Proposal to widen access to immunotherapy for six types of cancer, and treatments to prevent fungal infections

Medicines Consultation Closed

What we’re proposing

We want to hear from you about a proposal to widen access to four treatments:

Cancers

  • pembrolizumab (branded as Keytruda) from 1 October 2024 for a range of cancers; and
  • nivolumab (branded as Opdivo) from 1 November 2024 for kidney cancer.

Infections

  • posaconazole and voriconazole (tablets and oral liquids) from 1 October 2024 for prevention of invasive fungal infections in severely immunocompromised people.

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 the first 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

We want to hear your feedback about our proposal to widen access to immunotherapy for six types of cancer, and treatments to prevent fungal infections. Consultation closes at 4pm Friday 26 July 2024. Feedback can be emailed to consult@pharmac.govt.nz

For the key information: Read our summary

What would the effect be?

Immunotherapy for cancer

Pembrolizumab would be funded as an initial treatment for eligible people with:

advanced triple-negative breast cancer.

recurrent or metastatic head and neck squamous cell carcinoma (head and neck cancer).

unresectable or metastatic colorectal (bowel) cancer.

Pembrolizumab would also be funded if the cancer has progressed after initial treatment for eligible people with:

advanced urothelial carcinoma (bladder cancer).

Hodgkin lymphoma (a type of blood cancer).

Nivolumab would be funded for second line treatment of advanced renal cell carcinoma (kidney cancer) if the cancer has progressed after initial treatment.

We anticipate around 500 people would receive immunotherapy for the above cancers in the first year of funding. 

Antifungals for prophylaxis

Posaconazole and voriconazole would be funded for the prevention of invasive fungal infections (IFI) for those at high risk of severe fungal infection (eg people with blood cancers and particular treatments).

We anticipate around 400 people would be eligible for these antifungal treatments in the first year of funding.

Effects on the health sector

Immunotherapy for cancer

We expect that this proposal would contribute to achieving better outcomes for people with cancer. We also acknowledge that this proposal would have a substantial impact on the health system of New Zealand. Some of these impacts are described below:

  • additional doctor appointments and follow-up appointments
  • additional ‘chair time’ and nursing time for administration of these treatments, which are delivered by intravenous infusion in hospitals
  • increased demand on hospital pharmacy services
  • increased demand for laboratory and pathology services
  • increased demand for radiology services
  • increased demand for supportive care and management of any unwanted side effects (including admission to hospital).

We also anticipate that as a result of better treatment, and people living longer healthier lives, that there would be a reduction in care needed to manage progressed cancer.

We continue to engage with our health sector partners, including Health New Zealand | Te Whatu Ora and the Cancer Control Agency | Te Aho o Te Kahu to implement new funding decisions. Feedback on how the health system would manage the impact from this is welcome.

Antifungals

We expect this proposal would result in fewer admissions to hospital for management of invasive fungal infections and reduce the need for IV administration of antifungals.

Infusion services

Both nivolumab and pembrolizumab are administered as intravenous infusions. We have estimated that across these proposals there would be an additional 1,230 infusion hours required for administration in the first year of funding, and that this would increase to over 3,400 infusion hours per year by the fourth. We note there would be a reduction to infusion burden as a result of some of these proposals (eg pembrolizumab for colorectal cancer), while others would result in an increase.

Pathology services

PD-L1 testing is available in New Zealand pathology laboratories for certain types of cancer.

The 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.

The CPS score would determine eligibility for immunotherapy for two of the cancer types included in this proposal and are in line with the clinical advice we have received:

  • Advanced triple-negative breast cancer with a CPS score ≥10
  • Recurrent or metastatic HNSCC with a CPS score ≥1

PD-L1 testing and the proposed CPS scoring is not currently undertaken on a routine basis for these cancer types. It would need to be funded and accessible in all regions to prevent geographical inequities.

We are working with the supplier of pembrolizumab to support implementation of PD-L1 testing and CPS scoring in the cancer types in this proposal. This would be similar to what occurred during the early stages of funding for advanced non-small cell lung cancer and would reduce the initial impact on the health system.

Microsatellite instability high (MSI-H) and deficient DNA mismatch repair (dMMR)

Normal cells in people’s bodies have a system that detects and repairs mistakes that happen when people’s DNA is copied. Sometimes the body’s system stops working properly. MSI-H/dMMR occurs when the mismatch repair mechanism does not work properly, and mistakes are not repaired. When this happens, errors in the DNA increase and can cause cancer.

