Economía y salud
BOLETÍN INFORMATIVO - Año 2014. Julio. nº 80
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The UK’s National Institute for Health and Care Excellence (NICE) and the application of evidence-based policy making



Alec Miners (author for correspondence)*
Senior Lecturer in Health Economics
Faculty of Public Health and Policy
London School of Hygiene and Tropical Medicine
London, WC1 9SY, UK
Email: alec.miners@lshtm.ac.uk

Laia Maynou-Pujolràs
Faculty of Public Health and Policy
London School of Hygiene and Tropical Medicine, UK
Email: laia.maynou-pujolras@lshtm.ac.uk

Francis Ruiz*
NICE International, London, UK
Email: Francis.Ruiz@nice.org.uk

* Potential conflicts of interest: AM is a current member on one of NICE’s Technology Appraisal Committees and its Decision Support Unit.  FR is an employee of NICE.

 

The UK’s National Institute for Health and Care Excellence (NICE) came into existence in 1999, following growing concerns over the geographical variation in the care provided by the publicly funded National Health Service (NHS), specifically the phenomenon of the so called “post-code” prescribing, where access to treatment appeared more reliant on where an individual lives, rather than on "need" or any other relevant criteria. It currently operates as a “non-departmental body”, primarily serving both the English and the Welsh NHS. While funded by public money through general taxation, it has an “arm’s length” relationship with the government, undertaking its activities as an independent national institution focussed on evidence-based policy making. 

Until April 2013, NICE’s role was to produce evidence-based guidance on the “appropriate” use of a wide range of health-related topics under a number of “programmes”. They included programmes for specific treatments such as drugs and devices (Centre for Health Technology Assessment, which includes the Technology Appraisals programme), public health topics (Centre for Public Health Excellence) and clinical guidelines relating to pathways of care (Centre for Clinical Practice). Following the implementation of the Health and Social Care Act of 2012, the Institute has also become responsible for producing guidance in Social Care. NICE has been described as a "health technology assessment" body, but in contrast to the many institutions it is often compared with, NICE is responsible for turning evidence into direct guidance for the NHS, in addition to gathering and synthesising the relevant evidence.

While precise topics, processes and methodologies vary by programme, the institution is committed to produce all of its guidance in accordance with a set of core principles (see Table 1) (NICE, 2014). Specifically, it is committed to formulating guidance using the best available evidence, in a clear and transparent manner, allowing for stakeholder engagement at many stages of its processes. Indeed, the application of these core principles has been described as key features necessary for the successful operation of HTA programmes and institutions more generally (Drummond et al., 2008; Chalkidou et al., 2009). NICE’s decision-making process is characterised by the use of independent advisory bodies whose members, drawn from academia, industry and the NHS, are not employed by the Institute. During their deliberations, these bodies are required to apply both technical and social value judgements as set out in NICE’s processes. The latter includes circumstances when a technology could be recommended despite a seemingly unfavourable cost-effectiveness profile, for example, because of reasons relating to the severity of the underlying disease. Although not listed as core principles, NICE also attempts to be consistent in terms of its deliberations and recommendations, and it is conscious that each time it communicates a decision, it is effectively setting a precedent for future decisions in a quasi-legal sense (NICE, 2008).  That is, NICE’s judgements on particular issues are often cited by stakeholders in subsequent appraisals to support their arguments.

NICE’s functions do not stop at the point at which guidance is issued, it is also committed to supporting implementation through a variety of means, including: the provision of “tools” to assess the local budget impact of its recommendations, the commissioning of reports examining uptake, and the development of lay versions of its guidance designed to help raise awareness among patients and the public. Moreover, the legal status of all guidance produced by NICE is reinforced by the NHS Constitution (Department of Health, 2013), a document that sets out what NHS staff, patients and public are entitled to from the health service, including the right to “drugs and treatments that have been recommended by NICE for use in the NHS, if [the patient’s] doctor says they are clinically appropriate.” Indeed, the NHS is legally obliged to fund and make available medicines and treatments recommended by NICE's technology appraisals (with its predominant focus on drugs), within three months of guidance publication. Nevertheless, consistent implementation of NICE’s guidance generally remains an ongoing challenge, despite the availability of a number of financial and non-financial levers. The NICE Implementation Collaborative, a recent initiative aiming at addressing the uneven uptake of NICE’s recommendations, is a partnership between: the NHS, the life sciences industry, healthcare professional bodies, key health organisations and the public. It aims to identify barriers to implementation in four key areas initially (osteoporosis, stroke, diabetes and heart disease) and provide practical advice on how these barriers may be overcome.

Leaving aside the ongoing difficulties with implementation, NICE has, since its inception, been associated with often significant controversy, sometimes leading to changes in its methods and processes. For example, it encountered a lengthy legal challenge to its recommendations on the use of particular drugs for the treatment of Alzheimer’s disease (Stevens et al., 2011). In addition, public announcements from senior political figures have sometimes left it to function under seemingly difficult circumstances (Stevens et al., 2011) and the Institute needs to remain aware at all times of other external factors that could affect the way it operates (Adams and McAfferty, 2014). Moreover, while “transparency” in terms of decision making is generally regarded as an important process factor, it can add considerably to the time it takes to produce guidance (Casson et al., 2013), the cost of producing it and on a more philosophical level, lays bare the factors on which recommendations can be criticised. Indeed, it has been argued that explicit decision making can serve only to “increase tensions, conflict and instability” (Mechanic, 1995). Nevertheless, despite the controversy NICE generates in the UK, it retains broad political support, and its approach to multi-stakeholder engagement and open, evidence-based priority setting is often regarded internationally as the gold standard to be emulated where possible as an alternative to implicit and often suboptimal priority setting approaches.

