Proposal to widen access to Trikafta and Kalydeco and fund Alyftrek for the treatment of cystic fibrosis
What we’re proposing
Tell us what you think about this proposal to widen access to existing treatments and fund a new treatment for people with cystic fibrosis (CF) through a provisional agreement with Vertex Pharmaceuticals (Australia) Party Limited. The proposal includes:
- Elexacaftor/tezacaftor/ivacaftor (Trikafta) – Widening of access for all people with CF with eligible mutations and listing of 2 new presentations
- Ivacaftor (Kalydeco) - Widening of access for people with CF with eligible mutations responsive to Kalydeco and listing 2 new presentations
- Vanzacaftor/tezacaftor/deutivacaftor (Alyftrek) – Funding of a new treatment for all people with CF with eligible mutations
If approved, these changes would be implemented from 1 April 2026.
Impact of the proposal
If approved, we estimate that around 35 people would benefit from this decision in the first year of funding, increasing to 47 people in year 5.
This proposal could help reduce demand on health sector services, as these treatments are expected to reduce the need for management of respiratory exacerbations, maintenance therapies including physiotherapy, and treatments for pancreatic insufficiency and inadequate growth (nutritional supplementation).
Approval of this proposal would enable improved equitable access to effective medicines for New Zealanders.
Consultation closes at 5pm, Wednesday 11 February 2026 and feedback can be submitted via our online form.
What would the effect be?
- From 1 April 2026, elexacaftor with tezacaftor, ivacaftor and ivacaftor (branded as Trikafta) funding would be widened to include all people who have an eligible mutation and meet certain clinical criteria.
- From 1 April 2026, ivacaftor (branded as Kalydeco) funding would be widened to include people who have an eligible mutation responsive to Kalydeco and meet certain clinical criteria.
- From 1 April 2026, vanzacaftor/tezacaftor/deutivacaftor (branded as Alyftrek) would be funded for all people who have an eligible mutation and meet certain clinical criteria.
Who may be interested
- People with cystic fibrosis, their whānau, caregivers, and communities
- People interested in the funding of medicines for cystic fibrosis and rare disorders
- Respiratory physicians, paediatricians, respiratory nurses, and other clinicians and health professionals involved in the management of cystic fibrosis
- Advocacy and support groups for people with cystic fibrosis
- Health New Zealand – Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by cystic fibrosis
- Pharmacies and wholesalers
- Pharmaceutical suppliers
About cystic fibrosis
Cystic fibrosis affects around 500 New Zealanders of all ages. The condition occurs when someone is born with two faulty genes, which causes the body to make abnormally thick mucus. The mucus stops organs working well and results in infection. People living with cystic fibrosis have shorter lives because of the condition. Cystic fibrosis is a chronic condition that can also cause other conditions, including diabetes and diseases of the liver and bone.
There is no cure for cystic fibrosis. The current treatments for people with cystic fibrosis who are unable to access a CFTR modulator are known as supportive care. This can take up a lot of time, with many healthcare appointments and sometimes hospital admissions. This impacts people and their caregivers’ ability to do day-to-day activities, such as going to school and work.
About Trikafta, Kalydeco, and Alyftrek
Trikafta, Kalydeco and Alyftrek are branded medicines known as CFTR modulators. They are all oral medicines in either tablet or granule form taken daily. They support improved function of the faulty protein to make thinner mucus. This stops the mucus blocking the body’s organs. CFTR modulators significantly improve lung function, patient weight, and other symptoms of cystic fibrosis, reducing the likelihood of people being admitted to hospital. We expect that these benefits would allow people with cystic fibrosis to live healthier, longer lives.
