Brazil is an upper-middle-income country with a high human development index (HDI) of 0.765 (2019). The Unique Health System (SUS) is a universal, decentralised system, free at point-of-care, although 27% of Brazilians have voluntary supplementary health insurance. Medicines are provided free-of-charge through the SUS, though there are a few exceptions where co-payment is required. Around 87% of the country’s expenditure with medicines and medical devices corresponds to out-of-pocket, highlighting the importance of price regulation. Marketing authorisation and maximum price approval are mandatory market entry requirements for medicines. Pricing policies include maximum price approval, regulation of mark-ups, tax exemption, annual price adjustment and a mandatory discount for government procurement and enforcement mechanisms. The pricing of new drugs considers the patent status and added therapeutic benefit. It is a combination of health technology assessment and external or internal reference pricing, while drugs with active ingredients in the market follow internal reference pricing. The maximum price of generics must be up to 65% of the reference’s price. The maximum approved prices and public procurement prices are publicly available. Brazil has a value-based decision-making process for incorporating medicines and other technologies at the SUS. Current areas of work include horizon scanning, participation of patients in decision-making and re-assessment of technologies. As a decentralised system, medicines are procured by the Ministry of Health, states and municipalities, according to their level of responsibility. Pricing and reimbursement policies, including a consolidated generics policy, have been important in promoting transparency, predictability, and price stability, in turn contributing to cost-containment and access. Ongoing challenges include high rates of judicialisation, medicines with excessive prices not commensurate with their clinical benefits, no provision for pricing review, problems related to governance and politics. To address these challenges, the authors have three main recommendations. First: improving regulatory governance, second: incentivising the development and promoting access to medicines with stronger evidence, added clinical benefit and fair prices, and third: increasing awareness among stakeholders, avoiding judicialisation and minimising its impact; contributing to closing the gap between innovation and access to medicines.
The United States (US) is the largest economy in the world and the largest pharmaceutical market, accounting for 40% of the global expenditure on pharmaceuticals and almost half of the global pharmaceutical pipeline. This review describes prescription drug regulation, pricing and coverage in the US and provides perspectives for policy reform. With an unregulated market-based pricing system for drugs, the US pays on average 3 to 4 times higher prices for branded prescription drugs than other industrialized countries. Challenges posed by rising drug prices create affordability problems that threaten the American population’s health as well as the sustainability of the US healthcare system. The US stands out as the country with the highest health expenditure per capita, at about 17% of its gross domestic product, and with pharmaceuticals representing over 12% of the total health expenditure. Health coverage is strongly dependent on employmentbased private insurance, with government programs like Medicare and Medicaid providing coverage to older and poorer populations, respectively. Coverage for outpatient prescription drugs is included in most, if not all, private health insurance plans and government programs. Although some drug pricing policy reforms have been proposed in recent years, no major nationwide initiatives have been successful in the US thus far. High drug prices might not only impact the US care system’s efficiency, but can also have a ripple effect to other countries like Brazil that use the US for external reference pricing, even if those countries may have other price regulation mechanisms in place. This is particularly important for new therapies for which no other international prices may be available in the global market besides the one from the US. The growing budgetary pressures from rising drug prices underscore the need for US drug pricing reform and highlight the need for global pricing mechanisms that can help ensure early access to new technologies at fairer prices.
Portugal é um país europeu com elevado Índice de Desenvolvimento Humano (IDH) e um sistema de saúde com extensa cobertura. Alinhado com as recomendações da Organização Mundial da Saúde, Portugal pratica regulação de preços de medicamentos para garantir maior acesso mantendo a sustentabilidade financeira. Nesse ínterim, a avaliação de tecnologias em saúde é reconhecida como ferramenta fundamental para a tomada de decisão informada de financiamento. Em consonância com os desafios enfrentados por outros países nessa área nos últimos anos, as metodologias e critérios utilizados na avaliação de diferentes tecnologias de saúde tem sido colocados a prova. Esse artigo apresenta uma visão geral do sistema de saúde e do sistema de avaliação de tecnologias em Portugal quanto às políticas mais recentes adotadas também em regulação de preços, incluindo os mais recentes desafios que esta área tem confrontado.
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