Decision to widen access to nivolumab and ipilimumab for resectable melanoma

Medicines Decision

What we’re doing

We're pleased to announce that funded access to nivolumab and ipilimumab will be widened to include treatment of resectable stage IIIB to IV melanoma from 1 May 2026.

This decision was subject to a consultation letter dated 24 February 2026. We received feedback from people living with melanoma and their whānau, clinicians, advocacy groups, suppliers, and other health sector stakeholders.

A summary of the main feedback themes raised through consultation, and our responses to these, are detailed further in the ‘Our response to what you told us’ section.

What does this mean for people?

This decision will enable funded access to nivolumab in combination with ipilimumab before surgery (neoadjuvant) for people with resectable melanoma to help reduce the risk of melanoma returning. It will also enable funded access to nivolumab after surgery (adjuvant) for people who require further treatment following nivolumab in combination with ipilimumab before surgery.

People who have a significant response following neoadjuvant nivolumab in combination with ipilimumab may not need further systemic treatment following surgery. This decision is anticipated to reduce the number of overall infusions and people’s time spent receiving treatment compared with current funded therapy for resectable melanoma.

In addition to benefiting people with resectable melanoma, as well as their whānau and carers, the anticipated reduction in infusions associated with this funding decision is expected to reduce pressure on infusion centres by around 1,000 infusion hours per year.

We estimate that around 155 people will receive nivolumab in combination with ipilimumab for resectable stage IIIB to IV melanoma in the first year of funding and that this will increase to around 166 people each year after five years of funding. We expect most of the people who receive nivolumab in combination with ipilimumab would have received funded pembrolizumab.

Transitional access for people receiving treatment in private facilities

People who are eligible for transitional access, who are receiving (or about to receive) treatment with nivolumab and ipilimumab for resectable stage IIIB to IV melanoma in a private facility as of 1 May 2026 will be able to receive funded treatment in that facility.

Transitional access to new funded cancer medicines for patients receiving treatment in private facilities | Ministry of Health website(external link)

Any changes to the original proposal?

Change to funded duration of transitional access for patients receiving treatment in private facilities

Feedback from clinicians and other health sector stakeholders told us that some people with resectable melanoma, who would receive funded nivolumab in combination with ipilimumab in private facilities through the transitional access policy, may not be able receive their entire treatment course within the 12-month period covered by the policy due to treatment delays.

We acknowledge that some people may need more than 12-months to complete their treatment course. As a result, we will consider extending transitional access funding beyond the 12-month period, on a case-by-case basis, for people who were eligible under the transitional access policy at the beginning of their treatment.

We will provide private providers with information on how to seek extended funding for their patients.   

Other changes

We have also made a small change to the wording of the nivolumab renewal eligibility criteria to ensure it covers funding for the intended group of people who develop recurrent, unresectable melanoma and require further treatment with nivolumab. 

No other changes have been made to the original proposal.

Who we think will be most interested

  • People with melanoma, their whānau, and carers
  • Oncologists, surgeons and other health professionals involved in the care of people with melanoma
  • Groups who support and advocate for people with melanoma
  • Health New Zealand | Te Whatu Ora
  • The Cancer Control Agency | Te Aho o Te Kahu
  • Hei Āhuru Mōwai | Māori Cancer Leadership Aotearoa
  • Hospital pharmacies
  • Pharmaceutical suppliers and wholesalers

Detail about this decision

Nivolumab

From 1 May 2026, funded access to nivolumab (Opdivo) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

Special Authority criteria will be amended in Section B to include the following indication (new criteria only shown):

Special Authority for Subsidy

Initial application – (stage III or IV resectable melanoma) 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. The individual is currently on treatment with nivolumab for neoadjuvant treatment of resectable stage IIIB, IIIC, IIID or IV melanoma and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
    1. The individual has resectable stage IIIB, IIIC, IIID or IV melanoma (excluding uveal) (see note); and
    2. The individual has not received prior funded systemic treatment in the perioperative setting for their stage IIIB, IIIC, IIID or IV melanoma; and
    3. The individual has ECOG performance score 0-2; and
    4. Treatment must be initiated prior to complete surgical resection; and
    5. Neoadjuvant nivolumab must be administered in combination with ipilimumab; and
    6. Nivolumab to be administered for maximum of two cycles prior to surgical resection.

