Medicines regulation, pricing and reimbursement in Brazil

Abstract

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.

Pharmaceutical Pricing and Reimbursement Policies: lessons learnt and perspectives for Brazil

“…1 The editorial, eight country case studies, namely Austria, Brazil, Greece, Canada, Italy, United Kingdom (UK), Portugal and the United States (US) (Table 1) and a perspective article about the Pharmaceutical Pricing and Reimbursement Policies (PPRI) network were published by country experts, outlining pricing and reimbursement policies in the context of their respective health systems, considering the life cycle of medicines. [2][3][4][5][6][7][8][9][10] As such, this series and, in particular its country case studies, provided a contribution to the field of pharmaceutical systems research, which is a rather young discipline. The UK alignment of life-science strategy with pharmaceutical regulation, pricing and reimbursement, combined with one of the highest proportions of uptaking of generics in the national health system (NHS); the different uses of health technology assessment (HTA), as in Canada, Italy, Portugal and UK, combining HTA and other pricing strategies, such as external reference pricing; the pricing regulation of generics and biosimilars, as in Austria, are some of the successful experiences to be highlighted (Table 1).…”

“…17 There are many challenges and opportunities for improvement. 3,[18][19][20][21][22][23][24] Brazil has increased its pharmaceutical expenditure on the SUS over the years, it has the second higher share of pharmaceutical expenditure (18.2%, 2019) in relation to total health expenditure than most of the countries in the series, behind Greece (variation from 11% in the US to 30.2% in Greece, both from 2020), considering data from Pharmaceutical spending in the Organisation for the Economic and Cultural Development (OECD) of 2021 or the latest available data. 25 Nevertheless, its 87,7% out-of-pocket pharmaceutical expenditure stands out and is a call for action for strengthening access, when compared with the out-of-pocket share of countries like US (10%), Canada (27%) or UK (41%) (acknowledging possible limitations in comparability due to methodological particularities).…”

“…New high-priced medicines, usually combined with limited added therapeutic benefit, can represent a high opportunity cost, therefore the use of HTA is crucial. 3,23,26,27 Strengthening the use of generics and biosimilars is internationally recognised as key for promoting access and cost-containment, and also requires a life-cycle perspective. Over the twenty years of enacting of the generics law, its market share in Brazil reached 13.7% (nominal value), and 35% of the volume of the pharmaceutical revenue in 2019.…”

“…28 There are different policy approaches for regulating non-original biologics in the country, with pricing regulation under review. 3,29 Therefore, looking at successful experiences, such as UK, Austria, and Portugal, can help Brazil expanding the use of generics and non-original biologics, beyond price regulation, in line with the WHO recommendation classified as "strong" of "Promoting the use of quality-assured generic and biosimilar medicines" 2,7,8,13 For stimulating innovation, a shift of the pharmaceutical policies rationale in Brazil, especially price regulation is also needed, mostly conducted at the market entry, sometimes seen by the industry as a "gate keeper", towards a life-cycle perspective. Examples, such as the UK, of an intersectoral approach in the revision of the pharmaceutical policies, aligned with the life-science strategy, including an earlier engagement with the industry with possible pre-submission joint-scientific advice, bringing together and aligning regulatory, pricing and HTA authorities, can facilitate the integration and streamlining of HTA along the medicines life-cycle.…”

“…They can stimulate research, development and innovation with more robust evidence and better and more meaningful clinical outcomes, and contribute to converting data into evidence, for supporting evidence-based decision-making, with a 'big data' approach. 3,23,27 Several countries use a combination of HTA and external reference pricing or other policy options, as recommended by WHO. 13 When using external reference pricing, there is flexibility on the basket of countries of similar development status, with most of the them conducting price reviews on a regular basis, besides other circumstances, such as expiry of patents, the introduction of new therapeutic options and by request of the manufacturers, also within a life-cycle perspective (Table 1).…”