Proposal to fund treatments for metastatic kidney cancer

Medicines Consultation Closes 24 Jan

What we’re proposing

We’re seeking feedback on a proposal to fund nivolumab in combination with ipilimumab for advanced kidney cancer through a provisional agreement with Bristol-Myers Squibb (NZ) Ltd.

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

  • widened access to nivolumab (brand name Opdivo) as an initial treatment for metastatic, clear cell renal cell carcinoma, the most common type of kidney cancer, subject to eligibility criteria
  • funding of ipilimumab (brand name Yervoy) for use in combination with nivolumab as an initial treatment for metastatic, clear cell renal cell carcinoma, subject to eligibility criteria
  • widened access to sunitinib for the treatment of metastatic renal cell carcinoma, regardless of treatment line or subtype.

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 5pm Friday 24 January 2025. Feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

First line treatments

Nivolumab is currently funded for the treatment of metastatic clear cell renal cell carcinoma (RCC) after people have received prior treatment for this condition. From 1 April 2025, access to nivolumab would be widened and ipilimumab would be funded. This would enable access to these treatments for people with an intermediate or poor risk prognosis who have not previously received treatment for their metastatic renal cell carcinoma.

We estimate that around 110 people each year would benefit from these treatments being funded.

We understand that there may be people privately funding nivolumab and ipilimumab. We would ensure that these people would be able to transition onto publicly funded nivolumab and ipilimumab if they met eligibility criteria when they started treatment.

Impact to the health sector

This proposal would place additional pressure on infusion centres with additional people receiving these intravenous cancer treatments. We estimate that there would be approximately 1800 additional infusion hours needed to administer this treatment to eligible people in the first year of funding, increasing to around 3300 additional hours each year by the fifth year of funding.

In addition, we anticipate that there would be an increased likelihood of immune related adverse events due to this combination immunotherapy treatment. We are aware that accessing treatment for people with steroid-refractory grade 3 or 4 immune related adverse events through Pharmac’s exceptional circumstances pathway is not ideal. We are exploring better ways to manage access to these medicines.

Second line treatments

Our clinical advisors told us nivolumab is unlikely to benefit people who have previously received this medicine and whose cancer has progressed. We are proposing to limit access to nivolumab for the second line treatment of clear cell RCC to those who have not previously received funded nivolumab.

This would mean that over time, there would be more people accessing oral tyrosine kinase inhibitors (TKIs), such as lenvatinib (with everolimus) after prior treatment.

We are also currently consulting on a proposal to fund axitinib as an additional oral second line treatment option from 1 April 2024.

Sunitinib

Sunitinib was included in the 2023/24 Annual Tender, which may result in a brand change for sunitinib.

In July 2024, Pharmac consulted on a proposal to widen access to sunitinib for metastatic RCC with good prognosis and update the criteria for pazopanib for people who cannot tolerate sunitinib, pending the outcome of the Annual Tender. We will communicate an outcome for this proposal as soon as we are able to.

This proposal would result in further widened access to sunitinib, which would enable its use at any line of treatment irrespective of RCC subtype.

At this time, we are unclear exactly how many people would benefit from this further widened access to sunitinib. However, we will have a better understanding of this once consultation feedback has been received on this proposal and the proposal to fund axitinib as an additional oral second line treatment option from 1 April 2024. We would communicate how many people would benefit from further widened access to sunitinib when we notify of an outcome for this proposal should it be approved.

Who we think will be interested

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

About renal cell carcinoma, nivolumab, ipilimumab and sunitinib

Renal cell carcinoma (RCC) is the most common type of kidney cancer. Around 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 is the most common histological subtype of RCC, accounting for around 70 to 80% of diagnoses.

Access to nivolumab was widened(external link) from 1 November 2024 for people whose clear cell RCC has progressed after initial treatment.

We recently funded lenvatinib with everolimus, an oral treatment for the second line treatment of clear cell RCC from 1 December 2024 and are currently consulting on a proposal to fund axitinib as an additional oral second line treatment option from 1 April 2024.

Both nivolumab and ipilimumab are immune checkpoint inhibitors, which block certain ‘checkpoint’ pathways, allowing the immune system to better fight the cancer. Nivolumab and ipilimumab block different checkpoints and when used together have a greater effect on immune response. This enhanced response also increases the risk of immune-related side effects, which can be serious.

Both medicines are given by intravenous infusion. Both treatments are used for the first four treatment cycles (induction) and then nivolumab is given on its own every two or four weeks.

Medsafe data sheet for nivolumab [PDF](external link) 

Medsafe data sheet ipilimumab [PDF](external link)

Sunitinib is a first-generation tyrosine-kinase inhibitor currently funded as a first line treatment for metastatic clear cell RCC, subject to eligibility criteria. It is an oral treatment that helps stop the growth and spread of cancer.

Medsafe data sheet for sunitinib [PDF](external link)

Why we’re proposing this

When we widened access to nivolumab as a subsequent treatment for metastatic clear cell RCC from 1 November 2024, we heard from health sector and other groups that there are high unmet health needs for first line treatments. We heard that nivolumab was more effective in this setting when used in combination with ipilimumab.

A funding application for nivolumab with ipilimumab was considered by the Cancer Treatments Advisory Committee (CTAC) at its July 2023 meeting. Our advisors told us that there is a high unmet health need for people with metastatic clear cell RCC and treatment with nivolumab and ipilimumab would improve outcomes compared to currently funded treatment options.

Record of the July 2023 Cancer Treatment Advisory Committee meeting [PDF, 529 KB]

Our advisors told us that people with metastatic clear cell RCC whose prognosis is poorer (ie intermediate and poor International Metastatic RCC Database Consortium (IMDC) risk prognosis) are most likely to benefit from nivolumab with ipilimumab and have the greatest health need in this setting.

