Decision to fund treatments for kidney cancer

11 March 2025

Medicines Decision

What we’re doing

We’re pleased to announce a decision to widen access to nivolumab and fund ipilimumab for renal cell carcinoma (kidney cancer) through an agreement with Bristol-Myers Squibb Limited.

From 1 April 2025 nivolumab, in combination with ipilimumab, will be funded as an initial treatment for people with metastatic clear cell renal cell carcinoma (RCC), subject to eligibility criteria.

We are also widening access to sunitinib for the treatment of metastatic RCC, regardless of treatment line or cancer 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 decision is one of many that we’re working on to put our budget increase into action.

Questions and answers on Pharmac's budget increase

This decision was subject to a consultation letter dated 19 December 2024. We received feedback from a range of stakeholders. We’re grateful to everyone for their feedback and have made several changes to the original proposal as a result.

What does this mean for people?

Nivolumab in combination with ipilimumab

From 1 April 2025 nivolumab (branded as Opdivo) in combination with ipilimumab (brand name Yervoy) will be funded for eligible people with intermediate or poor prognosis metastatic, clear cell, RCC as an initial treatment (first line).

We estimate that around 110 to 120 people will benefit from nivolumab in combination with ipilimumab each year.

We understand that there are people currently accessing these medicines through private funding arrangements. We have ensured that if the eligibility criteria were met when someone started treatment, they will be able to transition to publicly funded treatment.

As part of this decision, the use of nivolumab as a subsequent treatment (second or third line) will be restricted to those who did not receive nivolumab with ipilimumab as an initial treatment.

We recently funded two other treatments for people who experience disease progression during or following their initial treatment.

Lenvatinib with everolimus, from 1 December 2024
Axitinib, from 1 April 2025

We expect the use of these medicines to increase as a result of this decision, with around 60 to 70 people each year accessing them. You can read more about these medicines below.

Sunitinib

We have also made a decision to widen access to sunitinib to enable broader use for people with metastatic RCC from 1 April 2025.

Sunitinib is currently funded for metastatic, clear cell RCC as an initial treatment irrespective of prognosis. Its use in the first line setting will mostly be replaced by nivolumab in combination with ipilimumab.

As part of this decision we will remove these targeted funding restrictions, giving people more treatment options for different stages and types of metastatic kidney cancer. We consider that it would mostly be used as a later line treatment option.

Who we think will be interested

People with kidney cancer, their whānau and caregivers
Oncologists, urologists, clinical nurse specialists, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the care of people with kidney cancer
Groups who support and advocate for people with cancer
Health New Zealand | Te Whatu Ora (Health NZ) and Te Aho o Te Kahu | Cancer Control Agency
Hospital pharmacies
Hei Āhuru Mōwai | Māori Cancer Leadership Aotearoa
Pharmaceutical suppliers and wholesalers

Any changes to the original proposal?

This decision was subject to a consultation letter dated 19 December 2024. We received feedback from people with kidney cancer, their friends, families and whānau, clinicians and suppliers. We want to thank everyone for their feedback.

Overall, feedback was supportive of the proposal, however some people requested changes to the eligibility criteria. While we are unable to substantively change the eligibility criteria at this stage, we have amended the criteria to include access for people with sarcomatoid histology regardless of their International Metastatic RCC Database Consortium (IMDC) risk prognosis. We have also

made changes to the periods for initial and renewal Special Authority approvals;
broadened the types of health practitioners who can apply for a Special Authority;
amended dosing limits for nivolumab during the induction phase; and
added a criterion to enable people currently receiving these treatments through private arrangements to transition to publicly funded treatment.

A summary of the feedback received and our response to this is detailed below.

