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Abraham J, Balendran G. The Political Sociology of NICE: Investigating Pharmaceutical Cost-Effectiveness Regulation in the UK. SOCIOLOGY OF HEALTH & ILLNESS 2025; 47:e13878. [PMID: 39743684 DOI: 10.1111/1467-9566.13878] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/25/2024] [Revised: 11/15/2024] [Accepted: 11/22/2024] [Indexed: 01/04/2025]
Abstract
The National Institute for Health and Care Excellence (NICE) was established a quarter of a century ago in 1999 to regulate the cost-effectiveness of pharmaceuticals (and other health technologies) for the NHS. Drawing on medical sociology theories of corporate bias, neoliberalism, pluralism/polycentricity and regulatory capture, the purpose of this article is to examine the applicability of those theories to NICE as a key regulatory agency in the UK health system. Based on approximately 7 years of documentary research, interviews with expert informants and observations of NICE-related meetings, this paper focuses particularly on NICE's relationship with the interests of the pharmaceutical industry compared with other stakeholder interests at the meso-organisational level. Consideration of the interaction between the UK Government and the pharmaceutical industry in relation to NICE is presented together with the analysis of revolving doors and conflicts of interest of NICE experts/advisors. The nature of policy changes over time (e.g. accelerated assessment pathways and industry fees for regulatory appraisals) and how they relate to the relevant stakeholder interests is also investigated. It is concluded that NICE is largely characterised by neoliberal corporate bias, though some elements of its organisation are also consistent with theories of capture, pluralism and polycentricity.
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Affiliation(s)
- John Abraham
- Department of Medical Education, Brighton and Sussex Universities Medical School (BSMS), Brighton, UK
| | - Gowree Balendran
- Department of Global Health and Social Medicine, King's College London, London, UK
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Main B, Csanadi M, Ozieranski P. Pricing strategies, executive committee power and negotiation leverage in New Zealand's containment of public spending on pharmaceuticals. HEALTH ECONOMICS, POLICY, AND LAW 2022; 17:348-365. [PMID: 35382921 DOI: 10.1017/s1744133122000068] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/26/2023]
Abstract
This paper explores policy mechanisms behind New Zealand's remarkable track record of cost containment in public pharmaceutical spending, contrasting with most other advanced economies. We drew on a review of official policy documents and 28 semi-structured expert interviews. We found that decision making in pricing and reimbursement policy was dominated by a small group of managers at the Pharmaceutical Management Agency (PHARMAC), the country's drug reimbursement and Health Technology Assessment Agency, who negotiated pharmaceutical prices on behalf of the public payer. In formal negotiation over patented pharmaceutical prices these managers applied an array of pricing strategies, most notably, 'bundling' consisting of discounted package deals for multiple pharmaceuticals, and 'play-off tenders', whereby two or more pharmaceutical companies bid for exclusive contracts. The key pricing strategy for generic drugs, in contrast, was 'blind-tenders' taking the form of an annual bidding process for supply contracts. An additional contextual condition on bargaining over pharmaceutical prices was an indirect strategy that involved the cultivation of the PHARMAC's 'negotiation leverage'. We derived two cost containment mechanisms consisting in the relationship between pricing strategy options and various reimbursement actors. Our findings shed light on aspects of the institutional design of drug reimbursement that may promote the effective use of competitive negotiations of pharmaceutical prices, including specific pricing strategies, by specialist public payer institutions. On this basis, we formulate recommendations for countries seeking to develop or reform policy frameworks to better meet the budgetary challenge posed by pharmaceutical expenditure.
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Affiliation(s)
- Ben Main
- Department of Sociology, University of Durham, Durham, UK
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Behera B. Nusinersen, an exon 7 inclusion drug for spinal muscular atrophy: A minireview. World J Meta-Anal 2021; 9:277-285. [DOI: 10.13105/wjma.v9.i3.277] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2020] [Revised: 05/20/2021] [Accepted: 06/17/2021] [Indexed: 02/06/2023] Open
Abstract
Spinal muscular atrophy is an autosomal recessive neuromuscular disease with incidence of 1 in 5000 to 10000 live births and is produced by homozygous deletion of exons 7 and 8 in the SMN1 gene. The SMN1 and SMN2 genes encode the survival motor neuron protein, a crucial protein for the preservation of motor neurons. Use of the newer drug, Nusinersen, from early infancy has shown improvement in clinical outcomes of spinal muscular atrophy patients.
