APPENDIX 18
Memorandum by Dr Stephen Head, Chairman,
PACE (NC 72)
EVIDENCE FOR
THE NEW
INQUIRY INTO
THE NATIONAL
INSTITUTE FOR
CLINICAL EXCELLENCE
(NICE)
1. Summary. The concept of NICE was widely
welcomed by local NHS management but the way it currently functions
creates more difficulties than it solves. NICE must provide timely
advice, usually at the time of licensing, and if there are delays
NHS use should also be delayed. NICE should assess treatments
in more global health economic terms, especially considering the
current NHS environment (in terms especially of human and financial
resources) and explicitly include the Opportunity Cost of their
advice. More "ordinary" people should inform NICE advice:
NHS clinicians, managers and non-sectionist members of the public.
We do not believe these changes would do any harm to the Pharmaceutical
Industry's substantial interests in the NHS.
2. The authors. This evidence was prepared
by the Prescribing and Clinical Effectiveness (PACE) Group. This
is a committee of North Derbyshire Health Authority, which provides
advice to the local health community. The Authority, Primary Care
Trusts, Acute Trusts, the Community Trust and Local Medical Committee
are represented. Membership is largely professional with pharmacists,
hospital doctors, general practitioners, nurses and public health
specialists. One or more members of the Group would be willing
to attend to give oral evidence if requested. We feel our evidence
reflects the typical problems encountered by local health bodies
in coping with NICE as it currently works.
3. The duty to identify and meet health
needs remains a local function, at least until NICE has reported;
and local commissioning bodies are explicitly forbidden to defer
decisions on using new treatments "pending NICE guidance".
This leaves local managers having to try to "second guess"
what NICE will decide. Different local managers may guess differently:
hence perpetuating "Postcode Rationing" and be at risk
of major problems should they invest heavily in treatments that
NICE subsequently rejects or accepts only with rigorous conditions.
We believe NICE should report on treatments at or prior to licensing;
and where for whatever reason they fail to do so, there should
be a moratorium on NHS use pending NICE's assessment.
4. The need for such timely advice is not
helped by the quasi-judicial processes by which NICE operates.
Inevitably the most contentious issues, are the ones on which
guidance is most needed quickly, yet precisely those where delays
are most likely. This also appears to have affected the ability
of the organisation to consider all available evidence in some
cases. We believe NICE should report promptly "and regardless".
Organizations that wish to dispute NICE guidance may do so AFTER
it is issued, and if they make a successful case there is nothing
to stop revised guidance being issued later. Almost four years
after North Derbyshire Health Authority was taken to Judicial
Review for our policy on Beta-Interferon in multiple sclerosis,
the NHS is still waiting for a definitive answer to the place
of this drug in NHS practice.
5. Although committed to consider cost-effectiveness
in its deliberations, NICE does not answer the needs of local
health managers and clinicians on broader resource issues, nor
does it appear to make recommendations that are sensitive to current
resourcing problems. The anti-obesity drugs illustrate this, where
there is simply not the dietetic and nurse time available to provide
the level of support likely to make the drugs beneficial, and
indeed without such support it might be questionable if they were
being prescribed within their Product Licence.
6. The influenza drug Zanamivir was approved
by NICE, subject to certain conditions of use, yet fewer than
10 prescriptions were issued for it last Winter in North Derbyshire.
It runs totally counter to the current emphasis in Primary Care:
scarce resources being targeted at Chronic Disease Management
with the prospect of substantial proven health gain. We found
the suggestion of using Patient Group Directives a most worrying
solution, considering the novelty of the drug, reports of adverse
events, and the fact the most patients in the target group would
probably be unfit to attend a pharmacy anyway.
7. NICE should have a much sharper Health
Economic focus, not simply looking at the cost effectiveness of
individual therapies but global issues of funding, effects on
NHS resources, and the Opportunity Costs associated with adopting
new therapies.
8. Perhaps this process requires some "grass
roots" input. We have often felt advocacy groups: the Pharmaceutical
Industry, patient interest groups and clinicians or academics
with a special interest have dominated the evidence and hence
the conclusions of NICE. It is local clinicians and managers who
must implement the decisions; they should at least have a strong
say in how those decisions are made. Similarly patients' interests
could also be seen in "holistic" terms with the views
of patient/tax payers without a strong sectionist advocacy being
sought.
9. Given finite NHS funding we do not believe
these ideas pose a threat to the Pharmaceutical Industry. The
only way the Industry can do better from the NHS is through greater
global health funding, or a greater proportion of NHS funding
being spent on pharmaceuticals. Our proposals would threaten neither
of these two options, but would ensure NHS resources were used
in a more effective way to promote patient care. Given these realities
a NICE which really did address NHS management needs, with front
end (ie pre licensing) assessments and a cost sensitive evaluation
would do the Industry no harm. At least by correctly identifying
NHS impact (and hence sales) it would allow the Industry to plan
on a more rational and therefore more efficient basis.
2 January 2002
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