We understand from our clinical advisors that immunohistochemistry for deficient DNA mismatch repair (dMMR) is routinely undertaken in people with newly diagnosed colorectal cancer, although this may vary regionally. Testing for microsatellite instability is less common and requirements for this would likely increase if this proposal progressed.

As MSI-H/dMMR can be hereditary (passed down through families), for example Lynch syndrome (Bowel Cancer NZ website)(external link), this proposal may increase the number of requests for this testing in the health system.

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 cancer and their whānau and caregivers
  • Oncologists, 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

About pembrolizumab and nivolumab

Pembrolizumab and nivolumab are targeted cancer treatments called immunotherapies (immune checkpoint inhibitors), that work by helping the body’s immune system to fight cancer cells.

Pembrolizumab is currently funded for the treatment of advanced non-small cell lung cancer and metastatic melanoma. Nivolumab is currently funded for people with unresectable or metastatic melanoma.

Both medicines are approved by Medsafe for a number of different indications. Pembrolizumab is administered as a 30-minute intravenous infusion either every 3 weeks or every 6 weeks. Nivolumab is administered as a 30-minute intravenous infusion either every 2 weeks or every 4 weeks.

Pembrolizumab and nivolumab are listed in Section B of the Pharmaceutical Schedule as PCT only pharmaceuticals, which means that only Health New Zealand hospitals would be able to make subsidy claims.

Pembrolizumab for advanced triple-negative breast cancer

Triple-negative breast cancer is a type of breast cancer. Targeted funded treatments, such as trastuzumab, or hormonal treatments, such as tamoxifen or aromatase inhibitors, are ineffective for this type of cancer. Chemotherapy can be effective in treating triple-negative breast cancer, however many people still relapse early after treatment.

Breast cancer affects one in nine women over their lifetime, with 3,600 people diagnosed in 2021. Around 15% of all breast cancers, and 16% of metastatic breast cancers, are classified as triple-negative breast cancer.

Breast cancer is one of Pharmac’s Hauora Arotahi Māori areas of focus. Māori 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 compared with non-Māori women. Pacific people with breast cancer have the worst outcomes from breast cancer compared to other ethnicities.

We anticipate that around 30 people with triple-negative breast cancer would commence treatment with pembrolizumab in the first year of funding.

Why we’re proposing this

Pembrolizumab for the treatment of advanced triple-negative breast cancer was recommended for funding by the Cancer Treatments Advisory Committee (CTAC) in October 2023. Full details about the clinical advice we have received, and its status over time, is available on the Pharmac Application Tracker.

Our clinical advisors told us there is a high unmet health need and poor outcomes for people with triple-negative breast cancer. Pembrolizumab is expected to improve progression-free survival and overall survival and quality of life for people with triple-negative breast cancer who have a CPS score ≥10.

Our advisors considered that those with a CPS≥10 experience the greatest health benefit gains from pembrolizumab.

CTAC Meeting record October 2023 [PDF, 991 KB]

Application Tracker | Pembrolizumab for the treatment of advanced triple-negative breast cancer(external link) 

Details about our proposal

From 1 October 2024 access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication: 

Special Authority for Subsidy

Initial application – (breast cancer, metastatic) 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 recurrent or metastatic triple-negative breast cancer (that does not express ER, PR or HER2 IHC3+ or ISH+ [including FISH or other technology]); and
  2. Patient’s cancer has confirmed PD-L1 Combined Positive Score (CPS) is greater than or equal to 10; and
  3. Patient has received no prior systemic therapy in the recurrent or metastatic setting; and
  4. Patient has an ECOG score of 0–1; and
  5. Pembrolizumab is to be used in combination with chemotherapy; and
  6. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
  7. 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, metastatic). 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Pembrolizumab for head and neck squamous cell carcinoma (head and neck cancer)

The most common sites of head and neck cancer are nasopharyngeal (upper part of throat behind the nose) or oropharyngeal (tongue, tonsils, soft palate, and the side or back of the throat).

While some people can be treated with curative intent, those with recurrent or metastatic head and neck squamous Cell Carcinoma (HNSCC) have few treatment options and these are not very effective, leading to progressive physical decline and death.

HNSCC more commonly affects males. Oropharyngeal HNSCC disproportionately affects Māori and people in areas of higher socioeconomic deprivation compared to non-Māori or areas of less deprivation. Māori also have worse survival from HNSCC, which may be driven by slow access to diagnosis and treatments. 

