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

Medicines Consultation Closed

What we’re proposing

We’re seeking feedback on a proposal to fund four new treatments for cancer and respiratory conditions through a provisional agreement with AstraZeneca Ltd (AstraZeneca).

This proposal would result in the following treatments being funded from 1 January 2025:

osimertinib (branded as Tagrisso) for the initial treatment of EGFR mutated, locally advanced or metastatic non-small-cell lung cancer.

osimertinib (branded as Tagrisso) as a subsequent treatment of EGFR T790M mutated, locally advanced or metastatic non-small cell lung cancer.

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).

We estimate that in the first year of funding around 300 people would benefit from the osimertinib and trastuzumab deruxtecan. In the same period, we expect around 800 infants and young children would benefit from the funding of palivizumab. We anticipate that over 5,000 people would start on the budesonide with glycopyrronium and eformoterol triple inhaler in the first year of funding. After 5 years we estimate the number of people benefiting from these medicines would grow to over 17,000 people each year.

The provisional agreement with AstraZeneca also includes amendments to the contractual terms for olaparib (branded as Lynparza). No changes would be made to the funding of olaparib (currently funded for people with ovarian cancer subject to eligibility criteria) however the net price would reduce via a confidential rebate.

Eligibility criteria for olaparib [PDF](external link)

The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action. 

Questions and answers on Pharmac's budget increase

We want to hear your feedback about our proposal. Consultation closes at 4pm Monday 7 October 2024. Feedback can be emailed to consult@pharmac.govt.nz

Osimertinib for non-small cell lung cancer (NSCLC)

What would the effect be?

From 1 January 2025 osimertinib (branded as Tagrisso) would be funded for eligible people with locally advanced or metastatic non-small cell lung cancer (NSCLC), as both:

  • an initial treatment (first line) where the cancer has an activating epidermal growth factor receptor (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 or erlotinib)

Gefitinib Pharmaceutical Schedule listing(external link)

Erlotinib Pharmaceutical Schedule listing(external link)

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

We also understand there are around 25 people already accessing osimertinib through private funding arrangements. We would ensure that these people would be able to transition onto publicly funded osimertinib if they met the eligibility criteria when they started treatment.

Impact on pathology services

People who have received no prior treatment would require confirmation of an EGFR mutation. This is currently available to support access to the currently funded treatments (gefitinib and erlotinib).

People who progress after first line treatment would require confirmation of a T790M mutation to be eligible for osimertinib. Our clinical advisors have told us that testing for this mutation is needed to identify people who would benefit from osimertinib after progression on erlotinib or gefitinib. The majority of the need for confirmation of T790M mutational status would be present during the initial years of funding as we expect most people to receive osimertinib first line.

We understand that most people would be able to be tested for T790M mutation. However, some people may have insufficient tumour tissue for this test and may instead require a liquid biopsy. We understand there is variable access to funded liquid biopsy for confirmation of T790M mutational status across the country.

We have informed Health New Zealand | Te Whatu Ora that this testing may need to be available if osimertinib was funded. We welcome feedback on the feasibility and how testing to support implementation of this proposal would be managed.

Who we think will be interested

  • People with lung cancer, their whānau and caregivers
  • Oncologists, specialist nurses, 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 NZ | Te Whatu Ora and Te Aho o Te Kahu | Cancer Control Agency
  • Hospital pharmacies
  • Hei Āhuru Mōwai
  • Cancer Society
  • Pharmaceutical suppliers and wholesalers

About EGFR mutated non-small cell lung cancer (NSCLC) and osimertinib

EGFR mutated non-small cell lung cancer (NSCLC)

There are two main types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer. NSCLC accounts for about 80% of all lung cancers.

NSCLC is the leading cause of cancer-related death in Aotearoa New Zealand. Most people with lung cancer are diagnosed with advanced disease, at the locally advanced or metastatic stage. People with NSCLC typically have poor quality of life and have a poor prognosis.

EGFR mutated NSCLC is a subtype of NSCLC in which there is a specific mutation in the EGFR gene. This mutation leads to abnormal cell growth and contributes to the development and progression of the cancer.

NSCLC is a leading cause of the current life expectancy gap between Māori, Pacific people and non-Māori non-Pacific (Health Status Report 2023)(external link). Māori and Pacific people are diagnosed at a younger age, often presenting with later stage disease and experience worse outcomes from NSCLC than non-Māori, non-Pacific peoples. While Māori people have a lower rate of EGFR mutations compared to non-Māori, they are more likely to present with metastatic disease and would be expected to benefit from treatments funded in this setting. Pacific people have higher rates of EGFR mutations compared to non-Pacific people.  

