Decision to fund treatments for lung cancer, breast cancer and respiratory conditions

6 December 2024

What we’re doing

We’re pleased to announce a decision to fund four new treatments for cancer and respiratory conditions through an agreement with AstraZeneca Limited.

From 1 January 2025 the following treatments will be funded:

osimertinib (branded as Tagrisso) for the initial treatment of epidermal growth factor receptor (EGFR) mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC).
osimertinib (branded as Tagrisso) as a subsequent treatment of EGFR T790M mutated, locally advanced or metastatic NSCLC.
trastuzumab deruxtecan (branded as Enhertu) for the treatment of HER2-positive metastatic breast cancer.
palivizumab (branded as Synagis) for prevention of severe illness caused by respiratory syncytial virus (RSV) in infants and young children at high risk of RSV.
budesonide with glycopyrronium and eformoterol (branded as Breztri Aerosphere) as a single inhaler triple-therapy for the treatment of chronic obstructive pulmonary disease (COPD).

The agreement with AstraZeneca also includes amendments to the contractual terms for olaparib (branded as Lynparza).

Olaparib is currently funded for people with ovarian cancer subject to eligibility criteria [PDF](external link). No changes will be made to the funding of olaparib, however the net price will reduce through a confidential rebate.

This decision was subject to a consultation letter dated 12 September 2024. We received feedback from a wide range of stakeholders including people with cancer, their friends and their whānau, clinicians and patient support groups. We’re grateful to everyone for their feedback and have made several changes to the original proposal in response. A summary of the main themes raised for each part of this proposal, and our responses to feedback are at the end of each section.

Osimertinib for advanced non-small cell lung cancer

What does this mean for people?

From 1 January 2025 osimertinib (branded as Tagrisso) will be funded for eligible people with locally advanced or metastatic NSCLC with cancer that is non-squamous in origin, as both:

an initial treatment (first line) where the cancer has an activating EGFR mutation
a subsequent treatment (second line) where the cancer has an EGFR T790M mutation and has progressed after treatment with a first generation EGFR targeting tyrosine kinase inhibitor (gefitinib Schedule listing(external link) or erlotinib Schedule listing(external link)).

We estimate that around 130 people will benefit from first line treatment with osimertinib each year. We estimate that around 45 people will receive osimertinib as a second line treatment in the first year of funding, however this will decrease over time as more people access osimertinib first line.

We understand that there are 20 to 30 people currently accessing osimertinib through private funding arrangements. We have ensured that if the eligibility criteria were met when someone started treatment, they will be able to transition to publicly funded treatment.

Who we think will be interested

People with lung cancer, their whānau and caregivers
Oncologists, clinical nurse specialists, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with lung cancer
Groups who support and advocate for people with cancer
Health New Zealand | Te Whatu Ora (Health NZ) and Te Aho o Te Kahu | Cancer Control Agency
Hospital pharmacies
Hei Āhuru Mōwai
Pharmaceutical suppliers and wholesalers

Any changes to the original proposal?

We received feedback from clinicians, patient support and advocacy groups, laboratory services and patients. We want to thank everyone for their feedback. Overall, feedback was supportive, however many responders did request earlier access to osimertinib.

After considering feedback and seeking further advice from our expert clinical advisors, we have amended the eligibility criteria for access to osimertinib as follows:

Enabled osimertinib be used in combination with chemotherapy when used as first line treatment
Removed reference to stage in the criteria
Increased the ECOG performance status(external link) upper limit to 3 from 2.
Enabled the use of prior chemotherapy in either the adjuvant setting and/or whilst awaiting EGFR test results
Changed the prescriber type to any relevant practitioner.

We have also made other minor wording changes to the criteria for clarity.

A summary of the feedback received and our response to this is detailed below.

Details about our decision

From 1 January 2025 osimertinib (Tagrisso) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Osimertinib	Tab 40 mg	Tagrisso	30	$9,310.00
Osimertinib	Tab 80 mg	Tagrisso	30	$9,310.00

A confidential rebate will apply to Tagrisso that will reduce the net price. Tagrisso will have protection from delisting and subsidy reduction until 31 December 2027.

