1.  INTRODUCTION

  1.1  Breakthrough Breast Cancer is the UK's leading breast cancer charity and is committed to fighting breast cancer through research, campaigning and education. Breakthrough has established the UK's first dedicated breast cancer research centre, in order to realise our vision: a future free from the fear of breast cancer. Breakthrough campaigns for policies that support breast cancer research and improved services, as well as promoting breast cancer education and awareness amongst the general public, policy makers, health professionals and the media.

  1.2  Breakthrough works closely with healthcare professionals, patient advocates, and researchers. Our memorandum incorporates the views of Breakthrough and members of its Campaigns & Advocacy Network (Breakthrough CAN)—which is made up of over 800 individuals and organisations. Many members of Breakthrough CAN have personal experience of breast cancer as well as being involved in and working alongside their local NHS to try to deliver better treatments and services for people affected by breast cancer and their families. Breakthrough CAN members are also involved in the work of the National Institute for Health and Clinical Excellence (NICE), for example by providing their views on NICE consultations, new technologies and clinical guidelines. Comments from Breakthrough CAN members are included throughout this submission.

  1.3  Breakthrough welcomes this inquiry into NICE. Our memorandum focuses on the work of NICE, areas where NICE has developed and the challenges it currently faces. Breakthrough staff and CAN members would be willing to provide oral evidence to this inquiry, if the committee would find this useful.

2.  THE ROLE OF NICE

  2.1  NICE plays a vital role in reducing inequalities in access to quality care and treatment by establishing best practice guidance to be followed across the NHS in England and Wales. Breakthrough Breast Cancer believes it is very important that all patients receive the same standard of care no matter where they live.

  2.2  By providing guidance that is based on both clinical and cost effectiveness, NICE also plays an important role in ensuring that patients receive effective treatments and care that also provide value for money.

  2.3  It is important that all guidance produced by NICE continues to carry weight in order to reduce the post code lottery in accessing services, standards of care and treatments. Many Primary Care Trusts (PCTs) will wait until NICE has published guidance on new treatments before it prescribes to patients. It is only then that they have a statutory duty to do so. However, as clinical guidelines produced by NICE are not mandatory, there is significant variability regarding their implementation. All patients should expect to be given the best practice of care, regardless of where they live.

3.  PUBLIC CONFIDENCE AND UNDERSTANDING OF NICE

  3.1  Breakthrough Breast Cancer welcomes the move by NICE to run consultations on many of their processes, such as the technology appraisal process, clinical guideline development and interventional procedures appraisal process. This demonstrates a willingness to be efficient and inclusive.

  3.2  It is very important that NICE continues to provide opportunities for the public, individual patients and stakeholder organisations to be involved in their work. Breakthrough welcomes the opportunities it has to involve staff and Breakthrough CAN members in the work of NICE. For example, a Breakthrough CAN member was chosen as a patient expert in the Single Technology Appraisal of Herceptin; a staff member was chosen as a patient expert in the Single Technology Appraisal of docetaxel; and a staff member was selected to be on the Guideline Development Group for the update of the Familial Breast Cancer guidelines.

  3.3  Public confidence in the role of NICE is mixed. High profile debates over negative decisions by NICE (most recently demonstrated over the Alzheimer's treatments donepezil, rivastigmine and galantamine) and the variability of access to treatments, [45]services and standards of care strongly influences the public's opinion of NICE. Quotes from Breakthrough CAN members highlight a range of views:

"I think NICE have improved dramatically since their inception and there is more understanding in the media and elsewhere about their role." Breakthrough CAN member

"I think we only hear about the work of NICE when it hits the headlines." Breakthrough CAN member

"I think [NICE guidance] is too much based on cost-effectiveness." Breakthrough CAN member

  3.4  Public confidence may be largely affected by a lack of understanding of the role of NICE. Whilst many people would agree with the core principle of NICE to reduce inequality in access to treatments and care, there is a lack of understanding of how NICE produces guidance and how it makes its decisions. This is illustrated by some quotes from Breakthrough CAN members:

"I don't know enough about NICE." Breakthrough CAN member

"The idea of NICE is good but I'm not sure how it works in practice." Breakthrough CAN member

"NICE could do a better job of explaining their decisions—there might be very good reasons for their decisions but the media report them as a yes or no and it's not that straightforward." Breakthrough CAN member directly involved in the work of NICE

  3.5  Public expectations of NICE and healthcare overall continue to rise as they became increasingly aware of both the role of NICE and the many new treatments that are being developed and licensed for use in the UK. Breakthrough believes NICE will face mounting pressure to produce guidance on an increasing number of treatments. As advances in technology result in more targeted and expensive treatments, NICE will face greater levels of objections to negative decisions which may appear to be driven by cost factors.

"We pay for our health during our working lives in National Insurance contributions—we are entitled to the drugs." Breakthrough CAN member

"Misrepresentation in the media makes me angry as it raises expectations among patients and not always justifiably." Breakthrough CAN member

  3.6  Increased litigation and judicial reviews could be one of the more significant consequences NICE and PCTs will face.

