Market Access Overview
Brazil follows a decentralised healthcare system. Medicines must have a MA (Marketing Authorisation) from the ANVISA – Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency) before they can be marketed in Brazil. Drug prices are set during the marketing authorisation process through negotiations with the CMED – Câmara de Regulação do Mercado de Medicamentos (Pharmaceutical Market Regulation Council). Once a maximum price has been approved, treatments can be sold in the private sector. However, in order to be listed on the SUS – Sistema Único de Saúde (National Health System) for public reimbursement, drugs must be approved for use by the MoH (Ministry of Health), aided by an HTA (Health Technology Assessment) review from CONITEC – Comissão Nacional de Incorporação de Tecnologias (National Committee for Incorporation of Technologies), which makes recommendations on the incorporation, alteration, or exclusion of health technologies in the RENAME – Relação Nacional de Medicamentos Essenciais (National Medicines List) and the RENASES – Relação Nacional de Ações e Serviços de Saúde (National List of Health Actions and Services).
MAP provides insights on:
- Decision Makers – ANVISA processes
- Product Licensing – imposed deadlines on ANVISA
- Pricing – Drug classification, high price acceptability, constraints by local comparators, lowest IRP enforce, category I drugs, CMED’s price decisions, obtaining price through lawsuits
- Reimbursement – CONITEC non-recommendation