Proposal to fund treatments for Stage III and IV melanoma

Medicines Consultation Closes 04 Apr

What we’re proposing

We’re seeking feedback on a proposal to widen access to existing treatments and fund new treatments for people with melanoma (malignant skin cancer).

The proposal would result in the following changes from 1 June 2025, subject to eligibility criteria:

  • widened access to pembrolizumab (brand name Keytruda) for resectable stage IIIB to IV melanoma
  • listing of dabrafenib (brand name Tafinlar) and trametinib (brand name Mekinist) for:
    • resectable stage IIIB to IV BRAF mutated melanoma; and
    • metastatic or unresectable BRAF mutated melanoma

Dabrafenib and trametinib would be newly funded treatments for melanoma through a provisional listing agreement with Novartis New Zealand Ltd (Novartis).

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(external link)

Consultation closes at 4 pm on Friday 4 April 2025 and feedback can be emailed to consult@pharmac.govt.nz

Feedback form for people, families and whānau with lived experiences

Feedback form for health care professionals

Who we think will be interested

  • People with melanoma, their whānau, families and caregivers
  • Oncologists, specialist nurses, hospital pharmacists, radiologists, pathologists, primary care practitioners, and other health professionals involved in the care of people with melanoma
  • Groups who advocate for and support people with melanoma
  • Health New Zealand | Te Whatu Ora (Health NZ) and Te Aho o Te Kahu | The Cancer Control Agency
  • Hospital and community pharmacies
  • Hei Āhuru Mōwai | Māori Cancer Leadership Aotearoa.
  • 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, most commonly those who identify as NZ European/Other.

Melanoma can start in one area as a naevus or mole but often spreads throughout the body becoming metastatic and life threatening. As melanoma is a rapid growing tumour, around 10% of melanomas are metastatic at diagnosis and between 40% and 60% of advanced melanomas have a BRAF mutation.

Melanoma survival has significantly improved over recent years since immune checkpoint inhibitors, such as funded pembrolizumab and nivolumab, were funded for unresectable or metastatic disease.

Stage III melanoma occurs when the cancer has spread to nearby lymph nodes and/or other parts of the skin. While systemic treatments are currently used for advanced melanoma, treatment of stage III cancer is usually through cancer-removing surgery only. Despite the cancer being removed, some people’s cancer can recur.

About pembrolizumab (Keytruda)

Pembrolizumab is a targeted cancer treatment called an immunotherapy (immune checkpoint inhibitor), that works by helping the body’s immune system to fight cancer cells.

Pembrolizumab is currently funded for the treatment of advanced skin, lung, breast, bowel, Hodgkin lymphoma, head and neck and bladder cancers. 

Pembrolizumab is approved by Medsafe for a number of different indications. It is given as a 30-minute intravenous infusion either every 3 weeks or 6 weeks.

Medsafe Datasheet (Keytruda)(external link)

Pembrolizumab is listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health NZ hospitals are able to make subsidy claims. This would also apply to the proposed widening of access to pembrolizumab for resectable stage IIIB though to IV melanoma.

About dabrafenib (Tafinlar) and trametinib (Mekinist)

Dabrafenib and trametinib are oral cancer treatments that target the BRAF and MEK pathways. Both the BRAF and MEK pathways are important for cell growth and survival.

These pathways can be overactive in some cancers, such as BRAF mutated melanoma. The two treatments are often used together to create a stronger anticancer response and reduce resistance compared to either inhibitor alone.

Dabrafenib (capsule) and trametinib (tablets) are taken by mouth. Dabrafenib in combination with trametinib is approved by Medsafe for:

  • for the adjuvant treatment of individuals with Stage III melanoma with a BRAF V600 mutation, following complete resection.
  • for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Medsafe Datasheet (Tafinlar)(external link)

Medsafe Datasheet (Mekinist)(external link)

Why we’re proposing this

Overall, this proposal would enable access to treatment for eligible people with stage IIIB or later melanoma.

Resectable melanoma

We estimate that around 110 people would receive pembrolizumab in the peri-operative setting (around the time of surgery) for stage IIIB through to stage IV resectable melanoma in the first year of funding.

We estimate that around 20 people would receive dabrafenib and trametinib in the adjuvant setting for stage IIIB through to stage IV resectable melanoma in the first year of funding.

