Decision to widen access to immunotherapy for six types of cancer, and treatments to prevent fungal infection

Medicines Decision

What we’re doing

We're pleased to announce that we have made the decision to widen access to:

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 increase covers medicines for both cancer and non-cancer health conditions. This decision is one of many that we’re working on to put our budget increase into action.

Media release: Funding boost means more medicines for more New Zealanders

Who we think will be interested

  • People with cancer and their whānau and caregivers 
  • Oncologists, haematologists, infectious disease specialists, specialist nurses, hospital pharmacists, radiologists, pathologists and other health professionals involved in the care of people with cancer or at high risk of severe fungal infection 
  • Groups who support and advocate for people with cancer 
  • Health New Zealand and the Cancer Control Agency 
  • Hospital pharmacies 
  • Pharmaceutical suppliers and wholesalers 

Any changes to the original proposal?

This decision was subject to a consultation letter released on 5 July 2024. We received feedback from clinicians, advocacy groups, suppliers, consumers, and health sector stakeholders.

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback.

The feedback received was supportive, with some requests for amendments to eligibility criteria or wider access. Changes specific to each medicine/indication pair are outlined in their relevant section. Records of relevant meetings at which this feedback was discussed are in progress.

A summary of the main themes if they apply to more than one indication or if outside the scope of any one indication and our response to these

After consideration of this general feedback, we have made the following changes for all immunotherapy indications.

  • amended criteria for all immunotherapy to align so that people with an ECOG performance of status of 0 to 2 are eligible for treatment.
  • amended the eligibility criteria to ensure that those who have already commenced treatment with nivolumab or pembrolizumab will be able to transition to funded treatment if they met all criteria before starting treatment.

Sector impact

While this funding decision will make a real difference to the lives of people with these cancers, we know that this funding decision will have a substantial impact on the health and disability system of New Zealand.

We have worked, and will continue to work, with our health sector partners to support the equitable implementation of this funding decision.

Infusion capacity

This decision will have an impact on already stretched infusion services across the country. The changes made to the proposal after consultation, which enables access to treatment for more people, we consider would not have a substantial additional impact on infusion services. While there will be more people receiving treatment, we anticipate that the additional burden is not substantial.

Testing

Combined Positive Score (CPS) is a measure of PD-L1 expression in tumours. This helps to identify people with certain cancers who could benefit from immunotherapy. CPS score determines eligibility for people with triple negative breast cancer (CPS score ≥10) and head and neck cancer (CPS score ≥1). To reduce the impact of this on the health system initially, the supplier is supporting the health system by funding this testing for up to the first four months from 1 October 2024, while pathologist capacity and capability is increased.

Pembrolizumab for advanced triple-negative breast cancer

What does this mean for people?

From 1 October 2024, pembrolizumab (Keytruda) will be funded will be funded for people with advanced triple negative breast cancer subject to eligibility criteria.

We anticipate that about 40 people will benefit from pembrolizumab in the first year of funding, increasing to about 50 people each year after five years of funding.

Any changes to the original proposal

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

As a result of the feedback received, and after seeking further clinical advice we have amended the eligibility criteria to enable access to pembrolizumab for those with locally advanced triple negative breast cancer whose disease is unresectable and inoperable if treated with palliative intent (the cancer is not treated with curative intent).

A summary of the feedback and our responses follows.

Details of this decision

The eligibility criteria for pembrolizumab (Keytruda) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indication (new criteria shown only):

Initial application – (breast cancer, advanced) 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: 

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Either: 
      1. Patient has recurrent or de novo unresectable, inoperable locally advanced triple-negative breast cancer (that does not express ER, PR or HER2 IHC3+ or ISH+ [including FISH or other technology]); or
      2. Patient has recurrent or de novo metastatic triple-negative breast cancer (that does not express ER, PR or HER2 IHC3+ or ISH+ [including FISH or other technology]; and
    2. Patient is treated with palliative intent; and
    3. Patient’s cancer has confirmed PD-L1 Combined Positive Score (CPS) is greater than or equal to 10; and
    4. Patient has received no prior systemic therapy in the palliative setting; and
    5. Patient has an ECOG score of 0–2; and
    6. Pembrolizumab is to be used in combination with chemotherapy; and
    7. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
    8. Pembrolizumab is to be used at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 16 weeks.

