EXECUTIVE SUMMARY

  RCLCF has engaged with NICE as a Patient Group, in both the NICE Technology Appraisal Process and in the Clinical Guideline Process:

—  NICE decisions are increasingly being challenged, as many of their negative appraisals are deemed grossly unfair.

—  Public confidence in NICE is waning.

—  The opinions of Patient Groups do not appear to have weight within the process. Technology Appraisals are heavily influenced by health economists.

—  The NICE appraisal process is far too long. Patients with life threatening and debilitating illnesses do not have time to wait. Until a positive NICE appraisal, there are considerable barriers to patients receiving new technologies.

—  Having separate NICE and SIGN guideline writing processes represent a waste of resource. However, collaboration in literature review, as in the Lung Cancer Guideline, was unsuccessful.

—  NICE Technology Appraisals tend to be implemented. However, only some recommendations in Clinical Guidelines are acted on.

BACKGROUND

The Roy Castle Lung Cancer Foundation (RCLCF)

  The Foundation is a UK wide charity, dedicated to the defeat of lung cancer. It funds basic science research, tobacco control initiatives and work in lung cancer patient information, support and advocacy. The Foundation, through its network of lung cancer patient groups, its information helpline, its Patient Advisory Board and Annual Patient Meeting, has the ability to collect the views of lung cancer patients. Ensuring equitable access to best treatment is of clear and obvious importance.

RCLCF and NICE

  RCLCF has had contact with NICE, since the Institute was created. As a charity, reflecting the views of its lung cancer patient group, the Foundation has acted as a formal consultee in the NICE Health Technology Appraisal Process (submitting comment and attending two technology Appraisal Committee meetings, in 2001 and 2007) and also in the Guideline Development process. During the development of the NICE Guideline for the Diagnosis and Management of Lung Cancer, RCLCF's Medical Director chaired the Guideline Development Group. This three year process, including collaboration with the SIGN group, gives her a fairly unique perspective.

Why NICE's Decisions are Increasingly Being Challenged

  1.  Patients and their families are increasingly aware that the NHS, because of financial constraints, does not always provide the best treatment and care possible. For individuals, this is important. With widespread use of the internet and health information in the media, it is easy for patients and patient groups to find out what new technologies are widely available elsewhere. When NICE, then, make a decision contrary to this, patients will be aware of the unfairness. Also, with the Scottish Medicines Consortium making much speedier technology decisions, any time that SMC and NICE decisions are different, it will be deemed to be grossly unfair.

Whether Public Confidence in NICE is Waning

  2.  Yes. Without doubt, public confidence is waning. Recent high profile rejections by NICE, for technology in debilitating and life threatening illnesses, have been deemed to be unfair. There appears a lack of understanding by NICE, of the importance to individuals, of relatively small improvements in quality of life and control of symptoms.

NICE's Evaluation Process and Whether any Groups are Disadvantaged

  3.  It is our observation, given recent experience in the NICE Technology Appraisal Process, that although NICE asks Patient Groups and Clinical Experts for submission and advice, their focus appears to be on the Health Economic Assessment alone. Even when clinician and patient experts, are convinced of the benefits of a given technology, they are apparently ignored, if the findings of the Evidence Review Group differ. As a patient group engaged in the process, we are not convinced that our contribution is given weight.

The Speed of Publishing Guidance

Technology appraisals

  4.  There is no doubt that the established process was far too long. In diseases, such as lung cancer, where the median survival from diagnosis to death is only six months, patients do not have time to wait for new technology. As examples, NICE have recently appraised Pemetrexed and Erlotinib for advanced lung cancer. Part way through the process it was switched to the Single Technology Appraisal system. Despite this, EMEA approval was given for Pemetrexed in November 2004, with the guidance being issued in February 2007. For Erlotinib, EMEA approval was granted in September 2005, with the NICE guidance issues in March 2007. These timelines are far too long. It will be interesting to see what impact the Single Technology Appraisal process will have. We do, however, have concerns that the STA process will lead to a rejection of increasing numbers of technologies, recommending review of the guidance in one year. This will, of course, create delay for patients.

Clinical guidelines

  5.  The Clinical Guideline for Lung Cancer Diagnosis and Treatment took three years from scoping to publication. The "cut off" date for the research review was one year before the publication. This meant that the guideline was already out of date at the time it was published. This process is far too long and, given the rolling nature of research evidence, updating after two years is too long to wait for review.

The Appeal System

  6.  To date, we have no closely involved experience of the Appeal System. However, at the time of writing this submission, we are in the process of submitting Grounds for Appeal on the recently rejected Erlotinib review. It is somewhat ironic that, despite the length of the Technology Appraisal Process, we are required to lodge grounds for appeal within a mere 14 days of the decision. This, we find, to be a very short turn around, given the serious nature, to our patient group, of the situation.

Comparison with SIGN

  7.  At the same time as NICE was developing Guidance for Lung Cancer Diagnosis and Treatment, SIGN were updating its Lung Cancer Guideline. As the chair of the NICE development group, I observed the following:

—  In the NICE process, literature review and assessment of research papers are done by professional reviewers. In the SIGN process, the review is done by reviewers, but the assessment of papers is done by clinicians, in their spare time. This, I would suggest, adds clinical bias to the process and is a poor use of clinician time. It is my personal observation, that the NICE process is more independent and does work.

—  Collaboration was agreed in the literature review of the two lung cancer processes. SIGN undertook one third of the literature review for both processes, NICE one third for both processes and the final third, each undertook separately. This seemed reasonable in principle, however, was completely unsatisfactory for both groups.

—  As the two Guideline Development Groups had developed separate Guideline Scopes, there were some areas, felt key by the group, which were not covered by the others reviewers. This caused much complication.

—  During the process, the SIGN group had resource and personnel issues, which meant their timescales drifted massively. This had a delaying effect on the NICE process.

—  Having two separate processes, reviewing the same scientific literature, is a massive waste of resource. However, collaboration in the literature review, as carried out in this case, was unsuccessful.

The Implementation of NICE Guidance, Which is Acted on

Technology appraisals

  8.  It is clear that much attention is paid to these. Indeed, there is considerable difficulty for many patients and clinicians, in accessing new medicines (our experience is, obviously with anti-cancer medicines), until they have been approved by NICE. On approval, our experience suggests that this guidance is, in the main, implemented.

Clinical guidelines

  9.  Having had published guidance for Diagnosing and Managing Lung Cancer since February 2005, it is clear that many recommendations have not been implemented. For example, a key recommendation was that patients are able to access specialist lung cancer nurses, throughout their patient journey. Despite this, it is clear, that in some Trusts, such nurses are viewed as a "frill" and with current financial pressures, some lung cancer specialist nurse posts have been under threat, whereas others have been required to work shifts on general wards, reducing their lung cancer patient commitment.

  10.  That said, the recommendations, within the Clinical Guidelines, have given clinicians and patients a supporting tool, when negotiating service provision. Good examples from the lung cancer guideline are the provision of second line chemotherapy in advanced non small cell lung cancer and the provision of PET scanners.

Dr Jesme Fox

The Roy Castle Lung Cancer Foundation

March 2007