How much will Herceptin really cost?

Thank you for your thoughtful article about the difficult choices
that arise from the NICE recommendation about Herceptin. As a Chair of a
PCT that refused to fund Herceptin before it was licensed and had been
assessed by NICE I have been very involved in these debate. I agree that
NICE has not really resolved the issue as no guidance is given as to dis-
investment. This issue is at the heart of robust commissioning and as the
other reactions to your piece show, the decision rules must include
equity, cost-effectiveness and the assessment of quality of life. The
perspective of patients and their social networks must be taken into
account, and therefore you are correct in raising the profile of the 'non-
sexy' and predominantly chronic conditions. It is interesting that
research and our experience as PCTs show that when asking the public what
should be prioritised they will identify mental health, degenerative
diseases and prevention; however, when faced with individual choices about
so-called life-saving treatments, preferences centre around cancer and
other diseases that are perceived to be life-threatening. PCTs as strong
commissioners will have to play a prominent role in supporting clinicians
in facing up to the media, politicians and forceful patient groups to
disseminate the sort of information that you provide and to continually
emphasise that choices about dis-investment will have to be made if new
treatments are to be funded. These choices must balance individual need
and 'the common good' and require wide involvement and ownership. A close
partnership between PCTs, providers and clinicians is central to this
endeavour, and the type of evidence that you have provided will play an
important role in the continuing drive to offer equitable and evidence-
based patient care.

Competing interests:
None declared

Dear Editor, Barrett et al have written a powerful and useful paper,
which clearly picks out a significant problem with the present structure
of the health care prioritisation process in the UK.[1] This problem is of
course that while it is good that we have a body like NICE giving us cost
effectiveness recommendations. Without either the same or another body
having the responsibility for implementing these recommendations and
balancing the books, or having cost effectiveness recommendations for all
other already available treatments it is unclear how we ought to react to
these recommendations.

They are absolutely right that opportunity cost needs to be
considered. As other respondents have pointed out there is considerable
scope for saving money in our present practise, for example by using
generic medicines. New Zealand for example has actually reduced its
overall spending on pharmaceuticals while maintaining and increasing the
range of treatments available since 1998, mainly through the use of
generics and bulk purchasing.[2]

However, these measures are palliative rather than curative, they may
reduce our present need to prioritise health care, they will do little to
reduce our future need to implement prioritisation, to give just one
example of the potential new costs it is estimated that the costs of pig
xenografting will be 10 billion US$ / year by 2010 and that this market
will by that stage have only barely begun to reduce the pool of dialysis
patients.[3]

The real issue at stake here is what is the opportunity cost of using
cost effectiveness as our only, or at least primary tool of
prioritisation?

It is suggested that there are three main objections to using cost
effectiveness alone.[4]

1. Equality:
Suppose we can either distribute our resources such that either A, B &
C all end up with 10 units of value each or we can distribute resources
such that A ends up with 30 & B & C end up with 1. Cost
effectiveness recommends the second outcome which seems counter-intuitive.

2. Deservingness:
Suppose we can distribute our resources such that either A can get 7 &
B can get 3 or A can get 4 and b can get 7. Suppose the difference between
the two patients is that A's condition has nothing to do with their own
actions, indeed they have aimed to be fit and healthy all their life,
eaten right, only had that one glass of wine etc. B on the other hand is
an unrelenting risk taker and their condition has come about as a result
of their risk taking. (Be it smoking or bungee jumping... whatever you
think is a clear case of their condition primarily being as a result of
their own activities.) We might think it is unfair to consider the
treatment B prior to the treatment of A but again cost-effectiveness
recommends that we ought to.

3. Non-medical factors:
Traditionally cost effectiveness considers all factors which have an
effect on the outcome, regardless of whether they are medical factors or
not. But it is commonplace in medical practise to consider some factors
which are relevant to the outcome in terms of utility as factors that
shouldn’t be considered when we are deciding whether or not to treat. So
for example what the effects on the respective families will be, whether
the patient has good job prospects etc. Even if the consideration of
utility is just limited to medical considerations, such as the likelihood
of patient survival, there is some evidence that this is influenced by
factors we think shouldn't be used to influence medical decisions, so for
example one study showed that low income Americans had significantly lover
survival rates than high income Americans for 12 out of the 15 cancers
examined.[5] If this is generally the case then the utilitarian has
grounds for preferring to fund health care treatment of the affluent over
the poor because of its increased efficiency.

