Select Committee on Health Minutes of Evidence

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.


  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 of reasons:

    —  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 zanamivir.

    —  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 use. [1].

    —  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 Technology Appraisal.

    —  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.


  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 been addressed.


  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 guidance).


  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 NICE guidance.

    (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 quality.

    (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 NICE guidance.

    (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

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