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Affiliation(s)
- Bijaylaxmi Behera
- Department of Neonatology, Chaitanya Hospital, Chandigarh 160044, India
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Rickard E, Ozieranski P. A hidden web of policy influence: The pharmaceutical industry's engagement with UK's All-Party Parliamentary Groups. PLoS One 2021; 16:e0252551. [PMID: 34166396 PMCID: PMC8224875 DOI: 10.1371/journal.pone.0252551] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2021] [Accepted: 05/17/2021] [Indexed: 11/23/2022] Open
Abstract
Our objective was to examine conflicts of interest between the UK’s health-focused All-Party Parliamentary Groups (APPGs) and the pharmaceutical industry between 2012 and 2018. APPGs are informal cross-party groups revolving around a particular topic run by and for Members of the UK’s Houses of Commons and Lords. They facilitate engagement between parliamentarians and external organisations, disseminate knowledge, and generate debate through meetings, publications, and events. We identified APPGs focusing on physical or mental health, wellbeing, health care, or treatment and extracted details of their payments from external donors disclosed on the Register for All-Party Parliamentary Groups. We identified all donors which were pharmaceutical companies and pharmaceutical industry-funded patient organisations. We established that sixteen of 146 (11%) health-related APPGs had conflicts of interest indicated by reporting payments from thirty-five pharmaceutical companies worth £1,211,345.81 (16.6% of the £7,283,414.90 received by all health-related APPGs). Two APPGs (Health and Cancer) received more than half of the total value provided by drug companies. Fifty APPGs also had received payments from patient organisations with conflicts of interest, indicated by reporting 304 payments worth £986,054.94 from 57 (of 84) patient organisations which had received £27,883,556.3 from pharmaceutical companies across the same period. In total, drug companies and drug industry-funded patient organisations provided a combined total of £2,197,400.75 (30.2% of all funding received by health-related APPGs) and 468 (of 1,177–39.7%) payments to 58 (of 146–39.7%) health-related APPGs, with the APPG for Cancer receiving the most funding. In conclusion, we found evidence of conflicts of interests through APPGs receiving substantial income from pharmaceutical companies. Policy influence exerted by the pharmaceutical industry needs to be examined holistically, with an emphasis on relationships between actors potentially playing part in its lobbying campaigns. We also suggest ways of improving transparency of payment reporting by APPGs and pharmaceutical companies.
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Affiliation(s)
- Emily Rickard
- Department of Social and Policy Sciences, University of Bath, Bath, Somerset, United Kingdom
| | - Piotr Ozieranski
- Department of Social and Policy Sciences, University of Bath, Bath, Somerset, United Kingdom
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Skyrme SL. The Lived Experience of Inequalities in the Provision of Treatment for Hepatitis C. FRONTIERS IN SOCIOLOGY 2021; 6:649838. [PMID: 34141735 PMCID: PMC8204130 DOI: 10.3389/fsoc.2021.649838] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/05/2021] [Accepted: 05/18/2021] [Indexed: 06/12/2023]
Abstract
The issues of health, illness, stigma and inequalities in healthcare provision, areas that in my role as a social researcher were already of interest and concern, shifted to a different perspective when I was diagnosed with hepatitis C. From this altered position, my body and lifeworld were a nexus point for a range of ongoing challenges around staying as well as possible, and the struggle to get my healthcare needs met. There is a gap between the support provided for some ill and disabled people, and the help that they actually require. This is particularly so for conditions that are not well understood, that have a low public profile, limited funding, and/or are in some way stigmatised due to perceived differences to social norms. Hepatitis C is one such condition, it is a viral disease that is transmitted through blood-to-blood contact and it causes ongoing damage to the liver. Because of the systemic nature of the disease, individuals may struggle to cope with the demands of work and daily living, and their lifeworld and opportunities are frequently limited. It can be challenging for the patient to advocate for themselves due to low energy levels, self-blame for getting ill, and the stigma associated with the condition. The first generation of effective anti-viral drugs emerged from clinical trials in 2013, but in the United Kingdom context, access was only possible for those with advanced liver disease. Therefore, many patients felt compelled to purchase the anti-virals through Buyers Clubs, whereby generic versions of the drugs are imported for personal use at a fraction of the market cost. In this article I draw on my own lived experience of joining a Buyers Club as an example of how risks and benefits are weighed, and to explain the contexts in which decisions are shaped and made.
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Löblová O, Trayanov T, Csanádi M, Ozierański P. The Emerging Social Science Literature on Health Technology Assessment: A Narrative Review. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2020; 23:3-9. [PMID: 31952670 DOI: 10.1016/j.jval.2019.07.016] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/14/2018] [Revised: 05/13/2019] [Accepted: 07/26/2019] [Indexed: 06/10/2023]
Abstract
BACKGROUND Social scientists have paid increasing attention to health technology assessment (HTA). This paper provides an overview of existing social scientific literature on HTA, with a focus on sociology and political science and their subfields. METHODS Narrative review of key pieces in English. RESULTS Three broad themes recur in the emerging social science literature on HTA: the drivers of the establishment and concrete institutional designs of HTA bodies; the effects of institutionalized HTA on pricing and reimbursement systems and the broader society; and the social and political influences on HTA decisions. CONCLUSION Social scientists bring a focus on institutions and social actors involved in HTA, using primarily small-N research designs and qualitative methods. They provide valuable critical perspectives on HTA, at times challenging its otherwise unquestioned assumptions. However, they often leave aside questions important to the HTA practitioner community, including the role of culture and values. Closer collaboration could be beneficial to tackle new relevant questions pertaining to HTA.