Osimertinib will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Initial application – (NSCLC – first line) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

Patient is currently on treatment with osimertinib and met all remaining criteria prior to commencing treatment; or
All of the following:
1. Patient has locally advanced or metastatic, incurable, non-squamous non-small cell lung cancer (NSCLC); and
2. Any of the following:
  1. Patient is treatment naïve; or
  2. Patient has received prior chemotherapy in the adjuvant setting and/or while awaiting EGFR results; or
  3. Both:
    1. The patient has discontinued gefitinib or erlotinib due to intolerance; and
    2. The cancer did not progress while on gefitinib or erlotinib; and
  4. There is documentation confirming that the cancer expresses activating mutations of EGFR; and
  5. Patient has an ECOG performance status 0-3; and
  6. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal – (NSCLC – first line) from any relevant practitioner. Approvals valid for 6 months for applications where response to or stable disease with treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period.

Initial application – (NSCLC – second line) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

Patient is currently on treatment with osimertinib and met all remaining criteria prior to commencing treatment; or
All of the following:
1. Patient has locally advanced or metastatic, incurable, non-squamous non-small cell lung cancer (NSCLC); and
2. Patient has an ECOG performance status 0-3; and
3. The patient must have received previous treatment with erlotinib or gefitinib; and
4. There is documentation confirming that the cancer expresses T790M mutation of EGFR following progression on or after erlotinib or gefitinib; and
5. The treatment must be given as monotherapy; and
6. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal – (NSCLC – second line) from any relevant practitioner. Approvals valid for 6 months for applications where response to treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period.

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

We have also made small changes to the eligibility criteria for erlotinib and gefitinib to align with the criteria for osimertinib. We have also removed the pandemic circumstances renewal criteria, which was instated as part of Pharmac’s response to the COVID-19 pandemic and its impact on the health system (additions in bold, deletions in strikethrough).

Initial application only from a relevant specialist or medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

Patient has locally advanced, or metastatic, unresectable, non-squamous non-small cell lung cancer (NSCLC); and
There is documentation confirming that the disease expresses activating mutations of EGFR tyrosine kinase EGFR; and
Either Any of the following:
1. Patient is treatment naïve; or
2. Patient has received prior treatment in the adjuvant setting and/or while awaiting EGFR results; or
3. Both:
  1. The patient has discontinued osimertinib or [gefitinib/erlotinib] due to intolerance; and
  2. The cancer did not progress while on osimertinib or [gefitinib/erlotinib]; and
[Gefitinib/Erlotinib] is to be given for a maximum of 3 months

Renewal only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications where radiological assessment (preferably including CT scan) indicates NSCLC has not progressed.

Renewal (pandemic circumstances) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

The patient is clinically benefitting from treatment and continued treatment remains appropriate
[Gefitinib/Erlotinib] to be discontinued at progression
The regular Special Authority renewal requirements cannot be met due to COVID-19 constraints on health sector.

Our responses to what you told us:

Theme	Pharmac Comment
Supportive of the proposal, noting the impact this treatment would have for people living with EGFR mutated NSCLC	We’re grateful for people who took the time to share their stories with us. We are pleased to be able to fund this medicine for people with lung cancer.
Noted that T790M testing is not currently routinely available and reimbursed in the public health system, specifically availability of EGFR T790M mutation testing by liquid biopsy. This risks inequity of access.	We have provided information to Health NZ to support implementation of T790M testing in the public health system. We also understand that AstraZeneca will provide interim funding for T790M testing by liquid biopsy through IGENZ. We understand that this would support implementation of this proposal in the public health system while it builds testing capacity and the test can be reimbursed.
Requested amendments to the eligibility criteria to: Enable use of osimertinib in combination with chemotherapy Include people with an ECOG score of 3 in the group eligible for funding Allow people to start chemotherapy in the first line setting while awaiting EGFR results Include people who received adjuvant chemotherapy but have relapsed Remove specific staging criteria	We appreciate this feedback and have sought clinical advice from the Cancer Treatments Advisory Committee (CTAC) on these changes. Our clinical advisors supported these changes and as a result of this and the clinical advice received, we have amended the eligibility criteria in line with these requests.
Some people requested funding from an earlier date	We acknowledge that people would like to see medicines funded as soon as possible and this is especially acute for cancer. We acknowledge the difficulties that people and families/whānau experience while waiting for funded treatment. We are working as timely as possible to fund new medicines, both for cancer and non-cancer conditions, following our budget uplift in June 2024. The timing of new funding is dependent on a number of factors, including negotiation with suppliers, supplier lead times, sector readiness and relative priority of proposals on the Pharmac Options for Investment list.
Respondents noted that guidance on monitoring and management of this medicine is needed to support specialist GPs who may prescribe it (initial and continuation) on a specialist’s recommendation.	We have shared this feedback with the supplier of osimertinib. While we consider initiations would likely occur in secondary care, we intend to consider what Pharmac could do to help support Specialist GPs and other primary care practitioners who may prescribe this medicine.