Mate Pukupuku, lung cancer is a Hauora Arotahi (Māori health area of focus). Cancer is priority area in the Government Policy Statement on Health 2024-2027(external link).

Osimertinib

Osimertinib (Tagrisso) is an oral medicine, Medsafe approved for the treatment of NSCLC. Osimertinib belongs to a class of medicines known as tyrosine kinase inhibitors, that selectively bind to and block mutated forms of EGFR protein.

Gefitinib(external link) and erlotinib(external link) are both first-generation tyrosine kinase inhibitors that are currently funded for people with advanced or metastatic non-small cell lung cancers with mutations in the EGFR protein.

Osimertinib is a third-generation tyrosine kinase inhibitor that our advisors have told us has superior effectiveness to other funded tyrosine kinase inhibitors in the treatment of EGFR mutated NSCLC.

Osimertinib is available in 40mg and 80mg tablets and is taken orally every day.

Osimertinib Medsafe datasheet [PDF](external link)

Why we’re proposing this

Osimertinib was recommended for funding by the Cancer Treatments Advisory Committee (CTAC) in April 2021 as an:

  • initial treatment for patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer; and
  • as 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(external link) or erlotinib(external link))

Our clinical advisors told us there is a high unmet health need and poor outcomes for people with NSCLC, particularly those with treatment resistance to first generation tyrosine kinase inhibitors. Osimertinib is expected to improve progression-free survival, overall survival, and quality of life for people with EGFR mutated NSCLC compared to current treatment options.

CTAC meeting record April 2021 [PDF, 878 KB]

Application Tracker | Osimertinib for locally advanced or metastatic EGFRm NSCLC, first line(external link)

Application Tracker | Osimertinib for locally advanced or metastatic EGFR T790M positive NSCLC, second line(external link)

Details about our proposal

From 1 January 2025 osimertinib (Tagrisso) would 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

Osimertinib

Tab 40 mg

Tagrisso

30

$9,310.00

Osimertinib

Tab 80 mg

Tagrisso

30

$9,310.00

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

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

Initial application (NSCLC – first line) only from a relevant specialist or 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:

  1. Patient has locally advanced (Stage IIIb) or metastatic (Stage IV), non-squamous non-small cell lung cancer (NSCLC); and
  2. Either:
    1. Patient is treatment naïve; or
    2. 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
  3. There is documentation confirming that the disease expresses activating mutations of EGFR tyrosine kinase; and
  4. Treatment must be used as monotherapy; and
  5. Patient has an ECOG performance status 0-2; and
  6. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal (NSCLC – first line) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications that meet the following criteria:

Both:

  1. Response to treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period; and
  2. No evidence of disease progression 

Initial application (NSCLC – second line) only from a relevant specialist or 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:

  1. Patient has locally advanced (Stage IIIb) or metastatic (Stage IV), non-squamous non-small cell lung cancer (NSCLC); and
  2. Patient has an ECOG performance status 0-2; and
  3. The patient must have received previous treatment with erlotinib or gefitinib; and
  4. There is documentation confirming that the disease expresses T790M mutation of the EGFR gene 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) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications that meet the following criteria:

Both:

  1. Response to treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period; and
  2. No evidence of disease progression

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

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

What would the effect be?

From 1 January 2025 Trastuzumab deruxtecan (T-DXd) would be funded for eligible people with metastatic breast cancer which has:

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

People who are receiving trastuzumab emstansine for treatment of metastatic breast cancer at the listing date would also be eligible for T-DXd.

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

We also understand there are a small number of people already accessing T-DXd through private funding arrangements. We would ensure that these people would be able to transition onto publicly funded T-DXd if they met the eligibility criteria when they started treatment.

Impact on infusion services

This group of people currently receive trastuzumab emtansine (an intravenous infusion) for the treatment of their disease. We expect that this proposal would result in an additional 500 infusion hours in the first year and that this would increase to around 900 additional infusion hours after four years of funding.

