7 March 2023
In less than a month, people with cystic fibrosis (CF) - over the age of 6 who meet the eligibility criteria, will have access to funded Trikafta. From 1 April 2023 New Zealand will now join the more than 30 countries where Trikafta is publicly funded.
It is important to be aware of the criteria that people with CF are required to meet to be eligible for Trikafta in New Zealand. Please refer to the eligibility criteria below. If you have any questions or if you’re unsure about whether you are eligible, please speak with your CF Team.
Pharmac is pleased to be funding a treatment with the potential to greatly improve the health outcomes of people living with CF, and quality of life for families, and whānau.
The feedback they received from the consultation reflected what they had heard from the CF community and clinical advisors when assessing the application for Trikafta.
Pharmac acknowledged that they are grateful to those who took the time to provide feedback to the proposal, in particular those who courageously shared their personal stories.
WAS THERE ANY CHANGES TO THE ORIGINAL PROPOSAL FOR TRIKAFTA?
TESTS NEEDED BEFORE STARTING TRIKAFTA
There are some steps to go through before your CF Clinician can prescribe Trikafta:
HOW WILL GETTING ACCESS TO TRIKAFTA WORK?
COLLECTING YOUR TRIKAFTA
CONTINUING WITH EXISTING MEDICINES AND TREATMENTS
The approved eligibility criteria for Trikafta are as follows:
Special Authority for Subsidy.
Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
All of the following:
1. Patient has been diagnosed with cystic fibrosis; and
2. Patient is 6 years of age or older; and
3.1. Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or
3.2. Patient has a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
4.1. Patient has a heterozygous or homozygous F508del mutation; or
4.2. Patient has a G551D mutation or other mutation responsive in vitro to elexacaftor/tezacaftor/ivacaftor (see note a); and
5. The treatment must be the sole funded CFTR modulator therapy for this condition; and
6. Treatment with elexacaftor/tezacaftor/ivacaftor must be given concomitantly with standard therapy for this condition.
information here >
Rare mutations are reviewed on a regular basis. If additional rare mutations get added to the FDA list, anyone with these mutations who meet the access criteria would also be eligible to receive Trikafta.
Some people may have rare mutations which evidence shows respond to Trikafta, but are not covered by the access criteria. Prescribers can apply for a Named Patient Pharmaceutical Assessment (NPPA) for people with these rare mutations.
You should speak to your prescriber about these options.
UPDATE ABOUT WIDENING OF ACCESS TO KALYDECO AND FUNDING OF SYMDEKO
In CFNZ ‘s submission to Pharmac and in the community’s submission template, we highlighted the need to widen access to Kalydeco as part of the final agreement, and requested that funding of Symdeko be considered.
Unfortunately, neither medicine has been included in the final agreement between Pharmac and Vertex. This wasn’t the news we were hoping for. Below is the response from Pharmac:
CFNZ has urged Pharmac to widen access to Kalydeco and provide access to other CFTR therapies to everyone who would benefit, as quickly as practically possible. We have highlighted that there is no equity until everyone who can benefit from a CFTR therapy, has one.
CFNZ will continue to advocate for this to happen and fight for fair access for everyone who would benefit.