Trastuzumab deruxtecan (T-DXd) for HER-2 positive breast cancer

What does this mean for people?

From 1 January 2025 trastuzumab deruxtecan (T-DXd) will be funded for eligible people who have metastatic breast cancer that has:

progressed after prior trastuzumab treatment for metastatic disease, or
progressed within 6 months of adjuvant HER2 targeted treatment.

We estimate that around 120 people will receive T-DXd in the first year of funding, and that this will decrease to around 75 people each year after five years of funding.

We understand there are a small number of people already accessing T-DXd through private funding arrangements. We have ensured that if the eligibility criteria were met when someone started treatment, they will be able to transition to publicly funded treatment.

Who we think will be interested

People with breast cancer, their partners, family or whānau and caregivers
Oncologists, clinical nurse specialists, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with breast cancer
Groups who support and advocate for people with cancer
Health NZ | Te Whatu Ora and Te Aho o Te Kahu | Cancer Control Agency
Hospital pharmacies
Hei Āhuru Mōwai
Pharmaceutical suppliers and wholesalers

Any changes to our proposal?

We received feedback from clinicians, patient support groups, suppliers, and consumers. We want to thank everyone for their feedback. Overall, the feedback was supportive.

After considering feedback and seeking further advice from our expert clinical advisors, we have amended the eligibility criteria for access to this medicine as follows:

enabled people, for whom T-DXd cannot be tolerated, to change to trastuzumab emtansine (T-DM1) provided their cancer did not progress while receiving T-DXd
enabled people who have previously accessed T-DM1 to access T-DXd

A summary of the feedback received and our response to this is detailed below.

Details about our proposal

From 1 January 2025, trastuzumab deruxtecan (Enhertu) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Trastuzumab deruxtecan	Inj 100 mg per ml, 1 ml vial	Enhertu	1	$2,550.00
Trastuzumab deruxtecan	Inj 1 mg for ECP	Baxter	1 mg	$27.05

A confidential rebate will apply to Enhertu that will reduce the net price and it will have protection from delisting and subsidy reduction until 31 December 2027.

Trastuzumab deruxtecan will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Initial application only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

Patient is currently on treatment with trastuzumab deruxtecan and met all remaining criteria prior to commencing treatment; or
All of the following:
1. Patient has metastatic breast cancer expressing HER-2, IHC3+ or ISH+ (including FISH or other current technology); and
2. Patient has previously received trastuzumab and chemotherapy, separately or in combination; and
3. Either:
  1. The patient has received prior therapy for metastatic disease; or
  2. The patient developed disease recurrence during, or within six months of completing adjuvant therapy; and
4. Patient has a good performance status (ECOG 0-1); and
5. Patient has not received prior funded trastuzumab deruxtecan treatment; and
6. Treatment to be discontinued at disease progression.

Renewal only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for people meeting the following criteria:

Both:

The cancer has not progressed at any time point during the previous approval period whilst on trastuzumab deruxtecan; and
Treatment to be discontinued at disease progression.

Note: Prior or adjuvant therapy includes anthracycline, other chemotherapy, biological drugs, or endocrine therapy.

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

Trastuzumab deruxtecan will be listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical. This means that only Health NZ hospitals will be able to make subsidy claims.