We anticipate that around 80 people would commence treatment with pembrolizumab in the first year of funding.

Why we’re proposing this

Pembrolizumab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma was recommended for funding by CTAC in April 2022. Full details about the clinical advice we have received, and its status over time, is available on the Application Tracker.

Our advisors told us there is a high unmet health need and a lack of treatment options for people with recurrent or metastatic HNSCC, and a high incidence in people experiencing socioeconomic deprivation.

Our advisors considered that those with a CPS ≥1 would experience the greatest health benefit gains from pembrolizumab.

Our advisors considered that there was unclear evidence of benefit for people with a CPS score less than one. We are currently reviewing consultation feedback on a proposal to decline a funding application for this group of people. You can read more about this from the Application Tracker on the Pharmac website.

CTAC meeting record for April 2022 [PDF, 846 KB]

Application Tracker | Pembrolizumab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma(external link)

Details about our proposal

From 1 October 2024 access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication:

Special Authority for Subsidy

Initial application – (head and neck squamous 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. Patient has recurrent or metastatic head and neck squamous cell 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 0-1; 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 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 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Pembrolizumab for microsatellite instability-high or deficient mismatch repair (MSI-H/dMMR) colorectal cancer

Colorectal cancer (bowel cancer) affects the lower part of the gastrointestinal tract, called the colon and/or rectum. There are around 3,000 people diagnosed with colorectal cancer in New Zealand each year. Around 20% of people are diagnosed and found to have metastatic disease. New Zealanders are often younger at diagnosis compared to adults in the rest of the world. Around 90% of metastatic colon cancer is incurable and its prognosis is poor even when chemotherapy is used.

MSI-H/dMMR tumours have different health needs based on response rates to current treatments, durability of response, and the general prognosis. Up to 10% of colorectal cancers are dMMR.

Chemotherapy is the standard of care for people in New Zealand with colorectal cancer when surgery is not adequate or appropriate.

We are not aware of any evidence that MSI-H/dMMR tumours disproportionately affect Māori, Pacific or other groups in the community who experience health inequity. However, Māori and Pacific people are diagnosed with bowel cancer at younger ages and are more likely to have metastatic disease at diagnosis.

We anticipate that around 120 people would commence treatment with pembrolizumab in the first year of funding.

Why we’re proposing this

Pembrolizumab for the treatment of MSI-H/dMMR unresectable or metastatic colorectal cancer was recommended for funding by CTAC in July 2021. Full details about the clinical advice we have received, and its status over time, is available on the Application Tracker.

Our advisors told us there is a high health need of people with colorectal cancer and the evidence supported a durable response, improved progression free survival, improved overall survival for people with MSI-H/dMMR unresectable or metastatic colorectal cancer. They also told us that it would be more suitable than currently available treatments and noted that funding of pembrolizumab for this indication would result in a net reduction in infusion burden for the health system.

CTAC meeting record for July 2021 [PDF, 533 KB]

Application Tracker | Pembrolizumab for the treatment of MSI-H/dMMR unresectable or metastatic colorectal cancer(external link)

Details about our proposal

From 1 October 2024 access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication:

Special Authority for Subsidy

Initial application – (MSI-H/dMMR advanced colorectal cancer) 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 deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer; and
  2. Patient has not received prior systemic therapy administered in the metastatic setting; and
  3. Patient has an ECOG performance score of 0-1; and
  4. Baseline measurement of overall tumour burden is document clinically and radiologically; and
  5. 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 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:

Both:

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

Pembrolizumab for urothelial carcinoma (bladder cancer)

Urothelial carcinoma is the most common type of bladder cancer. If the cancer hasn’t spread, people can often be cured but those with advanced disease have a high rate of death. Around a quarter of people with this cancer are diagnosed with advanced disease and a very small number live beyond five years.

Current treatment of advanced urothelial carcinoma usually consists of chemotherapy. Treatment combinations, often include a platinum-based treatment for those who can tolerate it.

Urothelial carcinoma effects around 5 per 100,000 people, most commonly men. Māori and Pacific people are less likely to have this type of cancer compared to the wider population.

We anticipate that around 120 people would commence treatment with pembrolizumab in the first year of funding; however this would reduce to around 60 to 70 patients per year after.