Who we think will be interested

  • People with breast cancer, their whānau and caregivers
  • Oncologists, specialist nurses, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with breast cancer
  • Groups who support people with cancer
  • Health NZ | Te Whatu Ora and Te Aho o Te Kahu | Cancer Control Agency
  • Hospital pharmacies
  • Pharmaceutical suppliers and wholesalers
  • Hei Āhuru Mōwai
  • Cancer Society
  • Iwi Māori Partnership Boards
  • Tāngata Whaikaha Ministry of Disabled People

About breast cancer and trastuzumab deruxtecan (T-DXd)

Breast cancer affects one in nine women over their lifetime, with 3,600 people diagnosed in 2021. Around 10% of patients with breast cancer present with metastatic disease at the time of diagnosis, and the majority of women who relapse after definitive therapy for early stage or locally advanced disease will have metastatic disease.

HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). Around 15-20% of breast cancers are HER2 positive. HER2 positivity has an increased risk of disease recurrence and an overall worse prognosis.

Breast cancer is one of Pharmac’s Hauora Arotahi Māori health areas of focus. Māori and Pacific people are more likely to get breast cancer and when they do, they are more likely to be diagnosed at a later stage and experience worse outcomes than non-Māori non-Pacific people. Around 15-20% of people with breast cancer are HER2-positive, with similar proportions for Māori. The proportion of people with HER2-positive breast cancer is higher for Pacific people.

T-DXd is a targeted therapy that binds to HER2 receptors on cancer cells and releases the chemotherapy, preventing it from growing and dividing. It is a combination of trastuzumab (a HER2 targeting treatment) and deruxtecan (a type of chemotherapy).

T-DXd would displace the use of trastuzumab emtansine (TDM-1) in this setting, which is currently funded for people with metastatic breast cancer who meet similar eligibility criteria.

Eligibility criteria for trastuzumab emtansine [PDF](external link)

T-DXd is Medsafe approved for use in both HER2-positive and HER2-low breast cancer. It is administered as a ninety-minute infusion every three weeks until disease progression or unacceptable toxicity.

Trastuzumab deruxtecan Medsafe datasheet [PDF](external link)

Why we’re proposing this

Trastuzumab deruxtecan for the treatment of progressive or metastatic HER-2 positive breast cancer was recommended for funding by CTAC in April 2023.

Our advisors told us there is a high unmet health need and a lack of treatment options for people with locally advanced or metastatic HER-2 positive breast cancer. They told us T-DXd would provide meaningful improvements in both overall survival and progression free survival compared to current treatment options, with particular benefits for people with brain metastases.

Our advisors also told us that people currently receiving trastuzumab emtansine (TDM-1) for their metastatic disease would also benefit from T-DXd. They also told us that there is insufficient evidence of a benefit from using TDM-1 after T-DXd.

Trastuzumab emtansine listing in the Pharmaceutical Schedule(external link)

Application tracker | Trastuzumab derutexcan for metastatic breast cancer(external link)

CTAC meeting record April 2023 [PDF, 1.1 MB]

Details about our proposal

From 1 January 2025, trastuzumab deruxtecan (Enhertu) would 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

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

Trastuzumab deruxtecan would 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:

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. Both:
    1. Patient has not received prior funded trastuzumab deruxtecan treatment; and
    2. Any of the following:
      1. Patient has not previously received trastuzumab emtansine; or
      2. Patient was receiving trastuzumab emtansine for treatment of their metastatic breast cancer at 1 January 2025; or
      3. Patient previously received treatment with trastuzumab emtansine in the early breast cancer setting only; 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:

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

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

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

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

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

Special Authority for Subsidy

Initial application (metastatic breast cancer) 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:

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. Either
    1. Patient does not have symptomatic brain metastases; or
    2. Patient has brain metastases and has received prior local CNS therapy; and
  6. Patient has not received prior funded trastuzumab emtansine or trastuzumab deruxtecan treatment; and
  7. Treatment to be discontinued at disease progression.

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

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

What would the effect be?

From 1 January 2025 palivizumab (branded as Synagis) would be funded for prevention of severe illness caused by respiratory syncytial virus (RSV), for infants and young children at very high risk of RSV. Palivizumab would be available for the 2025 peak RSV season (usually between May and October in New Zealand) and onwards.

We estimate that around 800 infants and young children would receive treatment with palivizumab each year.

