Pharmaceutical policies for gaining access to high-priced medicines: a comparative analysis between England and Brazil

Vicente, Geison; Calnan, Michael; Rech, Norberto; Leite, Silvana

doi:10.1590/0103-1104202213422

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REVIEW • Saúde debate 46 (134) • Jul-Sep 2022 • https://doi.org/10.1590/0103-1104202213422 copy

Pharmaceutical policies for gaining access to high-priced medicines: a comparative analysis between England and Brazil

Políticas farmacêuticas para acesso a medicamentos de alto preço: uma análise comparativa entre Inglaterra e Brasil

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Although the National Health Service (NHS) and the Unified Health System (SUS) are systems with similar universal principles, they can show different political measure patterns in the pharmaceutical field. This paper aimed to provide a comparative analysis of pharmaceutical policies highlighting strategies to guarantee access and sustainability to High-Price Medicines (HPMs) in Brazil and England. We performed an integrative literature review in electronic databases, supplemented by grey literature searched on governmental platforms (laws, decrees, ordinances, and resolutions). A total of Forty-seven articles and seven policies were selected and categorized for analysis. The results showed that both countries apply distinct policies to ensure access to HPMs, among them, policies to define price and reimbursement and actions to regulate the use inside the system. Also, these countries apply distinct policies to their sustainability as local partnerships for product development in Brazil and confidential managed agreements with multinational industries in the England. In conclusion, despite similarities in principles, these countries have been proposing and applying distinct pharmaceutical policies to maintain access and ensure the sustainability of their health systems.

KEYWORDS
Health policy; Technology; High-Cost; Public health

No.	Inclusion criteria
1.	2009 - 2019
2.	Brazil and England
3.	a. Scientific reports and b. Grey literature
4.	English, Portuguese, and Spanish
5.	Describing issues related to legislations, regulations, policies or mechanism to access, usage or mechanism to sustain the access to expensive medicines such as reimbursement, payment, management in the system and policy makers’ aim
	Exclusion criteria
1.	Not describing any specific health legislations, regulations, policies or mechanism to access/sustainability related to expensive medicines in Brazil and England

Database and keywords
Embase: (“health care policy”:ti,ab,kw OR policy:ti,ab,kw) AND england:ti,ab,kw OR brazil:ti,ab,kw) AND medicine:ti,ab,kw OR drugs:ti,ab,kw OR pharmaceuticals:ti,ab,kw) AND access:ti,ab,kw OR accessibility:ti,ab,kw) AND reimbursement:ti,ab,kw AND pricing:ti,ab,kw AND funding:ti,ab,kw AND [2008-2018]/py
PubMed: ("High-cost" medicine^/drug^ OR "High-price" medicine^/drug^ OR "High-priced" medicine^/drug^ OR Expensive medicine^/drug^ OR Premium price medicine^/drug^ AND England [MeSH Terms] OR Brazil [MeSH Terms]) AND 'health care policy' AND 'management'
Scopus: ("High cost" medicine^/drug^) OR ("High price" medicine^/drug^) OR ("High priced" medicine^/drug^) OR (Expensive medicine^/drug^) AND ("England") OR ("Brazil") AND ("Policy^") OR ("Health Policy^")
LILACS: Policy OR Health Policy OR Política de saúde OR Políticas de saúde OR Política nacional de saúde OR Políticas nacionais de saúde OR Política de salud OR Políticas de salud OR Política nacional de salud OR Políticas nacionales de salud AND medicamento^* OR medicine^* AND custo OR preço OR precio OR costo OR precio AND Brazil OR Brasil OR England OR Inglaterra
Web of Science: ("High cost" medicine^/drug^) OR ("High price" medicine^/drug^) OR ("High priced" medicine^/drug^) AND ("England") OR ("Brazil") AND ("Policy^") OR ("Health Policy^")
SciELO: Policy OR Health Policy OR Política de saúde OR Políticas de saúde OR Política nacional de saúde OR Políticas nacionais de saúde OR Política de salud OR Políticas de salud OR Política nacional de salud OR Políticas nacionales de salud AND medicamento^* OR medicine^* AND custo OR preço OR precio OR costo OR precio
Documentary sources - grey literature
Public Health platforms Brazil: https://www.gov.br/saude/pt-br; England: https://www.gov.uk/government/organisations/public-health-england
Executive and Legislative platforms: Brazil: https://legislacao.presidencia.gov.br/; https://www.camara.leg.br/; England: https://www.parliament.uk/site-information/glossary/government/; https://eacea.ec.europa.eu/national-policies/eurydice/content/main-executive-and-legislative-bodies-93_en