The eligibility criteria for trastuzumab emtansine (Kadcyla) [PDF](external link) in Section B of the Pharmaceutical Schedule will be amended from 1 January 2025 as follows (additions in bold, relevant criteria shown only):

Initial application – (metastatic breast cancer) only from a relevant specialist or a medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Patient has metastatic breast cancer expressing HER-2 IHC3+ or ISH+ (including FISH or other current technology); and
Patient has previously received trastuzumab and chemotherapy, separately or in combination; and
Either:
1. The patient has received prior therapy for metastatic disease; or
2. The patient developed disease recurrence during, or within six months of completing adjuvant therapy; and
Patient has a good performance status (ECOG 0-1); and
Either
1. Patient does not have symptomatic brain metastases; or
2. Patient has brain metastases and has received prior local CNS therapy; and
Patient has not received prior funded trastuzumab emtansine; and
Either:
1. Patient has not received prior funded trastuzumab emtansine or trastuzumab deruxtecan treatment; or
2. Both:
  1. Patient has discontinued trastuzumab deruxtecan due to intolerance; and
  2. The cancer did not progress while on trastuzumab deruxtecan; and
Treatment to be discontinued at disease progression.

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

Our response to what you told us

Theme	Pharmac Comment
Supportive of the proposal, noting the impact this treatment would have for people with HER2 positive metastatic breast cancer.	We’re grateful for people who took time to share their stories with us. We are pleased to be able to fund this medicine for people with breast cancer.
Noted there would be additional infusion hours and resources needed to administer this medicine, and considered that community infusion centres, not necessarily linked to existing Health NZ facilities, should be scoped to support this. Highlighted infusion service access issues for rural populations, and considered there is a need to work alongside rural hospitals to ensure patients have a fair and consistent access to trastuzumab deruxtecan	We appreciate this feedback and have shared our estimates of additional infusion hours with Health NZ and in the consultation. We will share this feedback with our health sector partners and would remain responsive to changes in the health system that would support treatment closer to home.
Requested that people be able to access trastuzumab deruxtecan after prior treatment with trastuzumab emtansine. Specifically, that this not just be for people previously treated with trastuzumab emtansine prior to 1 January 2025.	We have sought clinical advice from CTAC on this change. Our clinical advisors told us there is strong evidence of benefit from trastuzumab deruxtecan following treatment with trastuzumab emtansine. Our advisors also told us this change would only affect a small number of people, as most be people would be treated with trastuzumab deruxtecan if it were clinically appropriate. As a result of this and the clinical advice received, we have amended the eligibility criteria accordingly.
Requested that people be able to change to trastuzumab emtansine if trastuzumab deruxtecan cannot be tolerated.	We have sought clinical advice from CTAC on this change. Our advisors told us that some people may experience severe adverse reactions from treatment with trastuzumab deruxtecan who would benefit from continued treatment with trastuzumab emtansine. As a result of this and the clinical advice received, we have amended the proposed eligibility criteria to allow for this.
Requested wider access for people with HER2-low metastatic breast cancer	We understand there are unmet health needs for people with HER2-low metastatic breast cancer. We have received a funding application for trastuzumab deruxtecan for this indication and intend to seek clinical advice at a future CTAC meeting. As we have not received a positive funding recommendation, nor assessed and prioritised this proposal against other options for investment, we are not able to progress this at this time. The status of the application for trastuzumab deruxtecan to treat people with HER2-low metastatic breast cancer(external link) is on our Application Tracker.
Requested wider access to trastuzumab emtansine for people whose cancer is refractory to trastuzumab deruxtecan	We have sought clinical advice from CTAC on this change. Our clinical advisors told us there is insufficient evidence of a benefit from trastuzumab emtansine after treatment with trastuzumab deruxtecan. We have not made changes to the criteria for trastuzumab emtansine as a result of this request. Find the clinical advice received on funding trastuzumab deruxtecan for people whose cancer did not respond to trastuzumab emtansine(external link) We would welcome a funding application for this use of trastuzumab emtansine to support consideration of this indication if evidence becomes available.

Palivizumab for prevention of severe illness from respiratory syncytial virus (RSV)

What does this mean for people?

From 1 January 2025 palivizumab (branded as Synagis) will be funded for the prevention of severe illness caused by respiratory syncytial virus (RSV), for infants and young children at very high risk of RSV.

Palivizumab will be available for the 2025 peak RSV season (usually between May and October in New Zealand) and onwards.