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Affiliation(s)
- Olga Löblová
- Department of Sociology, University of Cambridge, Cambridge, England, UK.
| | - Trayan Trayanov
- Department of Sociology, University of Cambridge, Cambridge, England, UK
| | - Marcell Csanádi
- Doctoral School of Pharmacological and Pharmaceutical Sciences, University of Pécs, Pécs, Hungary; Syreon Research Institute, Budapest, Hungary
| | - Piotr Ozierański
- Department of Social and Policy Sciences, University of Bath, Bath, England, UK
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Kang SY, Bai G, DiStefano MJ, Socal MP, Yehia F, Anderson GF. Comparative Approaches to Drug Pricing. Annu Rev Public Health 2019; 41:499-512. [PMID: 31874070 DOI: 10.1146/annurev-publhealth-040119-094305] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
The United States relies primarily on market forces to determine prices for drugs, whereas most other industrialized countries use a variety of approaches to determine drug prices. Branded drug companies have patents and market exclusivity periods in most industrialized countries. During this period, pharmaceutical companies are allowed to set their list price as high as they prefer in the United States owing to the absence of government price control mechanisms that exist in other countries. Insured patients often pay a percentage of the list price, and cost sharing creates some pressure to lower the list price. Pharmacy benefit managers negotiate with drug companies for lower prices by offering the drug company favorable formulary placement and fewer utilization controls. However, these approaches appear to be less effective, compared with other countries' approaches to containing branded drug prices, because prices are substantially higher in the United States. Other industrialized countries employ various forms of rate setting and price regulation, such as external reference pricing, therapeutic valuation, and health technology assessment to determine the appropriate price.
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Affiliation(s)
- So-Yeon Kang
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , ,
| | - Ge Bai
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , , .,Carey Business School, Johns Hopkins University, Baltimore, Maryland 21202, USA
| | - Michael J DiStefano
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , ,
| | - Mariana P Socal
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , ,
| | - Farah Yehia
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , ,
| | - Gerard F Anderson
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland 21205, USA; , , , , , .,School of Medicine, Johns Hopkins University, Baltimore, Maryland 21205, USA
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Rumbold B, Charlton V, Rid A, Mitchell P, Wilson J, Littlejohns P, Max C, Weale A. Affordability and Non-Perfectionism in Moral Action. ETHICAL THEORY AND MORAL PRACTICE : AN INTERNATIONAL FORUM 2019; 22:973-991. [PMID: 31866757 PMCID: PMC6890613 DOI: 10.1007/s10677-019-10028-4] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 08/23/2019] [Indexed: 06/10/2023]
Abstract
One rationale policy-makers sometimes give for declining to fund a service or intervention is on the grounds that it would be 'unaffordable', which is to say, that the total cost of providing the service or intervention for all eligible recipients would exceed the budget limit. But does the mere fact that a service or intervention is unaffordable present a reason not to fund it? Thus far, the philosophical literature has remained largely silent on this issue. However, in this article, we consider this kind of thinking in depth. Albeit with certain important caveats, we argue that the use of affordability criteria in matters of public financing commits what Parfit might have called a 'mistake in moral mathematics'. First, it fails to abide by what we term a principle of 'non-perfectionism' in moral action: the mere fact that it is practically impossible for you to do all the good that you have reason to do does not present a reason not to do whatever good you can do. And second, when used as a means of arbitrating between which services to fund, affordability criteria can lead to a kind of 'numerical discrimination'. Various attendant issues around fairness and lotteries are also discussed.
