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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7318 p409
25 September 2004

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NICE issues guidance on post-transplant therapy

Guidance on the use of immunosuppressive therapy following kidney transplantation has been issued this week by the National Institute for Clinical Excellence.

The recommendations make it clear that a number of treatment options should be available to renal transplant patients but NICE does impose certain restrictions.

For induction treatment, NICE recommends basiliximab (Simulect) or daclizumab (Zenapax). The guidance states that the drugs should be used as part of a calcineurin-inhibitor-based immunosuppressive regimen and that the cheapest should be used.

As far as a calcineurin inhibitor is concerned NICE says that either ciclosporin or tacrolimus (Prograf) can be used. The drug selected should be the one least likely to result in serious side effects in the patient being treated.

Mycophenolate mofetil (CellCept) is recommended as an option for immunosuppressive treatment in kidney transplant patients only when the patient is intolerant to calcineurin inhibitors or when there is high risk of nephrotoxicity. Sirolimus (Rapamune) is also recommended as part of the immunosuppressive regimen but only where there is proven intolerance to calcineurin inhibitors.

NICE does not expect implementation of the guidance to increase the total cost of prescribing immunosuppressants for renal transplantation. “In general terms, it is likely to lead to a consolidation of current treatment patterns,” the guidance states.

Andrea Devaney, principal pharmacist transplantation, Oxford Transplant Centre, Churchill Hospital, Oxford, said: “It is well known within renal pharmacy that each transplant unit has its preferred immunosuppression regimens, and there is much diversity between units across the UK. The long awaited publication of this NICE appraisal will give renal pharmacists the opportunity to review their immunosuppression protocols as part of the multidisciplinary team, in order for local protocols to comply with this advice.”

She added that the guidance clarified the role in transplantation of some of the more expensive immunosuppressive agents. “[This will be] helpful to both providers and purchasers of renal transplantation services.”

Andrew Dillon, chief executive of NICE, said: “Unusually for NICE guidance, these recommendations contain advice that may result in some medicines being prescribed outside the terms of their marketing authorisation. Because of the way these drugs are used in combination with each other, this already happens extensively. Our guidance will help manage such use and, of course, clinicians prescribing these drugs should ensure that patients are aware of when this is happening, and that they consent to their use in such circumstances.”

The full NICE guidance is published on the NICE website. An appraisal of immunosuppressive therapy for renal transplantation in children and adolescents is ongoing.

Guidance on the use of drotrecogin alfa (activated) in severe sepsis is also issued by NICE this week.

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