Proposal to fund medicines for cancer and infections, and to change the funded brand of palbociclib

Medicines Consultation Closes 24 Jan

What we're proposing

We’re seeking feedback on a proposal to fund new treatments for cancer and infections through a provisional agreement with Pfizer New Zealand Ltd (Pfizer). As part of this proposal, we are also proposing a change to the funded brand of palbociclib.

Multiproduct agreements like this that include a savings component help us maximise our medicines budget and make more medicines available for New Zealanders.

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

We estimate that around 75 people would benefit from these treatments in the first year of funding, increasing to 90 people each year after five years. 

Palbociclib is currently funded for the treatment of advanced hormone-receptor positive (HR-positive), and human epidermal growth receptor-2 negative (HER2-negative) breast cancer subject to eligibility criteria. It is currently used by around 550 people.

This proposal would result in the following changes to the funding of palbociclib:

  • from 1 April 2025, the net price of palbociclib (Ibrance) would reduce.
  • a new brand of palbociclib (Palbociclib Pfizer) would be funded from 1 July 2025.
  • all people receiving palbociclib would need to transition from Ibrance to the Palbociclib Pfizer brand of palbociclib by 1 December 2025.
  • from 1 December 2025 the Ibrance brand would be delisted from the Pharmaceutical Schedule.

Palbociclib Pfizer has been approved by Medsafe, is manufactured at the same site, to the same specifications, and is packaged similarly, to Ibrance.

We want to hear from people who are currently taking palbociclib for their advanced breast cancer to understand what support they would need with this brand change.

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 Friday 24 January 2025. Feedback can be emailed to consult@pharmac.govt.nz

Inotuzumabozogamicin for the treatment of relapsed or refractory acute lymphoblastic leukaemia/lymphoma

What would the effect be

From 1 April 2025, inotuzumab ozogamicin (Besponsa) would be funded for the treatment of relapsed or refractory (including minimal residual disease), CD22-positive, B-cell precursor acute lymphoblastic leukaemia/lymphoma (ALL).

We estimate that around 15 people would receive inotuzumab ozogamicin each year.

If approved, there would be an impact on infusion services with around 120 additional infusion hours needed each year to administer this treatment for those eligible.

Who we think will be interested

  • People with ALL, their whānau and caregivers
  • Haem-oncologists, haematologists, clinical nurse specialists, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with ALL
  • Groups who support and advocate for people with cancer
  • Health NZ | Te Whatu Ora and the Te Aho o Te Kahu | The Cancer Control Agency
  • Hospital pharmacies
  • Pharmaceutical suppliers and wholesalers
  • Hei Āhuru Mōwai
  • Cancer Society
  • Iwi Māori Partnership Boards

About ALL and inotuzumab ozogamicin

ALL is a type of blood cancer characterised by the rapid growth of lymphocytes (white blood cells) in the bone marrow and blood. B-cell ALL is an aggressive form of ALL that occurs when too many unhealthy B-cells are made. These cells can spread to other organs and impact their function in the body. 

A potentially curative allogenic stem cell transplant is often received by people with ALL. This involves using healthy blood stem cells from a donor and replacing the unhealthy cells in the individuals bone marrow.

Inotuzumab ozogamicin is made up of a monoclonal antibody (inotuzumab) that recognises the CD22 cell surface antigen, attached to a chemotherapy agent (ozogamicin). Once it binds to the cell receptor it is absorbed into the cell and triggers a process resulting in cell death.

Inotuzumab ozogamicin is Medsafe approved for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) and is delivered intravenously weekly in 3 to 4 week cycles.

Medsafe datasheet | inotuzumab ozogamicin [PDF](external link)

Why we’re proposing this

Inotuzumab ozogamicin for the treatment of people with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) including those with minimal residual disease was recommended for funding by the Cancer Treatments Advisory Committee (CTAC) in November 2021.

Our clinical advisors told us there is a high unmet health need and a lack of treatment options for people with relapsed or refractory CD-22 positive B-cell ALL. They told us inotuzumab ozogamicin would provide meaningful improvements in overall and progression free, survival compared to current treatment options. They also told us that it would increase the likelihood of someone progressing to an allogenic stem cell transplant, which could be curative.