Details about our decision

Nivolumab

From 1 April 2025, nivolumab (Opdivo) will 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	New 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	$27.62	$27.22

From 1 April 2025, access to nivolumab (Opdivo) will be widened in Section B of the Pharmaceutical Schedule as follows (addition in bold, deletions in strikethrough):

Initial application – (Renal cell carcinoma, first line) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

Patient is currently on treatment with nivolumab and met all remaining criteria prior to commencing treatment; or
All of the following:
1. The patient has metastatic renal cell carcinoma; and
2. The patient is treatment naïve; and
3. The patient has ECOG performance status 0-2; and
4. The disease is predominantly of clear cell histology; and
5. Any of the following:
  1. The patient has sarcomatoid histology; or
  2. Haemoglobin levels less than the lower limit of normal; or
  3. Corrected serum calcium level greater than 10 mg/dL (2.5 mmol/L); or
  4. Neutrophils greater than the upper limit of normal; or
  5. Platelets greater than the upper limit of normal; or
  6. Interval of less than 1 year from original diagnosis to the start of systemic therapy; or
  7. Karnofsky performance score of less than or equal to 70; and
6. Nivolumab is to be used in combination with ipilimumab for the first four treatment cycles at a maximum dose of 3 mg/kg; and
7. Nivolumab is to be used at a maximum maintenance dose of 240 mg every 2 weeks (or equivalent)

Initial application – (Renal cell carcinoma, second line) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist from any relevant practitioner. 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:

2.1 Patient has metastatic renal-cell carcinoma; and
2.2 The disease is of predominant clear-cell histology; and
2.3 Patient has an ECOG performance score of status 0-2; and
2.4 Patient has documented disease progression following one or two previous regimens of antiangiogenic therapy; and
Patient has not previously received a funded immune checkpoint inhibitor; and
2.5 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 from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

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
No evidence of disease progression; and
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 apply in Part II of Section H of the Pharmaceutical Schedule.

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

Ipilimumab

From 1 April 2025 ipilimumab (Yervoy) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
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

Ipilimumab will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Initial application - (renal cell carcinoma) from any relevant practitioner. Applications valid for 4 months for applications meeting the following criteria:

Either:

The patient is currently on treatment with ipilimumab and met all remaining criteria prior to commencing treatment; or
All of the following:
1. The patient has metastatic renal cell carcinoma; and
2. The patient is treatment naïve; and
3. The patient has ECOG performance status 0-2; and
4. The disease is predominant clear cell histology; and
5. Any of the following:
  1. The patient has sarcomatoid histology; or
  2. Haemoglobin levels less than the lower limit of normal; or
  3. Corrected serum calcium level greater than 10 mg/dL (2.5 mmol/L); or
  4. Neutrophils greater than the upper limit of normal; or
  5. Platelets greater than the upper limit of normal; or
  6. Interval of less than 1 year from original diagnosis to the start of systemic therapy; or
  7. 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 will apply in Part II of Section H of the Pharmaceutical Schedule.

Yervoy will 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.

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

Sunitinib

From 1 April 2025, the eligibility criteria for sunitinib will 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 4 months for applications meeting the following criteria:

Both:

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

Renewal – (RCC) from any relevant practitioner. Approvals valid for 4 months for applications where there is no evidence of disease progression

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

Our responses to what you told us:

