Select Committee on Health Appendices to the Minutes of Evidence

Annex 1


  1.1  The principle of a national decision-making body producing clear guidance on the use of evidence-based interventions was seen to be a sensible approach to eliminate post-code prescribing. It was recognised that a national decision was sometimes necessary for the use of some expensive pharmaceutical agents and/or highly emotive areas of prescribing where the evidence-base was limited but patient expectations were high. There were also the perceived advantages that there would be less duplication of effort across the country in terms of Health Technology Assessments and an improved prioritisation system for those technologies to be funded. It was assumed that the guidance would inform national and local budget-setting processes to ensure adequate service provision.

  1.2  Specific concerns have been raised by local general practitioners following the publication of a number of the guidance documents and the recent change to the National Health Service Act 1977 making implementation of NICE guidance mandatory within a limited timescale.


  2.1  Clarity—guidance is presented in a concise manner and is, in general, relatively clear on the use of individual agents or drug groups when considered in isolation—eg riluzole, drugs to treat mild to moderate Alzheimer's disease, methylphenidate. What is less clear is the use of some pharmaceutical interventions in relation to conventional/alternative agents or treatment regimens available, or where the agent should be considered as part of an overall treatment strategy. Examples include:

  2.1.1  Zanamivir in the treatment of influenza—compared to placebo not to the current practice of rest, fluids and simple analgesia. The use of amantadine was also not considered for this indication.

  2.1.2  Selective Cox-II inhibitors in treatment of rheumatoid arthritis and osteoarthritis—not compared to ibuprofen 400mg three times a day, or a "lower risk" anti-inflammatory agent co-prescribed with gastroprotection.

  2.1.3  Sibutramine and orlistat for treatment of obesity in adults—their place in an overall obesity strategy was unclear.

  2.2  Credibility—many of the concerns expressed by local GPs have been with regard to the clinical and cost-effectiveness of the technologies appraised, these are outlined in more detail in paragraph 5. Other specific concerns raised are in relation to:

  2.2.1  Intervention recommended despite limited diagnostic accuracy—zanamivir to treat influenza—guidance recommended that clinical guidelines for the diagnosis of influenza should be developed to improve diagnostic accuracy and enable effective targeting of appropriate therapy.

  2.2.2  Prescribing guidance in conflict with the Summary of Product Characteristics (SPC)—zanamivir to treat influenza —when prescribing any new drug with limited safety data, prescribers are recommended to prescribe only within the parameters of the current SPC. This was not the case with the guidance issued. This concern would appear to have been addressed in more recent guidance—sibutramine for treatment of obesity.

  2.2.3  Safety concerns—zanamivir to treat influenza—Glaxo Welcome revised warnings during July 2000 in the US; zanamivir should not generally recommended for treatment of influenza in patients with known airways disease. Despite this and limited evidence of clinical effectiveness, these patients were considered to be appropriate candidates for therapy in the NICE guidance. Locally the decision was made that the supply of zanamivir via a Patient Group Direction was inappropriate due to limited clinical and safety data.

  2.2.4  The implications of guidance on the workload in primary care—zanamivir to treat influenza—increased pressure on access to GP services, potential for increased consultations due to the common cold. Sibutramine and orlistat for the treatment of obesity—lack of clinicians specialised in the treatment of obesity, pressure to prescribe falls to GP.

  2.2.5  Concerns raised over data suppression and selective reporting of results by one manufacturer—use of selective Cox-II inhibitors for the treatment of rheumatoid arthritis and osteoarthritis.

  2.2.6  Disparity between the translation of the Health Technology Assessment report to guidance issued by the Appraisal Committee—riluzole for the treatment of Motor Neurone Disease.

  2.2.7  Emphasis of unpublished data on conclusions of Health Technology Assessment reports and subsequent appraisal—zanamivir to treat influenza

  2.3  Recommendations for consideration:

  2.3.1  Where necessary, develop clinical guidelines in conjunction with guidance in order to place the technology into an overall treatment strategy to encourage appropriately targeted therapy thereby maximising health gain. Consider all treatment options for the indication.


  3.1  Unfortunately not. NICE guidance has become an "additional" national focus for pharmaceutical and non-pharmaceutical technologies alongside National Service Frameworks (NSFs) and the numerous national and locally agreed treatment guidelines. As of January 2002, mandatory NICE guidance has effectively become another "must do" that competes with other national policies, including clinical governance and waiting lists and access targets, in terms of implementation and priority for resource from the unified allocation. By making NICE guidance mandatory, there is also the potential to divert funds from other technologies with a sound evidence-base and improved health gain but which are not to be reviewed by NICE and are effectively not a "must do". In addition to this local flexibility is lost with regard to planning service provision to ensure appropriate prescribing eg development of a strategy to manage obesity. GPs will be forced to fund the prescribing before support services are in place.