Renewal – (breast cancer, advanced) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

All of the following: 

  1. Any of the following:
    1. Patient’s disease has had a complete response to treatment; or
    2. Patient’s disease has had a partial response to treatment; or
    3. Patient has stable disease; and
  2. No evidence of disease progression; and
  3. Response to treatment in target lesions has been determined by a comparable radiologic assessment following the most recent treatment period; and
  4. Pembrolizumab is to be used at a maximum dose of 200 mg every three weeks (or equivalent); and
  5. Treatment with pembrolizumab is to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to pembrolizumab for this group of people with triple negative breast cancer.

We are pleased to be able to enable access to pembrolizumab for this group of people with triple negative breast cancer.

Requested that the eligibility criteria is amended to include pembrolizumab in combination with neoadjuvant chemotherapy for patients with high-risk early-stage triple-negative breast cancer.  

We understand there is a significant health need for people with high-risk early-stage triple-negative breast cancer.

We operate with a fixed budget, which means we have to make difficult choices about which medicines to fund, and for who, from within this budget. We are not able to include funding for early-stage triple-negative breast cancer at this time.

We have received a funding application for early-stage triple-negative breast cancer and this is currently under assessment.

Application Tracker | Pembrolizumab for early-stage triple-negative breast cancer(external link)

Requested the eligibility criteria include people with locally advanced inoperable triple-negative breast cancer.  

Our clinical advisors have told us that locally advanced triple-negative breast cancer is treated with curative intent. We note that this most appropriately considered through the funding application we have received for Stage II and III triple-negative breast cancer.

Application Tracker | Pembrolizumab for early-stage triple-negative breast cancer(external link)

We do however understand there is a significant health need for people with locally advanced, unresectable, inoperable triple-negative breast cancer and that these people are not treated with curative intent. We have sought advice regarding this from our clinical advisors (Cancer Treatments Advisory Committee [CTAC]) and have amended the eligibility criteria for pembrolizumab to enable access for this group of people provided they are treated with palliative intent. 

Pembrolizumab for head and neck cancer

What does this mean for people?

From 1 October 2024, pembrolizumab (Keytruda) will be funded will be funded for people with recurrent or metastatic head and neck squamous cell carcinoma (head and neck cancer) subject to eligibility criteria.

We anticipate that around 80 people will benefit from pembrolizumab in the first year of funding, increasing to about 140 people each year after five years of funding.

Any changes to the original proposal

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

After considering this feedback and seeking further clinical advice, we have amended the criteria to clarify that those with head and neck squamous cell carcinoma of mucosal origin (excluding nasopharyngeal carcinoma) are eligible for treatment with pembrolizumab.

Details of this decision

The eligibility criteria for pembrolizumab (Keytruda) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indication (new criteria shown only):

Initial application – (head and neck squamous cell carcinoma) 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: 

Either: 

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Patient has recurrent or metastatic head and neck squamous cell carcinoma of mucosal origin (excluding nasopharyngeal carcinoma) that is incurable by local therapies; and
    2. Patient has not received prior systemic therapy in the recurrent or metastatic setting; and
    3. Patient has a positive PD-L1 combined positive score (CPS) of greater than or equal to 1; and
    4. Patient has an ECOG performance score of 0-2; and
    5. Either:
      1. Pembrolizumab to be used in combination with platinum-based chemotherapy; or
      2. Pembrolizumab to be used as monotherapy.
    6. Pembrolizumab is to be used at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 16 weeks. 

