The regulatory, evaluation, pricing and reimbursement pathway for medicines in the UK: combining innovation and access

Abstract

The United Kingdom has universal healthcare systems, the National Health System (NHS), in its four nations, with healthcare services provided free of charge at the point of delivery. Approximately 10.5% of the UK population has voluntary supplementary private health insurance. While the provision of inpatient medicines is free of charge, medicines provided in the outpatient setting have a dispensing fee in some of the nations, such as the case of England (co-payment). The UK marketing authorisation process is called product licensing and is overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA). There are different licensing routes based on the intended market for launch. MHRA also offers early access schemes and pathways for products targeting unmet medical needs and promising technologies, that aim to accelerate and facilitate market and patient access to products in the UK. These schemes include the option for companies to engage early with regulators and other system partners such as health technology assessment (HTA) agencies. As soon as the technology is authorised, it is available at a list price. Prices for medicines are regulated in legislation and in schemes agreed between the industry association and the Department of Health and Social Care (DHSC). The prices for the NHS are negotiated between the government and the companies. Routine funding decisions in the NHS are guided by HTA evaluations informed by agencies such as the National Institute for Health and Care Excellence (NICE) in England, the Scottish Medicines Consortium (SMC) in Scotland, and the All Wales Medicines Strategy Group (AWMSG) in Wales. Many medicines and other technologies are subject to price negotiations in the NHS, sometimes with confidential price agreements. The NHS in England is legally mandated to routinely fund technologies recommended by NICE that have been evaluated by some of its programmes. The other UK nations have similar arrangements or recognise decisions made in England. The role and contribution of NICE and other HTA agencies in ensuring value for money and evidence-based decision making is well recognised worldwide.

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).…”

“…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.…”

“…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. 8 At the same time, strengthening the alignment and harmonisation of processes, repositories, databases and information systems, can contribute for example for generating post-marketing evidence.…”