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Transplantation & Live Donors

IMMUNOSUPPRESSIVE THERAPY FOR RENAL TRANSPLANTATION

NKF Submission to the National Institute for Clinical Excellence (NICE)

2^nd November 2003

To: Nina Pinwell, Cathryn Fuller, and Carole Longson

NICE Appraisal of Immunosuppresant drugs

Thank you for your letters of 3rd and 6th October - and for the weighty reports (ACD) which arrived for comment by the National Kidney Federation As you know the National Kidney Federation (NKF) is a charity run by patients suffering with End Stage Renal Failure (ESRF) for patients and carers dealing with ESRF. We provide a service for the 34,000 patients in the UK and for their carers. The 34,000 figure includes all Transplanted Kidney patients in the UK, hence our very real interest in this study.

You will recall that at the time this enquiry began the NKF did make a submission [click here for the latest submission sent to NICE by the NKF] to you stating that the most important aspect as far as patients were concerned, was the need to keep every available option open to both patients and clinicians to ensure that switching between drug therapies could occur whenever a graft (new kidney) was threatened Our studies (by way of survey) showed very clearly that a huge amount of switching is necessary for patients during the life of a graft as currently all drug therapies run into various different problems - in other words the current medications are not a total solution and all have problems - some of which are life threatening.

Grafts are the “;gold standard” for renal patients when compared to the horrors of dialysis, but it is a very precious treatment - available organs are rare and a huge investment of time, money and goodwill is invested in each and every transplant It cannot make sense to then risk the success of the graft because clinicians feel compelled to use a drug which is not their first choice, either immediately the Transplant is done or later during its life.

Your documents are of necessity very technical and difficult to read for a patient group, however, sadly we have reached the conclusion that your recommendations do have the effect of restricting doctors freedom to choose the most suitable immunosuppression for individual patients.

Your document focuses on acute rejection but seems to us to ignore the importance of maintaining good kidney function within a patient. All kidney patients are very aware that how the kidney performs in the first year after a transplant is a very good indicator of how the graft will fair in the long term - this matter is, we think, a vital indicator as to whether the Kidney will or will not survive and serve the patient for a prolonged period.

Your document appears to give doctors little (if any) latitude to change the medication if the patient concerned appears to be suffering reduced or declining kidney function It cannot be right, that a patient on the standard approved medication must remain on that same treatment even though it is obvious that it is leading to a declining kidney function (and eventual graft loss). It seems to us that your rules will contribute to the declining function rather than assist this critical situation. There must, as we have always said, be the freedom granted to Doctors to deal with the individual patient situations they face by changing medication if they feel this is a better option for long term graft survival.

We understand your wish to define the choice of medications and the order in which you believe they should be used, but we do not believe that you have addressed the problem of a patient whose kidney function is plainly declining - this needs prompt and effective action if all is not to be lost. Please give doctors the freedom to change medications at this point if they believe that to do so would help to restore kidney function or halt its decline.

We are very hopeful that your experts will consider this submission and alter your document to enable doctors to tailor the drug regimens to the individual needs of each patient.

The National Kidney Federation has submitted this response to NICE by email in order to ensure that the view expressed can be taken into account before the Final Document deadline of 5pm on 4th November 2003 Please acknowledge receipt of this submission.

Tim Statham

Chief Executive
National Kidney Federation UK

Email:- tim.statham@btinternet.com
Web:- www.kidney.org.uk