Who we think will be interested

  • Whānau 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 NZ | 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 with an interest in treatments for childhood RSV
  • Pharmacies and wholesalers
  • Pharmaceutical suppliers of respiratory treatments
  • Iwi Māori Partnership Boards

About RSV and palivizumab

RSV is a highly contagious, common respiratory virus that causes lung and respiratory tract infections. RSV is the leading cause of hospitalisation for lower respiratory tract infections in infants. Historically RSV is usually present in the community between May and October in New Zealand. This is called the RSV season.

Infants who are born early, or have certain risk factors, are more likely to develop severe RSV-related illnesses and need to be hospitalised. Māori and Pacific infants and young children are more likely to be born prematurely and require preventative treatment.

Palivizumab is a humanised monoclonal antibody (IgG) that prevents severe respiratory illnesses caused by RSV. Palivizumab is not used to treat RSV once someone already has the infection.

Prevention is a focus under the Government Policy Statement on Health 2024-2027(external link) and this proposal would align with actions to ensure early access to preventative treatments and prioritise investments into children that support a good start to life. Respiratory health (Romaha Ora) is one of Pharmac’s Māori health areas of focus (Hauora Arotahi).

Palivizumab is administered as an intramuscular injection by a healthcare professional. The dose of palivizumab is based on an infant’s weight, at a dose of 15 mg per kg. It is administered once a month during the expected RSV season.

Palivizumab Medsafe Datasheet [PDF](external link)

Why we’re proposing this

Palivizumab was temporarily funded for the 2022 and 2023 RSV seasons from special funding made available to Pharmac as part of the Government’s response to COVID-19 and its impacts.

Decision to fund palivizumab in May 2022

Our clinical advisors told us it would be important to fund palivizumab during this time while there was still uncertainty about how the COVID-19 pandemic and its response would affect the health system.

We then sought clinical advice from Pharmacology and Therapeutics Advisory Committee (PTAC) about enduring funding of palivizumab for prevention of RSV in May 2023. Our advisors told us that palivizumab is effective at reducing hospitalisations for RSV and recommended that palivizumab be funded. They considered that during its funding, palivizumab helped reduce hospitalisations from RSV which had a positive impact on the health system, particularly in paediatric intensive care units and hospital children’s wards, as well as on caregivers and whānau.

After the separate funding for the COVID-19 response ended, Pharmac re-assessed palivizumab to see how its health benefit to New Zealand compares to all other treatments we would like to fund from the CPB. Due to budgetary constraints at the time, we were not able to extend the temporary funding for palivizumab in January 2024.

Media release: End of temporary funding for palivizumab

Following the funding uplift in June 2024, we’re proposing to fund RSV permanently from the Combined Pharmaceutical Budget. We are pleased that we have reached a commercial arrangement with the supplier that would enable funding for all infants born prior to 32 weeks gestation.

Palivizumab was previously funded as a PCT only medicine and was managed through relevant hospital units and pharmacies. We are proposing that the same claiming rules would apply for this proposal.

Application tracker | Palivizumab for prevention of RSV(external link)

PTAC meeting record May 2023 [PDF, 1.2 MB]

We are aware of other potential funding options for RSV prevention, including nirsevimab and maternal vaccination however have not received funding applications for these. This proposal would not prevent other medicines or vaccines from being funded in the future. We would welcome funding applications for other treatments for prevention of RSV in young people.

Details about our proposal

From 1 January 2025, palivizumab (Synagis) would 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 would apply to Synagis that would reduce the net price and it would have protection from delisting and subsidy reduction until 31 December 2027.

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

Initial application only from a paediatrician. Approvals valid for 6 months for applications meeting the following criteria:

Either:

  1. Child was born in the last 2 years and has severe lung, airway, neurological or neuromuscular disease that requires ongoing, life-sustaining ventilation/respiratory support in the community; or
  2. Both:
    1. Infant was born in the last 12 months; and
    2. Either:
      1. Infant was born less than 32 weeks’ and zero days gestation; or
      2. Both:
        1. Infant has haemodynamically significant heart disease; and
        2. Any of the following:
          1. Infant has unoperated simple congenital heart disease with significant left to right shunt (see Note a); or
          2. Infant has unoperated or surgically palliated complex congenital heart disease; or
          3. Infant has severe pulmonary hypertension (see Note b); or
          4. Infant has moderate or severe left ventricular (LV) failure (see Note c)

Notes:

  1. Infant requires/will require heart failure medication, and/or infant has significant pulmonary hypertension, and/or infant will require surgical palliation/definitive repair within the next 3 months.
  2. Mean pulmonary artery pressure more than 25 mmHg.
  3. LV Ejection Fraction less than 40%.