Trikafta is approved for use in New Zealand and is available in four fixed dose combinations. Detail about the approved indications is provided in the Trikafta Medsafe datasheet [PDF](external link)
Kalydeco is approved for use in New Zealand and is available in five fixed dose combinations. Detail about the approved indications is provided in the Kalydeco Medsafe datasheet [PDF](external link)
Alyftrek is approved for use in New Zealand and is available in two fixed dose combinations. Detail about the approved indications is provided in the Alyftrek Medsafe datasheet [PDF](external link)
Why we’re proposing this
Trikafta was funded in April 2023 for people with CF aged 6 years and older. Vertex submitted a funding application for Trikafta for people aged 2-5 years in February 2024. In August 2024 our clinical advisors on the Respiratory Advisory Committee recommended that Trikafta for people with CF aged 2-5 years should be funded with a high priority. You can read more about the advice here:
Application Tracker | Trikafta for CF, aged 2-5 years(external link)
A consumer submitted a funding application for Kalydeco for people with responsive mutations in August 2021. In April 2022 our clinical advisors on the Respiratory Advisory Committee recommended that Kalydeco access be widened for people with responsive mutations with a high priority. You can read more about the advice here:
Application Tracker | mutations responsive to ivacaftor(external link)
Vertex submitted a funding application for Alyftek for people aged 6 years and older in November 2024. In May 2025 the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that Alyftrek should be funded with a high priority for people with CF aged 6 years who are not eligible for Trikafta. For people, who are eligible for Trikafta, PTAC provided a cost-neutral recommendation. You can read more about the advice here:
Application Tracker | Alyftrek for CF, aged 6 years, eligible for Trikafta(external link)
Application Tracker | Alyftrek for CF, aged 6 years, ineligible for Trikafta(external link)
Details about our proposal
Trikafta
From 1 April 2026, elexacaftor with tezacaftor, ivacaftor and ivacaftor (Trikafta) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Elexacaftor with tezacaftor, ivacaftor and ivacaftor |
Tab elexacaftor 100 mg with tezacaftor 50 mg, ivacaftor 75mg (56) and ivacaftor 150mg (28) |
Trikafta* |
84 OP |
$27,647.39 |
|
Elexacaftor with tezacaftor, ivacaftor and ivacaftor |
Tab elexacaftor 50 mg with tezacaftor 25 mg, ivacaftor 37.5mg (56) and ivacaftor 75mg (28) |
Trikafta* |
84 OP |
$27,647.39 |
|
Elexacaftor with tezacaftor, ivacaftor and ivacaftor |
Oral granules elexacaftor 100 mg with tezacaftor 50 mg, ivacaftor 75 mg (28) and ivacaftor 150 mg (28), sachets |
Trikafta |
56 OP |
$27,647.39 |
|
Elexacaftor with tezacaftor, ivacaftor and ivacaftor |
Oral granules elexacaftor 80 mg with tezacaftor 40 mg, ivacaftor 60 mg (28) and ivacaftor 59.5mg (28), sachets |
Trikafta |
56 OP |
$27,647.39 |
*currently listed presentations.
A confidential rebate would apply to Trikafta that would reduce its net price.
Trikafta would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (additions in bold, deletions in strikethrough):
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; and2.Patient is 6 years of age or older; and3.Either3.1.Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or3.2.Patient has a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
4.Either4.1.Patient has a heterozygous or homozygous F508del mutation; or4.2.Patient has a G551D mutation or other mutation responsive in vitro to elexacaftor/tezacaftor/ivacaftor (see note); and
5.The treatment must be the sole funded CFTR modulator therapy for this condition; and6.Treatment with elexacaftor/tezacaftor/ivacaftor must be given concomitantly with standard therapy for this condition.
Note:
Eligible mutations are listed in the Food and Drug Administration (FDA) Trikafta prescribing information Trikafta Medsafe data sheet https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f354423a-85c2-41c3-a9db-0f3aee135d8d/spl-doc https://www.medsafe.govt.nz/profs/Datasheet/t/trikaftatab.pdf(external link)
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Elexacaftor with tezacaftor, ivacaftor and ivacaftor (Trikafta) would continue to be listed as a ‘PCT only – Special Authority’ in Section B of the Pharmaceutical Schedule as it is now. This means that funded treatment could only be claimed from a Health New Zealand - Te Whatu Ora hospital pharmacy.
