Keeping Pace with Pharmaceutical Innovation: The Importance of the NICE Methods Review

Catchpole, Paul; Barrett, Victoria

doi:10.1007/s40273-020-00918-2

Cited by 6 publications

(5 citation statements)

References 10 publications

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“…In England and Wales, the National Institute for Health and Care Excellence appraises the clinical and cost-effectiveness of newly approved therapies and issues recommendations for public coverage in the National Health Service. 57 The Institut national d’excellence en santé et en services sociaux agency plays a similar role in the province of Québec, with the mandate to assess the clinical benefits and costs of therapies or services. 58 The experience and expertise of these groups should be applied to the assessment of the relevance of new therapies derived from human tissues and cells.…”

Section: Recommendationsmentioning

confidence: 99%

Tissue and Cell Donation: Recommendations From an International Consensus Forum

Ibáñez

Humphreys

Lomero³

et al. 2023

Transplantation Direct

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Background. Organ, tissue, and cell donation and transplantation legislation and policies vary substantially worldwide, as do performance outcomes in various jurisdictions. Our objective was to create expert, consensus guidance that links evidence and ethical concepts to legislative and policy reform for tissue and cell donation and transplantation systems. Methods. We identified topic areas and recommendations through consensus, using nominal group technique. The proposed framework was informed by narrative literature reviews and vetted by the project’s scientific committee. The framework was presented publicly at a hybrid virtual and in-person meeting in October 2021 in Montréal, Canada, where feedback provided by the broader Forum participants was incorporated into the final manuscript. Results. This report has 13 recommendations regarding critical aspects affecting the donation and use of human tissues and cells that need to be addressed internationally to protect donors and recipients. They address measures to foster self-sufficiency, ensure the respect of robust ethical principles, guarantee the quality and safety of tissues and cells for human use, and encourage the development of safe and effective innovative therapeutic options in not-for-profit settings. Conclusions. The implementation of these recommendations, in total or in part, by legislators and governments would benefit tissue transplantation programs by ensuring access to safe, effective, and ethical tissue- and cell-based therapies for all patients in need.

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Section: Recommendationsmentioning

confidence: 99%

Tissue and Cell Donation: Recommendations From an International Consensus Forum

Ibáñez

Humphreys

Lomero³

et al. 2023

Transplantation Direct

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“…The Treasury ‘Green Book’ also recommends a discount rate of 1.5%, as opposed to the 3.5% per annum used by NICE. Using a raised discount rate drives down the presently perceived value of lives saved and suffering relieved in the future 49 , 50 . The impacts of this are particularly likely to undermine the economic viability of curative and other long-term treatments given to children or young adults to prevent long-term harm.…”

Section: The Strengths and Weakness Of ‘Cost Per Qaly’-based Pricingmentioning

confidence: 99%

The political economics of cancer drug discovery and pricing

Taylor

2020

Drug Discovery Today

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Highlights Despite falling age-specific mortality rates cancers are causing a rising proportion of all deaths. Anticancer medicines now cost 0.1−0.2% of the typical OECD country’s GDP. Although complex, imperfect and politicised, markets for innovative medicines are delivering important benefits. Without enhanced risk sharing and value based pricing the intellectual property laws facilitating much drug discovery may become politically unsustainable. Better methods for judging the cost effectiveness of new therapies will require changes in the way the value of future benefits is calculated. Globally, equitable access to innovative therapies demands differential (Ramsey) pricing.

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“…Given the implications of such decisions for those who contribute to and benefit from national health systems, centralised processes are often put in place to ensure that they are seen to be made fairly (Kenny and Joffres, 2008). In the UK, these fall under the remit of the National Institute for Health and Care Excellence (NICE), a public body which has come to be seen as a world-leader in health care priority-setting (Smith, 2004; Timmons et al ., 2016; Schaefer and Schlander, 2018; Littlejohns et al ., 2019; Catchpole and Barrett, 2020).…”

Section: Introductionmentioning

confidence: 99%

The normative grounds for NICE decision-making: a narrative cross-disciplinary review of empirical studies

Charlton

2022

HEPL

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The National Institute for Health and Care Excellence (NICE) is the UK's primary health care priority-setter, responsible for advising the National Health Service on its adoption of health technologies. The normative basis for NICE's advice has long been the subject of public and academic interest, but the existing literature does not include any comprehensive summary of the factors observed to have substantively shaped NICE's recommendations. The current review addresses this gap by bringing together 29 studies that have explored NICE decision-making from different disciplinary perspectives, using a range of quantitative and qualitative methods. It finds that although cost-effectiveness has historically played a central role in NICE decision-making, 10 other factors (uncertainty, budget impact, clinical need, innovation, rarity, age, cause of disease, wider societal impacts, stakeholder influence and process factors) are also demonstrably influential and interact with one another in ways that are not well understood. The review also highlights an over-representation in the literature of appraisals conducted prior to 2009, according to methods that have since been superseded. It suggests that this may present a misleading view of the importance of allocative efficiency to NICE's current approach and illustrates the need for further up-to-date research into the normative grounds for NICE's decisions.

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Keeping Pace with Pharmaceutical Innovation: The Importance of the NICE Methods Review

Cited by 6 publications

References 10 publications

Tissue and Cell Donation: Recommendations From an International Consensus Forum

Tissue and Cell Donation: Recommendations From an International Consensus Forum

The political economics of cancer drug discovery and pricing

The normative grounds for NICE decision-making: a narrative cross-disciplinary review of empirical studies

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