Memorandum by the NHS Alliance (NC 128)
1. The NHS Alliance welcomes the opportunity
to contribute to the Select Committee's review of NICE and is
prepared to give evidence in person.
2. The NHS Alliance is a national membership
organisation rooted in primary care and draws its membership from
both primary care organisations in the UK and individuals working
in primary care. In particular it reflects the critical partnership
between lay people, managers and clinicians in planning, securing
and evaluating effort to improve the health of local populations.
This critical partnership at local level is reflected in the recent
policy document "Shifting the Balance of Power" now
being implemented in England.
3. The NHS Alliance is committed to values
of fairness, equity and collaborative working within a structure
that is mutually supportive and accountable. Both national and
local organisations have an important role to play in delivering
those values. NICE is no exception to this.
The role of NICE is to:
Support frontline clinicians by setting
out clearly which new treatments are effective for which patients.
Sort out the wheat from the chaff
so that we know which treatment should enter mainstream practice
To ensure that all parts of the NHS
are provided with the most up to date information on what is clinically
effective, and what is not.
While ensuring that the services
patients get are of a high quality and effective, to help the
Government bear down on unequal access to services.
3 JUNE 1998DOH
4. Essentially, NICE provides a mechanism
for the national rationing of health care interventions. It is
right that there should be a national role in making these decisions,
which involve judgements as to both effectiveness and cost-effectiveness.
5. There are serious problems in the current
operational arrangements involving NICE. These are detailed below.
These are not limited to the operation of NICE itself but include
the arrangements surrounding NICE. For instance the arrangements
for the selection of items to be subject to a technology appraisal
are not within the remit of NICE itself but rather the Secretary
of State and Welsh Assembly advised by the Technology Appraisal
Group. This paper will comment on this and similar matters.
6. There are significant issues relating
to the funding of NICE decisions. If there is to be a national
input into rationing decisions, which there should be, then the
responsibility for funding the consequences of those decisions
cannot be delegated satisfactorily to a local level. The current
arrangements have the capacity to distort local priorities. In
this sense, NICE must take account of affordability as well as
effectiveness as well as cost effectiveness.
7. The NHS Alliance would argue that there
is a need for guidance at two levels. Firstly at the level concerning
those interventions, including drugs, that must be made available
on grounds of equity to the entire population given the prevalence
and incidence of the disease. These should be nationally funded
as we understand new products are when recommended by NICE in
Wales. The second level represents treatments that may be made
available because they are of use, but where decisions would be
at the discretion of the local funding authority and subject to
local judgement. This would allow for local needs and priorities
to be brought to the fore in decision-making. The extent to which
local priorities will apply will depend upon the disease area.
For example, the prevalence of diabetes in Newham is perceived
to be seven times the national average. It is axiomatic that the
local emphasis on diabetes will be greater in Newham than in some
other areas of the country. NICE guidance is simply too broad
brush to be sensitive to local circumstances. In some instances
there is anecdotal evidence of NICE supported therapies being
suppressed because of local budget pressures.
8. There is an emerging tendency for funding
bodies to avoid the immediate funding of treatments that are listed
in the NICE programme. This is known as "NICE blight".
This may result in effective treatments being denied to patients
whilst NICE undertakes a review. The Department of Health has
issued guidance that health authorities should not use an impending
NICE review as a reason to avoid making a decision concerning
the use of a particular intervention but in our experience, this
is common and is not in the best interests of patient care.
9. There is another form of NICE blight.
That may occur where an intervention is not on the NICE work programme
(decided at a political level not by NICE). This may result in
those patients whose conditions are not deemed to be of national
priority being disadvantaged. Epilepsy would be an example. In
the pursuit of national equity, which the NHS Alliance would support,
there is a real danger of producing an even more sinister form
of rationing than postcode prescribingbased on whether
or not the patient has a "politically correct" disease.