We are pleased to have reached a commercial arrangement with the supplier that has enabled progression of a proposal for people regardless of their transplant eligibility.

Our clinical advisors also told us that they expected a reduction in hospital stay duration and reduced adverse events compared with currently funded treatments for B-cell ALL. The links below provide further context to this proposal:

Application tracker | Inotuzumab ozogamicin for relapsed/refractory CD22-positive acute lymphoblastic leukaemia (ALL)(external link)

Application tracker | Inotuzumab ozogamicin for relapsed/refractory CD22-positive acute lymphoblastic leukaemia (ALL) bridge to transplant(external link)

CTAC meeting record November 2021 [PDF, 698 KB]

Cancer is a priority area in the Government Policy Statement on Health 2024-2027 | Ministry of Health(external link).

Details about our proposal

From 1 April 2025, inotuzumab ozogamicin 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

Inotuzumab ozogamicin

Inj 1 mg, vial

Besponsa

1

$14,457.00

Inotuzumab ozogamicin

Inj 1 mg for ECP

Baxter

1

$14,457.00

A confidential rebate would apply to Besponsa that would reduce its net price. It would have protection from delisting and subsidy reduction until 30 September 2028.

Inotuzumab ozogamicin 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 4 months for patients meeting the following criteria: 

All of the following: 


Renewal – only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for patients meeting the following criteria:  

All of the following: 

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

Inotuzumab ozogamicin 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.

Crizotinib for advanced ROS1 mutated NSCLC

What would the effect be

From 1 April 2025 crizotinib (branded as Xalkori) would be funded for people with advanced ROS1 mutated non-small cell lung cancer (NSCLC).

We estimate that around 20 people would receive crizotinib in the first year of funding, and this would decrease to around 10 people each year after five years of funding.

If approved, there would be less people accessing infusion services. We estimate a reduction of around 460 infusion hours in the first year of funding, reducing to around 200 hours each year after five years of funding.

Funded access to immune checkpoint inhibitors

Access to immune checkpoint inhibitors (pembrolizumab and atezolizumab) for the treatment of advanced NSCLC is currently limited to those without an EGFR of ALK mutation.

We have received advice that immune checkpoint inhibitors also have poor efficacy in ROS1 mutated NSCLC. Our advisors have told us that it would be appropriate to limit access to crizotinib for people without this mutation if funded for people with ROS1 mutated NSCLC.

Both pembrolizumab and atezolizumab have Principal Supply Status until 31 March 2026. Should this proposal be approved, we are proposing to amend the criteria to limit access to pembrolizumab and atezolizumab for only those without a ROS1 mutation (in addition to EGFR and ALK mutations) from 1 April 2026.  

Impact on laboratory and pathology services

Our clinical advisors told us that all people who or are diagnosed with advanced NSCLC would require confirmation of an ROS1 mutation to determine eligibility for crizotinib. We estimate that there would be around 1,000 people needing a test per year. Of these, we would expect only 1 to 2% to have a ROS1 mutation.

We understand that this test is not routinely available currently. We have informed Health New Zealand | Te Whatu Ora that this testing would need to be available if crizotinib was funded.

We welcome feedback on:

  • the feasibility of implementation of these testing requirements
  • how testing to support implementation of this proposal would be managed
  • if the timeframes for implementation of funding for crizotinib are appropriate, or if these need to be reconsidered.

Who we think will be interested

  • People with lung cancer, their whānau and caregivers
  • Oncologists, respiratory physicians, 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 | The Cancer Control Agency
  • Hospital pharmacies
  • Hei Āhuru Mōwai
  • The Cancer Society
  • Pharmaceutical suppliers and wholesalers

About NSCLC and crizotinib

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 a poor prognosis. NSCLC can be further broken down by histology into squamous (around 25-30%) or non-squamous (around 70-75%) NSCLC.

ROS1 mutated NSCLC is a subtype of NSCLC in which there is a specific mutation in the ROS1 gene. This leads to abnormal cell growth and contributes to the development and progression of the cancer. People with ROS1 mutated NSCLC tend to be younger and can have limited or no previous tobacco smoking history.

NSCLC is a leading cause of the current life expectancy gap between Māori, Pacific people and non-Māori non-Pacific peoples (Health Status Report 2023 | Health NZ(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. However, at this time it is not clear whether either Māori or Pacific have different rates of ROS1 mutated NSCLC compared to non-Māori, non-Pacific people.

