Decision to widen access to Trikafta and Kalydeco and fund Alyftrek for the treatment of cystic fibrosis

Medicines Decision

What we’re doing

We're pleased to announce a decision to widen access to existing treatments and fund a new treatment for people with cystic fibrosis (CF) through an agreement with Vertex Pharmaceuticals (Australia) Party Limited.

From 1 April 2026, the following changes will be implemented:

  • 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

This decision was subject to a consultation letter dated 22 January 2026. We received feedback from a wide range of stakeholders including consumers, their whānau and families, clinicians, pharmacists and patient support groups. We’re grateful to everyone for their feedback and have made some changes to the original proposals as a result. A summary of the main feedback themes raised for each part of this proposal, and our responses to these, are detailed further in this document.

Who we think will be most 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

Trikafta, Kalydeco, and Alyftrek for people with cystic fibrosis

What does this mean for people?

From 1 April 2026, vanzacaftor/tezacaftor/deutivacaftor (branded as Alyftrek) will be funded for all people who have an eligible mutation and meet certain clinical criteria. The funding of elexacaftor with tezacaftor, ivacaftor and ivacaftor (branded as Trikafta) and ivacaftor (branded as Kalydeco) will be widened to include people who have eligible mutations and meet certain clinical criteria.

We anticipate that around 35 people will benefit from this decision in the first year of funding, increasing to 47 people in year 5. 

This decision will allow people to access treatment earlier and address the high health need that currently exists for those under 6 years old with CF.

This decision will also 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).

Any changes to the original proposal?

Following consultation, changes have been made to the wording of the Special Authority criteria to improve alignment across all three treatments and inclusion of the broadest eligible mutation lists.  

Detail about this decision

Trikafta

From 1 April 2026, elexacaftor with tezacaftor, ivacaftor and ivacaftor (Trikafta) will 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

A confidential rebate will apply to Trikafta that will reduce its net price.

Trikafta will 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; and
    2. Patient is 6 years of age or older; and
  2. Either
    1. Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or
    2. Patient has a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
  3. Either
    1. Patient has a heterozygous or homozygous F508del mutation; or
    2. Patient has a G551D mutation or other mutation responsive in vitro to elexacaftor/tezacaftor/ivacaftor (see note); and
  4. The treatment must be the sole funded CFTR modulator therapy for this condition; and
  5. Treatment with elexacaftor/tezacaftor/ivacaftor must be given concomitantly with standard therapy for this condition.

Notes:

Eligible mutations are listed in the Food and Drug Administration (FDA) Trikafta prescribing information https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f354423a-85c2-41c3-a9db-0f3aee135d8d/spl-doc(external link) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212273s015lbl.pdf(external link)

Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule.

Elexacaftor with tezacaftor, ivacaftor and ivacaftor (Trikafta) will 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 can only be claimed from a Health New Zealand - Te Whatu Ora hospital pharmacy.

Kalydeco

From 1 April 2026, ivacaftor (Kalydeco) will 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

A confidential rebate will apply to Kalydeco that will reduce its net price.

Kalydeco will 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:

  1. Patient has been diagnosed with cystic fibrosis; and
  2. Either:
    1. Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or
    2. Patients must have a sweat chloride value of at least 60 mmol/L; and
      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
  3. 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 Patients must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis or by Macroduct sweat collection system; and
  4. Treatment with ivacaftor must be given concomitantly with standard therapy for this condition; and
    5. 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
  5. 6. 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 will apply in Part II of Section H of the Pharmaceutical Schedule. 

Ivacaftor (Kalydeco) will 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 can 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) will 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

84 OP

$29,029.76

A confidential rebate will apply to Alyftrek that will reduce its net price.

Alyftrek will 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:

  1. Patient has been diagnosed with cystic fibrosis; and
  2. Either:
    1. Patient has two cystic fibrosis-causing mutations in the cystic fibrosis transmembrane regulator (CFTR) gene (one from each parental allele); or
    2. Patient has a sweat chloride value of at least 60 mmol/L; and
  3. Either:
    1. Patient has a heterozygous or homozygous F508del mutation; or
    2. Patient has a mutation responsive to vanzacaftor/tezacaftor/deutivacaftor (see note); and
  4. The treatment must be the sole funded CFTR modulator therapy for this condition; and
  5. Treatment with vanzacaftor/tezacaftor/deutivacaftor must be given concomitantly with standard therapy for this condition.

Note:  Eligible mutations are listed in the in the Food and Drug Administration (FDA) Alyftrek prescribing information        https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218730s002lbl.pdf(external link)

Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule. 

