EXECUTIVE SUMMARY

  1.  Help the Aged recognises the important role that NICE has to play in ensuring the clinical effectiveness of drugs and providing evidence based best practice, clinical guidelines to improve the quality of clinical practice. However, the credibility of NICE is at stake unless action is taken to:

(a)  Establish NICE as a valid assessor of evidence of clinical effectiveness by separating this from the role of "rationing" what is funded.

(b)  Improve communication with stakeholders.

(c)  Redress the balance between implementation of clinical effectiveness of drugs and clinical guidelines.

  2.  There is a conflict between the roles of making an objective assessment of clinical effectiveness and making a judgement about funding based on economics and cost. These roles should be separated so that NICE is seen as a valid assessor of evidence. Central Government should be responsible for making a decision about funding based on the evidence supplied by NICE.

  3.  The reports published by NICE on the assessment of the clinical effectiveness of drugs and the decisions for funding are inaccessible to the public as the language is overly technical and there is no attempt to address some of the concerns that will be raised by the public about quality of life and people's experience of using the drugs.

  4.  The system of stakeholder engagement is too complex and time consuming and therefore excludes many smaller organisations from fully participating.

  5.  There is an imbalance in the media attention given to decisions on the funding of drugs and the publication of clinical guidelines and the impact of their implementation on the quality of clinical care. This means that the public perception of NICE is as a rationing body for the NHS.

  6.  Implementation of guidelines for drugs are also implemented and monitored with more vigour than the clinical guidelines which are poorly implemented with no real monitoring or performance by SHAs or the Healthcare Commission.

INTRODUCTION

  7.  Help the Aged has welcomed clinical guidelines aimed at improving outcomes for older people for example, dementia, falls and continence. We have however been disappointed in the poor implementation of this guidance and the relatively low priority that it is given by the NHS.

  8.  Help the Aged have been contacted by members of the public who have been unhappy with some of the decisions made about specific drugs, for example those drugs for people with Alzheimer's disease. We have found the information provided to the public on the NICE website to be poorly communicated and inaccessible. We have also been disappointed with the limited focus of NICE in assessing clinical effectiveness against the cost benefit, as it has not taken account of people's experience and the personal cost.

Why NICE's decisions are increasingly being challenged

  9.  NICE produces clinical guidelines based on best practice and technical analysis of the benefits and costs of drugs, leading to a decision on whether the drugs assessed should be provided by the NHS. It is the latter that receives the most challenge from the public and other stakeholders.

  10.  The public see the role of NICE as rationing which drugs can and cannot be provided, with the key factor being cost versus clinical effectiveness. The analysis which determines whether a drug is funded or not does not include the evidence of people's experience or the quality of their life. This means that some decisions inevitably provoke a response questioning the decision and requiring the reasoning be explained.

  11.  Although NICE make the reports available on how they assessed each drug and reached a decision, these are not presented in a way that is accessible to the public. They are very technical reports that could only be easily understood by other medics. The information is not presented in a way that is open to challenge as the language is inaccessible.

  12.  The decision making process for which drugs can be used by the NHS is therefore exclusive. This means that stakeholders such as charities and the public find other ways of making their views heard, for example lobbying and approaching the media.

  13.  The disadvantage of this is that some unpopular decisions get better coverage than others, if they are more attractive to the media. This potentially creates an unfair system if increased media coverage and the resulting public pressure leads to a reversal of decisions.

  14.  NICE have an important role to play in reviewing the clinical effectiveness of different drugs. However, they need to consider benefits within a wider context, including the user's experience and quality of life.

  15.  Decisions should be communicated in a clear and transparent way with collaborative dialogue that can respond to challenge in a constructive way. NICE should be proactive in explaining why decisions have been made that seem counter intuitive.

Whether public confidence in the institute is waning and if so why?

  16.  Help the Aged believe that public confidence in NICE is waning and this concerns us, as we recognise the importance of having an independent organisation that ensures the clinical effectiveness of drugs and provides best practice clinical guidance.

  17.  There is an inherent conflict between making objective clinical and technical assessments and those based on economics and cost. We recommend the separation of these two functions so that NICE is seen as a valid assessor of evidence and not a "rationer" of drugs.

  18.  The system of stakeholder participation is too complex and time consuming. Smaller organisations do not have the resources to engage or participate fully, thereby excluding important voices.

  19.  The NICE system excludes "softer" measures of efficacy and focuses on scientific evidence only which excludes important information.

  20.  There is an imbalance in the implementation of clinical guidelines and those for drugs, with the latter having more rigorous implementation. NICE needs to have adequate funding to promote the implementation of clinical guidelines.

  21.  NICE needs to develop effective public relations to promote the impact that the best practice guidance is having on the quality of clinical practice. This can only happen if local systems are put in place to audit the effectiveness of implementation and measure the outcomes.

  22.  Public confidence may well increase if the impact of NICE was more balanced with the outcomes of implementation of clinical guidelines promoted.

Whether any particular groups are disadvantaged by NICE's evaluation process?

  23.  The process is not inclusive as it is not communicated effectively to stakeholders. The reports are overly technical and are written in a way that is only accessible to professionals with a medical or scientific background. Neither is there an opportunity for clear and open dialogue, this results in lobbying organisations and individuals finding alternative routes. For example, using the media to help campaign for the use of Herceptin. This drug received a lot of media attention and public support as the cancer lobby is powerful, with a great deal of public support and many campaigners to mobilise. It is unlikely that there would be the same level of interest and support in, continence, for example, which is a far more taboo subject with weaker and less co-ordinated lobbing groups. This is why it is important to get the process right and to ensure that it is inclusive and open to challenge in a fair and constructive way.

The Implementation of NICE Guidance

  24.  As already stated there is an imbalance of implementation on the guidelines for drugs and clinical practice. Clinical guidelines are not implemented with any vigour. There are not effective local monitoring systems in place or systematic regulation.

  25.  The Healthcare Commission assesses NHS trusts against the core standard to implement national service framework standards and NICE guidance. However, the arms-length approach of regulation means that performance against specific guidance and NSF standards is not assessed unless part of a one-off improvement review or audit. There is not a recurring and systematic assessment of implementation for specific clinical practice guidance.

  26.  NHS trusts should carry out internal audits on the implementation of NICE guidance.

  27.  Strategic Health Authorities need to have robust systems in place to monitor the implementation of clinical guidelines

RECOMMENDATIONS FOR ACTION

  28.  NICE should provide clear, plain English reports on the clinical effectiveness of drugs in a way that is accessible to all stakeholders.

  29.  NICE should consider the quality of life to individuals as well as the cost benefit to the state in considering the clinical effectiveness of drugs.

  30.  The Government should take responsibility for funding decisions based on the independent report of clinical effectiveness provided by NICE. The current arrangement means that NICE has two conflicting roles, assessing clinical effectiveness and making a decision one funding. The funding decision is a political one. The Government is responsible for managing the public purse, and as such should take responsibility and be accountable for the tough decisions as to what the NHS can and cannot afford, based on independent evidence.

  31.  The implementation of clinical guidelines should be improved by:

—    NICE strengthening this role within its own organisation;

—    SHAs monitoring the performance of trusts against NICE guidance and NSF standards; and

—    NHS trusts carrying out regular audits on implementation of NICE guidance and NSFs.

Help the Aged

March 2007