Crizotinib is a targeted cancer therapy that blocks the signals from a faulty protein that is over produced in people with ROS1 mutated NSCLC. This selectively prevents the growth of cancer cells.  

Crizotinib is available as a capsule and is taken orally every day.

Medsafe Datasheet | Crizotinib [PDF](external link)

Why we’re proposing this

Crizotinib for the treatment of people with ROS1 mutated NSCLC was recommended for funding by CTAC in April 2021.

Our clinical advisors told us that there is a very high unmet health need for people with advanced ROS1 mutated NSCLC. While people with this cancer are currently eligible for immune checkpoint inhibitors, our clinical advisors have told us that there is poor evidence of health benefits from using immune checkpoint inhibitors for this group of people.

Our advisors told us that crizotinib would meaningfully improve overall survival, progression free survival, quality of life and have less side effects, for people with advanced ROS1 mutated NSCLC compared to currently funded treatments.

Crizotinib is an oral medicine and this proposal would free up infusion capacity. It would also benefit people living rurally or who are unable to travel to infusion centres for whatever reason (lack of public transport options, disabling travel environments, a lack of social supports). The links below provide further context to this proposal:

Application tracker | Crizotinib for ROS-1 mutated NSCLC(external link)

CTAC meeting record April 2021 [PDF, 878 KB]

CTAC meeting record July 2023 [PDF, 529 KB]

Mate pukupuku (lung cancer) is a Hauora Arotahi (Māori health area of focus).

Cancer is also a priority area in the Government Policy Statement on Health 2024-2027 | Ministry of Health(external link).

Details about our proposal

From 1 April 2025, crizotinib (Xalkori) 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

Crizotinib

Cap 200 mg

Xalkori

60

$7,250.00

Crizotinib

Cap 250 mg

Xalkori

60

$7,250.00

A confidential rebate would apply to Xalkori that would reduce its net price. It would have protection from delisting and subsidy reduction until 30 September 2028.

Crizotinib 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 locally advanced or metastatic, unresectable, non-squamous non-small cell lung cancer; and
  2. There is documentation confirming that the patient has a ROS1 rearrangement using an appropriate ROS1 test; and
  3. Patient has an ECOG performance score of 0-2; and
  4. Baseline measurement of overall tumour burden is documented clinically and radiologically.

Renewal - 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: 

Both:

  1. Response to treatment has been determined by comparable radiological 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.

Ceftazidime with avibactam for resistant infection

What would the effect be?

From 1 April 2025 ceftazidime with avibactam (Zavicefta) would be funded for people with infections caused by carbapenem resistant enterobacteriaceae (CRE) that have limited other treatment options available. Ceftazidime with avibactam would only be funded for use in Health NZ | Te Whatu Ora hospitals.

We estimate that around 30 people would benefit from ceftazidime with avibactam as a treatment option for people with CRE infections in the first year of funding, increasing to around 60 people each year after five years of funding.

Who we think will be interested?

  • People with carbapenem resistant infections
  • Clinical microbiologists and infectious disease physicians.
  • Infection control health care workers.
  • Healthcare professionals involved in the care of people with multidrug resistant infections
  • Health NZ | Te Whatu Ora hospitals and other organisations who deliver services and support for people with drug resistant infections
  • People or groups who support those living with multidrug resistant infections
  • Pharmacies and wholesalers

About CRE infections and ceftazidime with avibactam

CRE are a type of bacteria that are resistant to one or several antibiotics called carbapenems. Carbapenems are a class of broad-spectrum antibiotics used to treat a range of bacterial infections that may have proven resistant to treatment with other antibiotic(s).

Multi drug-resistant organisms (MDROs) are an increasingly serious health concern worldwide. People infected with MDROs have fewer, or in some cases, no other treatment options. These people have significantly poorer health outcomes as a result. Those at highest risk of infection are immunocompromised or those who have been hospitalised for a prolonged period.

Around 30 people are diagnosed with a CRE infection in New Zealand annually, however, this is projected to double over the next ten years.

Zavicefta is a combination treatment of an antibiotic and a β-lactamase inhibitor. Ceftazidime is a third-generation cephalosporin which interferes with the cell walls of bacterial cells leading to cell death. Avibactam protects ceftazidime from destruction by certain bacterial enzymes that resistant bacteria make.

