Proposal to widen access to nivolumab and ipilimumab for resectable melanoma

Medicines Consultation Closes 09 Mar

What we’re proposing

Tell us what you think about this proposal to widen access to nivolumab (brand name Opdivo) and ipilimumab (brand name Yervoy) for the treatment of resectable stage IIIB to IV melanoma from 1 May 2026.

Consultation closes at 5 pm, Monday 9 March 2026 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

From 1 May 2026, funded access to nivolumab and ipilimumab would be widened to include treatment of resectable stage IIIB to IV melanoma for people who meet certain eligibility criteria; these eligibility criteria are outlined in the ‘Details about our proposal’ section.

This proposal would enable funded access to nivolumab in combination with ipilimumab for a limited number of treatment cycles as neoadjuvant treatment (before surgery) to help reduce the risk of melanoma returning. The proposed widened access to nivolumab would also enable funded adjuvant treatment (after surgery) for eligible people who do not have a significant response following neoadjuvant treatment and surgery.

People who have a significant response following neoadjuvant nivolumab in combination with ipilimumab may not need further systemic treatment following surgery; as a result, this proposal is anticipated to reduce the total number of treatment-associated infusions and people’s time spent receiving treatment compared with current funded therapy.

In addition to benefiting the person being treated, their whānau and carers; the anticipated reduction in infusions associated with this proposal is also expected to reduce pressure on infusion centres and reduce overall health sector costs.

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

Who we think will be 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

About melanoma (skin cancer)

Melanoma is a type of skin cancer that forms in melanocytes, the cells that give your skin pigment, generally caused by cumulative exposure to UV radiation from the sun. New Zealand has the highest incidence of melanoma recorded in the world. Over 7,000 New Zealanders are diagnosed with melanoma each year, with over 3,000 people being diagnosed with invasive disease. Melanoma is diagnosed most in those who identify as NZ European/Other.

Stage III melanoma occurs when the cancer has spread to nearby lymph nodes and/or other parts of the skin. Stage IV melanoma occurs when the cancer spreads to more distant sites in the body.

Melanoma survival has improved over the last decade, contributed to by the funding of immune checkpoint inhibitors, such as funded pembrolizumab and nivolumab, for unresectable or metastatic melanoma in 2016.

In 2025, funded access to pembrolizumab (brand name Keytruda) was widened to enable treatment of resectable or resected melanoma. At the same time, dabrafenib (Tafinlar) and trametinib (brand name Mekinist) were funded for treatment of resected, and unresectable or metastatic BRAF mutated melanoma. Our clinical advisors told us that that these treatments would help to reduce the likelihood of melanoma recurrence for those with resectable or resected melanoma and improve survival for people with metastatic BRAF mutated melanoma.

This proposal would provide an additional funded treatment option for people with resectable melanoma that helps to reduce the risk of melanoma returning after surgery.

About nivolumab and ipilimumab

Nivolumab and ipilimumab are immune checkpoint inhibitors, which block certain ‘checkpoint’ pathways, allowing the immune system to better fight certain types of cancer. Nivolumab and ipilimumab block different checkpoints and when used together have a greater effect on the immune response.

Both medicines are administered via intravenous infusion, meaning people receiving these medicines must attend an infusion clinic to have the treatment administered by a qualified health professional.

Pharmac already funds nivolumab and ipilimumab for certain cancers for people who meet eligibility criteria. Nivolumab is currently funded for unresectable or metastatic melanoma and renal cell carcinoma (kidney cancer). Ipilimumab is currently funded for renal cell carcinoma when used in combination with nivolumab.

Both medicines are approved by Medsafe – further information on these medicines can be found in the Medsafe Datasheets for these medicines listed below:

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

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

Nivolumab and ipilimumab for resectable melanoma

Nivolumab in combination with ipilimumab are administered for two treatment cycles prior to surgery for resectable melanoma. Individuals who have a significant response following neoadjuvant treatment may not require further systemic treatment following surgery.

People who do not have a significant response following neoadjuvant treatment and surgery may go on to receive up to 11 further cycles of nivolumab, without ipilimumab, or further targeted treatment with dabrafenib and trametinib, if they have BRAF mutated melanoma. This would enable response-directed therapy after surgery to be tailored to people’s clinical circumstances. 

Clinical advice received from the Cancer Treatments Advisory Committee in September 2025 informed us that nivolumab, when given in combination with ipilimumab for resectable melanoma before surgery, followed by response directed therapy after surgery, reduces the likelihood of melanoma returning compared to when adjuvant nivolumab is used alone after surgery. Our advisors also informed us that combined therapy with nivolumab and ipilimumab may be associated with an increased risk of non-surgery related adverse events compared with nivolumab therapy alone.

Record of the September 2025 Cancer Treatments Advisory Committee [PDF, 373 KB]

Neoadjuvant treatment with these medicines may be associated with a significant response following surgery in nearly two-thirds of people receiving treatment. Those who have a significant response to neoadjuvant treatment and surgery may not need further treatment after surgery. This is expected to result in fewer ongoing infusions and hospital visits for some people with melanoma, their families, and carers.

Reducing the number of treatment cycles is also anticipated to help ease pressure on infusion clinics and the wider health system. We anticipate this proposal would result in ~1,000 fewer infusion hours per year and would reduce health sector costs.

Why we’re proposing this

When we widened funded access to pembrolizumab for resectable melanoma, and funded dabrafenib and trametinib for resected and unresectable or metastatic melanoma in 2025, we received clinician feedback that we should consider funding nivolumab in combination with ipilimumab for resectable melanoma.

This feedback highlighted the increasing demand on infusion services to administer oncology treatments and how widening access to nivolumab and ipilimumab for resectable melanoma would help to reduce the demand on these services whilst making available another valuable treatment option for treatment of resectable melanoma. Following this feedback, we received a clinician led funding application for widened access to these treatments.

Following our assessment of this proposal, informed by our clinical advisors and external stakeholder feedback, we anticipate that widening access to nivolumab and ipilimumab for resectable melanoma would make available another valuable funded treatment option that would help to reduce the risk of melanoma returning following surgery and that is expected to result in additional benefits for some people, their whanau and carers, and the wider health system, through reduced infusion requirements.

As a result, we are now proposing to widen access to nivolumab and ipilimumab for resectable melanoma.

Details about our proposal

Nivolumab

From 1 May 2026, funded 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 (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 and adjuvant treatment with nivolumab; 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 would 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) 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 (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 would apply in Part II of Section H of the Pharmaceutical Schedule.

Nivolumab and ipilimumab are listed in Section B of the Pharmaceutical Schedule as ‘PCT only’ pharmaceuticals, which means that only Health NZ hospitals are able to make subsidy claims.

Transitional access for people receiving treatment in private facilities

In April 2025, the Government approved a transitional access policy for cancer patients receiving, or about to receive, treatment with newly publicly funded medicines within the same private facilities from when Pharmac starts funding them.

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

People who meet eligibility criteria 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 would be able to receive funded treatment in that facility for up to 12 months.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm, Monday 9 March 2026

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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