Kalydeco
From 1 April 2026, ivacaftor (Kalydeco) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Ivacaftor |
Tab 150 mg |
Kalydeco* |
56 |
$29,386.00 |
|
Ivacaftor |
Oral granules 75 mg, sachet |
Kalydeco* |
56 |
$29,386.00 |
|
Ivacaftor |
Oral granules 50 mg, sachet |
Kalydeco* |
56 |
$29,386.00 |
|
Ivacaftor |
Oral granules 25 mg, sachet |
Kalydeco |
56 |
$29,386.00 |
|
Ivacaftor |
Oral granules 13.4 mg, sachet |
Kalydeco |
56 |
$29,386.00 |
*currently listed presentations.
A confidential rebate would apply to Kalydeco that would reduce its net price.
Kalydeco would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (additions in bold, deletions in strikethrough):
Special Authority for Subsidy
Initial application only from a respiratory specialist or paediatrician any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
All of the following:
- Patient has been diagnosed with cystic fibrosis; and
- Patient must have at least one mutation on the list of CFTR mutations that produce CFTR protein and are known to be responsive to ivacaftor**; and Either:
2.1. Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; or
2.2. Patient must have other gating (class III) mutation (G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R) in the CFTR gene on at least 1 allele; and - Patients must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
- Treatment with ivacaftor must be given concomitantly with standard therapy for this condition; and
- Patient must not have an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing treatment with ivacaftor; and
- The dose of ivacaftor will not exceed one tablet or one sachet twice daily
7. Applicant has experience and expertise in the management of cystic fibrosis.
Note:** Mutations listed in Table 3 of the Food and Drug Administration (FDA) Ivacaftor prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203188s038lbl.pdf(external link)
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Ivacaftor (Kalydeco) would be listed as a ‘PCT only – Special Authority in Section B of the Pharmaceutical Schedule instead of PCT only - Specialist. This means that funded treatment could only be claimed from a Health New Zealand - Te Whatu Ora hospital pharmacy, as it is now.
Alyftrek
From 1 April 2026, vanzacaftor with tezacaftor and deutivacaftor (Alyftrek) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule for the first time, as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Vanzacaftor with tezacaftor and deutivacaftor |
Tab vanzacaftor 10 mg with tezacaftor 50 mg and deutivacaftor 125 mg |
Alyftrek |
56 OP |
$29,029.76 |
|
Vanzacaftor with tezacaftor and deutivacaftor |
Tab vanzacaftor 4 mg with tezacaftor 20 mg and deutivacaftor 50 mg |
Alyftrek |
56 OP |
$29,029.76 |
A confidential rebate would apply to Alyftrek that would reduce its net price.
Alyftrek would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:
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:
- Patient has been diagnosed with cystic fibrosis; and
- Either:
- Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or
- Patient has a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
- Either:
- Patient has a heterozygous or homozygous F508del mutation; or
- Patient has a mutation responsive to vanzacaftor/tezacaftor/deutivacaftor (see note); and
- The treatment must be the sole funded CFTR modulator therapy for this condition; and
- Treatment with vanzacaftor/tezacaftor/deutivacaftor must be given concomitantly with standard therapy for this condition.
Notes:
Eligible mutations are listed in the Alyftrek Medsafe data sheet
https://www.medsafe.govt.nz/profs/Datasheet/a/Alyftrektab.pdf(external link)
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Vanzacaftor with tezacaftor and deutivacaftor (Alyftrek) would be listed as a ‘PCT only – Special Authority’ in Section B of the Pharmaceutical Schedule. This means that funded treatment could only be claimed from a Health New Zealand - Te Whatu Ora hospital pharmacy.
We are not proposing that CFTR modulators be dispensed through community pharmacies at this time. This is due to the high cost of these medicines. To reduce the number of times people need to travel to their nearest hospital, Health New Zealand - Te Whatu Ora Hospitals would be able to dispense three months’ worth of treatment at a time and this would be made visible in the Pharmaceutical Schedule.
To provide feedback
Fill out our online form by 5pm, Wednesday 11 February 2026 to provide feedback.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
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