Category	Definition	Categories example
Pre-launch	Includes policies to anticipate budget impact in the health system due to new medicines development (preclinical phase)	Horizon scanning activities
Peri-launch	Includes policies to manage the entry of new medicines in the market reflecting their clinical and therapeutic value for the system or the society	Prices regulatory setting
Peri-launch		Reimbursement or financing methods
Post-launch	Includes policy measures required to ensure access to and use of medicines in the health system	Guidelines and formularies for treatment management and cooperation agreements

Policies	Strategies	Definition	Brazil	England
3.2 Pre-launch	3.2.1 Horizon Scanning Activities^15-18	Activity-making to identify new emerging health technologies with potential use to predict possible impacts on the health system	Yes	Yes
3.3 Peri-launch	3.3.1 Profit limitation^{¹⁹19 England. Department of Health & Social Care. The 2019 Voluntary Scheme for Branded Medicines Pricing and Access. [access in 2019 Dec 10]. Available in: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761834/voluntary-scheme-for-branded-medicines-pricing-and-access-chapters-and-glossary.pdf. https://assets.publishing.service.gov.uk...}	Rate-of-return regulation for companies and an overall limit spending on branded medicines over the lifetime of the agreement	No current activities	Yes
	3.3.2 External price referencing^20-22	Practice of using the price(s) of a medicine in several countries in order to derive a benchmark to set or negotiate the price of a medicine in a given country	Yes	No current activities
	3.3.3 Health technology assessment ^14,23-28	A tool employed to assess the use of new medicines to consider the safety, efficacy, effectiveness, organizational variables, economic implications, the social consequences, and the legal and ethical aspects	Yes	Yes
	3.3.4 Pharmacoeconomic analyses including health economic threshold ^23,29-31	Most frequent analysis is cost-utility or cost-effectiveness defining a tool and the limit between costs and benefits by incremental cost-effectiveness ratios per quality-adjusted life year	Under development	Yes
	3.3.5 Value-based in pricing ^32-36	Process whereby pricing of medicine is regulated per its therapeutic value aggregate, depending heavily on the context of the country and economic and cultural needs. Value based on price has been proposed as a logical and fair policy to promote access and reward useful innovation	No current activities	Yes
	3.3.6 Multiple Criteria Decision Analysis ^37,38	Extension of decision theory that supports decision-makers with multiple (possibly conflicting) objectives by decomposing the decision objectives into key criteria	No current activities	Under development
	3.3.7 Managed entry agreements ^39-43	Contract of funding and/or sharing risk between government and manufacturers to manage entry in the health system with possible decrease of the high budget impact and uncertainty of effectiveness. MEAs have a common denominator, increasing access to new medicines in a context of uncertainty and higher price. These Managed entry agreements exist in two formats: outcome-based and financial agreement	Under development	Yes
3.4 Post-launch	3.4.1 Guidelines and formularies rules ^20,44-46	Support which should be recommended within clinical practice guidelines with strong methodological competencies necessary, considering both clinical expertise and skills in the systematic assessment of the available evidence	Yes	Yes
	3.4.2 National policies or plan for Rare Diseases ^47-54	Policy or regulatory initiatives, programs, or other established mechanisms that influence and facilitate patient access to orphans	Yes	Yes
	3.4.3 National policies or plan for oncological diseases ^55-61	Policy or plan that may be influence regulatory framework for access to treatment, including medicines for oncological diseases	Yes	Yes
	3.4.4 Compulsory licensing and productive development policy^62-66	Transfer of intellectual property formalized during specific years to develop the medicine in public industries	Yes	No current activities
	3.4.5 Accelerated or fast-track access ^{⁶⁷67 England. Accelerated Access Review: Final Report - Review of innovative medicines and medical Technologies. 2016. [access in 2020 Jul 24]. Available in: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf. https://www.gov.uk/government/uploads/sy...}	An intersectoral (industry, public sector, academia, patients) articulation to identify key priorities and develop a sustainable framework for the adoption of innovation, simplifying the development and approval process, pricing, assessment, and commercial regulation	No current activities	Yes

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[1] Conflict of interests: non-existent