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EDITORIALS: John Appleby, Nancy Devlin, and David Parkin NICE's cost effectiveness threshold BMJ 2007; 335: 358-359 [Full text]

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Exports from Britain

Andrea Messori   (26 August 2007)

NICE's cost-effectiveness threshold

Philip D Home   (28 August 2007)

NICE could drive down drug costs

Timothy D Heymann   (28 August 2007)

QUALYs and thresholds

Andrew N Bamji   (28 August 2007)

The threshold is not the only issue

Daphne I Austin   (28 August 2007)

More "uncomfortable truths"

David Kernick   (31 August 2007)

NICE's cost effectiveness threshold may not be too generous

Richard W Barker   (11 September 2007)

Exports from Britain 26 August 2007
Andrea Messori, Coordinator, Laboratory of Pharmacoeconomics Azienda Careggi, 50134 Firenze, ITALY Send response to journal: Re: Exports from Britain	In 2004, Richard Smith [1] predicted that “NICE may prove to be one of Britain's greatest cultural exports, along with Shakespeare, Newtonian physics, the Beatles, Harry Potter, and the Teletubbies.“ As far as Italy is concerned, his words were not entirely prophetic. From Shakespeare to the Teletubbies, we actually get many imports from the UK; however, the implementation of cost-effectiveness by our drug regulatory organism (AIFA) remains dramatically absent. If one scans all electronic documents produced in the 2000s by AIFA (website: www.agenziafarmaco.it accessed on 26th August 2007 ), the words “QALY” or “quality adjusted life year” appear only in two educational documents. For comparison purposes, the same search in the FDA website (www.fda.gov/search.html) gives a total of 446 documents. The grim consequence for our national health system is that drugs with very unfavourable cost effectiveness (e.g. erlotinib in pancreatic cancer [2] or first-line sunitinib in renal cancer [3]) are reimbursed with no awareness that these treatments are the opposite of value for money. So, is it better using an imperfect methodology for decision- making [4] or using no methods at all? My personal preference favours Topo Gigio [5] rather than the Teletubbies. So, if all but one among Shakespeare, Newtonian physics, NICE, the Beatles, Harry Potter, and the Teletubbies are to be exported from Britain to Italy, the benefit to the Italian population can probably be maximised by choosing a threshold that admits NICE and its methods and rejects the Teletubbies. REFERENCES 1. Smith R. The triumph of NICE. BMJ 2004;329:7459. 2. Grubbs SS, Grusenmeyer PA, Petrelli NJ, Gralla RJ. Is it cost- effective to add erlotinib to gemcitabine in advanced pancreatic cancer? Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 6048. 3. Scottish Medicines Consortium (SMC). Minutes of the SMC Meeting held on Tuesday 5 June 2007, website: http://www.scottishmedicines.org.uk 4. Appleby J, Devlin N, Parkin D. NICE's cost effectiveness threshold. BMJ 2007;335:358-359. 5. Anonymous. Wikipedia, the free encyclopedia. Website http://en.wikipedia.org/wiki/Topo_Gigio Competing interests: None declared
NICE's cost-effectiveness threshold 28 August 2007
Philip D Home, Professor of Diabetes Medicine Newcastle University, NE2 4HH, UK Send response to journal: Re: NICE's cost-effectiveness threshold	Appleby and colleagues suggest that the cost-effectiveness threshold used by NICE Technology Appraisals (TAs) is too high, seemingly because the £20-30 000 per QALY guideline is higher than average NHS expenditure per QALY gained.1 Accordingly NICE decisions may be making the NHS less efficient. But this comparison appears misplaced. There are a number of reasons for that: 1. NICE TAs deal with a selected group of expensive new technologies for the most part; in themselves these would be expected to be less cost- effective than average. 2. The average NHS cost/QALY gained has been established over decades of health care, but funding of newly introduced technologies should reflect the current funding base not that of the past; typically NICE decisions are funded out of new money. 3. The opportunity funding forgone by paying for new technologies recommended by NICE would have been most likely to be used to gain more marginal (high cost) QALYs in the service. 4. While new drugs (and other technologies) are usually more expensive and less cost-effective than currently used medications, the latter are getting cheaper notably through coming off patent. This allows room for newer less-cost effective technologies without the overall cost per QALY gained necessarily rising. Examples are many, but cholesterol-lowering drugs and breast cancer chemotherapy would both show increased overall cost-effectiveness without the newer drugs NICE has approved. Disclaimer: The views expressed are those of the author and do not purport to represent those of NICE. Competing interests: PDH advises manufacturers on new drug/technology developments, and is Vice-chair of the NICE Appraisals Committee.
NICE could drive down drug costs 28 August 2007