We estimate that around 830 infants and young children will receive palivizumab each year. We anticipate that this would help reduce hospitalisations from RSV, particularly in paediatric intensive care units, neonatal units and children’s wards.

Who we think will be interested

Family or whānau, and or caregivers of infants at risk of RSV-related illness
Paediatric services and healthcare professionals involved in the care of infants at risk of severe complications from RSV-related illness
Health New Zealand | Te Whatu Ora hospitals and other organisations who deliver services and support for infants born prematurely or otherwise at risk of severe complications from RSV-related illness
People or groups including public health practitioners with an interest in treatments for or disease control of childhood RSV
Pharmacies and wholesalers
Pharmaceutical suppliers and wholesalers

Any changes to our proposal?

We received feedback from clinicians, health professional colleges, and other organisations with an interest in RSV prevention. We want to thank everyone for their feedback. Overall, feedback was supportive.

After considering feedback and seeking further advice from our expert clinical advisors, we have amended the eligibility criteria for access to this medicine as follows:

enabled access for all children at specifically high-risk of RSV related illness (criterion 2) for those up to 2 years of age
enabled access for all children up to 2 years of age with severe immunodeficiency who have not received a stem cell transplant
clarified that palivizumab is to be used during the annual RSV season only.

We also received feedback requesting the ‘PCT only’ restriction on palivizumab be removed to allow for community administration and claiming. We discussed this further with stakeholders and understand there is currently no publicly funded service for the administration of palivizumab in the community. As such, palivizumab will be able to be dispensed within Health NZ hospitals only. However, we would be responsive to enabling access to palivizumab in the community setting, should there be a service and infrastructure set up to support delivery and reimbursement in the community. We intend to share this feedback with Health NZ to support these considerations.

A summary of the feedback and our response to this is detailed below.

Details about our proposal

From 1 January 2025, palivizumab (Synagis) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Palivizumab	Inj 100 mg per ml, 1 ml vial	Synagis	1	$1,700.00

A confidential rebate will apply to Synagis that will reduce the net price and it will have protection from delisting and subsidy reduction until 31 December 2027.

Palivizumab will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

Palivizumab to be administered during the annual RSV season; and
Either:
1. Both
  1. Infant was born in the last 12 months; and
  2. Infant was born at less than 32 weeks zero days’ gestation; or
2. Both
  1. Child was born in the last 24 months; and
  2. Any of the following:
    1. Child has severe lung, airway, neurological or neuromuscular disease that requires ongoing ventilatory/respiratory support (see Note A) in the community; or
    2. Both:
      1. Child has haemodynamically significant heart disease; and
      2. Any of the following:
        
        Child has unoperated simple congenital heart disease with significant left to right shunt (see Note B); or
        
        Child has unoperated or surgically palliated complex congenital heart disease; or
        
        Child has severe pulmonary hypertension (see Note C); or
        
        Child has moderate or severe left ventricular (LV) failure (see Note D); or
      3. Child has severe combined immune deficiency, confirmed by an immunologist, but has not received a stem cell transplant; or
      4. Child has inborn errors of immunity (see Note E) that increase susceptibility to life-threatening viral respiratory infections, confirmed by an immunologist.

Renewal from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Palivizumab to be administered during the annual RSV season; and
Child was born in the last 24 months; and
Any of the following:
1. Child has severe lung, airway, neurological or neuromuscular disease that requires ongoing ventilatory/respiratory support (see Note A) in the community; or
2. Both:
  1. Child has haemodynamically significant heart disease; and
  2. Any of the following:
    1. Child has unoperated simple congenital heart disease with significant left to right shunt (see Note B); or
    2. Child has unoperated or surgically palliated complex congenital heart disease; or
    3. Child has severe pulmonary hypertension (see Note C); or
    4. Child has moderate or severe left ventricular (LV) failure (see Note D); or
  3. Child has severe combined immune deficiency, confirmed by an immunologist, but has not received a stem cell transplant; or
  4. Child has inborn errors of immunity (see Note E) that increase susceptibility to life-threatening viral respiratory infections, confirmed by an immunologist.

