TOPIC GUIDE: Access to modern medicine
"NICE does a good job of recommending which new drugs should be made available on the NHS"
PUBLISHED: 01 Jan 2009
AUTHOR: Tony Gilland
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The National Institute for Health and Clinical Excellence (NICE) is an agency of the National Health Service (NHS) charged with promoting clinical excellence in NHS service providers in England and Wales [Ref: Politics.co.uk]. NICE guidance sets standards in four different areas: guidance to encourage good public health; guidance on the care and treatment of people with specific conditions; guidance about when certain surgical procedures should be offered to the NHS; and guidance about when and under what circumstances drugs and other technologies should be prescribed on the NHS.
This fourth area is perhaps the one that has attracted the most public and media interest. These recommendations are based on a review of evidence of clinical and cost effectiveness for a particular technology. The majority of technologies assessed by NICE as part of its technology appraisals work programme are pharmaceuticals, but it has also considered medical devices and screening technologies. This debate topic, though, focuses on the issue of its recommendations with regard to pharmaceuticals. NICE was first proposed by the new Labour government in its 1997 White Paper, “The New NHS” [Ref: Official Documents]. At that time, with vast numbers of new drugs becoming available, there were wide local variations in commissioning practices leading to a situation dubbed as a ‘postcode lottery’, that is, whereby patients’ addresses determine access to particular treatments. The work of NICE represents an experiment in the use of Health Technology Assessment (HTA) aimed at improving overall patient access to medicines on the NHS. As is well known, NICE’s work has proved controversial and received widespread media coverage.
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Access to modern medicine DEBATE IN CONTEXT
This section provides a summary of the key issues in the debate, set in the context of recent discussions and the competing positions that have been adopted.
Can we put a price on life?
A key task of NICE is to provide guidance as to whether a new treatment is better than current standard practice. One of the tools used in this decision making process is the cost per quality adjusted life year (or QALY) compared to the existing standard treatment. Whilst NICE does not officially stipulate a cost per QALY threshold [Ref: BMJ], it is widely understood that when the cost of a technology falls below £20,000 per QALY cost is unlikely to be an issue, but as costs rise above this level the justification for recommending the technology needs to be very strong and recommendations for treatments costing in excess of £30,000 per QALY are very rare.
Critics argue that the figures used by NICE for determining cost effectiveness are plucked out of thin air and lack scientific credibility [Ref: Independent]. Recent research coming out of the University of Newcastle and elsewhere finds that the public values life far more highly than NICE – between £35,000 and £70,000 a year [Ref: Northern Echo]. In recent years NICE has been the subject of high profile campaigns against its recommendations on new drugs to treat conditions such as breast cancer [Ref: Times Online], kidney cancer [Ref: Telegraph, Alzheimer’s [Ref: BBC News] and osteoporosis [Ref: Times Online]. One point of contention has been how to value treatments that extend the lives of terminally ill patients by months. NICE has recently announced changes to its technology appraisal process to allow greater flexibility in the recommendations that can be made about the use of end of life treatments. This has lead to in principle recommendation for a kidney cancer drug which can increase survival by a year, though this decision was also influenced by the drug manufacturer offering to provide the first cycle of treatment on the NHS for free [Ref: BBC News].
As an indication that NICE is placing too stringent a hurdle in front of new drugs, complaint has been made that the UK lags behind other comparable countries in its uptake of new drug treatments. However, this is a comparison that NICE’s chief executive, Andrew Dillon, rejects as simplistic and invalid [Ref: Pharma Focus]. There have also been wide discussions about the sharing out of drugs. Concerned about rising drug bills, other governments have expressed an interest in learning from the work of NICE [Ref: NY Times]. With a limited NHS budget, it is argued that some patients are bound to lose out and therefore tough decisions have to be made.
Drug rationing is a necessary evil?
Whilst NICE rejects the idea that it is in the business of rationing drugs, and points out that questions of affordability are for government only, it is widely regarded as playing a role in helping to control the growth of NHS expenditure on drugs. Indeed, a recent House of Commons Health Select Committee Report on NICE argues that drug rationing in the NHS is essential and that NICE plays a vital role in this regard [Ref: Parliament] and calls for more appraisal, not less, by NICE [Ref: Guardian]. From 2002 the NHS was put under a duty to provide funding to cover NICE recommendations and NICE point out that their recommendations have lead to around an additional £2 billion pounds of drugs expenditure on the NHS.
However, the Health Select Committee Report also raises points of concern, most notably that: the process is too slow; more emphasis should be placed on disinvestment of old technologies; wider benefits to society should be taken into account in NICE’s cost benefit analyses; and that NICE needs to work more closely with industry to access enough information to make its assessment – though NICE contend that it provides industry with ample opportunity to input into its assessments [Ref: NICE]. It also points out that the legislation which established the organisation and its remit prohibit it from taking account of the wider social impacts of disease, such as the impact on family and carers and the ability of suffers to take up employment. The chairman of NICE, Professor Sir Michael Rawlins, welcomed some of the Select Committee’s findings and pledged to speed up NICE’s processes. However, in an interview with The Observer newspaper, Rawlins has also lambasted the pharmaceutical industry for overpricing vital new medicines to boost profits [Ref: Guardian]. In the interview Rawlins warns of perverse incentives for pharmaceutical company executives to hike the prices of new drugs to help maintain high profits as they enter a period where a lot of their big earning drugs are coming off patent.
Deterring innovation or a counter to special pleading?
