Mycophenolate mofetil / Mycophenolic acid (Arzip®, CellCept® / Myfortic®) – Immunosuppression in adult solid organ transplant patients – 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.

NICE TA No. 85 states:

1.3 Mycophenolate mofetil is recommended for adults as an option as part of an immunosuppressive regimen only:

· where there is proven intolerance to calcineurin inhibitors, particularly nephrotoxicity leading to risk of chronic allograft dysfunction, or

· in situations where there is a very high risk of nephrotoxicity necessitating minimisation or avoidance of a calcineurin inhibitor.

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.

April 2006 NICE No. 99:

NICE has made the following recommendations about the use of immunosuppressive drugs in children and adolescents receiving kidney transplants:

Doctors should consider using mycophenolate mofetil as part of immunosuppressive treatment after kidney transplantation only when a person has to stop taking a calcineurin inhibitor, or has to take a lower dose.

(NICE does not recommend the use of mycophenolate sodium as part of immunosuppressive regimens for children or adolescents undergoing kidney transplantation.)

September 2009: The TAG ratified an updated version of the shared care agreement which included details of the risk of Pure Red Cell Aplasia (PRCA) which was highlighted by the MHRA in July 2009.

September 2012: The TAG ratified a revised version of the agreement which also included Arzip® (MMF) and Myfortic® (mycophenolic acid as mycophenolate sodium). The different salt forms are not interchangeable and should not be switched because of pharmacokinetic differences.

November 2014:  The shared care agreement was reviewed and the TAG recommended under “Specialist Monitoring” that an amendment be made stating “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 amendments.

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

Although this treatment is SCG-commissioning responsibility the 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 (Renal Transplant Clinical Reference Group – CRG) SSC 1466 (January 2015) regarding the cost-effective use of transplant immunosuppressants.

March 2015:  The 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 mycophenolate mofetil / mycophenolic acid, 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.

March 2018: The TAG supported a revised version of the shared care agreement which had been updated in line with other SCA for use in autoimmune disease regarding guidance added regarding the need for effective contraception in patients taking MMF and their partners as per MHRA drug safety warning (Feb 2018).

March 2018:

Noted and supported by the Norfolk and Waveney CCGs’ Drugs & Therapeutics Committee.

April 2018: Noted and supported by the  Norfolk and Waveney CCGs’ Joint Strategic Commissioning Committee (JSCC).