APPENDIX 6
Supplementary evidence by Croydon Health
Authority (NC 31A)
Copy of a letter dated 13 August from
South and West Health Authorities Pharmaceutical Advisors to the
Head of MPI Group Department of Health
NATIONAL INSTITUTE
OF CLINICAL
EXCELLENCE (NICE)
The Pharmaceutical Advisers from the South West
Health Authorities would like to raise our concerns regarding
the NICE with you. As you will be aware there is disquiet about
the guidance that NICE has issued such that it is our belief that
the laudable aims of the NICE are under threat. We have considerable
experience of managing the entry of new medicines through our
Area Prescribing Committees and feel that some of the lessons
that we learnt could be adopted by the NICE.
Prior to the NICE, the Wessex Development and
Evaluation Committee (DEC) undertook evaluations prioritised by
the South West Health Authorities and provided us with clear recommendations.
Attached is the whole decision matrix (as updated in March 1998)
which led to one of the following five recommendations being made:
— Strongly supported—good evidence
of excellent or ordinary value for money, or moderate quality
of evidence of excellent value for money.
— Supported—poor evidence of
excellent value for money or good evidence of ordinary value for
money.
— Limited support—evidence of
poor value for money or poor evidence of ordinary value for money.
— Not supported—evidence of more
harm than good.
— Not proven—evidence inadequate
or inconclusive.
This framework was invaluable to Health Authorities
in setting our priorities and we strongly believe that adopting
a similar approach would increase the credibility of the NICE.
As the NICE's workload increases it will be impossible to implement
all the guidance immediately. Adopting a mechanism for prioritisation
should ensure that interventions supported by strong evidence,
which will have the biggest impact on health gain, would be introduced
as quickly as possible.
When implementing NICE guidance we have to contend
with all other competing priorities, for example, National Service
Frameworks (NSFs) and NHS Plan requirements. Prioritisation of
NICE guidance will help to ensure the place of NICE guidance against
these other competing demands.
There have been inconsistencies in the representation
of the evidence in NICE guidance. For example,
— The zanamivir (Relenza) guidance
relied heavily on unpublished data which is not recommended by
the exponents of Evidence Based Medicine.
— The rosiglitazone guidance appears
to ignore the hard outcome data from the UKPDS for insulin in
combination with metformin or sulphonylureas by suggesting that
rosiglitazone (which only has HbA1c rather than hard outcome data
to support its use) should be offered as an alternative to insulin.
We are also concerned that the NICE does not
appear to adopt a consistent approach to evaluating the cost effectiveness
of interventions. In particular, the guidance for both riluzole
and drugs for Alzheimer's disease discuss the lack of reliable
cost effectiveness information but then recommends these treatments.
However, we understand that the guidance for the treatments for
multiple sclerosis is being held up because of concerns regarding
the methodology used to assess cost benefit. We believe that a
consistent approach, similar to that developed by DEC, should
be adopted.
As Health Authority Pharmaceutical Advisers
we would recommend that the draft technology appraisals are available
to all at an early stage and that the NHS has the same right of
appeal as invited specialists, patient organisations and the manufacturers.
Prior to publication, pharmaceutical company representatives have
often seen the draft guidance but we only know the evidence base,
which has not proved to be a good predictor of NICE guidance.
We feel that adopting the current approach is excluding the wealth
of knowledge and experience that the NHS has developed over the
years. Pharmaceutical Advisers and our colleagues in Public Health
could provide valuable input into the NICE's guidance at an early
stage.
The current system of secrecy also places us
in a difficult situation on publication of NICE guidance, as we
receive enquiries from within the NHS, the press and public. On
one occasion the press had seen the guidance but the NICE website
had not posted it so we could not obtain it. We believe that those
in the NHS who will be responsible for implementing NICE guidance
(usually Public Health, Pharmaceutical Advisers and PCT Prescribing
Leads) should be allowed sight of the guidance before it is released
to the press.
Public expectation is immense, fuelled by the
media, and it is necessary to recognise the time it takes to bring
all the relevant local players together to plan local implementation
of the NICE's guidance. Therefore, we would urge you to consider
setting realistic timescales for the implementation of NICE guidance
within the guidance, and public information, so that public expectation
is realistic. Using a prioritisation scheme similar to that used
by DEC would provide a strong basis on which to set realistic
timescales. For example, a classification of "urgent implementation"
might be employed with a time-scale of three to six months, whereas
a classification of "recommended use" might require
implementation over the following three years, recognising the
financial frameworks that Health Authorities and Primary Care
Trusts operate within.
We are also concerned to see that the NICE does
not appear to have a robust "Declaration of Interests"
procedure. We believe that the NICE should be up front and seek
and publish in their guidance any material interests relevant
to the guidance from all members of the Appraisal Committee as
well as patient organisations and specialists consulted during
the development of the guidance. The Department of Health's recently
published guidance provides extremely useful advice that we believe
must be followed if the NICE is to be perceived as a credible
body.
We hope that our thoughts will be seen as constructive
as is our intention. We want the NICE to succeed but believe that
fundamental changes along the lines we suggest above are necessary
in order for the NICE to be seen as a credible body by the NHS.
We would be happy to discuss any issues with you or your representatives
further if you think this would be helpful.
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