On the other hand, the pharmaceutical industry has criticised the lack of transparency in the models employed by NICE to reach its decisions and the uncertainty surrounding much of the data employed. According to the Association of the British Pharmaceutical Industry (ABPI) the current situation deters innovation and undermines patient access to modern medicines, especially in the case of rare diseases with small target populations [Ref: ABPI]. NICE would counter [Ref: NICE] that the promise of new treatments is a factor they consider when deciding whether the high cost of a new drug justifies its use within the NHS and that they go to great lengths to fully involve stakeholders, including patient groups and the pharmaceutical industry, in their decision making processes [Ref: BMJ]. Others have criticised the relationship between drugs companies and patient advocacy groups, implying that the funds that drug companies provide to patient groups are a tacit way of exerting high profile moral pressure on NICE to recommend their expensive new drugs [Ref: Independent]. The ABPI counter that there are strong codes of conduct governing such donations within the industry and that the relationship is a transparent one. Another concern in is the phenomenon of ‘NICE-blight’ [Ref: CIVITAS]. Whilst some agree that the current situation - whereby some Primary Healthcare trusts are refusing to provide drugs in the absence of NICE guidance - is preventing much needed drugs from reaching patients quickly, others argue that the time taken to properly evaluate new drugs is essential [Ref: spiked].
The extent to which NICE has shifted its position on a number of occasions, most recently its decision to adopt a more flexible approach to treatments benefiting the terminally ill, may be seen as an indication of it having made errors in the past but being open to persuasion and new evidence [Ref: Daily Mail]. It may also be a symptom of the intense moral and political pressure that the organisation is under to acquiesce to high profile and emotive campaigns.
At the end of the day, whilst NICE has become a fulcrum for debate over access to and the cost of a wide array of new drug treatments, the underlying issues are much bigger than whether NICE has acted effectively. The role of Primary Care Trusts in deciding how to implement NICE guidance; the responsibility of politicians towards setting health care priorities; the effectiveness of the pharmaceutical industry; the burdens of regulation; the patient choice agenda and the role of the media in focusing attention on emotive individual cases all need to be taken into consideration and weighed up in this debate. Perhaps one central question raised is whether a national body providing general guidance, based on necessarily uncertain data, can ever satisfy the demands and anxieties of individual patients.
It is crucial for debaters to have read the articles in this section, which provide essential information and arguments for and against the debate motion. Students will be expected to have additional evidence and examples derived from independent research, but they can expect to be criticised if they lack a basic familiarity with the issues raised in the essential reading.
Politics.co.uk 30 January 2009
Gardiner Harris New York Times 2 December 2008
Nigel Hawkes The Times 2 May 2008
Lyndsay Moss The Scotsman 25 January 2008
Jeremy Laurance The Independent 21 November 2006
Parliament Publications and Records
Denis Campbell Observer 11 January 2009
Anne Johnstone The Herald 11 October 2008
Kate Foster Scotland on Sunday 5 October 2008
Gaby Hinsliff Observer 17 August 2008
Harriet Adcock The Pharmaceutical Journal 19 May 2007
Nick Triggle BBC News 9 November 2005
Dr Michael Fitzpatrick spiked 7 October 2005
Russell Miller The Sunday Times 9 November 2008
Nina Lakhani Independent 12 October 2008
Carolyn Churchill The Herald 2 October 2008
The Herald 8 September 2008
Libby Purves The Times 11 August 2008
Jonathan Waxman The Times 8 August 2008
Sophie Goodchild Independent on Sunday 2 April 2006
Jenny Hope Daily Mail 27 December 2008
The Telegraph 22 December 2008
Simon Crompton Times Online 8 November 2008
Libby Purves The Times 11 August 2008
The Lancet 12 November 2007
Tom Moberly Pharmaceutical Journal 10 November 2007
Alastair Kent BMJ 7 May 2007
Barbara Mintzes BMJ 5 May 2007
The Royal College of Physicians of Edinburgh (RCPE) 2007
Stephen Pollard The Times 16 October 2006
Stephen Cragg The Times 11 November 2005
Mick Hume Times Online 11 November 2005
Michael D Rawlins& Anthony J Culyer BMJ 24 July 2004
Alan Maynard, Karen Bloor, Nick Freemantle BMJ 24 July 2004
Mark Jones and Ben Irvine Civitas Health Unit September 2003
Jerome Burne Guardian 21 March 2002
Zosia Kmietowicz BMJ 15 December 2001
Sarah Boseley Public Finance Magazine 9 July 1999
Definitions of key concepts that are crucial for understanding the topic. Students should be familiar with these terms and the different ways in which they are used and interpreted and should be prepared to explain their significance.
Useful websites and materials that provide a good starting point for research.
Today programme, BBC Radio 4 18 August 2008
Today programme, BBC Radio 4 17 August 2008
Mark Jones and Ben Irvine Civitas Health Unit September 2003
Department of Health 1997
House of Commons Health Committee Report 2007-08
Links to organisations, campaign groups and official bodies who are referenced within the Topic Guide or which will be of use in providing additional research information.
IN THE NEWS
Relevant recent news stories from a variety of sources, which ensure students have an up to date awareness of the state of the debate.
The Telegraph 22 January 2009
The Times 19 January 2009
Guardian 3 January 2009
Independent 2 January 2009
Sunday Herald 26 December 2008
BBC News 26 December 2008
The Sunday Times 7 December 2008
Telegraph 23 October 2008
Scotsman 6 October 2008
Independent 1 October 2008
Gaby Hinsliff Observer 17 August 2008
Scotsman 7 August 2008
Scotsman 1 July 2008
Medical News Today 13 May 2008
The Herald 8 April 2008
Scotsman 25 January 2008
Guardian 10 January 2008
The Times 14 November 2007
Scotsman 10 September 2007
BBC News 9 July 2007
Daily Telegraph 24 April 2007
Guardian 9 June 2006 9 June 2006
Guardian 28 April 2006
Daily Telegraph 10 June 2005
Independent 2 March 2005
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