2.1 Kidney transplant is used to treat established kidney failure, which is severe and irreversible impairment of kidney function. After a kidney transplant, immunosuppressive therapy is used to reduce the risk of rejection of the transplanted kidney (or 'graft') and prolong its survival.
2.2 Between April 2016 and March 2017, 3,042 kidney transplants were done in adults in the UK; 2,682 of these were in England. At the end of 2014, approximately 31,150 people in the UK were having immunosuppressive therapy after a kidney transplant, including 26,100 people in England.
2.3 Immunosuppressive therapy aims to prevent acute rejection and optimise the function of the transplanted kidney, while minimising the adverse effects of immunosuppression (such as increased risk of infection, cancer, diabetes and cardiovascular disease). Immunosuppressive therapy can be categorised as induction therapy or maintenance therapy. Induction therapy is an intensive immunosuppression regimen that is used for up to 2 weeks around the time of transplant and may include polyclonal or monoclonal antibodies. Maintenance therapy starts immediately after transplant and continues for life.
2.4 NICE's technology appraisal guidance on immunosuppressive therapy for kidney transplantation in adults was published in 2004. It recommended basiliximab, daclizumab, tacrolimus, mycophenolate mofetil and sirolimus, in certain circumstances, as options for immunosuppressive therapy for kidney transplant in adults. Since that appraisal, the marketing authorisation for daclizumab has been withdrawn, new technologies (rabbit anti-human thymocyte immunoglobulin, mycophenolate sodium, belatacept, a prolonged-release formulation of tacrolimus, and everolimus) have received marketing authorisations, and some of the technologies are available as generics.