Executive Summary

  The Cystic Fibrosis Trust wishes to put its experience of NICE before the Health Select Committee for the following reasons:

  1.  Since the launch of NICE, the Cystic Fibrosis Trust has worked constructively with them to try and improve the care of those with Cystic Fibrosis.

  2.  We are becoming increasingly frustrated by the lack of output, lack of adequate communication as to why this is, and concern that for a condition affecting a relatively modest number of people, the Government is reluctant to set targets or standards which often lead to sub-optimal care.

  3.  In this context, we feel that those with Cystic Fibrosis are a disadvantaged group. There are no nationally agreed clinical guidelines which those offering CF care have to meet.

Background

  The Cystic Fibrosis Trust have actively engaged with NICE on a number of its initiatives. These include:

—    the consultation process on living donor lung transplantation;

—    the use of IVs at home;

—    breast feeding; and

—    the use of a particular antibiotic, TOBI.

  However, our concern focuses on the lack of clarity as to where our detailed application for a clinical guideline for all aspects of the care of children and adults with Cystic Fibrosis to be developed by NICE has gone.

Detailed Case

  Having contacted NICE in 2002 to better understand how topics were selected for consideration by NICE, we were informed that there was to be an imminent web-based consultation and applications could be made by individuals or patient groups for a particular technology appraisal or a clinical guideline. The announcement was, in fact, made just before Christmas 2002. The Cystic Fibrosis Trust worked very hard over the Christmas and New Year period and submitted an application on 29 January 2003 for a clinical guideline. A copy of this application is attached.

  We then waited to hear how the application had been received and whether it would be reviewed. We heard nothing until May 2004, one year and four months after our application had been sent in. We were very pleased to receive an e-mail which stated that we had successfully gone through the first tier of the sifting process, a committee appropriately called the Topic Sift Committee, and we were now going to be referred to the Advisory Committee for topic selection. We were pleased to hear that an eminent CF Consultant, Dr Diana Bilton of Papworth Hospital, had been appointed as a medical adviser to this committee. The Cystic Fibrosis Trust was asked to comment on the briefing notes for this committee, which we did in June 2004 (copy attached).

  We then heard, in December 2004, from two or three CF Consultants who had been asked to attend a meeting to discuss this report. They were given virtually no notice and were very concerned that at such short notice they were unable to attend.

  At a similar time, the Cystic Fibrosis Trust was invited to attend and indeed to lead a workshop organised by NICE on the pilot study which had resulted in the web-based application and the processes being considered for its expansion. We were told at that stage that we were invited as a successful applicant of the process, which we were very pleased to hear, but this was the first news we had that we were indeed a successful applicant. The Cystic Fibrosis Trust attended the workshop and learnt a great deal more about the process.

  Then all went quiet once more. We heard nothing in 2005, and in spite of frequent requests for information from NICE were unable to get any feedback as to what was happening to our application. We decided to attend the NICE Conference in December 2005 with the specific objective of finding the status of our application and where it was in the system. Three of us from the Cystic Fibrosis Trust attended—Rosie Barnes (Chief Executive), Cara Doran (Expert Patient Adviser) and Jacqueline Ali (Publications Officer). We spoke to the Chairman of NICE as well as a number of key individuals, and nobody was able to give us any information about what had happened to our application. However, we were promised feedback from the Planning & Resources Director, Andrea Sutcliffe. We followed the Conference with a letter to Andrea Sutcliffe and to Professor Sir Michael Rawlins, and wrote again to Sir Michael on 3 February 2006. We received a reply dated 24 February 2006 informing us that our proposal had been considered by the Joint Planning Group and would be considered again at their next meeting in March 2006, after which Andrea Sutcliffe would write and let us know any decisions taken.

  Again, we heard nothing and in spite of frequent checking of the website, could find no reference to our application.

  We subsequently learnt that Dr Jayne Spink, who whom we had had a good working relationship at the Gene Therapy Advisory Committee, had transferred to NICE as Associate Director in the Centre for Clinical Practice. We dropped her a line to see if she could check on the whereabouts of our application. She replied to let us know that she had spoken to Professor Sir Michael Rawlins, who would contact us to let us know what the current position was. This was in June 2006.

  We are now in March 2007 and, as far as we can tell, are no nearer getting a clinical guideline. We would be delighted to hear that this is not the case. However, having worked very hard on behalf of a vulnerable patient group over the Christmas and New Year of 2002-03, it does seem unreasonable that we still have no idea whether our proposal has been accepted and whether we are going to get a guideline for the care of Cystic Fibrosis patients.

  We do not think this would be a particularly onerous task, as the Cystic Fibrosis Trust has well-developed guidelines which were broadly accepted by the Department of Health as part of the series of National Definition Sets which were drawn up by the Health Regions before they were abolished. The National Definition Set for Cystic Fibrosis (Number 10) is appended to this report. It has no particular status within the NHS or the Department of Health as it was a regional document, but does illustrate the fact that some work has been done on this in the past which resulted in a reasonably satisfactory outcome.

  We have no idea whether our guideline is still in the system at all and is either bogged down somewhere within NICE or at Ministerial level, or has been dropped or abandoned.

Why We Are so Concerned

  Apart from the fact that the Cystic Fibrosis Trust is frustrated, having worked hard and consulted widely to produce the submission in January 2003, and having come up against a complete opaqueness and lack of clarity as to the subsequent process, we are particularly concerned that a very vulnerable group of patients is not protected by any national standard, either a Government target or a NICE guidance. Although Ministers and officials within the Department of Health state that this is not a barrier to good care, the reality within the harsh economic climate of the current NHS is very different. PCTs and hospital trusts do what they have to do to achieve Government targets and to meet NICE guidelines, leaving precious little resource, either in time or money, to make adequate provision for conditions for which their performance will not be measured. Some CF patients are looked after well in spite of this situation, but many are getting mediocre or sub-optimal care. In addition, the high standard of service which has been provided by specialist consultants, specialist nurses, specialist physiotherapists and specialist dietitians in the past is being threatened. The new generation of clinicians is less likely to work the very long hours to provide a comprehensive service, but will complete the hours they are contracted to work. In addition, many hospital trusts are looking to cut back dramatically on Specialist nurses, physiotherapists and dietitians who are absolutely key to proper CF care. Without some form of protection, either via a Government target or a NICE guideline, it is hard to see how the current service will be adequately protected, never mind how it will be developed and expanded to meet the changing needs of CF patients as they live longer and new treatments become available.

One Hopeful Sign

  Separately, the Cystic Fibrosis Trust responded to Lord Warner's review of specialised conditions, of which Cystic Fibrosis is one. Professor Sir David Carter's report was extremely helpful. The process was open, transparent and relatively speedy, and Lord Warner's resulting recommendations were very encouraging. We do hope that the arrangements for commissioning CF care, in England at least, will improve as a result of these recommendations if they are properly implemented.

  The future care of CF patients does need to be secured, and the combination of a NICE guideline for the clinical care of those with CF and a properly implemented specialist services commissioning process under the banner of the Strategic Health Authorities would be a good start.

Rosie Barnes

Cystic Fibrosis Trust

March 2007