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

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

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

What would the effect be?

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

Trelegy Ellipta Pharmaceutical Schedule listing(external link)

We estimate that over 5,000 people would 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 whānau, caregivers and loved ones.
  • Healthcare professionals involved in the care of people with COPD
  • Health NZ | Te Whatu Ora hospitals and other organisations who deliver services and support 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
  • Iwi Māori Partnership Boards

About COPD and budesonide, glycopyrronium and formoterol (Breztri Aerosphere)

COPD is a common lung disease that causes breathing problems. It is also known as emphysema and chronic bronchitis. COPD results from a blockage or damage to the lungs that causes restricted airflow, coughing, wheezing, breathing problems, and tiredness. Medicines for COPD work by opening and reducing swelling in the airways.

COPD is estimated to affect 15% of all New Zealanders aged over forty-five years. It is the fourth leading cause of death in New Zealand behind cancer, heart disease and stroke. COPD is permanent, disabling and frequently progressive.

Respiratory health (Romaha Ora) is one of Pharmac’s Māori health areas of focus (Hauora Arotahi) and a priority area in the Government Policy Statement on Health 2024-2027(external link). The health burden of COPD is one of the most significant sources of healthcare inequity in New Zealand. Māori and Pacific peoples are more likely to experience and are more severely impacted by COPD compared to other ethnic groups.

Amongst New Zealanders aged fifty to sixty-four years, Māori are approximately five times more likely to die from COPD-related causes than non-Māori and are affected by COPD up to twenty years earlier. Māori are three times more likely and Pacific peoples are four times more likely to be admitted to hospital for COPD than non-Māori, non-Pacific people. *

(*) Best Practice Advocacy Centre New Zealand (BPAC). Available from: www.bpac.org.nz(external link)  

COPD is more frequent in communities with higher levels of socioeconomic deprivation and higher smoking rates. Over 85% of cases of COPD are estimated to be caused by inhalation of tobacco smoke.**

(**) The Asthma Foundation. COPD in New Zealand. Available from: www.asthmafoundation.org.nz(external link)

Breztri Aerosphere is a combination of three medicines in a single inhaler.

  • budesonide reduces inflammation and swelling the lungs.
  • glycopyrronium is a bronchodilator that keeps airways open by blocking the tightening of smooth muscle around the airways.
  • eformoterol is another bronchodilator that opens airways by relaxing the muscles around the airways in the lungs.

These three chemicals (budesonide, glycopyrronium and eformoterol) and other types of ICS/LAMA/LABA medicines are administered by use of either a single or dual Inhaler.

Breztri Aerosphere Medsafe datasheet [PDF](external link)

Why we’re proposing this

In May 2024, Pharmac made the decision to fund fluticasone furoate with umeclidinium and vilanterol (branded as Trelegy Ellipta), a single inhaler triple-therapy for the treatment of COPD.

Media release: More treatments available to 30,000 New Zealanders

Budesonide with glycopyrronium and eformoterol would provide people with another option to treat their COPD with a single inhaler triple-therapy.

Our advisors have told us that there is an equivalent clinical benefit from multiple inhaler triple therapy to that of triple therapy from a single inhaler, but that there are significant suitability benefits from combining the treatment in a single inhaler. These include better adherence to treatment, an easier to use regimen (once daily), and reduced chances of errors when administering compared to triple therapy from multiple inhalers.

Funding a triple therapy single inhaler may also be equity enhancing by reducing barriers for people to access treatment from multiple inhalers.

Application Tracker | Budesonide with glycopyrronium and eformoterol for moderate to very severe COPD in adults(external link)

PTAC meeting record November 2023 [PDF, 796 KB]

Details about our proposal

From 1 January 2025, budesonide, glycopyrronium and eformoterol (Breztri Aerosphere) metered dose inhaler would 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 would apply Breztri Aerosphere that would reduce the net price and it would have protection from delisting and subsidy reduction until 30 June 2028.

Budesonide with glycopyrronium and eformoterol would 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:

  1. Patient has a diagnosis of COPD confirmed by spirometry or spirometry has been attempted and technically acceptable results are not possible; and
  2. 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
  3. 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Contractual amendments to Lynparza

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

Eligibility criteria for olaparib [PDF](external link)

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm Monday 7 October 2024.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.