Renewal – (head and neck squamous cell carcinoma) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria: 

All of the following: 

  1. Any of the following:
    1. Patient’s disease has had a complete response to treatment; or
    2. Patient’s disease has had a partial response to treatment; or
    3. Patient has stable disease; and
  2. No evidence of disease progression; and
  3. Pembrolizumab is to be used at a maximum dose of 200 mg every three weeks (or equivalent); and
  4. Treatment with pembrolizumab is to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to pembrolizumab for this group of people with head and neck cancer.

We are pleased to be able to enable access to pembrolizumab for this group of people with head and neck cancer.

Requested that eligibility criteria be amended to clarify that those with squamous cell carcinoma of mucosal origin be eligible for treatment and that those with nasopharyngeal carcinoma be excluded in line with the clinical trial populations.

We appreciate this feedback and we have sought clinical advice from CTAC on the appropriateness of this amendment. Our clinical advisors indicated that:

  • the cause of nasopharyngeal carcinoma is different
  • this group was not included in the pivotal trial which informed the funding proposal
  • it would be appropriate to amend the eligibility criteria for head and neck squamous cell carcinoma to specify this. 

As a result of this and the clinical advice received, we have amended the eligibility criteria to clarify that those with head and neck squamous cell carcinoma of mucosal origin are eligible for treatment.

Requested that the eligibility criteria be aligned with the Medsafe-registered indications for pembrolizumab in head and neck squamous cell carcinoma, as PD-L1 testing requirements could introduce inequities for patients. 

We have received clinical advice which indicates that the efficacy of pembrolizumab in those with a CPS score less than 1 is limited. In light of this, our clinical advisors recommended that the funding application for pembrolizumab for ‘all-comers’ regardless of CPS score be declined. 

Application Tracker | Pembrolizumab for all-comers with HNSCC(external link)

We have received clinical advice from CTAC that most patients in New Zealand receive a biopsy before proceeding with treatment. Given this, we consider the requirement for PD-L1 testing remains appropriate. Our advisors consider that the number of people for whom a biopsy would not be possible would be very low. Where there are exceptional circumstances meaning biopsy cannot be undertaken and testing is not possible, we would consider Special Authority waiver applications from clinicians for access to treatment. 

Pembrolizumab for unresectable or metastatic colorectal (bowel) cancer

What does this mean for people?

From 1 October 2024, pembrolizumab (Keytruda) will be funded will be funded for people with unresectable or metastatic colorectal (bowel) cancer subject to eligibility criteria.

We anticipate that around 120 people will benefit from pembrolizumab in the first year of funding, and that around 110 people will receive pembrolizumab each year after three years of funding.

We estimate that an additional 110 people will benefit from treatment in the second or later line setting in the first year of funding and that this will reduce quickly as newly diagnosed people receive treatment in the first-line setting.

Any changes to the original proposal

We received feedback from clinicians, advocacy groups, suppliers, consumers and health sector stakeholders. We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal.

After considering this feedback and seeking further clinical advice from our advisors, we have amended the criteria to enable access to pembrolizumab for those with:

  • unresectable colorectal cancer; and
  • unresectable or metastatic colorectal cancer who have received prior treatment for their disease in the palliative setting (the cancer is not treated with curative intent).

Details of this decision

The eligibility criteria for pembrolizumab (Keytruda) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indication (new criteria shown only):

Initial application – (MSI-H/dMMR advanced colorectal cancer) 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: 

Either: 

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Either:
      1. Patient has deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer; or
      2. Patient has deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) unresectable colorectal cancer; and
    2. Patient is treated with palliative intent; and
    3. Patient has not previously received funded treatment with pembrolizumab; and
    4. Patient has an ECOG performance score of 0-2; and
    5. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
    6. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 16 weeks.

Renewal – (MSI-H/dMMR advanced colorectal cancer) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria: 

All of the following: 

  1. No evidence of disease progression; and
  2. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent); and
  3. Treatment with pembrolizumab is to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to pembrolizumab for this group of people with colorectal cancer.

We are pleased to be able to enable access to pembrolizumab for this group of people with colorectal cancer.