Timothy D Heymann, Reader in Health Management and Consultant Physician and Gastroenterologist Imperial College London, Tanaka Business School, London SW7 2AZ Send response to journal: Re: NICE could drive down drug costs	Someone, somewhere does need to grapple with the decision over the value that is placed on health: we also need to ensure that the National Health Service (NHS) and the nation live within their means. In their editorial[1], Appleby et al focus on an important issue, the cost effectiveness threshold. They imply that a figure could be agreed that is as robust and transparent as the Bank of England interest rate that is set by the independent Monetary Policy Committee. But quality adjusted life years (QALYs) are inherently less objective than interest rates. They depend on the surveyed views of people whose perceptions may vary with their health status and over time. Even were there agreement on a cost per QALY threshold, it may be appropriate to embrace new drugs or technologies if there is scope for reducing their cost through use and experience. Rather than set up another committee to determine a threshold whose reliability and relevance may be open to challenge and whose effect on NHS spending may be difficult to predict, it may be better to focus more explicitly on the cost side of the equation. The NHS and patients obviously would benefit if the NHS pays less for any given drug or technology. Now may be the ideal time for the National Institute for Health and Clinical Excellence to open such discussions with pharmaceutical companies as arrangements for the reimbursement for pharmaceuticals are currently under scrutiny in the United Kingdom[2]. This seems to work well elsewhere[3]. 1 NICE's cost effectiveness threshold John Appleby, Nancy Devlin, David Parkin BMJ 2007;335:358-359 2 Transparency in health technology assessments Alan Maynard BMJ 2007;334:594–595 3 Value for money is nothing new Michael Brougham BMJ.2007; 335: 318 Competing interests: None declared
QUALYs and thresholds 28 August 2007
Andrew N Bamji, Consultant rheumatologist Queen Mary's Hospital, Sidcup, Kent DA14 6LT Send response to journal: Re: QUALYs and thresholds	One of the major concerns of rheumatologists (who have been involved with NICE submissions for a series of expensive drugs for the treatment of rheumatoid arthritis (RA) and other inflammatory joint diseases) is "what is contained in a QUALY assessment". The answer, many believe, is not enough. If it were clear that there was a cost assessment of the potential reduction in orthopaedic costs, of the economic cost of putting someone on the sick register, or of the similar costs to carers, then we might be happier to accept that patients might be denied treatment. If someone with RA is turned from a working taxpayer into a benefit recipient then the drug cost might be totally offset by the difference between the tax revenue lost added to the disability benefits paid. For biologic agents, which are often considered in people of working age, the income level of a patient to be in positive credit balance may be quite low. There is the additional question of whether the exhibition of biologics and other similar drugs might, if given early enough, provike sustained disease remissions - which would significantly reduce the medical on-costs of the drugs themselves. Much as I hate to use that hackneyed phrase "more research is needed" it would be helpful to have clear answers to these two questions. Competing interests: I am a physician with an interest in offering effective and expensive treatments to patients, and current President of the British Society for Rheumatology
The threshold is not the only issue 28 August 2007
Daphne I Austin, Consultant in Public Health West Midlands Specialised Commissioning Team, B16 9RG Send response to journal: Re: The threshold is not the only issue	Many PCTs have long wished to see a lowering of the NICE threshold in order to bring it into line with their own decision making. This would seem more ethical given that NICE and PCTs are both committing the resources of a common budget. However it is not just the threshold that needs review, but also the assumption that any treatment below the threshold will automatically receive funding. Treatments with QALYs below any given threshold do not always represent good value for money. This is because, as Appleby et al point out, the QALY measure does not distinguish between one individual gaining 365 days extension to life and 365 individuals each gaining one day. I think the public would be surprised to learn that many cancer treatments falling below the current threshold provide only a few weeks extension to life - sometimes only a matter of 6-8 weeks - at a cost of hundreds of millions of pounds. One cancer patient gaining one year of life and 9 patients gaining 6 weeks each are not equivalent health outcomes and I am not aware of any PCT that would choose to invest in the latter regardless of what the treatment's QALY turns out to be. A QALY below the threshold is not enough to grant funding. Rather this should be seen as the threshold for putting forward treatments for prioritisation against other competing healthcare and service needs. In this context the size and nature of the health gain becomes very important. Competing interests: None declared
More "uncomfortable truths" 31 August 2007