Vanzacaftor with tezacaftor and deutivacaftor (Alyftrek) will be listed as a ‘PCT only – Special Authority’ in Section B of the Pharmaceutical Schedule. This means that funded treatment can only be claimed from a Health New Zealand - Te Whatu Ora hospital pharmacy.

CFTR modulators will not be funded when 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 will be able to dispense three months’ worth of treatment at a time.

What you told us

Thank you to those who took the time to give feedback. A summary of the main themes raised, and our responses are below. 

Theme

Pharmac Comment

Supportive of proposal

Removal of the age restrictions will ensure equitable access and improved health outcomes. Numerous responses emphasised that these medicines are life-changing and life-extending.

Respondents stressed that early intervention was critical to prevent avoidable irreversible damage.

This proposal will improve equity of access for people living in remote or rural areas currently facing disproportionate treatment barriers.

We are pleased to be progressing a proposal with a positive impact for New Zealanders living with CF and their whānau, as well as reducing some resource requirements for Health New Zealand services.

Feedback on the proposal 

Ensure practical support is provided to make funding work. This includes clear national clinical guidance, family-friendly resources and education.

We plan to work with the supplier and prescribing clinicians to ensure appropriate resources and education are provided to treaters, people with CF and their families.

Improve transparency on eligibility, timelines, and implementation, so families can plan and don’t feel forced to make major decisions (e.g. relocation) under uncertainty.

Use trusted global evidence and established international practice to accelerate time-to-access rather than redoing work already done elsewhere.

We acknowledge not having certainty on when or if treatments ranked on the Options for Investment (OFI) list will be funded can be very unsettling and make future planning difficult.

Applications ranked on our OFI list are treatments that we would like to fund if budget allowed, noting that Pharmac operates within a fixed budget.

We recognise the importance of equitable, publicly funded access and this is something we will continue to consider as we explore future improvements to our advice and assessment processes.

Changes to the proposal

Requests to remove “PCT Only” restrictions [funding only if dispensed through a hospital pharmacy] and allow community pharmacy dispensing via nominated community pharmacies.

If the centralised model remains, introduce reimbursement for courier costs (noted as sometimes substantial).

Request that Pharmac investigate options for distribution of Kalydeco, Trikafta and Alyftrek to streamline arrangements for clinicians and improve ease of access for patients.

We acknowledge the risk of access barriers resulting from restricting dispensing to Health NZ hospitals.

Dispensing these treatments through community pharmacies would incur significant extra costs for Health New Zealand.

We intend to monitor this and will engage with Health New Zealand to consider different distribution mechanisms in the future to support access to these medicines in a way that minimises the burden on people living with cystic fibrosis and their whānau.

Have the criteria cover all eligible mutations including rare genotypes

The Special Authority criteria for each of the treatments refers to the FDA managed list of eligible mutations. These lists are regularly updated to include all mutations responsive to treatment.

Pharmac will continue to assess applications for use outside the Special Authority Criteria on a case-by-case basis via the Named Patient Pharmaceutical Assessment (NPPA) pathway.

Request that Pharmac amends its proposed criteria for access to Trikafta and Alyftrek to include links to the FDA prescribing criteria for each medicine.

Request to add a provision to enable those with CF who do not have two Class 1 mutations to be eligible for treatment. This would widen further access to modulators.

Since speaking with the supplier following consultation feedback, we understand the FDA mutation list currently contains a broader list of eligible mutations and is likely to be updated more frequently in the future. Therefore, we plan to continue to reference the FDA list.

We plan to seek expert clinical advice on the requested changes for those who do not have two Class 1 mutations and are not proposing to make the requested changes at this time. Until further advice is obtained, patients with Class 1 mutations can continue to be assessed through the Named Patient Pharmaceutical Assessment (NPPA) pathway.

Request that Pharmac amends its proposed criteria for access to Kalydeco to remove the separate requirement for sweat chloride or at least align the criteria with Trikafta and Alyftrek.

Our clinical advisors were supportive of a change to diagnostic testing and we have amended and simplified the sweat chloride requirement in the criteria for all three treatments.

Request that Pharmac review and revise the eligibility criteria for all three treatments to provide consistency across the three modulator therapies, as far as practically possible.

Our clinical advisors were supportive of aligning criteria where practically possible. In response we have removed criteria that is no longer clinically relevant to help simplify and align criteria across all three treatments.

Request to allow general practitioners to prescribe after initial specialist initiation.

The proposed criteria allow for an initial application from any relevant practitioner and do not restrict prescribing to hospital clinicians. However, all prescriptions must be dispensed at a hospital pharmacy.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.