Why we’re proposing this

Pembrolizumab for the second-line treatment (if the cancer has progressed after initial treatment) of advanced urothelial carcinoma was recommended for funding by CTAC in April 2019. Full details about the clinical advice we have received, and its status over time, is available on the Application Tracker. Further advice regarding the use of immunotherapy for second-line treatment of advanced urothelial carcinoma was received in October 2023. [PDF, 710 KB]

Our advisors have told us that pembrolizumab would provide a durable response and an overall survival benefit compared to chemotherapy for people with urothelial carcinoma. We also expect the quality of life for people living with this cancer to improve with pembrolizumab compared to currently funded options.

CTAC meeting record for April 2019 [PDF, 710 KB]

CTAC meeting record for October 2023 [PDF, 991 KB]

Application Tracker | Pembrolizumab for the second-line treatment of advanced urothelial carcinoma(external link)

Our advisors also considered first-line treatment, however they told us that the benefit over platinum-based therapy was uncertain and recommended the application be declined. The funding application was declined by Pharmac in March 2022.

Decision to decline inactive medicines funding applications {March 2022)

Details about our proposal

From 1 October 2024 access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication:

Special Authority for Subsidy

Initial application – (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. 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Pembrolizumab for Hodgkin lymphoma

Hodgkin lymphoma is a type of blood cancer of the lymphatic system (a part of the immune system), and mainly affects the lymphocytes. People with relapsed or refractory disease are those who have not benefitted from treatment or have deteriorated after a response to chemotherapy. They typically go on to be treated with further chemotherapy and, if eligible, autologous stem cell transplant, which is curative approximately half of the time.

For those patients with relapsed or refractory Hodgkin lymphoma that are ineligible to receive, or have already received, an autologous stem cell transplant, there are currently limited treatment options.

In New Zealand, approximately 100 patients are diagnosed each year and approximately 80% have good outcomes after first line chemotherapy treatment. We have limited information on the impacts of Hodgkin lymphoma on Māori, Pacific people or others experiencing health inequities.

We anticipate that around 20 people would commence treatment with pembrolizumab in the first year of funding.

Why we’re proposing this

Pembrolizumab for the treatment of relapsed or refractory Hodgkin lymphoma was recommended for funding by CTAC in July 2021. Full details about the clinical advice we have received for pembrolizumab for the treatment of those ineligible for autologous SCT is available on the Pharmac Application Tracker. Full details about the clinical advice we have received for pembrolizumab for the treatment of those who have already received an autologous stem cell transplant is also available on the Application Tracker.

We currently fund brentuximab vedotin for this patient group, however our advisors considered that there would be a preference to treat relapsed/refractory Hodgkin lymphoma with pembrolizumab.

CTAC meeting record July 2021 [PDF, 533 KB]

Application Tracker | Pembrolizumab to treat people ineligible for autologous SCT(external link)

Application Tracker | Pembrolizumab to treat people who have already received an autologous stem cell transplant(external link)

Details about our proposal

From 1 October 2024 access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication:

Special Authority for Subsidy

Initial application – (relapsed/refractory Hodgkin lymphoma) from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. Patient has relapsed/refractory Hodgkin lymphoma after two or more lines of chemotherapy; and
  2. Patient has not previously received funded pembrolizumab; and
  3. Response to pembrolizumab is to be reviewed after 12 weeks; and
  4. Pembrolizumab to be administered at doses no greater than 200 mg once every 3 weeks.

Renewal – (relapsed/refractory Hodgkin lymphoma) 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 after 3 doses; and
  2. Treatment remains clinically appropriate, the patient is benefitting from treatment and treatment is being tolerated; 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Nivolumab for renal cell carcinoma (kidney cancer)

Renal cell carcinoma (renal cell adenocarcinoma, RCC) is the most common type of kidney cancer.

People with advanced or metastatic disease and an intermediate or poorly favourable prognosis usually receive targeted treatment with sunitinib or pazopanib. There are no targeted treatment options funded in New Zealand if sunitinib or pazopanib stop working.

RCC is more common in men. Māori are often diagnosed at a younger age compared to non-Māori and are 52% more likely to die of their cancer than non-Māori. People living in the most socioeconomically deprived areas have reduced survival compared to those from less deprived areas.

We anticipate that around 120 people would commence treatment with nivolumab in the first year of funding and following this, it would reduce to around 60 new people each year.

Why we’re proposing this

Nivolumab for the second-line treatment (ie if the cancer has progressed after initial treatment) of advanced renal cell carcinoma was recommended for funding by CTAC in August 2017. Full details about the clinical advice we have received, and its status over time, is available on the Pharmac Application Tracker.

