SUMMARY

  I believe the NICE process is unnecessarily bureaucratic, it is not responsive to the needs of patients or the clinicians tasked with their care.

  It takes no account of extant approvals and licenses from other Countries—ie the EU. It is slow, autocratic and trying to find someone who will take responsibility for the patients lives lost while it rumbles through its work, is as impossible as trying to get a life saving drug to a terminally ill patient before they die. That is the blunt truth of the situation. Where an approval and prescribing history exists for a drug then that drug should be fast tracked and seen to be fast tracked by the general public.

1.   Why NICE's decisions are increasingly being challenged

  Patients have realized that the NICE system does not take proper and full account of the rights and interests of patients. It does not consider the needs and interests of patients with the same weight it attaches to cost effectiveness. The process is not open and certainly not accessible or understandable to ordinary people. Patients and the public are not engaged with, they feel impotent against such an arrogant attitude and feel that recourse to the law represents their only way of calling bodies like this to account.

2.   Whether public confidence in the Institute is waning, and if so why

  Genuine members of the public are increasingly cut out of the process. Real Patient involvement is minimal and is considered tokenism. The process for a genuine and sincere patient who feels they have something to offer is so convoluted that , especially if you are a patient battling illness, the whole process seems designed to prevent your views being heard. The work of the institute is not generally advertised to the Public. Support Groups are not consulted. Cancer Networks are not consulted. the voice of the individual is not felt to be important:

"They will do what they want to do".

  Why should the public have confidence in an institution they cannot connect with and feel so distant from. The language used by staff in response to enquiries from members of the public is archaic and often incomprehensible ie scoping workshops, 14th wave pre appraisal drafts and remits?? Email responses are impersonal and could well just come from an automated system. It is impossible to have any effect on the system which is rigid and unresponsive to the needs of the very people it is meant to be serving.

3.   NICE's evaluation process, and whether any particular groups are disadvantaged by the process

  The obvious groups disadvantaged are those patients with a terminal illness. I am a kidney cancer patient. If my disease spreads the prognosis will be 8 to 12 months. The process for NICE to approve a drug has been quoted to me at 18 months to 2 years. Should I really feel this is an evaluation process that is responsive, proactive or one that cares whether I live or die? There must be a fast track process for treatments that are of benefit to terminally ill patients or those whose disease will progress. The absolute maximum time to approve or refuse a life saving drug should be 3 months.

4.   The speed of publishing guidance

  NICE must take into account the process of licensing and approvals that drugs have gone through in the European Union. If the treatments have been assessed by the EU then that prior process should count for something and the drugs should just go immediately to a final phase assessment. The drugs will have been evaluated. The same applies for other Countries who have licensed and approved drugs as safe and efficacious. What is the point of all the Countries in the EU subjecting the drugs to individual checks if it is obvious that they have already been assessed and approved by other Countries. See previous point number 3 for comments that while this process is slowly grinding towards a published document, patients needing the drugs will have died waiting.

5.   The appeal system

  This needs to be publicised in the National press, there needs to be statutory consultees. the appeal panel should comprise patients ( not representatives of national charities but patients personally affected by the decision that will be made). Patients have the unique view which is just as valid as that of the health economist and that of the clinician.

6.   Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN)

  I cannot comment on this—I have no direct knowledge of the this organisation.

7.   The implementation of NICE guidance, both technology appraisals and clinical guidelines (which guidance is acted on, which is not and the reasons for this)

  I cannot comment on this. I do not have any experience of which guidance is or is not acted upon, whether the guidance issued is mandatory or not—and nor do I suspect do other members of the public.

Rose A Woodward

Cancer Patient

23 March 2007