Although HTA is not new to Spain, May 2013 saw the introduction of the framework for Therapeutic Positioning Reports (Informes de Posicionamiento Terapéutico; IPTs). At least part of the rationale for its creation was to bring transparency and a faster pace to the pricing and reimbursement processes. However, while similar to NICE in terms of its objectives and processes, there are a number of potentially important differences in terms of the latter. First, cost-effectiveness assessments are pivotal to NICE’s decision-making processes, at least within the Technology Appraisals programme.  Our understanding of the IPTs process is that the inclusion of cost-effectiveness assessments is currently optional.  Second, the draft IPTs assessment document is due to be completed within 70 days of the Committee for Medicinal Products for Human Use (CHMP), granting marketing authorisation. This is an incredibly short (and ambitious) period, certainly in comparison with NICE’s processes, particularly given that access to appropriate registration data by the necessary authorities at this stage could be complicated. Third, while stakeholder engagement is advocated, it is not entirely clear how and when in the assessment process this would take place. Last, while the IPTs are to be produced at a national level, the implementation of appropriate policies will be left to regional authorities, not all of whom have currently subscribed to the process. There is a risk that this weakens the longer term viability of the process.

In conclusion, there has been a significant growth in the number of HTA agencies globally in the past decade, motivated by a number of factors including: the tightening of health care budgets, increasing user expectations for better care, and the expansion of markets for new technologies. While there is no absolutely right or wrong way to establish such an agency, and local contexts should always be taken into account, a set of core principles, including transparency and stakeholder participation, have been identified, which are likely to be important to help sustain and embed a culture of evidence-based priority setting. Perhaps more importantly, there also needs to be a political commitment to support such activities, and ensure that they take place in an environment of openness and independence.

Table 1: NICE’s Core Principles

Core Principle

Meaning

Evidence

Recommendations are made on the basis of the best available evidence on clinical and cost-effectiveness

Expert opinion

Recommendations are made by independent committees with a wide range of expertise

Public involvement

All committees include lay members (members from the general public)

Independence, consultation and transparency

The Department of Health chooses the topics for NICE to evaluate, but has no further involvement, and are free from Government influence.
Recommendations are always consulted on, to allow a wide range of stakeholders to comment. An appeal process against final recommendations also exists

Review

Guidance is regularly reviewed at appropriate intervals

Social values and equity considerations

Recommendations take into account social values, formulated by NICE's Citizens Council

Methodological developments

There is a commitment to using and developing methods that remain ‘fit-for-purpose’ and internationally recognised

Source: NICE (2014).


References

Adams B, McAfferty H (2014). Cancer drugs fund: assessing a difficult legacy 2014. Available at: http://www.pharmafile.com/news/182224/cancer-drugs-fund-assessing-difficult-legacy.

Casson SG, Ruiz FJ, Miners A (2013). How long has NICE taken to produce Technology Appraisal guidance? A retrospective study to estimate predictors of time to guidance. BMJ Open, 3(1).

Chalkidou K, Tunis S, Lopert R, Rochaix L, Sawicki PT, Nasser M, et al (2009). Comparative effectiveness research and evidence-based health policy: experience from four countries. The Milbank quarterly, 87(2):339-67.

Department of Health (2013). The NHS constitution 2013 [03/04/2014]. Available at: http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-for-england-2013.pdf.

Drummond MF, Schwartz JS, Jonsson B, Luce BR, Neumann PJ, Siebert U, et al (2008). Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care, 24(3):244-58; discussion 362-8.

Mechanic D (1995). Dilemmas in rationing health care services: the case for implicit rationing. BMJ, 310(6995):1655-9.

National Institute for Health and Care Excellence (2014). NICE Charter [03/07/2014]. Available at: http://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf.

National Institute for Health and Care Excellence (2008). Social value judgements principles for the development of NICE-guidance: the second edition. Available at: http://www.nice.org.uk/Media/Default/About/what-we-do/Research-and-development/Social-Value-Judgements-principles-for-the-development-of-NICE-guidance.pdf.

Stevens A, Chalkidou K, Littlejohns P (2011). The NHS: assessing new technologies, NICE and value for money. Clinical Medicine, 11(3):247-50.

 


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Editores del boletín: Carlos Campillo (campillo@ocea.es) y Cristina Hernández Quevedo (C.Hernandez-Quevedo@lse.ac.uk). Editora de redacción: Cristina Hernández Quevedo (C.Hernandez-Quevedo@lse.ac.uk). Comité de redacción: José Mª Abellán Perpiñán, Manuel García Goñi, Ariadna García Prado, Miguel Ángel Negrín, Vicente Ortún, Luz María Peña. Han colaborado en este número: Josep M. Argimon, Alina Baciu, Soledad Benot López, Anna García-Altés, Silvia Garrido García, Paula González, George Isham, Francisco Jódar Sánchez, Inés Macho Stadler, Rose Marie Martinez, Laia Maynou-Pujolràs, Ricard Meneu, Alec Miners, Toni Mora, Ana I. Moro Egido, Pau Olivella, Vicente Ortún, Francis Ruiz, Martin Sepulveda, N. Regina Rabinovich, Eduardo Sánchez-Iriso, David Sánchez Pardo, Marcos Vera-Hernández.