Notes:

Ventilatory/respiratory support includes those on home oxygen, CPAP/VPAP and those with tracheostomies in situ managed at home
Child requires/will require heart failure medication, and/or child has significant pulmonary hypertension, and/or infant will require surgical palliation/definitive repair within the next 3 months
Mean pulmonary artery pressure more than 25 mmHg
LV Ejection Fraction less than 40%
Inborn errors of immunity include, but are not limited to, IFNAR deficiencies

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

Palivizumab will be listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health NZ hospitals will be able to make subsidy claims.

Our response to what you told us

Theme	Pharmac Comment
Consider funding of an RSV vaccine for people over 60 years of age	We have received a funding application for this vaccine for people over 60(external link) which was deferred by the Immunisation Advisory Committee in March 2024 [PDF, 373 KB] due to uncertainty of disease incidence, vaccine efficacy, duration of protection and any need for revaccination. As we have not received a positive funding recommendation, nor prioritised this proposal against other options for funding, we are not able to progress this at this time.
Requested removal of ‘PCT only’ restrictions to enable use in the community setting and reduce burden on hospital services	We understand that palivizumab could be administered in community settings. However, we note there is no established service to deliver it in the community at this time. We have discussed this with stakeholders, who, while supportive of future availability in the primary care setting, considered an administration programme would be difficult to deliver within current funding and capacity mechanism. As a result, until the appropriate mechanism is established, this will need to be dispensed in a Health NZ hospital. We remain open to consideration of enabling access to palivizumab in the community setting, should there be a service set up to support delivery and reimbursement in primary care. We intend to continue to work with our health sector partners to ensure that if this were set up, there would be a mechanism for reimbursement in the community.
Noted the need for funding of nirsevimab or clesrovimab for all infants, as well as maternal RSV vaccination in order to implement a fulsome RSV prevention strategy.	We understand that there may be more effective and suitable treatments and vaccines in development for this indication. We have not received funding applications for any of these and note they are not yet approved by Medsafe nor has a submission been made. We would welcome funding applications should a regulatory submission to Medsafe be made. We have engaged with the supplier of nirsevimab in relation to a potential application to Pharmac and submission for Medsafe approval. However, to date this has not occurred.
Requested amendments to the access criteria to: Include all children at specifically high risk, up to 2 years of age Include children with severe immunodeficiency who are unable to receive a stem cell transplant Restrict access to use only during the annual RSV season (autumn to spring months).	We appreciate this feedback and have sought clinical advice on these changes. Our clinical advisors told us these changes would be appropriate to capture high-risk children in the criteria and that there would be no more than 50 additional eligible children per year. They also told us that palivizumab should only be administered during annual RSV seasons, particularly to ensure that administration does not begin immediately following the 1 January 2025 listing. As a result of this feedback and the clinical advice, we have amended the eligibility criteria to address these issues and included renewal criteria for those at specifically high risk of RSV.
Requested the same criteria as were used in 2022/23.	The criteria for access to palivizumab are wider than were used in 2022/23 when palivizumab was temporarily funded. All children born up to 32 weeks’ gestational age would be eligible. The previous criteria included children born up to only 28 weeks’ gestational age unless they were Māori or Pacific. We are pleased to have reached a commercial arrangement with the supplier that has enabled funded access for all infants born under 32 weeks’ gestational age.

Budesonide, glycopyrronium and eformoterol for chronic obstructive pulmonary disease (COPD)

What will this mean for people?

From 1 January 2025 the budesonide, glycopyrronium and eformoterol aerosol inhaler (branded as Breztri Aerosphere) will be funded for people with moderate to severe chronic obstructive pulmonary disease (COPD). This will provide an additional triple-inhaler option alongside the currently funded fluticasone furoate with umeclidinium and vilanterol inhaler (Trelegy Ellipta Schedule listing(external link)).

We estimate that over 5,000 people will start using this inhaler in the first year, increasing to around 16,000 people each year after five years of funding.

Who we think will be interested

People living with COPD, their families or their whānau, caregivers and loved ones
Respiratory physicians, clinical nurse specialists and healthcare professionals involved in the care of people with COPD
Health New Zealand | Te Whatu Ora hospitals and other organisations such as regional pulmonary rehabilitation and support groups who deliver services for people with COPD
People or groups who support and have an interest in treatments for COPD
Pharmacies and wholesalers
Pharmaceutical suppliers of respiratory treatments and wholesalers

Any changes to our proposal?