Renewal – (stage III or IV resectable melanoma) 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:
Any of the following:

  1. All of the following:
    1. The individual has received funded neoadjuvant treatment with nivolumab in combination with ipilimumab; and
    2. Adjuvant treatment with nivolumab is required; and
    3. Treatment must be initiated within 13 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery; and
    4. Nivolumab must be administered as monotherapy; and
    5. Nivolumab to be discontinued at signs of disease recurrence or at completion of 12 months total treatment duration including any systemic neoadjuvant treatment (equivalent to 11 adjuvant cycles at 480 mg every 4 weeks plus initial 2 neoadjuvant treatment cycles); or
  2. All of the following:
    1. The individual has received neoadjuvant treatment with nivolumab and ipilimumab; and
    2. The individual has unresectable or metastatic melanoma (excluding uveal) stage III or IV; and
    3. The individual meets initial application criteria for nivolumab for unresectable or metastatic melanoma; or
  3. All of the following:
    1. The individual has received neoadjuvant treatment with nivolumab and ipilimumab; and
    2. The individual has received treatment with nivolumab for unresectable or metastatic melanoma; and
    3. The individual meets the renewal criteria for nivolumab for unresectable or metastatic melanoma.

Note:

  1. Stage IIIB, IIIC, IIID or IV melanoma defined as per American Joint Committee on Cancer (AJCC) 8th Edition.
  2. Disease must be completely resectable and amenable to curative intent surgery, including stage IV disease.

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

Prescribers are not able to apply for multiple Special Authority initial applications for the same chemical, within two years. To enable funded access to nivolumab for people who have developed recurrent unresectable, or metastatic melanoma, following 6 months or more after completing neoadjuvant +/- adjuvant nivolumab for resectable melanoma; we have included criteria within the nivolumab stage III or IV resectable melanoma renewal criteria (see sections 2 and 3 of the above renewal criteria) to enable prescribers to apply for continued nivolumab funding for eligible people in this circumstance.

Ipilimumab

From 1 May 2026, funded access to ipilimumab (Yervoy) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

Special Authority criteria will be amended in Section B to include the following indication (new criteria only shown):

Special Authority for Subsidy

Initial application – (stage III or IV resectable melanoma) 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. The individual is currently on treatment with ipilimumab for neoadjuvant treatment of resectable stage IIIB, IIIC, IIID or IV melanoma and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
    1. The individual has resectable stage IIIB, IIIC, IIID or IV melanoma (excluding uveal) (see note); and
    2. The individual has not received prior funded systemic treatment in the perioperative setting for their stage IIIB, IIIC, IIID or IV melanoma; and
    3. The individual has ECOG performance score 0-2; and
    4. Treatment must be prior to complete surgical resection; and
    5. Neoadjuvant ipilimumab must be administered in combination with nivolumab; and
    6. Ipilimumab to be administered for maximum of two cycles prior to surgical resection.

Note:

  1. Stage IIIB, IIIC, IIID or IV melanoma defined as per American Joint Committee on Cancer (AJCC) 8th Edition.
  2. Disease must be completely resectable and amenable to curative intent surgery, including stage IV disease.

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

Our response to what you told us

We’re really grateful for the time people took to respond to the consultation on our funding proposal. A summary of the main themes raised in feedback and our responses can be seen in the table below.

Theme

Pharmac comment

General feedback in support of proposal

Supportive of the proposal, which would provide funded access to an international standard of care treatment, which, for many patients, would reduce the number of total infusions needed, providing benefit for patients, carers and the wider health sector.

We are pleased that our decision to widen access to nivolumab and ipilimumab for resectable melanoma will benefit New Zealanders and the health sector.

Feedback not in support of proposal

Although this proposal may improve treatment options for melanoma, which is most prevalent among the NZ Pakeha, its overall impact on reducing cancer inequities in Aotearoa is limited unless accompanied by simultaneous investment in treatments targeting cancers that disproportionately affect Māori and Pacific People.

Pharmac’s funding activities should be considered in terms of their potential to reduce disparities in health outcomes between population groups and support those with the highest health needs.

We acknowledge that significant health inequities are present for Māori and Pacific people.

For all our funding decisions, we consider the impact on Māori and other population groups experiencing health disparities within our Factors for Consideration, the framework we use when making funding decisions. More information on our Factors for Consideration can be found on our website.

Factors for Consideration

Feedback on immune-related adverse event management

Noted the number of people experiencing immune-related adverse events may increase as a result of widened access to nivolumab and ipilimumab due to the increased rate of these side effects associated with dual immune checkpoint inhibitor use.

There is a need to have ready funded access to abatacept which may be required to treat life threatening immune related adverse events such as myocarditis and Triple M syndrome (myocarditis, myositis and myasthenia gravis).

Highlighted that combination treatment with nivolumab and ipilimumab is associated with immune-related adverse events, which can be severe and may require urgent, highly specialised hospital treatments, including pharmaceuticals. It is important that hospital specialists have ready and timely access to such medications.

Implementation should include clear clinical pathways and education to support early recognition and management of these toxicities across services where patients presenting with these toxicities may present.

We acknowledge the importance of having timely and ready access to treatments for side effects of immune checkpoint inhibitors.

Both infliximab and tocilizumab are funded via the Pharmaceutical Schedule for steroid refractory toxicity from immune checkpoint inhibitors.

