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
Share this Topic Guide:
INTRODUCTION
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.
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.
Who decides?
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.
ESSENTIAL READING
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.
National Institute for Health and Clinical Excellence
Politics.co.uk 30 January 2009
British Balance Benefit vs Cost of Latest drugs
Gardiner Harris New York Times 2 December 2008
Q&A: National Institute for Health and Clinical Excellence
Nigel Hawkes The Times 2 May 2008
Medicines man with eye on patient care
Lyndsay Moss The Scotsman 25 January 2008
The Big Question: What is Nice’s role, and why is it limiting access to Alzheimer’s drugs?
Jeremy Laurance The Independent 21 November 2006
Excerpt from house of commons debate on NICE
Parliament Publications and Records
FOR
NHS patients to get better drug access
Denis Campbell Observer 11 January 2009
The lives that slip through the cracks
Anne Johnstone The Herald 11 October 2008
Cancer patients ‘expect too much from the NHS’
Kate Foster Scotland on Sunday 5 October 2008
Health chief attacks drug giants over huge profits
Gaby Hinsliff Observer 17 August 2008
Cash for Medicines: Is NICE price right?
Harriet Adcock The Pharmaceutical Journal 19 May 2007
Why some drugs are not worth it
Nick Triggle BBC News 9 November 2005
Patient Power can Harm your health
Dr Michael Fitzpatrick spiked 7 October 2005
AGAINST
Cancer patients sentenced to an early death by bureaucrats
Russell Miller The Sunday Times 9 November 2008
The price of life – it was £20,000. Now NHS drugs body recalculates
Nina Lakhani Independent 12 October 2008
What price cancer victims’ drugs?
Carolyn Churchill The Herald 2 October 2008
Scotland must foster drug innovation
The Herald 8 September 2008
NHS rationing is a reality we should deal with
Libby Purves The Times 11 August 2008
We need cancer drugs. NICE must go
Jonathan Waxman The Times 8 August 2008
Cancer: Two women tell their stories
Sophie Goodchild Independent on Sunday 2 April 2006
IN DEPTH
Terminally ill cancer patients to be given more life extending drugs on NHS after NICE U-turn
Jenny Hope Daily Mail 27 December 2008
At last, a life-saving choice for patients
The Telegraph 22 December 2008
Do medication top-up fees mean the end of the NHS?
Simon Crompton Times Online 8 November 2008
NHS rationing is a reality we should deal with
Libby Purves The Times 11 August 2008
Herceptin and early breast cancer: a moment for caution
The Lancet 12 November 2007
Can the NHS buy fair access to drugs?
Tom Moberly Pharmaceutical Journal 10 November 2007
Should patient groups accept money from drug companies? Yes
Alastair Kent BMJ 7 May 2007
Should patient groups accept money from drug companies? No
Barbara Mintzes BMJ 5 May 2007
Response to Health Select Committee Report
The Royal College of Physicians of Edinburgh (RCPE) 2007
Stephen Pollard The Times 16 October 2006
NHS bodies have difficult choices to make and judges are not the best people to make them
Stephen Cragg The Times 11 November 2005
Is this unqualified Health Secretary really helping the cancer patients?
Mick Hume Times Online 11 November 2005
National Institute for Clinical Excellence and its value judgments
Michael D Rawlins& Anthony J Culyer BMJ 24 July 2004
Challenges for the National Institute for Clinical Excellence
Alan Maynard, Karen Bloor, Nick Freemantle BMJ 24 July 2004
Has NICE eliminated the postcode lottery?
Mark Jones and Ben Irvine Civitas Health Unit September 2003
Jerome Burne Guardian 21 March 2002
Government insists NHS pays for drugs approved by NICE
Zosia Kmietowicz BMJ 15 December 2001
Can a Nice distinction end a messy NHS?
Sarah Boseley Public Finance Magazine 9 July 1999
KEY TERMS
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.
BACKGROUNDERS
Useful websites and materials that provide a good starting point for research.
Sir Michael Rawlins, chairman of NICE and Richard Barker, ABPI
Today programme, BBC Radio 4 18 August 2008
Professor David Taylor from the University of London discusses how much the NHS spends on drugs
Today programme, BBC Radio 4 17 August 2008
Nice or nasty: has nice eliminated the ‘postcode lottery’ in the NHS?
Mark Jones and Ben Irvine Civitas Health Unit September 2003
Department of Health 1997
National Institute for Health and Clinical Excellence
House of Commons Health Committee Report 2007-08
Channel 4
ORGANISATIONS
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.
Kidney cancer drugs available in Wales but not in England
The Telegraph 22 January 2009
Court challenge to NICE over osteoporosis treatment
The Times 19 January 2009
Terminally ill cancer patients to get expensive drugs on the NHS
Guardian 3 January 2009
Drug access hope for cancer sufferers
Independent 2 January 2009
Asthmatics to be denied life-changing drug twice
Sunday Herald 26 December 2008
NHS to get quicker drug approval
BBC News 26 December 2008
SNP to scrap NHS ban on top-up healthcare
The Sunday Times 7 December 2008
Just a tenth of NHS surplus would give expensive cancer drugs to all, charity claims
Telegraph 23 October 2008
Health service must evolve at same pace as medical world
Scotsman 6 October 2008
Analysis: Are patient protests being manipulated?
Independent 1 October 2008
Health chief attacks drug giants over huge profits
Gaby Hinsliff Observer 17 August 2008
Patients denied access to kidney cancer drugs
Scotsman 7 August 2008
Doctors’ leader hits out at ‘inhumane’ NHS care rules
Scotsman 1 July 2008
Scottish Medicines Consortium Rules Against Breakthrough Treatment For Devastating Blood Cancer
Medical News Today 13 May 2008
Drugs chief asks: should the young get priority over elderly patients?
The Herald 8 April 2008
Dying cancer patient wins battle to get NHS funding for treatment
Scotsman 25 January 2008
Drug rationing essential for health service, MPs say
Guardian 10 January 2008
Rent a home in Scotland and get cancer drugs free
The Times 14 November 2007
Watchdog’s U-turn on drug for MS patients
Scotsman 10 September 2007
Cancer drug rejected for NHS use
BBC News 9 July 2007
Daily Telegraph 24 April 2007
Charities welcome draft approval for breast cancer drug
Guardian 9 June 2006 9 June 2006
NHS delay on new breast cancer drugs
Guardian 28 April 2006
Cancer drug delay ‘will cost lives’
Daily Telegraph 10 June 2005
Business Analysis: Drug firms in fury over U-turn on Alzheimer’s treatments
Independent 2 March 2005
AUDIO/VISUAL
This site contains links to websites operated by parties other than Debating Matters. Although we make every effort to ensure links are current, they will sometimes break after Topic Guide publication. If a link does not work, then the publication reference and date should enable you to find an alternate link. If you find a broken link do please send it to the webmaster for review.
TOPIC GUIDE MENU
Select the relevant option
Related topic guides