4.  THE EVALUATION PROCESS AND PUBLISHING OF GUIDANCE

  4.1  There is currently a lack of clarity over how topics are selected for appraisal by NICE. For example, Herceptin for early stage breast cancer treatment was referred by the Secretary of State for Health, Patricia Hewitt, to a fast-track appraisal, following the announcement of significant clinical trial results in May 2005. If this had not happened, there would have been a significant delay in this important treatment being available to patients across the NHS. As the Prime Minister made clear at the time:

"The steps recently announced by my right hon Friend the Secretary of State for Health should mean that the drug [Herceptin] is available throughout the country as swiftly as possible. Because the matter arises as a result of the National Institute for Health and Clinical Excellence guidelines, we are looking at how we can speed up the process in cases where it particularly matters to people who may be desperately ill and who think there is a drug on the market that can help them. We all accept that at present the procedures are too slow. The idea of NICE is an excellent idea. It has a broad measure of support, but we need to make sure that its processes work more quickly so that what has happened in the case of this drug is not repeated."

Prime Minister, The Rt Hon Tony Blair MP, 19 October 2005

  4.2  The introduction of the Single Technology Appraisal (STA) process has undoubtedly provided a quicker, more efficient system for producing guidance recommendations on new treatments.

  4.3  Breakthrough welcomes the recent amendment to the STA process which now allows all patient organisations to provide a statement regarding a new technology. Previously, it was felt that the new STA process significantly reduced the input from the patient perspective, only allowing a few individuals to provide their views. Such views may not have been truly representative of affected patient populations thus this recent change goes someway to address this issue. This is an issue that was recognised by both patient organisations and patients alike:

"I like the idea of the process being speeded up but don't want this to happen without full participation and involvement of all interested parties." Breakthrough CAN member

"I think it is important that patient representatives are fully conversant with all aspects of the illness and can represent all views not just their individual ones." Breakthrough CAN member

  4.4  Whilst the new appraisal process reduces the amount of bureaucracy, it is questionable whether NICE currently has the capacity and resources to cope with the increasing numbers of technologies being developed. NICE must be reactive to such increasing demands and ensure capacity is available to produce guidance promptly and appropriately.

"NICE seems to lack the resources to undertake the masses of work required to evaluate all possible future drugs." Breakthrough CAN member

  4.5  Furthermore, it is not clear whether NICE is sufficiently resourced with appropriate systems to deal with advances in treatments, many of which will cost significantly more than current available treatments thus the current cost thresholds applied by NICE may no longer be appropriate. Breakthrough is concerned that if NICE does not review its current cost thresholds there is a danger that the NHS will not keep up-to-date with treatment advances and that patients in England and Wales will not be offered the most effective treatments for their conditions. For example, breast cancer patients in the UK have lower survival rates than many other countries in Europe[46] thus cannot afford to be denied the most effective treatments.

  4.6  There is concern that the existence of different organisations and systems for producing guidance on new technologies and standards of care in the UK actually introduces a post-code lottery. The fact that organisations, such as the Scottish Medicines Consortium, the Scottish Intercollegiate Guidelines Network and the All Wales Medicines Strategy Group, are all producing guidance, and in different ways, causes confusion and sometimes also anger. There appears to be a lack of consistency on what guidance is prioritised, on what basis the guidance is produced and the length of the process to produce guidance.

"It is very wasteful and inefficient to have more than one organisation in the UK evaluating new drugs and, in comparison with the SMC, NICE seems to be much less efficient. This is not acceptable." Breakthrough CAN member

5.  NICE'S DECISIONS

  5.1  There is concern that the decisions made by NICE do not fully take into account quality of life issues for patients. The process by which decisions are made places greater weight on the evidence for survival benefits of treatment and care, than on improvements to quality of life. This is an issue of particular importance to cancer patients, particularly those with advanced, metastatic cancer. Patients with metastatic breast cancer typically have limited treatment options and, understandably, want access treatments and care that will give them the chance of an improved quality of life to spend more quality time with their friends and families. For these patients, the importance of quality of life cannot be underestimated. Breakthrough believes NICE should review their decision-making processes to take greater account of quality of life issues, and consider whether there is future scope to include the wider benefits to society of new technologies and care options, such as the longer term savings of investments, in their decision-making.

"In determining cost effectiveness it would seem important to consider future cost to the health service and other care services." Breakthrough CAN member

"NICE should look to the future—life-saving drugs will eventually save money for the NHS in terms of long term care / hospital treatment etc." Breakthrough CAN member

  5.2  As a research charity, Breakthrough believes it is vital that proven results from clinical research are promptly translated into benefits for all clinically eligible patients. It is important that the NICE appraisal process is as efficient as possible so that patients may benefit quickly, by having the capacity to undertake the work ensuring that unnecessary delays are not introduced.

  5.3  An example of where the NICE's appraisal process may be delayed is the use of the system to appeal decisions. If an appeal to a decision of an STA is made, this can significantly delay the issuing of guidance to the NHS. While it is necessary that the right to appeal is maintained, it should be ensured that the appeal system is not used to obtain clarification or deliberately delay guidance.