Ceftazidime with avibactam is used to treat CRE infections and is administered intravenously for up to two weeks.  

Medsafe datasheet | ceftazidime with avibactam [PDF](external link)

Why we’re proposing this

A funding application for ceftazidime with avibactam was considered by the Anti-Infective Subcommittee in May 2019 (now Anti-infectives Advisory Committee), who recommended it for funding.

Our advisors told us that ceftazidime with avibactam would improve survival and reduce the risk of acute kidney failure in people infected with CREs.

Ceftazidime with avibactam is currently used in some Health New Zealand | Te Whatu Ora hospitals and accessed through Pharmac’s Named Patient Pharmaceutical Assessment (NPPA) process. Progressing this proposal would make it easier to access for all hospitals and allow clinicians to initiate treatment faster. 

We expect that funding ceftazidime with avibactam would improve health outcomes for people with CRE infections and reduce length of hospital stays. The links below provide further context to this proposal:

Application Tracker | Ceftazidime with avibactam - therapy for infections caused by carbapenem resistant Enterobacteriaceae (CREs)(external link)

Anti-Infective Subcommittee meeting record May 2019 [PDF, 386 KB]

Anti-Infective Advisory Committee meeting record September 2022 [PDF, 168 KB]

Details about our proposal

From 1 April 2025, ceftazidime with avibactam (Zavicefta) would be listed in 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

Ceftazidime with avibactam

Inj ceftazidime 2000 mg with avibactam 500 mg

Zavicefta

10

$2,250.00

Zavicefta would have protection from delisting and subsidy reduction until 30 September 2028.

Zavicefta would be listed in Part II of Section H of the Pharmaceutical Schedule subject to the following eligibility criteria:

Restricted

Initiation 

Clinical microbiologist or infectious disease specialist 

Both: 

  1. Proven resistant micro-organism, based on microbiology report; and
  2. Proven infection with carbapenem-resistant Enterobacteriaceae (CRE)

Note: Where appropriate, treatment with ceftazidime with avibactam should be administered in combination with aztreonam, if available 

Axitinib for the subsequent treatment of renal cell carcinoma (RCC)

What would the effect be?

From 1 April 2025 axitinib (branded as Inlyta) would be funded as a second-line treatment for eligible people with locally advanced or metastatic renal cell carcinoma (RCC).

This follows from recent decisions to fund nivolumab and lenvatinib with everolimus for those with previously treated RCC. These provide additional treatment options for around 90 eligible people a year who progress after their initial treatment.

We appreciate that there are unmet health needs for first line treatments of metastatic RCC. We have received several applications for combination treatments that include immunotherapy, which are at different stages in our process. 

Applications to fund medicines for renal cell carcinoma | Application Tracker(external link)

We estimate that axitinib would be used by around 10 people a year, however this may vary depending on the uptake of nivolumab and lenvatinib with everolimus, or if the following proposal is approved:

Proposal to fund treatments for metastatic kidney cancer

Who we think will be interested?

  • People with kidney cancer, their whānau and caregivers
  • Oncologists, specialist nurses, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with cancer.
  • Groups who support and advocate for people with cancer
  • Health NZ | Te Whatu Ora and Te Aho o Te Kahu | The Cancer Control Agency
  • Hospital pharmacies
  • Hei Āhuru Mōwai
  • Cancer Society
  • Pharmaceutical suppliers and wholesalers

About renal cell carcinoma and axitinib

Renal cell carcinoma (RCC) is the most common type of kidney cancer. Approximately 600 people are diagnosed with RCC each year in New Zealand.

RCC is more common in men than women. Māori are often diagnosed at a younger age and are more likely to die from RCC than non-Māori. In addition, people living in the most socioeconomically deprived areas also have reduced survival compared to those living in less deprived areas.

Clear cell RCC (ccRCC) is the most common histological subtype of RCC accounting for around 70-80% of all RCC.

Nivolumab (an immunotherapy treatment, given as an intravenous infusion) was funded from 1 November 2024 for people whose ccRCC has progressed after initial treatment. We also recently funded lenvatinib with everolimus, an oral treatment for the second line treatment of ccRCC from 1 December 2024.

