NKF Campaigns Zone:
Transplantation & Live Donors

IMMUNOSUPPRESSIVE THERAPY FOR RENAL TRANSPLANTATION

To:-
Nina Pinwill
Technology Appraisal Project Manager
11 Strand
London
WC2N 5HR

Email: np@nice.nhs.uk
Fax: 020 7766 9123

6 September 2002

Submission in respect of the above NICE appraisal.
By the
National Kidney Federation
6 Stanley Street
Worksop, Notts, S81 7HX
Telephone 01909 487795

This submission is similar in content to the submission made by the National Kidney Federation on 15th May 2002 (Click here to view the earlier submission) in respect of the scoping procedure for this appraisal. The National Kidney Federation, now wishes not only to re-state the points made in that document but also to add to that submission. This document therefore commences with existing submitted material and is then followed with new material/evidence shown at the end.

The importance of transplantation as one form of therapy for renal patients cannot be over-stated. Transplantation can return a relatively normal quality of life to those on dialysis, and may even prevent, in some cases, a patient ever having to go onto dialysis. However, transplantation is not a cure, and transplanted patients remain on medication for the rest of their lives, or until the transplant fails and a return to dialysis is called for. Transplanted patients suffer from the side effects of the existing range of immunosuppressive drugs. Whilst these effects can be minor in nature, they can also be major and the results life threatening.

Immunosuppressive drugs have still some way to go in development and discovery before all dialysis patients will feel comfortable trading the existing certainty of a life on dialysis with the uncertainty of a life on immunosuppressive drugs.

It is for these very real reasons, that the NKF regards the continuation of research and development into new and better immunosuppressive drugs as absolutely vital to our patients wellbeing. We would be extremely concerned if the result of the NICE appraisal were in any way to restrict the use of existing drugs or hamper the development and trial of new drugs.

The NKF understands that with the very latest drugs, there does not yet exist sufficient data for a full appraisal of their effectiveness. However it is these latest immunosuppressive drugs that appear to hold out the best promise of improved quality of life for transplant patients, with a reduced risk of significant side effects and long-term kidney damage. We regard the continued availability of these new drugs as absolutely essential to the welfare of our renal patients.

The National Kidney Federation urges NICE not to restrict in any way at all the availability of all the current drug therapies or those under development. It is the very fact that a range of drug therapy possibilities exists that enables experimentation between the drugs either singly or in combinations. Many patients have been able to keep their new kidneys by virtue of the existing freedom doctors have to switch drugs as and when required in response to a patient’s changing medical condition.

Transplant Patient Surveys

Earlier this year, the NKF commissioned two surveys of its transplant patient membership to look at the issues surrounding their drug treatment. These surveys, carried out with financial support from Fujisawa and Wyeth, were distributed via the NKF’s magazine “Kidney Life” (total readership of 18,000 transplant and dialysis patients) and were completed by 2,500 and 2,000 kidney transplant patients respectively. They have provided further strong evidence of the need to maintain the availability of the widest range of immunosuppressive drugs and to actively encourage further research and development of new treatments.

The results of the first survey were published in the Summer 2002 edition of our magazine, “Kidney Life”. The original questionnaire, the survey results, and the article published in “Kidney Life” are attached with this submission.

A key finding from the survey (as highlighted in the table in the “Kidney Life” article on its front cover) was the large number of kidney transplant patients who continue to be switched from one immunosuppressive drug while being maintained on treatment. The extent of this drug “switching” clearly demonstrates the fact that clinicians need to have the ability to vary a patient’s immunosuppressive therapy in response to developing medical needs, and also to individualise drug regimens to minimise side effects. The ability to switch between different immunosuppressive drugs, and different combinations thereof, thus must remain a cornerstone of ensuring optimum treatment of kidney transplant patients. The NKF believes that this survey provides very strong supporting evidence that all the current immunosuppressive drugs are very necessary, and that all need to remain available if patients are not to lose their transplants early.

The second NKF survey, carried out this spring, focused on the issue of drug compliance. Although the results have yet to be formally published, a key finding has been the considerable drug burden that kidney transplant patients have to cope with. Over two thirds of respondents reported taking six or more different types of medicine every day and almost 1 in 5 said that they took ten or more different medicines each day. While few responders reported regularly missing any of their medicines, around 15% occasionally failed to take their prescribed medicines with the immunosuppressant, the most likely type of drug to be missed.

The NKF would further maintain that the considerable drug burden faced by transplant patients again emphasises the need to find additional and better drugs immunosuppressive drugs with fewer side effects, and that when found, NICE must facilitate their use.

In conclusion, I would like to re-iterate that maintaining access to the existing range of immunosuppressive drugs and encouraging the research and development of new, better immunosuppressive agents with fewer side effects remains essential to ensuring the well being of kidney transplant patients. We would be opposed to any recommendations or guidance from NICE that sought to restrict availability or access to the widest possible range of such treatments.

Yours sincerely

Timothy F Statham OBE

Chief Executive
National Kidney Federation