If treatment with infliximab or tocilizumab is not considered appropriate treatment, we are happy to consider a Named Patient Pharmaceutical Assessment (NPPA) application. We have previously considered Rapid NPPAs for treatments of immune-related adverse events for people with exceptional circumstances unable to use the funded alternatives.

In 2025, we commissioned a GoodFellow Unit webinar(external link) to support education on immune-related adverse events associated with immune checkpoint inhibitors.

We will be engaging with health sector stakeholders throughout the implementation of this decision to understand how we may further support management of immune-related adverse events.

Feedback on eligibility criteria

Request to incorporate specific neoadjuvant dosing information into eligibility criteria given it is not currently commonly used, to help prevent dosing errors.

We have not included specific neoadjuvant dosing information in the eligibility criteria. The rationale for including specific dosing information for adjuvant nivolumab is to specify the maximum amount of treatment that will be funded, rather than specifying the dosing regimen for the purpose of clinical decision-making.

We understand that specific dosing information is available through the ACT-NOW Systemic Anti-Cancer Therapy Regimen Library(external link).

The proposed eligibility criteria require starting adjuvant nivolumab within 13 weeks of surgery unless delayed for recovery. In practice, surgical capacity and multidisciplinary team coordination, may affect this. Clarification is needed on how funding can be accessed if there are system‑related delays that impact treatment initiation.

 

We acknowledge that health sector constraints may delay initiation of adjuvant treatment with nivolumab if required following neoadjuvant treatment. We would be happy to consider Special Authority waivers, should this circumstance occur.

Details on how clinicians can apply through our waivers process are available on the Pharmac website.

Special Authority Waiver

The proposal notes that patients with a significant response to neoadjuvant therapy may not require further systemic treatment. It would be helpful to clarify how “significant response” will be defined and assessed (e.g., pathology-based response criteria, imaging, and MDT decision-making) to ensure consistency across centres.

We have not specified how treatment response should be assessed within the eligibility criteria. We understand from clinical advice that this will be determined through pathology-based response assessment. We plan to continue engaging with sector stakeholders during implementation to support consistency in practice.

Request to remove the exclusion of uveal melanoma from the eligibility criteria, noting that nivolumab and ipilimumab funding in Australia does not exclude this group.

Noted that patients with uveal melanoma were excluded from the NADINA trial, as well as those with mucosal melanoma. However, mucosal melanoma is not excluded from funding eligibility.

Request to consider widening access to nivolumab and ipilimumab for people with ocular melanoma, including those with metastatic disease.

Funded access to nivolumab and ipilimumab has not been widened further at this time.

We intend on seeking further clinical advice on the use of immune checkpoint inhibitors for the treatment of uveal/ocular and mucosal melanoma to better understand their place in therapy for these groups.

Feedback to consider funding other treatments

Request to consider widening funded access to sunscreen, which could negate the need for expensive systemic treatment by preventing melanoma occurrence.

We have not received an application asking us to fund sunscreen for a wider group of people. If we did, we would consider assessing it through our usual funding process.

Information on how to submit a funding application is available on the Pharmac website.

Make a medicine funding application

Request to consider funding tebentafusp (Kimmtrak) for the treatment of metastatic ocular melanoma.

We have not received a funding application for tebentafusp.

We understand that tebentafusp (Kimmtrak) is not approved for use in New Zealand by Medsafe. To consider funding tebentafusp for uveal/ocular melanoma, the supplier would need to submit to Medsafe for regulatory approval, in parallel with us receiving and then assessing a funding application for this treatment.

Feedback on transitional access 

Clinicians and other health sector stakeholders

Request to consider whether the transitional access period could be extended beyond 12 months to ensure that the full course of treatment is covered. Noting that some patients may not be able to receive their full treatment course within 12-months if there are treatment delays. 

Transitional access policy is unlikely to capture patients due to the short number of neoadjuvant cycles. To assist public cancer teams, transitional access should be open for a longer period of time, instead of the limited one-month eligibility timeframe.

Private cancer facilities would like to provide more treatments under this policy to help reduce the burden on specialist appointments and chair time in the public system and ensure that treatment delivered in a timely manner as this is crucial in conjunction with appropriate surgical planning. 

Transitional access is intended for patients who are currently receiving treatment in private facilities, or are about to start treatment, when the specific cancer medicine becomes publicly funded.

We acknowledge that some people who are treated with nivolumab and ipilimumab may not be able to receive their full treatment course within 12-months due to treatment delays. If this does occur, we will consider extending funding beyond 12-months for people who were eligible under the transitional access policy at the beginning of their treatment. We will provide private providers with information on how to seek extended funding for their patients. 

People must already be receiving private treatment with nivolumab and ipilimumab for resectable melanoma on 1 May 2026, or have initiated private treatment within one month from this date to be eligible under the transitional access policy.

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.