We received feedback from clinicians, advocacy groups, suppliers and consumers. We want to thank everyone for their feedback. Overall, feedback was supportive, however concerns were raised about the environmental impact of the propellent used in the inhaler. In response to this feedback we have worked with the supplier to bring an alternative formulation with a lower environmental impact to New Zealand, should this gain Medsafe approval.

More about the development of the new inhaler | AstraZeneca website(external link)

We have not made any other changes to this proposal following consultation feedback. A summary of the feedback and our response to this is detailed below.

Details about our proposal

From 1 January 2025, the budesonide, glycopyrronium and eformoterol (Breztri Aerosphere) metered dose inhaler will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Budesonide with glycopyrronium and eformoterol	Aerosol inhaler budesonide 160 mcg with glycopyrronium 7.2 mcg and formoterol 5 mcg per dose	Breztri Aerosphere	120 dose OP	$79.15

A confidential rebate will apply to Breztri Aerosphere that will reduce the net price, and it will have protection from delisting and subsidy reduction until 30 June 2028.

Budesonide with glycopyrronium and eformoterol will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Both:

Patient has a diagnosis of COPD confirmed by spirometry, or spirometry has been attempted and technically acceptable results are not possible; and
Either:
1. Both:
  1. Patient is currently receiving an inhaled corticosteroid with long acting beta-2 agonist (ICS/LABA) or a long acting muscarinic antagonist with long acting beta-2 agonist (LAMA/LABA); and
    
    Clinical criteria:
  2. Any of the following:
    1. Patient has a COPD Assessment Test (CAT) score greater than 10; or
    2. Patient has had 2 or more exacerbations in the previous 12 months; or
    3. Patient has had one exacerbation requiring hospitalisation in the previous 12 months; or
    4. Patient has had an eosinophil count greater than or equal to 0.3 × 10ˆ9 cells/L in the previous 12 months; or
2. Patient is currently receiving multiple inhaler triple therapy (inhaled corticosteroid with long-acting muscarinic antagonist and long-acting beta-2 agonist – ICS/LAMA/LABA) and met at least one of the clinical criteria above prior to commencing multiple inhaler therapy.

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

Our response to what you told us

Theme	Pharmac Comment
Considered that this funding is less critical than other urgent funding needed for respiratory conditions.	We appreciate this feedback. We have reached a commercial arrangement with the supplier that means we have been able to progress Breztri Aerosphere for funding. There are a number of other funding applications for respiratory conditions at various stages in our process – this proposal for Breztri Aerosphere will not affect our consideration of the other proposals.
Noted the environmental impacts of the hydrofluoroalkane (HFA) propellant of Breztri, particularly compared to already funded triple inhalers	We acknowledge the greenhouse gas environmental impact of inhalers with HFA’s. As a result, we have secured agreement with the supplier to fund an inhaler with an alternative propellant that has a substantially lower environmental impact should this receive Medsafe approval. This would be under the same terms as the inhaler to be listed from 1 January 2025.
Considered Breztri should only be funded for people for whom the currently funded triple inhaler is unsuitable.	We consider that the prescribing clinician, in consultation with the patient, is best placed to decide which inhaler is the best option. We are pleased to have reached a commercial arrangement with the supplier of Breztri that gives people this choice.
Requested an amendment to eligibility criteria to include people who cannot get a spirometry test done for any reason.	We sought clinical advice on the same feedback when we consulted on a proposal to fund Trelegy Ellipta. Our clinical advisors told us that spirometry is a necessary diagnostic tool for people with COPD, and that relying on clinical diagnosis alone may lead to overdiagnosis and the use of this inhaler by people who are unlikely to benefit from it. Based on this advice we have not removed the requirement that ensures spirometry is attempted.

Contractual amendments to Lynparza

Olaparib (branded as Lynparza), is currently funded for people with ovarian cancer subject to eligibility criteria [PDF](external link). As a part of the provisional agreement, the confidential net price of olaparib will reduce via confidential rebate from 1 January 2025 and it will have protection from delisting and subsidy reduction until 31 December 2027.