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Affiliation(s)
- Benedict Rumbold
- Department of Philosophy, University of Nottingham, Nottingham, UK
| | - Victoria Charlton
- Department of Global Health & Social Medicine, King’s College London, London, UK
| | - Annette Rid
- Department of Bioethics, The Clinical Center, U.S. National Institutes of Health, Bethesda, MD USA
| | - Polly Mitchell
- Department of Philosophy, University College London, London, UK
| | - James Wilson
- Department of Philosophy, University College London, London, UK
| | - Peter Littlejohns
- School of Population Health and Environmental Sciences, King’s College London, London, UK
| | | | - Albert Weale
- Department of Political Science, University College London, London, UK
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Paradigms in operation: explaining pharmaceutical benefit assessment outcomes in England and Germany. HEALTH ECONOMICS POLICY AND LAW 2019; 15:370-385. [PMID: 30975237 DOI: 10.1017/s1744133119000203] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Health technology assessments (HTAs) are used as a policy tool to appraise the clinical value, or cost effectiveness, of new medicines to inform reimbursement decisions in health care. As HTA organisations have been established in different countries, it has become clear that the outcomes of medicine appraisals can vary from country to country, even though the same scientific evidence in the form of randomised controlled trials is available. The extant literature explains such variations with reference to institutional variables and administrative rules. However, little research has been conducted to advance the theoretical understanding of how variations in HTA outcomes might be explained. This paper compares cases of HTA in England and Germany using insights from Kuhn (1962, The Structure of Scientific Revolutions, 2nd edn. Chicago: The University of Chicago Press) and Hall (1993, Policy paradigms, social learning, and the state: the case of economic policymaking in Britain. Comparative Politics 25, 275-296) to demonstrate how policy paradigms can explain the outcomes of HTA processes. The paper finds that HTA outcomes are influenced by a combination of logical issues that require reasoning within a paradigm, and institutional and political issues that speak to the interaction between ideational and interest-based variables. It sets out an approach that advances the theoretical explanation of divergent HTA outcomes, and offers an analytical basis on which to assess current and future policy changes in HTA.
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10
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Quantifying potentially infectious sharing patterns among people who inject drugs in Baltimore, USA. Epidemiol Infect 2018; 146:1845-1853. [PMID: 30070187 DOI: 10.1017/s0950268818002042] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023] Open
Abstract
Mixing matrices quantify how people with similar or different characteristics make contact with each other, creating potential for disease transmission. Little empirical data on mixing patterns among persons who inject drugs (PWID) are available to inform models of blood-borne disease such as HIV and hepatitis C virus. Egocentric drug network data provided by PWID in Baltimore, Maryland between 2005 and 2007 were used to characterise drug equipment-sharing patterns according to age, race and gender. Black PWID and PWID who were single (i.e. no stable sexual partner) self-reported larger equipment-sharing networks than their white and non-single counterparts. We also found evidence of assortative mixing according to age, gender and race, though to a slightly lesser degree in the case of gender. Highly assortative mixing according to race and gender highlights the existence of demographically isolated clusters, for whom generalised treatment interventions may have limited benefits unless targeted directly. These findings provide novel insights into mixing patterns of PWID for which little empirical data are available. The age-specific assortativity we observed is also significant in light of its role as a key driver of transmission for other pathogens such as influenza and tuberculosis.
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Schrecker T. Priority Setting: Right Answer to a Far Too Narrow Question? Comment on "Global Developments in Priority Setting in Health". Int J Health Policy Manag 2018; 7:86-88. [PMID: 29325408 PMCID: PMC5745873 DOI: 10.15171/ijhpm.2017.66] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2017] [Accepted: 05/23/2017] [Indexed: 12/18/2022] Open
Abstract
In their recent editorial, Baltussen and colleagues provide a concise summary of the prevailing discourse on priority-setting in health policy. Their perspective is entirely consistent with current practice, yet they unintentionally demonstrate the narrowness and moral precariousness of that discourse and practice. I respond with demonstrations of the importance of 'interrogating scarcity' in a variety of contexts.
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Affiliation(s)
- Ted Schrecker
- School of Medicine, Pharmacy and Health, Durham University, University Boulevard, Stockton-on-Tees, UK
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Tomkins A, Lee V. Intervention to improve management of acute hepatitis C infection in a UK sexual health clinic. Int J STD AIDS 2017; 29:195-197. [DOI: 10.1177/0956462417727193] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
A case note review was conducted for all newly-diagnosed acute hepatitis C virus (HCV)-infected patients attending our sexual health clinic pre- and post-implementation of an HCV clinic proforma between January 2010 and September 2016. In total, 87 patient notes were included (40 pre-intervention, 47 post-intervention) of whom 81 were HIV-positive. Data were collected regarding documentation of the following: baseline investigations, four-weekly HCV viral load monitoring, risk assessment, partner notification, advice given and Public Health England (PHE) notification. Appropriate baseline investigations, four-weekly monitoring of HCV viral loads, risk assessment and advice documentation all improved in the post-intervention group when compared to pre-intervention. PHE notification and partner notification remained below the national standard post-intervention, with educational measures among relevant staff implemented accordingly. This audit demonstrates improvement across several key areas post clinic proforma implementation.
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Affiliation(s)
- A Tomkins
- The Hathersage Centre, The Northern Contraception, Sexual Health and HIV Service, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
| | - V Lee
- The Hathersage Centre, The Northern Contraception, Sexual Health and HIV Service, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
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