Requested access to pembrolizumab for people who have received prior lines of treatment due to the timing of pembrolizumab funding for colorectal cancer.

We appreciate this feedback and sought further clinical advice on this from CTAC.

Our clinical advisors told us there is a health benefit for people with unresectable or metastatic colorectal cancer from treatment with pembrolizumab in people who have previously received treatment and that it should be funded. These records are in progress.

Following this advice, we have amended the eligibility criteria to enable access for those who have received prior systemic therapy.

Requested inclusion of people with ‘unresectable’ colorectal cancer in the eligibility criteria for pembrolizumab.

We sought further clinical advice on this feedback from CTAC. Our clinical advisors considered that unresectable colorectal cancer is treated the same way as metastatic disease and that these people can be expected to receive the same benefit from treatment with pembrolizumab. Following this advice, we have amended the eligibility criteria to enable access for people with unresectable colorectal cancer.  

Requested progression of funding for pembrolizumab for unresectable or metastatic non-colorectal cancers, in particular MSI-H/dMMR endometrial cancer.  

We understand there is a significant unmet health need for people with endometrial and other non-colorectal cancers that express MSI-H/dMMR. 

We have received a funding application for unresectable or metastatic MSI-H/dMMR cancers that have progressed after receiving previous treatment.

CTAC recommended this be deferred and considered there was insufficient mature data for pembrolizumab as a tumour agnostic treatment and that further assessment could be considered for individual tumour entities based on the availability of evidence demonstrating benefit from pembrolizumab treatment. CTAC noted that there are trials conducted for treatment of MSI-H/dMMR endometrial cancer.

Record of CTAC meeting July 2021 [PDF, 533 KB]

We have not received a funding application for pembrolizumab for dMMR/MSI-H endometrial cancer and would welcome an application for this or information to support further consideration of pembrolizumab in this context.

How to submit a funding application

We have received a funding application for dostarlimab for the treatment of endometrial cancer with or without deficient mismatch repair (dMMR) status. This application was considered by CTAC in July 2024 (records of this meeting are in progress).

Application Tracker | Dostarlimab for endometrial cancer(external link)

Pembrolizumab for advanced urothelial carcinoma (bladder cancer)

What does this mean for people?

From 1 October 2024, pembrolizumab (Keytruda) will be funded for people with advanced urothelial carcinoma (bladder cancer) if the cancer has progressed after previous treatment.

We anticipate that about 80 people will benefit from pembrolizumab in the first year of funding and that around 65 people will receive pembrolizumab each year after four years of funding.

Any changes to the original proposal

We received feedback from clinicians and consumers. We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal.

There have been no changes to the proposal pembrolizumab for the second line treatment of advanced urothelial carcinoma (bladder cancer) as a result of the feedback received.

Details of this decision

The eligibility criteria for pembrolizumab (Keytruda) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indications (new criteria shown only):

Initial application – (Urothelial carcinoma) 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: 

Either: 

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Patient has inoperable locally advanced (T4) or metastatic urothelial carcinoma; and
    2. Patient has an ECOG performance score of 0-2; and
    3. Patient has documented disease progression following treatment with chemotherapy; and
    4. Pembrolizumab to be used as monotherapy at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 16 weeks.

Renewal – (Urothelial carcinoma) 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. Any of the following:
    1. Patient’s disease has had a complete response to treatment; or
    2. Patient’s disease has had a partial response to treatment; or
    3. Patient has stable disease; and
  2. No evidence of disease progression; and
  3. Pembrolizumab is to be used as monotherapy at a maximum dose of 200 mg every three weeks (or equivalent); and
  4. Treatment with pembrolizumab is to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to cancer immunotherapy for this group of people with bladder cancer.

We are pleased to be able to enable access to pembrolizumab for this group of people with bladder cancer.

Requested widening access to enable the use of pembrolizumab in the first-line setting as consolidation treatment after chemotherapy.

