About the tacrolimus brand change
End of transition period on 31 October 2014
From 1 May 2014 to 31 October 2014, PHARMAC changed the funded brand of tacrolimus, an immunosuppressant mainly used to prevent organ transplant rejection.
The funded brand of tacrolimus changed from Prograf to Tacrolimus Sandoz.
When did the change take effect?
- Tacrolimus Sandoz was listed on the Pharmaceutical Schedule from 1 May 2014.
- There was a six month transition period to enable transplant services to support patients through the change to Tacrolimus Sandoz. The transition period ran from 1 May to 31 October 2014.
This page contains:
Friday 31 October marks the end of the six month transiton period for the Prograf to Tacrolimus Sandoz brand change.
The Sole Supply period starts 1 November 2014, therefore repeat dispensings for Prograf will not be subsidised after Friday, 31 October 2014.
This brand change has been carefully controlled and managed by transplant services. We know people depend on this medicine to help prevent organ rejection so we've been very careful with the change and have worked closely with health professionals to ensure patients are well supported.
The majority of the 1300 patients needing to be switched have successfully been transitioned to Tacrolimus Sandoz.
Thank you to those services that have been in contact with us and provided us with updates about how it’s been going. We've really appreciated the on-going communication.
We've been pleased to see community pharmacy working where they can with transplant services to provide an excellent level of patient care during this transition.
For community pharmacists who may have patients yet to be switched to Tacrolimus Sandoz, please contact the prescriber or transplant service involved to:
- confirm which brand to dispense, and
- confirm that monitoring plans are in place for the brand change.
Wastage has been able to be claimed on the Prograf brand of tacrolimus from 1 August 2014 through until 31 October 2014. This allows pharmacists to claim up to a maximum of 90% of one pack of each strength during this period.
If you have any concerns or queries, please contact the Enquiry team at PHARMAC on 0800 660 050 between 9am-5pm.
PHARMAC has taken advice from experts on transplant medicine throughout this brand change process. The Transplant Immunosuppressant Subcommittee, which provides advice to PHARMAC, includes some of New Zealand’s foremost experts on transplant medicine.
In March 2010, the subcommittee was asked to consider whether changing the brand of tacrolimus was appropriate. The committee’s advice was that there did not appear to be a reason not to award sole supply for tacrolimus.
Following this advice, PHARMAC issued a request for proposals to suppliers, seeking proposals for tacrolimus supply. Tacrolimus Sandoz, which had been approved as safe and effective by Medsafe, emerged as a potential alternative to Prograf.
In September 2012, as a result of this commercial process, PHARMAC sought further advice from the clinical subcommittee about a potential change to the Tacrolimus Sandoz brand.
The subcommittee considered Tacrolimus Sandoz to be bioequivalent to Prograf (releasing the same amount of active pharmaceutical into the blood at the same time), but because of individual variations between patients, this change needed to be carefully managed.
In December 2012 PHARMAC sought public submissions on a proposal to change to the Tacrolimus Sandoz brand.
This consultation raised some questions for PHARMAC to consider with the wider health sector around changing the brand. As a result PHARMAC held discussions with leading clinicians and transplant services about aspects of the proposal and how any brand change might be managed. Transplant centres made it clear that they wanted to lead management of any brand change with patients. PHARMAC took this advice on board as it headed towards a decision.
In January 2014 PHARMAC issued an updated proposal for sole supply. This included a provision to maintain a small number of patients (gastro-intestinal transplant patients) on Prograf. Feedback on this proposal was supportive, and PHARMAC notified the decision in March 2014.
Last updated: 12 December 2018