10. There is a need for NICE to consider
the wider aspects of therapeutic intervention for a specific disease
and not just one intervention. For instance, in the area of mental
health, it would be desirable to consider the merits of all interventions
for the treatment of say, schizophrenia and not just atypical
antipsychotics. The narrow approach currently adopted may exclude
important treatments such as cognitive behavioural therapy or
even complementary therapy. There is a need for NICE to recognise
the "opportunity cost" of a particular intervention.
For example the relative merits of funding Relenza versus spending
the money required on extra nursing hours to visit the frail elderly
at risk from influenza.
11. Perhaps of greater concern is that NICE
have not connected their production of technology assessments
(both drugs and non drug interventions) with the issue of treatment
guidelines and referral guidance. Such a disjointed approach runs
the risk of at best, damaging the credibility of NICE guidance
and at worse, producing confusion.
12. The credibility of NICE is a matter
we understand that the Committee wishes to focus on. The NHS Alliance
would observe that NICE does not have universal support and that
its credibility has been damaged by perceived U-turns on Relenza,
and the shifting of arguments from those of effectiveness to one
of pricing in respect of beta-inteferons for the treatment of
Multiple Sclerosis. We would draw the attention of the Committee
to findings from a survey of Primary Care Organisations undertaken
by the NHS Alliance in March 2001.
A significant number (57 per cent)
of respondents felt under undue or inappropriate pressure from
central priorities. A further 14 per cent specifically cited NICE
in this regard.
91 per cent were very concerned or
fairly concerned that local prescribing budgets may be affected
53 per cent felt it was likely that
they would have to restrict other treatments to fund those approved
51 per cent of clinicians advised
that they felt their clinical decisions may or are compromised
78 per cent of GPs responding advised
they would not prescribe zanamivir in spite of the guidance of
NICE to do so.
Credibility has been further stretched, we understand,
by technical errors in NICE guidance. An example of this would
be the suggestion that Relenza be made available through Patient
Group Directions when this was not possible as the product was
a "black triangle" drug.
13. As a result of these problems of credibility
and funding together with other issues, the NHS Alliance is aware
that the implementation of NICE guidance has been patchy. The
government has responded by making the funding of NICE recommendations
mandatory. This may simply move the argument from one of funding
to one of evidence.
14. As has been previously indicated, it
is appreciated that NICE do not select items for appraisal. This
is in direct contrast with the comparable body in Scotland, the
Health Technology Assessment Board. Whoever selects the items
for assessment, it is necessary for the process to be more inclusive,
transparent and to take account of NHS priorities at the "sharp
end" than is currently perceived to be the case.
15. NICE is of course a Special Health Authority
and is appointed by the Secretary of State and accountable to
him/her. Whilst this arrangement continues calls for greater independence
of NICE are specious. The NHS Alliance notes that the lack of
independence of NICE may damage its credibility with those in
the front line of the NHS.
16. NICE applies to England and Wales but
not Scotland and Northern Ireland. Arrangements are therefore
potentially duplicatory and confusing. There should be one body
across the UK that gives guidance to the NHS. The position is
further confused by the existence of other bodies such as the
Scottish Medicines Commission (Consortium?) the All Wales Medicines
Strategy Group and the CREST in Northern Ireland. The NHS Alliance
is concerned that the existence of so many different bodies may
impact upon equity and implementation across the UK.
17. Finally, NICE was established not only
to give guidance to the NHS and those working within it, but also
patients. It does this by including a section on guidance for
patients in each of its technology assessments. This is of limited
value. NICE should be issuing guidance for patients that is much
wider and related to therapeutic areas and not specific interventions.
There is an opportunity to advise patients of what they might
expect from the NHS, what their responsibilities are, and the
relative merits of different interventions that would assist with
informed choice and concordance including patient participation
in medicine taking. This opportunity is being missed at present
The NHS Alliance supports the existence of a
strong, credible body at national level to issue guidance to the
NHS on effectiveness. For reasons both within and outside of the
control of NICE, its activities fall short of this and its own
objectives. The operating principles of NICE, and the context
in which it works, need urgent review and can be improved by addressing
the issues identified in this paper.