We understand there may be benefit from using immune checkpoint inhibitors in the first-line setting as consolidation treatment after chemotherapy. However, we have not been able to include this group in this funding decision. 

We have received preliminary advice from our advisors on this group in October 2023 (4.1.9) and would welcome a funding application to support consideration of immunotherapy for this indication. 

Record of CTAC meeting October 2023 (4.1.9) [PDF, 991 KB]

How to submit a funding application

Pembrolizumab for relapsed or refractory Hodgkin lymphoma

What does this mean for people?

From 1 October 2024, pembrolizumab (Keytruda) will be funded will be funded for people with relapsed or refractory Hodgkin lymphoma subject to eligibility criteria.

We anticipate that about 19 people will benefit from pembrolizumab in the first year of funding and that this will reduce to around 14 people each year after two years of funding.

Any changes to the original proposal

We received feedback from clinicians and advocacy groups. We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal.

As a result of this feedback, we have:

  • amended the eligibility criteria to enable this and have extended the initial approval period from 3 months to 4 months.
  • aligned the eligibility criteria for pembrolizumab to that of brentuximab vedotin to clarify that those who have previously received an autologous stem cell transplant are eligible for pembrolizumab. 

Details of this decision

The eligibility criteria for pembrolizumab (Keytruda) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indications (new criteria shown only):

Special Authority for Subsidy 

Initial application – (relapsed/refractory Hodgkin lymphoma) 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: 

Either: 

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Either:
      1. Both:
        1. Patient has relapsed/refractory Hodgkin lymphoma after two or more lines of chemotherapy; and
        2. Patient is ineligible for autologous stem cell transplant; or
      2. Patient has relapsed/refractory Hodgkin lymphoma andhas previously undergone an autologous stem cell transplant; and
      3. Patient has not previously received funded pembrolizumab; and
      4. Pembrolizumab to be administered at doses no greater than 200 mg once every 3 weeks.

Renewal – (relapsed/refractory Hodgkin lymphoma) 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 received a partial or complete response to pembrolizumab; and
  2. Treatment with pembrolizumab is to cease after a total duration of 24 months from start (or equivalent of 35 cycles dosed every 3 weeks).

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to cancer immunotherapy for this group of people with Hodgkin lymphoma.

We are pleased to be able to enable access to pembrolizumab for this group of people with Hodgkin lymphoma.

Requested amendments to the criteria to enable some flexibility regarding assessment of response for logistical reasons.  

We appreciate this feedback and have amended the initial Special Authority approval period to 4 months. We consider that this would support the flexibility in assessing treatment response.  

Nivolumab for advanced renal cell carcinoma (kidney cancer)

What does this mean for people?

From 1 November 2024, nivolumab (branded as Opdivo) will be funded for the second-line treatment of people with advanced renal cell carcinoma (kidney cancer) if the cancer has progressed after previous treatment.

We anticipate that about 120 people will benefit from nivolumab in the first year of funding, reducing to about 60 people each year after the first year of funding.

Any changes to the original proposal

We received feedback from clinicians and consumers. We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal.

There have been no changes to the proposal for nivolumab for the second line treatment of advanced renal cell carcinoma (kidney cancer) as a result of the feedback received.

Details of this decision

The eligibility criteria for nivolumab (Opdivo) in Section B of the Pharmaceutical Schedule will be amended from 1 November 2024 subject to include the following indication (new criteria shown only):

Initial application – (Renal cell carcinoma) 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. 

Either: 

  1. Patient is currently on treatment with nivolumab and met all remaining criteria before starting treatment; or
  2. All of the following:
    1. Patient has metastatic renal-cell carcinoma; and
    2. The disease is of predominant clear-cell histology; and
    3. Patient has an ECOG performance score of 0-2; and
    4. Patient has documented disease progression following one or two previous regimens of antiangiogenic therapy; and
    5. Nivolumab is to be used as monotherapy at a maximum dose of 240 mg every 2 weeks (or equivalent) and discontinued at disease progression.

