NICE's cost effectiveness threshold
BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39308.560069.BE (Published 23 August 2007) Cite this as: BMJ 2007;335:358
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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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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.
Competing interests: No competing interests
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
Competing interests: No competing interests
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/...
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.
Competing interests: No competing interests