INTRODUCTION

  The Hepatitis C Trust is the only UK national charity for hepatitis C (HCV). It provides information, support and representation for all those affected by the disease. The charity was started, and is fully staffed, by patients. [85]

EXECUTIVE SUMMARY

  1.  Guidance is being challenged and the public are losing confidence in NICE because of a lack of understanding about the Institute's role and remit. An increased emphasis on `patient choice' is at odds with NICE's perceived role as gatekeeper to some NHS treatments. NICE have a very difficult job in counteracting these claims and communicating with the public, despite having a good track record at consulting with a wide range of patients. Many PCTs are failing to implement NICE guidance because they lack resources or have miscalculated the need for treatment in their area. This is particularly short-sighted because failure to treat an infectious disease such as HCV will increase future costs and burden of the disease.

WHY IS NICE GUIDANCE INCREASINGLY BEING CHALLENGED AND WHY IS PUBLIC CONFIDENCE IN THE INSTITUTE WANING

  2.  The various challenges to guidance could be perceived as due to a lack of confidence in the institute. The two are intrinsically linked.

  3.  Public confidence is waning and guidance is being challenged because patients misunderstand the role and remit of NICE. In our experience patients often do not realise that NICE is an independent body and see it as an extension of the NHS designed as a gatekeeper to clinical resources, and with an agenda to save money. Therefore when a decision is made not to recommend certain clinical treatment, patients assume this decision is based solely on financial arguments. This idea has been perpetuated by certain sections of the media while NICE's ability to rebut these arguments does not seem particularly strong or effective.

  4.  The concept of patient "choice" in healthcare may also have had an impact, in that patients could feel they are entitled to treatment that may not necessarily be suitable to their condition. When denied this treatment this is interpreted as being denied to the right to choose. This again could be improved by providing the public with better information about what treatment is appropriate.

NICE's Evaluation Process and Whether Particular Groups are Disadvantaged by the Process, and the Speed of Publishing Guidance

  5.  In our experience NICE's evaluation process is very thorough. The speed at which guidance is published can be slow at times but we accept this is often a consequence of the rigorous evaluation process.

  6.  A large proportion of patients with HCV have previously been, or still are, intravenous drug users (IDUs). This is a group that could easily be marginalised and disadvantaged by the evaluation process. In reality we have found that NICE has listened carefully to representations from The Hepatitis C Trust on behalf of such patients and have changed their technology appraisals as a consequence. For example in 2003/4 NICE considered the use of pegylated interferon and ribavirin for moderate to severe chronic HCV but stated that current IDUs "have high rates of discontinuation in trials and relatively high rates of psychiatric comorbidities, and thus do not achieve high success rates with interferon therapy." The Trust objected strongly to this both on the grounds of its accuracy and because we were concerned that the NHS would use this to deny treatment to current IDUs. Our objections were noted and the NICE committee amended the wording accordingly to `Current injecting drug users can have high rates of discontinuation in trials, and thus do not achieve success rates in trials with interferon alfa therapy as high as those obtained by other participants. However, there is evidence that where adherence is achieved, success rates are not significantly different'. They added: `the evidence provided by the experts persuaded the Committee that current information indicated that HCV re-infection rates for people on interferon or peginterferon therapy were low in those who continue to inject illicit drugs. Thus, although rates of discontinuation of injecting drug users in trials have been high, the Committee was prepared to accept that in naturalistic settings, the rate of discontinuation would not be so great as to prevent the treatment being cost effective.' We are very happy with this outcome and feel it demonstrates NICE's willingness to engage with patients.

The Implementation of NICE Guidance, Both Technology Appraisals and Clinical Guidelines

  7.  NICE has issued guidance on the use of combination anti-viral medicine for mild, moderate, and severe, chronic HCV. The decision on whether to treat a patient with mild HCV or whether to wait until the disease has reached a moderate stage is a decision the patient is asked to make. Put simply, if you have the disease and want treatment for it, NICE recommends you have it.

  8.  It is clear from the audit we carried out on behalf of the All-Party Parliamentary Hepatology Group (`A Matter of Chance') and from demands on our advocacy service that implementation of NICE guidance is patchy across the country, another so-called `post-code lottery.' Outright refusals to offer treatment are rare but instead patients are made to wait unacceptably long times. As a result waiting times to start treatment vary from a matter of just days to almost 2 years. There appear to be 4 main reasons for this—ignorance of obligations under NICE, budgetary constraints, insufficient staffing levels and problems in the commissioning process between Primary Care Trusts (PCTs) and NHS Hospital Trusts.

  9.  In particular, some PCTs do not seem to accept that guidance set out in NICE Technology Appraisals is mandatory or they feel it is `less mandatory' than other priorities such as balancing their budgets or they think that there is no time limit to implementation so that, provided they make NICE treatment available to a patient at some point (say, next financial year or even the one after), they are operating within NICE guidance.

  10.  In one case we came across a hospital (Addenbrookes in Cambridge) that changed the protocol for HCV treatment from that set out in NICE guidance in order to ration treatment by discontinuing it in certain cases after 3 months where it should have been continued for a full 48 weeks. This allowed them to treat more patients but to the disadvantage of others. The need for rationing appears to have been dictated by the failure of local PCTs to commission services adequately.

The Hepatitis C Trust

March 2007