Renewal – (Renal cell carcinoma) 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. Any of the following:
    1. Patient’s disease has had a complete response to treatment; or
    2. Patient’s disease has had a partial response to treatment; or
    3. Patient has stable disease; and
  2. No evidence of disease progression; and
  3. Nivolumab is to be used as monotherapy at a maximum dose of 240 mg every 2 weeks (or equivalent) and discontinued at disease progression.

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of widening of access to cancer immunotherapy for this group of people with clear cell renal cell carcinoma.

We are pleased to be able to enable access to nivolumab for this group of people with clear cell renal cell carcinoma.

Posaconazole and voriconazole for the prevention of invasive fungal infection

What does this mean for people?

From 1 October 2024, posaconazole and voriconazole (all currently funded presentations) will be funded for the prevention of fungal infection subject to eligibility criteria.

We anticipate that around 430 people will benefit from posaconazole and voriconazole in the first year of funding, increasing to about 530 people each year after five years of funding.

Any changes to the original proposal

We received feedback from clinicians, pharmacists, advocacy groups, suppliers and health sector partners. We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal.

As a result of the feedback received we have:

  • extended the initial approval period to 6 months because continued treatment is only anticipated in those with ongoing risk of infection.
  • broadened the prescriber type to include paediatric haematologists and oncologists.
  • made other minor changes to the criteria for clarity.

Details of this decision

The eligibility criteria for posaconazole tablets and oral liquid (Posaconazole Juno and Posaconazole Devatis) and voriconazole tablets and oral liquid (Vttack and Vfend) in Section B of the Pharmaceutical Schedule will be amended from 1 October 2024 to include the following indication (new criteria shown only; criteria shown apply to either posaconazole or voriconazole, and are marked “[Posaconazole/Voriconazole]” to indicate the specific agent):

Special Authority for Subsidy 

Initial application – (Invasive fungal infection prophylaxis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

Both:  

  1. The patient is at risk of invasive fungal infection; and
  2. Either:
    1. [Posaconazole/voriconazole] is prescribed by, or recommended by a haematologist, transplant physician, infectious disease specialist, paediatric haematologist, or paediatric oncologist; or
    2. Prescribing [posaconazole/voriconazole] follows a protocol or guideline that has been endorsed by the Health New Zealand - Te Whatu Ora Hospital in the specific settings where there is a greater than 10% risk of invasive fungal infection (IFI).

Renewal – (Invasive fungal infection prophylaxis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

Both:  

  1. The patient is at risk of invasive fungal infection; and
  2. Either:
    1. [Posaconazole/Voriconazole] is prescribed by, or recommended by a haematologist, transplant physician, infectious disease specialist, paediatric haematologist, or paediatric oncologist; or
    2. Prescribing [posaconazole/voriconazole] follows a protocol or guideline that has been endorsed by the Health New Zealand - Te Whatu Ora Hospital in the specific settings where there is a greater than 10% risk of invasive fungal infection (IFI).

Similar eligibility criteria will also apply in Part II of Section H of the Pharmaceutical Schedule, which includes restrictions applying to voriconazole injection (Voriconazole AFT).

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Comment

Consultation feedback was supportive of this proposal to the widen access to antifungals for prevention of invasive fungal infection.

We are pleased to be able to enable access to these azole antifungals for those at high risk of invasive fungal infection.

Requested increasing approval period to 6 months as treatment can be required for longer than 3 months.   

We have made amendments to the Special Authority criteria which increases the Special Authority approval period to 6 months. We anticipate that continued treatment is only anticipated in those with ongoing serious immunosuppression. 

Requested that the Special Authority criteria be amended to include paediatric haematologist or paediatric oncologist. 

The Special Authority criteria has been updated to broaden who can prescribe these azole medicines to include paediatric haematologists or paediatric oncologists. 

Requested the eligibility criteria for posaconazole include treatment of possible, probable or proven invasive fungal infection.  

We appreciate this feedback and that this is not necessarily clear.

