Memorandum by Helen Marlow, Pharmaceutical
Adviser, Croydon Health Authority (NC 31)
The role of Pharmaceutical Adviser includes
supporting the Area Prescribing Committee (APC) develop local
prescribing policy, and support local implementation of NICE guidance
relating to medicines. Part of the remit of the APC in Croydon
is to advise on the relative priority of new drugs, and take a
strategic overview of the implementation of NICE guidance relating
to medicines. This report will focus on the Technology Appraisal
work of NICE.
2. IS NICE PROVIDING
NICE has a very difficult job to do, and has
high expectations to meet. This inquiry presents a good opportunity
for a stock take of whether NICE is meeting its objectives and
fulfilling the expectation of the NHS. A single national process
for evaluating new health technologies through NICE is welcome,
however sometimes the guidance can cause some confusion, rather
than making clear recommendations. NICE guidance may take a narrow
focus on a drug, rather than considering broader therapeutic aspects
of treatment, this can result in confusion, and some unanswered
questions about the use of a particular technology. For example,
NICE guidance on Proton Pump Inhibitors (PPIs) for dyspepsia does
not consider, or comment on the use of these drugs in patients
on non-steroidal anti-inflammatory drugs who have not had a gastrointestinal
bleed, although this is one of the common uses for PPIs.
From its inception there has been a perception
from within the NHS that NICE would produce high quality, credible
guidance. Sadly NICE's credibility has been damaged for a number
There was a certain amount of incredulity
within the NHS when NICE reversed its decision not to recommend
zanamivir for the treatment of influenza. There appeared to be
very little change in the evidence supporting the use of the zanamivir,
and there was a perception that there must have been external
pressure put on NICE to make a positive decision in favour of
Recommendations made by NICE can
appear to contradict the conclusions of the Health Technology
Assessment. There may be good reasons for this, but these are
often not made clear in the final guidance from NICE. For example
the Technology Appraisal for riluzole for motor neurone disease.
Guidance issued by NICE should be
evidence based, however there are times when recommendations made
by NICE do not appear to be consistently evidence-based. Where
this is the case this needs to be explained and a rationale given
for a recommendation. For example both rosiglitazone and pioglitazone
have been recommended by NICE to be used in circumstances where
there is a lack of published hard outcome data to support their
Credibility has been lost with some
clinicians, where guidance has been issued that appear to be at
odds with many clinicians' views. For example use of glycoprotein
IIb/IIIa inhibitors for unstable angina, where some cardiologists
and public health doctors feel there is very limited benefit from
use of these drugs for this indication.
The quality of critical appraisal
of clinical trials used to form the basis of Health Technology
Assessment (HTA) reports commissioned by NICE is variable. For
example the HTA for zanamivir, sibutramine, and the COX II inhibitors.
The HTA reports can include unpublished
data, which has not been subject to the same level of scrutiny
as peer reviewed published data. Much of the unpublished data
used for the HTA reports is not in the public domain, and therefore
is not open to proper scrutiny following publication of the NICE
There is a perceived conflict of
interest within the Department of Health that damages the credibility
of NICE, because the Head of Medicines, Pharmacy and Industry
Division is responsible for the Pharmaceutical Industry as well
as medicines within the NHS.
NICE does not appear to have a robust
"Declaration of Interests" procedure. In particular
material interests of those involved in developing guidance should
be declared at the time guidance is published.
There is a real need, and desire within the
NHS to have access to national, high quality, evidence based evaluations
of health technologies that provide the basis for local decision
making. NICE has the potential to provide this, but a tension
exists between national advice from NICE, and the statutory responsibility
of health authorities and PCTs to promote a comprehensive health
service locally within a fixed budget. NICE guidance has the potential
to distort local priorities by focusing on one issue, without
looking at the broader context of local health needs, which health
authorities and PCTs have to do. In some circumstances, particularly
where considerable controversy exists, NICE guidance may provide
clarity and a national focus, but in other circumstances NICE
guidance may create greater tensions locally because of the effect
it has on local priority setting.
4. GUIDANCE LOCALLY
Presently there is a lack of local ownership
of NICE guidance. There are several possible reasons for this:
The groups and individuals that NICE
consults when developing it's Technology Appraisals are generally
"the great and the good", and those with a vested interest
in the technology being assessed. Frontline NHS staff and policy
makers are not consulted in the drafting of NICE Technology Appraisals.