Theme	Pharmac Comment
Supportive of the proposal	We’re grateful for people who took the time to share their stories with us. We are pleased to be able to fund nivolumab in combination with ipilimumab and widen access to sunitinib for people with kidney cancer.
Requested that people who are receiving nivolumab in combination with ipilimumab through private arrangements be able to receive funded treatment in the public health system	We appreciate this feedback, and as a result we have updated the eligibility criteria to enable people currently accessing nivolumab in combination with ipilimumab to transition to publicly funded treatment provided they met the eligibility criteria prior to initiating treatment.
Requested access for people with clear cell RCC with sarcomatoid histology regardless of IMDC prognosis, as sarcomatoid histology is an independent risk factor for poor prognosis and poor response to tyrosine kinase inhibitors, regardless of IMDC prognostic group	We appreciate this feedback, as a result we have amended the criteria to include people with clear cell RCC with sarcomatoid histology in the eligibility criteria, regardless of their IMDC risk prognosis.
Noted the dosing proposed for nivolumab is incorrect for the induction phase and requested the criteria allow for up to 3 mg/kg dosing every three weeks	We’re grateful for this feedback. We have amended the dose restrictions for nivolumab to allow for a maximum nivolumab dose of 3 mg/kg every three weeks during the induction phase.
Requested inclusion of IMDC favourable prognosis group	Our clinical advisors have also recommended funding nivolumab in combination with ipilimumab regardless of IMDC risk prognosis. They recommended this be funded with a low priority, compared to the high priority for people with intermediate or poor prognosis. Record of the July 2023 CTAC meeting [PDF, 529 KB] This application is currently under assessment. We are not in a position to include people with good prognosis at this time, however, we will be undertaking further assessment of this proposal to determine if it can be progressed in the future. We note that Pharmac recently widened access to sunitinib from 1 February 2025 for use in people with good prognosis.
Requested removal of the requirement for predominantly clear cell histology in the criteria for nivolumab in combination with ipilimumab	When considering this funding application, our expert clinical advisors told us that funding for nivolumab in combination with ipilimumab should be targeted to those with predominantly clear cell histology. Record of the July 2023 CTAC meeting [PDF, 529 KB] As part of this decision, we are also widening access to sunitinib so that it can be a treatment option for metastatic RCC regardless of clear cell histology. We would welcome a funding application or further information to support consideration of nivolumab in combination with ipilimumab, or other treatments for people with non-clear cell RCC. Information on how to make a funding application is available on our website. Anyone can make an application to Pharmac at any time.
Requested removal of the requirement that the patient be treatment naïve	When considering this funding application, our expert clinical advisors told us that funding for nivolumab in combination with ipilimumab should be targeted to those who are treatment naïve, ie they have not previously had treatments specifically for the condition. They also told us there is limited evidence to support a health benefit from using these medicines after prior exposure to them in the RCC treatment setting. Record of the July 2023 CTAC meeting [PDF, 529 KB] In November 2024, Pharmac funded nivolumab for the second or third line treatment of metastatic renal cell carcinoma. This remains a funded treatment option for people who do not receive nivolumab in combination with ipilimumab as their first line of treatment.
Remove dosing restrictions on both medicines to allow the clinician to determine the appropriate dose	The dosing restrictions in the eligibility criteria are aligned with the clinical advice we received and approved dosing in the Opdivo Medsafe datasheet [PDF](external link). We have proposed these as maximum dosing restrictions, which would allow for clinicians to use lower or less frequent dosing where necessary and appropriate.
Considered the strict eligibility criteria may create new “rare disease” categories for those who are ineligible under the proposed criteria but could potentially benefit from treatment	Pharmac uses eligibility criteria to target funding to those who have the greatest health needs and/or are most likely to benefit from the treatment. These are based on the advice we receive from our expert clinical advisors. We have a Named Patient Pharmaceutical Assessment (NPPA) pathway for consideration of funding for individuals whose clinical circumstances are exceptional, and their needs cannot be met by the Pharmaceutical Schedule. Making a NPPA Application We also welcome funding applications for other groups who could benefit from nivolumab in combination with ipilimumab. Anyone can make an application to Pharmac. Making a funding application
Requested nivolumab in combination with ipilimumab be funded for metastatic melanoma	We appreciate that people would like to see nivolumab in combination with ipilimumab funded for more types of cancer. We have received a funding application for nivolumab in combination with ipilimumab to treat metastatic melanoma. After we consulted to decline it in December 2023, we sought further clinical advice regarding this application from the Cancer Treatments Advisory Committee in October 2024. These records will be published shortly on our website when finalised. You can follow the status of this application on our Application Tracker(external link).
Requested funding of pembrolizumab-based combinations, noting that some people may respond better to this.	We acknowledge that people’s disease may respond differently to other treatment combinations and that there is a need for these options to be funded. We have received funding applications for both: pembrolizumab in combination with axitinib (Application Tracker)(external link) pembrolizumab in combination lenvatinib (Application Tracker)(external link) Both treatment combinations have been recommended for funding by our clinical advisors. They are currently under assessment prior to ranking as options for investment, which will help us determine if they can be funded within our fixed budget. The funding of nivolumab in combination with ipilimumab at this time would not prevent these from being funded in the future.