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Challenges in the Clinical Protocol and Therapeutic Guidelines (PCDT) Implementation for Congestive Heart Failure (CHF): Access to Sacubitril/Valsartana After Incorporation Into Brazilian Unified Health System


Assunção-Costa L1, da Silva Barbosa L2, Machado JFF2
1Federal University of Bahia, Salvador, BA, Brazil, 2Instituto Nacional de Assistência Farmacêutica e Farmacoeconomia, Salvador, Brazil

Problem Statement: It is estimated there are 26 million people in the world with CHF. In Brazil, the prevalence of CHF is approximately 2 million patients1,2. A new therapeutic class has been included in the American and European guidelines for the standard care of heart failure with reduced ejection fraction (HFrEF). The agencies of the United Kingdom (NICE), Canada (CADTH), Australia (PBAC), France (HAS) and Scotland (SMC) incorporated the drug into clinical protocols between 2015 and 20173,4,5,6. In 2019, sacubitril/valsartan was incorporated into the Brazilian Unified Health System (SUS) for symptomatic NYHA II class II CHF patients, with a left ventricular ejection fraction less than or equal to 35%, BNP (B-type natriuretic peptide) > 150, refractory to treatment with ACE inhibitors and/or ARBs and aged 75 years or less, according to PCDT3.

Description: In 2022, a panel of experts and managers from Health Departments from four Brazilian states was held to discuss the challenges and perspectives for access to sacubril/valsartan in the new PCDT.

Lessons Learned: The main barriers pointed out by the panelists were: 1) the protocol inclusion criteria limits access to a large portion of patients due to the requirement of the BNP exam, which has a reimbursement valued by the Ministry of Health (R$27.00) much lower than the market value (R$650.00); 2) the age limitation up to 75 years; 3) differences in patient access to health services in each Brazilian state; 4) delay in the process for purchasing the pharmaceutical product; 5) excessive document requirements to receive the product; and 6) lack of dissemination and knowledge about PCDT for SUS physicians.

Stakeholder perspective: Panelists pointed out the main challenge is to equate these barriers and Improvement of communication in the implementation of PCDT in a country of continental dimensions.