In addition, NHS Prescribing Advisers have been told by NICE that
the NHS has no right of appeal against NICE guidance. This is
not good basis on which to build local ownership.
Some NICE guidance, particularly
for medicines used in primary care, does not adequately address
many of the issues we have with the management of patients and
local care pathways. This is because guidance appears to have
been developed without full consideration of the therapeutic context
of the intervention.
There is no opportunity for the NHS
to provide practical feedback to NICE about how it's guidance
is received and implemented in practice, thus enabling some "closing
of the loop".
There are a number of issues around the implementation
of NICE guidance within the NHS:
The NHS is being required to implement
an enormous number of initiatives at the moment, which means most
of the NHS, but particularly GPs, are feeling overwhelmed with
work. In primary care implementation of the National Service Frameworks
(NSF) is a clinical priority, NSF guidance is clear, and there
is local ownership of the NSFs through local implementation groups.
This means that the capacity of the NHS to actively implement
guidance being issued by NICE is very limited.
The different way primary and secondary
care prescribing is funded within the NHS potentially affects
the way NICE guidance is funded, and thus implemented. GPs Terms
of Service require them to prescribe what is needed for their
patients, and they do not usually wait for funding before prescribing
a new drug. GPs prescribing budgets are less constrained than
their secondary care colleagues, who usually have very tight cash-limited
prescribing budgets, where new drugs are usually only prescribed
following funding being agreed with commissioners.
Clinical information systems particularly
in secondary care are not generally good enough to support implementation
of NICE guidance, or audit whether it has been implemented at
an individual patient level. Even if good information systems
were available there is a lack of manpower resources to retrieve
and analyse the information.
The National Prescribing Centre published
a guide to Implementing NICE Guidance last August. This guide
is helpful, but the broader strategic issues of implementing NICE
guidance in terms of capacity and resources needed to implement
and audit NICE guidance in an already stretched service have not
5. ACTIVELY PROMOTING
In some cases NICE guidance has ensured equitable
access to treatment for patients. But perversely in some circumstances
patients access to treatment maybe delayed for several reasons:
If it is known an intervention is
going to be appraised by NICE only limited funding maybe made
available locally pending publication of NICE guidance. This may
result in a waiting list for drugs rather than a waiting list
for treatment. If NICE guidance were timelier this would be less
likely to happen.
The focus and priority afforded to
NICE guidance may distort local priority setting; meaning money
is diverted to fund NICE guidance rather than locally identified
priorities. So patients may not be able to access treatments other
than those appraised by NICE or recommended in a NSF. The introduction
of Directions to the NHS to require Health Authorities and Primary
Care Trusts to fund the recommendations of NICE Technology Appraisals
within three months may magnify this problem further. The three-month
requirement to fund and implement may not always be realistic
when changes to services need to be made, particularly in secondary
care. For example, increased access to endoscopies (PPIs for dyspepsia
The perception that NICE reversed it's decision
not to recommend zanamivir for the treatment of influenza because
of strong political pressure raised some concern about NICE's
independence from government. There is presently some concern
within the NHS that despite the proposed recommendations in NICE's
Final Appraisal Determination on beta interferon and glatiramer
for multiple sclerosis, this recommendation may be circumvented
in some way. If this does happen it will increase concern regarding
external pressure on the work of NICE.
(a) The Department of Health considers how
the NHS can be best supported to manage the tension between local
priority setting, and the requirement to locally fund and implement
(b) NICE develops a strategy for addressing
the gap that exists between being a single national focus and
having locally owned guidance, including how the NHS can be consulted
about NICE Technology Appraisals, and feedback from the NHS to
"close the loop".
(c) NICE should be more open and transparent
about the reasons why there is an apparent contradiction between
HTA assessment and final recommendations in some guidance.
(d) The Scottish Intercollegiate Guidelines
Network (SIGN) produces high quality, user-friendly guidance and
should be seen as model of good practice.
(e) The Health Technology Assessments used
by NICE in Technology Appraisals need to be of a more consistent
(f) To increase their usefulness NICE Technology
Appraisals need to make recommendations in a broader therapeutic
context where possible.
(g) The Department of Health considers what
further resources and support it can give the NHS to implement
(h) NICE keeps some emergency slots for fast
tracking Technology Appraisals to ensure improved timeliness.
(i) Unpublished information used in Health
Technology Appraisals should be published in the public domain.
1 Gale E Lessons from the glitazones: a story of drug
development. Lancet 2001; 357: 1870-75. Back