Tacrolimus (oral) – Immunosuppressive therapy to prevent organ rejection in solid organ transplant in adults – as per NICE TA 481

Overview | Immunosuppressive therapy for kidney transplant in adults | Guidance | NICE

NICE recommendations, summary of meeting discussions, links to additional supporting docs etc.

November 2004:

The TAG noted NICE TAG No. 85 which stated:

1.2 Tacrolimus is an alternative to ciclosporin when a calcineurin inhibitor is indicated as part of an initial or a maintenance immunosuppressive regimen in renal transplantation for adults. The initial choice of tacrolimus or ciclosporin should be based on the relative importance of their side-effect profiles for individual people.

1.5 These recommendations contain advice that may result in some medicines being prescribed outside the terms of their marketing authorisation. Clinicians prescribing these drugs should ensure that patients are aware of this, and that they consent to their use in such circumstances.

July 2012: The TAG noted Commission on Human Medicines letter:

Oral tacrolimus prescribed/ dispensed by brand to avoid medication errors regarding the importance of ensuring that the same brand is correctly and consistently provided in order to prevent toxicity and rejection.

September 2012: Shared Care Agreement reviewed and approved by the TAG.

November 2014:  The Shared Care Agreement was reviewed with a recommendation for a change regarding the requirement for blood testing to state “the specialist will provide the patient directly with an ICE form to receive phlebotomy from their nearest service.”  The TAG supported continued use of the Agreement subject to the recommended amendments.  The Agreement to be reviewed further in May 2016.

November 2014:  The NHS Norfolk & Waveney CCGs D&TCG noted and supported the TAG recommendation.

Although SCG commissioning responsibility, continued use of a Shared Care Agreement is required until repatriation of prescribing responsibility from primary care is complete (unlikely before April 2016).

March 2015:  The TAG noted and acknowledged the NHSE SSC 1466 (January 2015) regarding the cost-effective use of transplant immunosuppressants.

March 2015:  The NHS Norfolk & Waveney CCGs’ D&TCG noted the NHSE SSC 1466 (January 2015).

May 2016: The TAG and the N&W D&TCG agreed to extend use of the shared care agreement until May 2017 whilst repatriation of patients to specialist care is on-going.

November 2017:

The TAG acknowledged NICE TA 481 (Oct 17) and re-affirmed a traffic light classification of Amber (Option for GP prescribing under an approved shared care agreement) for immediate-release tacrolimus, which is a SCG-commissioning responsibility treatment, the costs of which are currently being recouped by the CCGs from NHS England to cover any prescribing by GPs.

The use of the current shared care agreement to be extended until the end of March 2018 when use of all local shared care agreements is to be reviewed.

November 2017:

The TAG’s recommendation to extend use of the shared care agreement was noted and supported by the D&TCG.