So which principles should we use? Well that is up for debate, but we
ought to at least consider some of the more egalitarian accounts of
distributive justice in health care such as those developed by Norman
Daniels, Robert Veatch and Ronald Dworkin as alternatives or at least
constraints on the consequentialism embraced by cost
effectiveness.[6][7][8][9][10][11]

References:
1.Ann Barrett, Tom Roques, Matthew Small, and Richard D Smith How much
will Herceptin really cost?
BMJ 2006; 333: 1118-1120
2. National Advisory Committee on Health and Disability, Prioritising
Health Services: A background paper for the National Health Committee.
2004.
http://www.nhc.govt.nz/publications/PDFs/prioritisation-
backgroundpapers.pdf
3. Hancock WW. The Business of xenotransplantation. American Society of
Transplant Physicians Newsletter. 1997; 4(4).
4. Beauchamp, Tom L. Walters, LeRoy. Justice in the distribution of
health care. In: Contemporary Issues in Bioethics. Fourth Edition.
Belmont, CA: Wadsworth; 1994: 675-752.
5. Gorey, K. et al, “An International Comparison of Cancer Survival:
Toronto, Ontario and Detroit Metro Areas,” American Journal of Public
Health 87(7):1156-1163 (07/1997)
6. Beauchamp, T. and Childress, J. Principles of Biomedical Ethics, 5th
ed. New York: Oxford Univ. Press, 2001.
7. Daniels, N., Just Health Care. Cambridge: University Press, 1985.
8. Daniels N, Sabin J. Setting Limits Fairly: Can We Learn to Share
Medical Resources? Oxford: Oxford University Press, 2002.
9. Veatch, R. “Justice, the Basic Social Contract, and Health Care.
Reprinted in Contemporary Issues in Bioethics 5th edition, edited by Tom
L. Beauchamp and LeRoy Walters (Belmont, CA: Wadsworth, 1999),pp.368–374.
10. Dworkin, R. Sovereign Virtue: The Theory and Practice of Equality.
London: Harvard University Press, 2000.
11. McMillan J, Sheehan M, Austin D, Howell J. Ethics and opportunity
costs: have NICE grasped the ethics of priority setting? J Med Ethics,
Vol. 32, No. 3. (March 2006), pp. 127-128.

Competing interests:
None declared

Barret et al(1) identify many issues in their analysis of the
consequences of NICE’s ruling on Herceptin. They point out that “the real
cost of Herceptin is in the other patients not treated, whether they are
patients with cancer or those with other conditions” i.e. the opportunity
cost. They conclude that “medical professionals ultimately have to make
these difficult decisions” but they ought to go further and acknowledge
the competing demands that medical professional across multiple
disciplines place on limited resources and also recognise the
responsibility on medical professionals to ensure the judicious use of
publicly funded resources.

If as they say, it seems that no one has suggested which treatments
should be cut then it may be because they have not looked widely enough
for the answers. Moon and Bogle recently highlighted savings of £1.1
billion over five years available from promoting the generic substitution
of statins used for the primary and secondary prevention of cardiovascular
disease(2). The Strategic Health Authority covering the oncology centre
where Barret et al are employed estimates that it can save £20 million
pounds from implementing such a generic substitution policy(3). This would
have no significant impact on patient care. These potential savings
reflect inefficiencies arising from prescribing decisions that may be
viewed as averted wastage. It is too easy to blame NICE when healthcare
professionals can do so much more to make more judicious use of what has
already been provided.

Clinicians currently have little incentive to seek prescribing
savings particularly if savings are then used to stem deficits. Devolving
prescribing costs into locally held unified budgets for clinical service
delivery across multiple disease areas would promote negotiation and
priority setting. This would ensure that the opportunity costs and
potential benefits of resource allocation strategies were directed toward
the environment where the decisions are made rather than indirectly
impacting on other unrelated areas. Oncologists, cardiologists and GP’s
working at the “clinical coal face” would have to talk to each other and
ensure the sensible use of public funds. Primary Care Trusts would have to
improve their performance considerably(4).

