding CPTG available. For 50 indications (43.5%), no health guidance was found, indicating an unmet need for these diseases within the SUS. Notably, for 41 diseases (82% of the 50 diseases without CPTG), Conitec has not conducted a technology appraisal for any selected drugs.
Conclusion: Conitec represents progress in the health technology assessment (HTA) in Brazil. However, many health conditions with medicines authorized for sale have not been assessed yet, and the lack of protocols and guidelines is evident. Brazil also lacks transparent prioritization for HTA. Monitoring technologies entering the country to prioritize Conitec assessments could improve the scenario. A comprehensive examination is required to explore the extent of the unmet needs for conditions without health guidance currently, as state and local levels have autonomy to supplement national policies.