  3.2  In an environment where there are numerous policy documents with limited funding available, it is necessary to "prioritise the priorities". Inevitably this will result in a postcode service provision through either the decision not to fund a drug therapy or the need to suspend services in order to fund an overspend. Locally, the latter is currently the case.

  3.3  There is a degree of confusion locally over the place of NICE clinical guidelines in relation to NSFs eg Post-MI clinical guidelines versus NSF for Coronary Heart Disease, Mental Health NSF local treatment guidelines for the management of schizophrenia and depression versus future NICE guidelines. In addition to this, guidance issued is often in conflict with the Drugs and Therapeutics Bulletin (zanamivir, pioglitazone, rosiglitazone and sibutramine), a publication held in high regard.

  3.4  Recommendations for consideration:

  3.4.1  Publish guidance that is already pre-prioritised and includes more realistic timescales. For those interventions that require immediate implementation (within 6 months), funding should be allocated in year. Guidance allowing longer-term implementation, reflecting the health gain achieved from the intervention, would enable planning of services and an assessment of the budgetary implications. Although this would have the potential to result in postcode prescribing, it would allow some local flexibility to reflect local population health needs and services.

  3.4.2  If national policy (NICE and NSFs) continues to be issued with targets for implementation then this must be reflected by realistic budgetary uplift to the unified allocation.


  4.1  It is widely accepted that ownership of guidelines is highest in those who have been involved in the development of such guidance. For a number of years, the local Prescribing Committee has brought together general practitioners, public health specialists, pharmaceutical advisers and secondary care consultants to appraise the evidence base of chosen drugs and plan implementation. Whilst it is recognised that national guidance is a sensible approach to avoid duplication of effort, some loss of local ownership is inevitable.

  4.2  Whether NICE guidance has been acted upon in an appropriate manner will obviously depend on the person/organisation asked ie NICE or a general practitioner with overall clinical responsibility for prescribing.


  5.1  As mentioned previously there have been concerns raised locally regarding the clinical significance and quality of evidence on which some of the guidance has been based and how transferable these results are to general practice.

  5.2  Zanamivir to treat influenza:

  5.2.1  The initial Health Technology Assessment report concluded that there was an insufficient evidence base in "at risk" patients to recommend the routine use of zanamivir. The data was suggestive of a benefit but did not reach statistical significance.

  5.2.2  An additional submission, in confidence, studied the use of the drug in only one group of "at risk" patients, those with asthma and COPD. The primary outcome measure, time to alleviation of symptoms, did not reach statistical significance when analysed by intention to treat. Despite this and safety concerns highlighted in the US for this patient group, NICE guidance endorsed the use of zanamivir in such patients.

  5.2.3  The majority of patients in the trials considered were under the age of 65 years. However, zanamivir was recommended for use in the over 65 year age group.

  5.2.4  Patients participating in the trials presented well within 48 hours duration of symptoms, it is unclear whether this would happen in general practice.

  5.2.5  Trials documented a high prevalence of influenza (unclear in supplemental report) and low vaccination rate, again questioning the validity of results outside the trial environment.

  5.2.6  The overall reduction in duration of symptoms was small and the reduction in use of antibiotics (of borderline significance) was seen as an inappropriate indicator for assuming a reduction in hospital admissions and death.

  5.3  Orlistat and sibutramine in the treatment of obesity:

  5.3.1  Although the trials have shown statistically significant differences in weight loss compared to placebo, the mean differences between treatment groups were sometimes small and therefore may not be clinically significant. This may also apply to secondary outcomes measured eg changes in lipid levels and indicators of glycaemic control. It is therefore left to the prescribing GP to decide whether these differences are of clinical significance to their patients.

  5.3.2  A positive result reported in one trial may have been over-emphasised due to the failure to analyse by intention-to-treat.

  5.3.3  Both drugs have not been shown to be effective and safe in the longer-term.

  5.3.4  Weight loss following cessation of therapy is usually regained over time and therefore the use of anti-obesity drugs may detract from patients making long-term healthy lifestyle changes.

  5.3.5  Many contraindications, potential drug interactions and stringent requirements for monitoring make sibutramine difficult and impractical to use—Drugs and Therapeutics Bulletin 2001; 39(12): 89-91.

  5.4  In terms of cost-effectiveness of guidance issued, it is recognised that pharmacoeconomic analysis is a relatively new science and is only as robust as the data included. Much of the evidence on cost-effectiveness of newer interventions remains inconclusive due to insufficient information and therefore it is recommended that these data models be viewed with caution. Despite this, the Institute has issued guidance that requires vast sums of investment for drugs where the cost-effectiveness of such interventions is uncertain (riluzole, zanamivir, drugs to treat Alzheimer's disease).


  6.1  It is unclear from the guidance documents whether Appraisal Committee members have interests to declare and, if they do, there is no indication as to how the Institute deal with these potential conflicts of interest or if the individual is distanced from the appraisal process in any way.

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Prepared 8 July 2002