Introducing a system of ‘reference pricing’ where drug reimbursement
is pegged to the price of a therapeutically equivalent generic drug could
do much to resolve these types of issues at source. Clinicians could
decide whether to pay a premium for a non-generic drug from regional
budgets or fund new technologies such as Herceptin.

External pressures that should not determine who is treated and what
they are treated with can affect prescribing decisions made by medical
professionals. Specialist professional groups that adopt a narrow
viewpoint can play such a countervailing role. Their guidelines are
usually uncosted and promote recomendations that do not consider the
impact across other specialties. Suggested targets for reducing
cholesterol advocated by the Joint British Societies(5) are a prime
example of recommendations for clinical practice that are likely to have a
significant resource impact, are completely uncosted and may cause harm by
constraining resources such as those for oncology care. Uncosted
recommendations are inexpensive to make but may be expensive to implement
in both mortality and financial terms.

Disinvestment will promote allocative efficiency but as clinicians we
must also disinvest ourselves of a myopic clinical mindset that results in
“silo medicine”. Expecting NICE to provide the all the answers is to be
blind to our own faults and only shifts the blame.

REFERENCES

1. Barrett A, Roques T, Small M et al. Rationing. How much will
Herceptin really Cost? BMJ 2006;333:1118-1120 (25 November),

2. Moon JC, Bogle RG. Switching statins. BMJ 2006;332: 1344-5. (10
June.)

3. Statins - the SHA perspective. Achieving Clinical Efficiency. A
practical case study. Kate Gill, Head of Service Development, East of
England SHA
http://www.heart.nhs.uk/scripts/default.asp?site_id=23&id=28050 (accessed
24 November)

4. O’ Dowd A. Watchdog brands two thirds of NHS trusts as "fair" or
"weak"
BMJ 2006;333:769 (14 October)

5. British Cardiac Society, British Hypertension Society, Diabetes
UK, HEART UK, Primary Care Cardiovascular Society, The Stroke Association.
JBS 2: the Joint British Societies' guidelines for prevention of
cardiovascular disease in clinical practice.
Heart 2005;91 (suppl V):v1-v52.

Competing interests:
Over the past 12 months RM has attended advisory boards for Novartis and Pfizer. Over the past 10 years RS has attended educational meetings, received travel grants, honorariums for lectures, and advisory boards from a number of pharmaceutical companies including AstraZeneca, Bayer, Fournier, GlaxoSmithKline, Pfizer, Merck, MSD, and Sanofi-Aventis. RM is a member of the Primary Care Cardiovascular Society and the South Asian Health Foundation. RM is an appraisal committee member within NICE and a participant within NICE guideline development groups.

The herceptin problem is yet another example of how much breast
cancer is costing not only those of us who get it but everyone. The No
More Breast Cancer Campaign argues that far greater efforts and resources
must be put into preventing the disease from occurring in the first place.

In any one year, breast cancer is devastating the lives of nearly a
quarter of a million women in the UK: women who are newly diagnosed, those
living with the disease from diagnoses made in the previous decade, and
fatalities. Incidence is rising across all age-ranges.

The No More Breast Cancer Campaign rejects the vision, put forward by
Karol Sikora and other key cancer strategists, that breast cancer will in
the future become an almost ubiquitous, non-fatal disease, to be
controlled by pharmaceutical drugs. The ‘good news story’ of improving
mortality rates must also be qualified. Unpublished government data,
recently obtained by the No More Breast Cancer Campaign, indicate that
mastectomy rates (total excisions) in England and Wales between 1990 and
2005 have increased 44 per cent overall. Most disturbingly, the upward
trend is just as drastic in women aged 15 to 44 years old, at 41 per cent,
evidence that breast cancer is rising in all age groups, and is not just a
disease of ageing.

The government must act urgently on pollutants. Endocrine-disrupting
chemicals in our food and in consumer products are suspected to contribute
to breast cancer. Over a third of the food we buy is contaminated with
pesticide residues, for example. The current regulation of chemicals in
cosmetics and consumer products is still poor, and the UK government must
support a strong European Chemicals Directive to protect human health.

When prevention becomes a priority, and the focus of the National
Health Service is on health rather than disease management, doctors will
faced less often with the kind of apalling dilemmas described by Ann
Barrett and colleagues.
www.nomorebreastcancer.org.uk

Competing interests:
None declared