We consider that those with possible, probable or proven invasive fungal infection would be eligible for treatment with posaconazole and voriconazole as this is intended for those at risk of invasive fungal infection. If this remains unclear, we would look to address this at a future date.

Requested that community pharmacy is able to claim wastage or on dispensing of posaconazole and voriconazole. 

We note that the voriconazole powder for oral suspension already has wastage claimable and that none of the other presentations do. We are not currently looking to apply wastage claimable for all presentations of posaconazole and voriconazole, as part of this proposal. However, we will continue to monitor this and consider adding wastage if necessary in the future.   

General feedback – our response to what you told us about more than one indication

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process.  The following table outlines the main themes received that apply to more than one medicine or indication and our response to these.

Theme

Pharmac Comment

Consultation feedback was supportive of this proposal, particularly with respect to the widening of access to cancer immunotherapies.

We appreciate this feedback. The advice we have received is that widening access to these treatments will provide substantial benefits to individuals, their families, and the wider health system.

Feedback requested access to immunotherapy for people who have previously received systemic treatment in the metastatic setting. 

We sought advice from CTAC in relation to this feedback in July 2024 and the Committee considered it would like to review the evidence for MSI-H/dMMR colorectal cancer (records in progress). The Committee considered pembrolizumab for previously treated MSI-H/dMMR colorectal cancer and recommended it be funded in August 2024 (records in progress).

Concerns that the limited number of laboratories able to perform PD-L1 CPS testing and a limited number of pathologists able to read the test may create inequities in access. 

We acknowledge that access to PD-L1 CPS (Programmed death-ligand 1 Combined Positive Score) testing is not consistently available nationally. We have highlighted this to Health New Zealand to support implementation.  

Inclusion of CPS score requirements in the relevant criteria have been recommended by our clinical advisors to ensure that treatment is targeted to those who would receive the greatest benefit. We are not proposing wider access through removal of CPS testing requirements for head and neck cancer and advanced triple-negative breast cancer at this time, in line with the clinical advice we have received from CTAC.

To reduce the impact of this on the health system initially, the supplier is supporting the health system by funding this testing for up to the first four months from 1 October 2024 for all hospitals, while pathologist capacity and capability is increased.

Concerns about the proposal having an impact on health sector resources, which are already under-resourced.

We have worked, and will continue to work, with our health sector partners (Health NZ, Ministry of Health and the Cancer Control Agency) to support the equitable implementation of this funding decision.

Requests to remove the ‘PCT Only’ listing for pembrolizumab on the Pharmaceutical Schedule. The feedback noted this prevents treatment from being delivered outside of hospital. 

While we understand the desire to alleviate impact on infusion services for the delivery of these medicines, removal of “PCT Only” is a complex system wide issue that would require significant change across health information systems. The PCT Only designation ensures that our claiming data is accurate for the purposes of rebates and forecasting. At this time, we are unable to make this change.

We note that PCT Only does not prevent medicines from being administered outside of Health New Zealand hospitals, however it requires the claim (and therefore dispensing to occur) to be submitted by a Health New Zealand hospital. We understand that there are already mechanisms in place where compounded pharmaceuticals are administered at sites contracted to Health NZ hospitals.

We do, however, remain responsive to requests from the sector to support implementation of this and other funding decisions for infused medicines. If there is a clinical need for these treatments to be delivered in another setting, we would work with our sector partners to support this while ensuring that reimbursement could occur.

Requested that the criteria for ECOG performance status should be 0-2, consistent with other indications for Pembrolizumab. 

Our clinical advisors have advised that an ECOG performance status(external link) of 0-2 is clinically appropriate for treatment across the range of indications included in this funding decision. 

We have amended the relevant Special Authority criteria to reflect this. 

Requested widening of access to immunotherapy to include other less common cancers.

We understand that immunotherapy is effective against a wide range of cancers. We would welcome a funding application or additional information to support consideration of immunotherapy for other indications not included in this decision.

How to submit a funding application

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