Our advisors have told us that that nivolumab could improve progression-free and overall survival, as well as quality of life of those impacted by kidney cancer, compared to currently funded treatments.

CTAC meeting record August 2017 [PDF, 259 KB]

Application Tracker | Nivolumab for the second-line treatment of advanced renal cell carcinoma(external link)

Details about our proposal

From 1 November 2024 access to nivolumab (Opdivo) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended In Section B to include the following indication:

Special Authority for Subsidy

Initial application – (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. 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:
    • Patient’s disease has had a complete response to treatment; or
    • Patient’s disease has had a partial response to treatment; or
    • 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 would apply in Part II of Section H of the Pharmaceutical Schedule.

About posaconazole and voriconazole

Posaconazole and voriconazole are triazole antifungal agents that can be used to prevent fungal infection. These agents work by inhibiting growth of invasive fungi within the body.

Posaconazole is currently funded for people either with acute myeloid leukaemia or are due to receive a stem cell transplant, who are at high risk for aspergillus infection. Current eligibility critiera are detailed in the Special Authority for posaconazole(external link).

Voriconazole is currently funded for people who are immunocompromised and have proven, probable, or possible invasive aspergillus infection or have fluconazole resistant candidiasis. Current eligibility criteria are detailed in the Special Authority for voriconazole(external link).

Both medicines are approved by Medsafe. They are administered orally taken every day following a loading dose.

Medsafe datasheet | posaconazole tablets [PDF](external link)

Medsafe datasheet | posaconazole oral liquid [PDF](external link)

Medsafe datasheet | voriconazole tablets [PDF](external link) (external link)

Medsafe datasheet | voriconazole oral liquid [PDF](external link)

Posaconazole and voriconazole for the prophylaxis of invasive fungal infections

Invasive fungal infections are systemic infections from yeasts or moulds growing in deep tissues. Compared to fungal infections of the skin, hair or nails, invasive infections have with high death rates and morbidity.

The global burden of invasive fungal infections increased in recent years due to the higher number of people who are immunocompromised due to various diseases or treatments. Prevention of fungal infections involves using preventative medicines. This is important for people with weakened immune systems, like those undergoing cancer treatments or organ transplants.

We expect this proposal would be reduce the number of hospitalisations from invasive fungal infections.

Why we’re proposing this

Widened access to posaconazole and voriconazole was recommended by the Anti-infective Advisory Committee in September 2022 for those at high risk of invasive fungal infection. Full details about the clinical advice we have received on voriconazole and posaconazole is available on the Pharmac Application Tracker.

Subsequently in April 2023 CTAC noted the recommendations and the proposed Special Authority criteria from the Anti-infective Advisory Committee. CTAC considered there to be a significant unmet need for access to posaconazole and voriconazole as prophylaxis of invasive fungal infection and recommended that the current criteria be simplified.

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

CTAC meeting record April 2023 [PDF, 1.1 MB]

Application Tracker | Posaconazole(external link)

Application Tracker | Voriconazole(external link)

Details about our proposal

Access to posaconazole tablets (brand name Posaconazole Juno), posaconazole oral liquid (brand name Posaconazole Devatis), voriconazole tablets (brand name Vttack) and voriconazole oral liquid (brand name Vfend) would be widened in Section B of the Pharmaceutical Schedule from 1 October 2024, to include the following new simplified eligibility criteria:

Special Authority for Subsidy

Initial application – (Invasive fungal infection prophylaxis) from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist.

Approvals valid for 3 months for applications meeting the following criteria:

Either:

  1. [the medicine, ie posaconazole or voriconazole] is prescribed by, or recommended by a haematologist, transplant physician or infectious disease specialist; or
  2. Prescribing [the medicine] is in accordance with 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 a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist.

Approvals valid for 3 months for applications meeting the following criteria:

Either:

  1. [the medicine, ie posaconazole or voriconazole] is prescribed by, or recommended by a haematologist, transplant physician or infectious disease specialist; or
  2. Prescribing [the medicine] is in accordance with 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 IFI.

Note that the eligibility criteria would be added to the existing Special Authority forms and would not be interchangeable. 

The proposed eligibility criteria may allow wider funded access than the Medsafe approved indications. Prescribing outside of Medsafe approved indications would need to follow Section 25 of the Medicines Act 1981. You can read more about section 25 of the Medicines Act 1981 on the Medsafe website(external link).

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

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm Friday 26 July 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.