Immunosuppressive therapy for kidney transplant in adults

Basiliximab, when used as part of an immunosuppressive regimen that includes a calcineurin inhibitor, is recommended as an initial option to prevent organ rejection in adults having a kidney transplant.

In August 2017, the use of basiliximab (with tacrolimus) and mycophenolate mofetil (with tacrolimus) is outside the terms of the marketing authorisations for basiliximab and for mycophenolate mofetil. If these combinations are prescribed, the prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. For further information, see the General Medical Council's guidance on Good practice in prescribing and managing medicines and devices.

The Department of Health has stated that the statutory funding requirement does not apply to drugs that are used outside the terms of their marketing authorisation.

Immediate-release tacrolimus, when used as part of an immunosuppressive regimen, is recommended as an initial option to prevent organ rejection in adults having a kidney transplant. Treatment should normally be started with the least expensive product. However, treatment can be started with an alternative dosage form if the least expensive product is not suitable (for example, if the person is not able to swallow capsules as a result of a disability or they are unable to have a particular ingredient because of allergy or religious reasons). Tacrolimus granules for oral suspension (Modigraf) should be used only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that to maintain therapeutic response when a patient is stabilised on a particular brand, oral tacrolimus products should be prescribed and dispensed by brand name only. If a prescriber considers that switching to a different brand of oral tacrolimus would be of benefit, the change requires careful supervision and therapeutic monitoring by an appropriate specialist. See the MHRA's advice on oral tacrolimus products.

Mycophenolate mofetil, when used as part of an immunosuppressive regimen, is recommended as an initial option to prevent organ rejection in adults having a kidney transplant. Treatment should normally be started with the least expensive product. However, treatment can be started with an alternative dosage form if the least expensive product is not suitable (for example, if the person is not able to swallow capsules as a result of a disability or they are unable to have a particular ingredient because of allergy or religious reasons).

In August 2017, the use of basiliximab (with tacrolimus) and mycophenolate mofetil (with tacrolimus) is outside the terms of the marketing authorisations for basiliximab and for mycophenolate mofetil. If these combinations are prescribed, the prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. For further information, see the General Medical Council's guidance on Good practice in prescribing and managing medicines and devices.

The Department of Health has stated that the statutory funding requirement does not apply to drugs that are used outside the terms of their marketing authorisation.

Rabbit anti-human thymocyte immunoglobulin, prolonged-release tacrolimus, mycophenolate sodium, sirolimus, everolimus and belatacept are not recommended as initial treatments to prevent organ rejection in adults having a kidney transplant.

The committee was unable to make recommendations on any of the technologies considered in this appraisal as options for preventing organ rejection in adults who are, or become, unable to have the technologies recommended in sections 1.1 to 1.3 or standard triple therapy with ciclosporin, azathioprine and a corticosteroid (for example, because of treatment failure, contraindications, or intolerance such as nephrotoxicity associated with calcineurin inhibitors, or thrombotic microangiopathy). This includes adults who:

• are unable to continue having their initial therapy and need to switch to another therapy during the life of their graft or

• have a second or subsequent transplant, having previously found that 1 or more of the recommended initial treatments or standard treatments are clinically unsuitable for example, because of treatment failure, contraindications or intolerance.

These recommendations are not intended to affect treatment with any of the technologies in this appraisal that was started in the NHS before this guidance was published. Adults having treatment outside these recommendations, or for whom the committee were unable to make a recommendation, may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.