Axitinib belongs to a class of medicines known as tyrosine kinase inhibitors, that selectively block some of the proteins involved in cancer growth. These inhibitors help to stop the growth and spread of cancer cells.

Axitinib is taken orally every day. Axitinib is available in different strengths so the dose can be adjusted to balance toxicity and efficacy.

Medsafe datasheet | Axitinib [PDF](external link)

Why we’re proposing this?

Axitinib was recommended for funding by the Cancer Treatments Subcommittee of PTAC (now CTAC) in 2017 for people with ccRCC as a subsequent treatment to sunitinib or pazopanib.

Our advisors told us axitinib would provide another treatment option and improve outcomes for people with ccRCC. The links below provide further context to this proposal:

Application Tracker | Axitinib for metastatic renal cell carcinoma, clear cell, second line(external link)

CTAC meeting record August 2017 [PDF, 259 KB]

Cancer is a priority area in the Government Policy Statement on Health 2024-2027 | Ministry of Health(external link)

Details about our proposal

From 1 April 2025 axitinib 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

Axitinib

Tab 1 mg

Inlyta

28

$536.40

Axitinib

Tab 5 mg

Inlyta

28

$2,682.00

A confidential rebate would apply to Inlyta that would reduce its net price. Inlyta would have protection from delisting and subsidy reduction until 30 September 2028.

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

Initial application - from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria: 

All of the following: 

  1. The patient has metastatic renal cell carcinoma; and
  2. The disease is of predominant clear cell histology; and
  3. The patient has documented disease progression following one previous line of treatment; and
  4. The patient has an ECOG performance status of 0-2.

Renewal - only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months where there is no evidence of disease progression.

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

Palbociclib brand change

What would the effect be?

Palbociclib (Ibrance) is supplied by Pfizer and is currently funded for the treatment of advanced hormone-receptor positive (HR-positive), human epidermal growth receptor-2 negative (HER2-negative) breast cancer, subject to eligibility criteria [PDF](external link).

Currently around 550 people are receiving palbociclib. As a part of this proposal, people receiving the Ibrance brand of palbociclib would need to change to the Palbociclib Pfizer brand sometime between 1 July 2025 and 1 December 2025.

Palbociclib Pfizer is manufactured at the same site to the same specifications, and is packaged similarly, to Ibrance. By changing brands of a palbociclib and receiving better pricing through this multiproduct proposal, we’re able to maximise the use of our medicines budget to make more medicines available to New Zealanders.

We want to hear from people who are currently taking palbociclib for their advanced breast cancer to understand what support they would need with this brand change.

Key dates

  • From 1 April 2025, the net price of palbociclib (Ibrance) would reduce
  • From 1 July 2025, a new brand of palbociclib (Palbociclib Pfizer) would be funded
  • All people receiving palbociclib (Ibrance) would need to transition to the Palbociclib Pfizer brand of palbociclib by 1 December 2025.
  • From 1 December 2025, the Ibrance brand would be delisted from the Pharmaceutical Schedule and everyone would need to use the Palbociclib Pfizer.

Why we’re proposing this

Our clinical advisors told us there are no clinical concerns with this proposed brand change and that Ibrance could be delisted from the Pharmaceutical Schedule once Pfizer Palbociclib is available. We are proposing a five-month transition period for people to change to the new brand.

Palbociclib Pfizer is Medsafe-approved for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer as a first line treatment in combination with an aromatase inhibitor and as a second line treatment in combination with fulvestrant.

Details about our proposal

From 1 July 2025, palbociclib (Palbociclib Pfizer) 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

Palbociclib

Tab 75 mg

Palbociclib Pfizer

21

$1,200.00

Palbociclib

Tab 100 mg

Palbociclib Pfizer

21

$1,200.00

Palbociclib

Tab 125 mg

Palbociclib Pfizer

21

$1,200.00

A confidential rebate would apply to Palbociclib Pfizer, reducing its net price. Palbociclib Pfizer would have protection from delisting and subsidy reduction until 30 November 2028.

As part of this proposal, from 1 April 2025 the net price of Ibrance would reduce by confidential rebate. This would apply until its delisting at the end of the transition period.

From 1 December 2025, the Ibrance brand of palbociclib would be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm Friday 24 January 2025

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

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