Tacrolimus brand change
Tacrolimus brand change a world first
New Zealand has become the first country in the world to shift virtually all transplant patients to a generic form of the immunosuppressant tacrolimus.
Tacrolimus is an important treatment for organ transplant recipients. It helps prevent the body’s immune system from mounting a response and potentially rejecting transplanted organs (including liver, kidney, pancreas, lung, heart, intestinal and bone marrow transplants).
Given what’s at stake, PHARMAC took a careful approach, seeking expert clinical advice over a long period of time, talking with transplant experts in New Zealand and overseas, and then working closely alongside transplant centres to implement the change.
Transplant centres in other countries had successfully changed to generic tacrolimus – but this had never been done at a national level.
With a few exceptions, all of the roughly 1300 New Zealand transplant patients have now changed to the Tacrolimus Sandoz brand. What this means for the health system is a $4 million per year saving – an important efficiency that means funding is available for other purposes while those same patients continue receiving quality treatment.
PHARMAC had been looking at the possibility of a tacrolimus brand change since 2009, and been through two rounds of consultation before a decision was made. PHARMAC’s main clinical committee PTAC and the Transplant Immunosuppressant Subcommittee considered tacrolimus numerous times. And PHARMAC went further, seeking tests and data to check clinical issues raised to ensure these were taken on board and thought through carefully.
As part of the change organ transplant patients required additional blood tests to ensure their blood levels of tacrolimus remained within therapeutic levels, when they changed brands. This was important to ensure the clinical success of the Prograf to Tacrolimus Sandoz brand change and to ensure that patient safety wasn’t compromised.
Because of this clinical complexity and the additional testing needed, the tacrolimus brand change was managed by hospital-based transplant services rather than community pharmacies or GPs. These are the experts in managing transplant patients, and the people who could be on the lookout to ensure the change went smoothly and was closely monitored.
PHARMAC worked closely with transplant services before, during and after the brand change including initially seeking their views to design the level and type of support required. Implementation activities included
- general brand change guidelines and information for clinicians, pharmacists and patients
- a workshop for transplant coordinators
- patient and transplant service resources including a pharmacy notification card, posters and letter templates
- community pharmacy practice software included an alert about the brand change to ensure no unplanned substitution was made
- close monitoring with regular reporting by the transplant services, and the progress of patients tracked by analysts at PHARMAC.
In general, we have had positive feedback from transplant services about the change. We’ve also held a debrief workshop with transplant coordinators, clinicians and pharmacists giving them an opportunity to feed back on the change.
The lessons learned, as well as feedback from the Transplant subcommittee about their experience of the brand change, will be invaluable when we’re considering implementing future complex changes.
Last updated: 30 October 2017