David Kernick, General Practitioner St Thomas Health Centre, Exeter, EX4 1HJ Send response to journal: Re: More "uncomfortable truths"	In exposing the “uncomfortable truths” that NICE’s quality adjusted life year (QALY) cost threshold has no basis in either theory or evidence, John Appleby and colleagues conveniently overlook a a number of other uncomfortable truths. That the concept of quality of life and its measurement is contested and that to compress the complexities of health outcomes into a measure between 0 and 1 reflects a triumph of hope over both evidence and experience. The confident assumption is that the NHS acts as a machine that is the sum of its component parts. Resources may be diverted from one health care service to another to give better value for money like pieces on board game. There is a common perception that there is a simple relationship between cause and effect over which there is political and managerial control. This overlooks the complex and uncertain interdependencies that characterise the NHS and the international experience that suggests that resource decision making is inherently messy. An alternative perspective is to develop qualitative approaches that are more flexible and sensitive to the heterogeneity of patients, doctors and their treatments. To recognise that the resources of human complexity i.e. intuition, common sense and the integrated judgement of a collection of stakeholders and experts may be better suited to the resolution of complex resource allocation problems than forcing reality into unrealistic technical considerations (1). Kernick D. Health economics and insights from complexity theory. In: Getting health economics into practice. (Editor: Kernick D) Radcliffe Medical Press 2002, Abingdon. Competing interests: None declared
NICE's cost effectiveness threshold may not be too generous 11 September 2007
Richard W Barker, Director General The Association of the British Pharmaceutical Industry, 12 Whitehall, London SW1A 2DY Send response to journal: Re: NICE's cost effectiveness threshold may not be too generous	Appleby and colleagues(1) make two points: that NICE’s cost effectiveness threshold may be too high; and that the threshold should be set by an independent “threshold committee”. The second of these points is interesting and worthy of further exploration but the proposed committee would face the same quandary as NICE about how and where to set the threshold(2). It is far from obvious that it would recommend a lower threshold than NICE’s current range of £20,000-£30,000 per QALY. The referenced analysis by Martin et al. demonstrates that if lower spending PCTs in one disease area increased their spend they would be expected to generate additional QALYs at a cost to the PCTs of around £19,000 each (2004/05 price terms) if spent on cancer care(3). But the marginal cost per QALY in PCTs may be much higher than that. Many PCTs explicitly, and reasonably, take into account other factors(4) apart from QALYs, which do not capture all aspects of benefit well. The pharmaceutical industry supports such an approach as QALYs fail adequately to measure patient benefits such as the convenience of an oral product(5). The NHS continues to fund activity with little proven value and so it is not the case that new technology automatically displaces something of demonstrably lower cost/QALY. It is likely that some PCT expenditure currently is either ineffective or has a cost per QALY above NICE’s threshold range due to limitations of the available evidence, particularly in respect of non-pharmaceutical innovations. While the Martin et al. study(3) is a valuable first step towards estimating the overall cost per QALY of current NHS spending, work to identify ineffective clinical practice – now part of NICE’s remit(6) – should assist the NHS in capturing the benefits of NICE guidance. Finally and crucially, as Appleby et al(1) and NICE recognise, the value for money of current interventions is not the sole basis for setting NICE’s cost-effectiveness threshold. Another very important consideration is society’s willingness to pay for a QALY. Preliminary work on this issue(7) suggests a threshold for life extending interventions upwards of £45,000 per QALY. In that light the NICE threshold that Devlin et al. find in practice(8) is not too generous. 1. Appleby J, Devlin N, Parkin D (2007). NICE’s cost effectiveness threshold: how high should it be? BMJ 335:358-359. 2. Culyer A, McCabe C, Briggs A, Claxton K, Buxton M, Akehurst R, Sculpher M and Brazier J (2007). Searching for a threshold, not setting one: the role of the National Institute for Health and Clinical Excellence. J Health Serv Res Policy Vol.12 No.1:56-58. 3. Martin S, Rice N and Smith PC (2007). The link between healthcare spending and health outcomes. Evidence from English programme budgeting data. London: The Health Foundation; June 2007. 4. Wilson E, Sussex J, Macleod C and Fordham R (2007). Prioritizing health technologies in a Primary Care Trust. J Health Serv Res Policy Vol.12 No.2:80-85. 5. Association of the British Pharmaceutical Industry (2007). Written evidence to the House of Commons Health Committee, available at: http://www.publications.parliament.uk/pa/cm200607/cmselect/cmhealth/503/503we11.htm 6. Government moves to curb number of ineffective treatments in the NHS. Department of Health press release 6th September 2006. 7. Mason H, Marshall A, Jones-Lee M, Donaldson C (2006). Estimating a monetary value of a QALY from existing UK values of prevented fatalities and serious injuries. Birmingham: National Coordinating Centre for Research Methodology. 8. Devlin N, Parkin D (2004). Does NICE have a cost effectiveness threshold and what other factors influence its decisions? A binary choice analysis. Health Econ 13:437-52. Competing interests: The Association of the British Pharmaceutical Industry is the trade association for more than 75 companies in the UK producing prescription medicines.