We understand that there are also unmet health needs for other types of metastatic RCC and later line treatment for people with metastatic clear cell RCC. However, our advisors have told us that there is limited evidence to support treatment selection and sequencing in these settings. Following substantial price reductions over recent years for sunitinib, we are pleased to be able to propose widened access to sunitinib to help address this unmet need.

Other first line treatment combinations

We understand from our clinical advisors that it would be beneficial to also fund a first line treatment containing an immune checkpoint inhibitor in combination with a tyrosine kinase inhibitor. These combination treatments work differently to nivolumab in combination with ipilimumab and some people may respond better to one or the other. The following relevant funding applications are currently under assessment:

Nivolumab in combination with cabozantinib | Application Tracker(external link)

Pembrolizumab in combination with lenvatinib | Application Tracker(external link)

Pembrolizumab in combination with axitinib | Application Tracker(external link)

This proposal would not prevent Pharmac from funding one or more of these combinations in the future.

Details about our proposal

Nivolumab

From 1 April 2025, nivolumab (Opdivo) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical

Formulation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Nivolumab

Inj 10 mg per ml, 4 ml vial

Opdivo

1

$1,051.98

$1,051.98

Nivolumab

Inj 10 mg per ml, 10 ml vial

Opdivo

1

$2,629.96

$2,629.96

Nivolumab

Inj 1 mg for ECP

Baxter

1 mg

$27.62

$27.22

The ECP price would be reduced from 1 April 2025, as we expect the amount of wastage for nivolumab would reduce as a result of this proposal.

From 1 April 2025, access to nivolumab (Opdivo) would be widened in Section B of the Pharmaceutical Schedule to include the following eligibility criteria:

Initial application – Renal cell carcinoma (first line) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Applications 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 patient is treatment naive; and
  3. The patient has an ECOG score of 0-2; and
  4. The disease is predominantly of clear cell histology; and
  5. The patient has intermediate or poor prognosis defined as
    Any of the following:
    1. Haemoglobin levels < the lower limit of normal; or
    2. Corrected serum calcium level > 10 mg/dL (2.5 mmol/L); or
    3. Neutrophils > the upper limit of normal; or
    4. Platelets > the upper limit of normal; or
    5. Interval of < 1 year from original diagnosis to the start of systemic therapy; or
    6. Karnofsky performance score of less than or equal to 70; and
  6. Nivolumab is to be used at a maximum dose of 240 mg every 2 weeks (or equivalent), and
  7. Nivolumab is to be used in combination with ipilimumab for the first four treatment cycles.

Renewal – Renal cell carcinoma (first line) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Applications 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 at a maximum dose of 240 mg every 2 weeks (or equivalent); and discontinued at disease progression.

The eligibility criteria for nivolumab when used as a second line treatment would also be amended in Section B of the Pharmaceutical Schedule from 1 April 2025 as follows (additions in bold, deletions in strikethrough, initial criteria shown only):

Initial application – Renal cell carcinoma (second line) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for applications meeting the following criteria.

Either:

  1. Patient is currently on treatment with nivolumab and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
  3. Patient has metastatic renal-cell carcinoma; and
  4. The disease is of predominant clear-cell histology; and
  5. Patient has an ECOG performance score of 0-2; and
  6. Patient has not previously received a funded immune checkpoint inhibitor; and
  7. Patient has documented disease progression following one or two previous regimens of antiangiogenic therapy; and
  8. 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.

Opdivo would continue to be listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health New Zealand | Te Whatu Ora hospitals can make subsidy claims.

Opdivo would have protection from delisting and subsidy reduction until 1 April 2028. There would also be a reduction to the net price for Opdivo through a confidential rebate.

Ipilimumab

From 1 April 2025, ipilimumab (Yervoy) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical

Formulation

Brand

Pack size

Price and subsidy

Ipilimumab

Inj 5 mg per ml, 10 ml vial

Yervoy

1

$5,000.00

Ipilimumab

Inj 5 mg per ml, 40 ml vial

Yervoy

1

$20,000.00

Ipilimumab

Inj 1 mg for ECP

Baxter

1 mg

$106.00

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

Initial application – from any relevant practitioner. Applications 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 patient is treatment naive; and
  3. The patient has an ECOG score of 0-2; and
  4. The disease is predominant clear cell histology; and
  5. The patient has intermediate or poor prognosis defined as:
    Any of the following:
    1. Haemoglobin levels < the lower limit of normal; or
    2. Corrected serum calcium level > 10 mg/dL (2.5 mmol/L); or
    3. Neutrophils > the upper limit of normal; or
    4. Platelets > the upper limit of normal; or
    5. Interval of < 1 year from original diagnosis to the start of systemic therapy; or
    6. Karnofsky performance score of less than or equal to 70; and
  6. Ipilimumab is to be used at a maximum dose of 1 mg/kg for up to four cycles in combination with nivolumab.

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

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

A confidential rebate would apply to Yervoy that would reduce its net price. Yervoy would have protection from delisting and subsidy reduction until 1 April 2028.

Sunitinib

From 1 April 2025, the current eligibility criteria for sunitinib [PDF](external link) would be amended in Section B of the Pharmaceutical Schedule as follows (new criteria shown only):

Initial application – (RCC) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria: 

Both:

  1. The patient has metastatic renal cell carcinoma; and
  2. Patient has not previously received funded sunitinib. 

Renewal – (RCC) from any relevant practitioner. Approvals valid for 3 months for applications where there is no evidence of disease progression.

 

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 5pm 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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