  5.4  The Final Appraisal Determination on Herceptin was appealed in July 2006 by Newbury and Community Primary Care Trust. The majority of the points involved in the appeal were actually regarding clarification of a number of statements within the guidance, rather than an outright objection to it. This could have been dealt with more effectively earlier in the appraisal process.

6.  IMPLEMENTATION OF NICE GUIDANCE

  6.1  Breakthrough Breast Cancer is concerned that guidance from NICE is not consistently implemented across the NHS. This results in disparities in access to treatments and the best standards of care, which have been shown to be clinically and cost effective. For example, Breakthrough is aware that there is wide variation in the use of Herceptin in the treatment of secondary breast cancer, as, in many places, it is not offered to all eligible patients who could benefit from it. [47]

  6.2  Currently, there appears to be little incentive to ensure guidance is implemented and there is a lack of penalty for non-implementation. This issue should be addressed as a priority by the Department of Health, NICE and the Healthcare Commission. One of the key principles of NICE is to ensure equality in access to the best standards of treatment and care—there is limited value to NICE's guidance if it is not implemented consistently.

"NICE should have more authority in making people follow the guidelines." Breakthrough CAN member

"A huge amount of time and expense goes into drawing together guidelines so implementation is very important." Breakthrough CAN member directly involved in the work of NICE

  6.3  For some services, there is wide variation in clinical practice as clinical guidance from NICE is not mandatory. Breakthrough is aware of variation in lymphoedema services for breast cancer patients despite NICE's Improving Outcomes in Breast Cancer (2002) guidance which stated that "networks should agree guidelines for identification and management of lymphoedema". The Lymphoedema Support Network, a national patient support group for this condition, has identified national deficits in service provision in the UK, with many parts of the country failing to offer any service. Where care is provided, it is delivered through acute specialist centres or palliative care centres, with few providing all elements of the required therapy.

  6.3  Information provided to Breakthrough by breast care nurses from across the UK has identified instances where the value of specialist breast care nurses is being questioned, with some having to justify their roles within hospitals and/or carry out non-specialist duties, taking them away from caring from breast cancer patients. The value of specialist breast care nursing posts, and their benefits to patients and impact on clinical outcomes, is clearly identified in NICE's Improving Outcomes in Breast Cancer (2002) guidance. Breakthrough is disappointed that in some areas specialist nurse posts are under threat and believes that there needs to be a review of the implementation of NICE clinical and commissioning guidance and how it is prioritised within the NHS.

  6.4  Women with significant risk of developing breast cancer because of their family history are entitled to annual mammography breast screening between the ages of 40-49 through a breast clinic. In addition, some women at high risk of developing breast cancer because of their family history may also be entitled to annual MRI screening from a young age. Women and healthcare professionals have told Breakthrough that they are struggling to access this "safety-net" screening as many PCTs are not commissioning the services.

"NICE guidance is one thing; it is another matter altogether implementing the guidelines at local level." Breakthrough CAN member

  6.5  Breakthrough is concerned that many PCTs are unprepared for new guidance which can result in resistance towards, and the lack of implementation of, guidance. Better horizon-scanning is very important in ensuring that plans are in place to react to and implement new NICE guidance. NICE could play a greater role in the initiation and success of horizon-scanning within the NHS, which is likely to result in a smoother take-up of new technologies and improvement in standards of care through more consistent implementation of their guidance.

7.  RECOMMENDATIONS FOR ACTION

  7.1  NICE must continue to involve the public, patients and patient organisations in its work and the development of guidance.

  7.2  NICE must ensure that it has sufficient capacity to provide thorough and prompt guidance within an environment of increasing numbers of technologies.

  7.3  NICE must ensure that it has sufficient capacity to, and demonstrate how, it will respond to increasing public expectations and make appropriate decisions within an environment of increasingly advanced and expensive technologies.

  7.4  Breakthrough urges NICE to review the current cost thresholds that are applied in cost effectiveness decisions, in the light of increasing numbers of advanced, expensive technologies.

  7.5  NICE must place greater weight on quality of life issues and Breakthrough also urges NICE to take into account wider benefits to society and future savings benefits when making their decisions regarding new technologies.

  7.6  Breakthrough believes that NICE should take a greater lead (alongside the Department of Health and Healthcare Commission) in ensuring implementation of their guidance within the NHS.

  7.7  Breakthrough believes that NICE could take a greater lead on implementing effective horizon-scanning within the NHS, in order to ensure that PCTs are able to effectively plan their services to be able to implement new guidance quickly and appropriately.

  7.8  NICE should ensure that the appeal system is used appropriately, ie to challenge recommendations rather than to achieve further clarity, which may include reviewing the STA system to allow for clarification at an earlier stage of the process.

Vicki Nash

Breakthrough Breast Cancer

March 2007

46   Coleman, MP (1999). Opinion: why the variation in breast cancer survival in Europe? Breast Cancer Research 1: 22-26. Back

47   Richard M (2006). Usage of cancer drugs approved by NICE: Report of Review undertaken by the National Cancer Director. Department of Health: London. Back