We anticipate that these numbers would remain relatively consistent in subsequent years.

We also anticipate that this proposal would reduce the number of people who would need nivolumab or pembrolizumab for unresectable or metastatic melanoma over time as less people would be expected to experience recurrence of their disease.

Adjuvant treatment

Pembrolizumab

In February 2019 we received a funding application for pembrolizumab for the treatment of resected stage III melanoma. The application was recommended for funding in November 2021(external link) by the Cancer Treatments Advisory Committee (CTAC). Our expert advisors told us pembrolizumab would reduce the likelihood of recurrence or metastases, however it was unclear if there would be a survival benefit from its use.

Application for pembrolizumab | Application Tracker(external link)

Dabrafenib with trametinib

In April 2024(external link), we sought clinical advice from CTAC regarding the use of targeted BRAF/MEK inhibitors for the treatment of resected stage III, BRAF mutated melanoma. Following further information from the supplier, CTAC considered evidence for dabrafenib and trametinib in October 2024 and recommended it be funded. The records from this meeting are not yet published.

Our advisors told us that BRAF/MEK inhibitors would not address the wider health need in stage III melanoma as not all people have a BRAF mutation. However, they would be a valuable treatment option for those people with BRAF mutations and be expected to reduce the likelihood of recurrence and improve survival for people.

Application for dabrafenib and trametinib | Application Tracker(external link)

Inclusion of resectable stage IV melanoma

As part of this proposal, we are proposing to include resectable stage IV melanoma in the group eligible for funding. We understand there is a small group of people with stage IV melanoma who currently cannot access funded immunotherapy. We understand that people in this group would be managed similarly to those with resectable stage IIIB-D disease.

Neoadjuvant treatment

We have heard from clinicians and other stakeholders that there is emerging evidence that it may be beneficial to enable access to pembrolizumab for a few cycles prior to resection. This would enable part of their treatment course with pembrolizumab to be provided before surgery (‘neoadjuvant’), rather than receiving the full treatment course after surgery (‘adjuvant’).

CTAC considered this data in April 2024(external link) and told us that neoadjuvant treatment followed by adjuvant treatment may improve outcomes compared to adjuvant treatment alone. We are proposing to enable flexibility for clinicians to prescribe pembrolizumab both before and after surgery. However, we acknowledge that this may impact how melanoma is treated in the New Zealand health system.

We are proposing criteria that would enable the use of pembrolizumab as a neoadjuvant treatment, provided that the total peri-operative treatment course (ie., before- and after-surgery) does not exceed 12 months worth of treatment.

We are proposing that either dabrafenib and trametinib, or pembrolizumab, would be able to be used for adjuvant treatment, depending on the individuals neoadjuvant response and BRAF mutation status.

Both neoadjuvant and adjuvant treatment would need to be initiated within 13 weeks of resection unless a delay is needed for post-surgery recovery.

Advanced melanoma

Currently around 370 people receive an immune checkpoint inhibitor for the treatment of stage IV unresectable or metastatic melanoma each year.

We estimate that around 130 people would receive dabrafenib and trametinib for stage IV unresectable or metastatic melanoma in the first year of funding and that this would decrease to around 80 people each year after five years of funding.

Pembrolizumab and nivolumab

Pembrolizumab and nivolumab are currently funded for eligible people with unresectable or metastatic melanoma, these have been funded since 2016.

Dabrafenib and trametinib

In August 2015 we received a funding application for dabrafenib and trametinib for the treatment of unresectable or metastatic melanoma with a BRAF mutation.

Application for dabrafenib with trametinib | Application Tracker(external link)

In November 2016(external link), the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that the application be declined.

Following publication of more evidence, the application was considered by CTAC in April 2024(external link). The Committee told us that BRAF/MEK inhibitors, such as dabrafenib and trametinib, would improve survival for eligible people when given as a second line treatment after progression on immunotherapy. They also told us a BRAF/MEK inhibitor would address a current unmet health need for people with BRAF mutated melanoma who experience intolerable side effects with immunotherapy.

CTAC recommended that dabrafenib and trametinib should be targeted to those whose disease has progressed after immunotherapy or where immunotherapy cannot be tolerated. However, we are pleased to have reached a commercial arrangement with the supplier that means we can propose funding without this restriction, giving a greater range of choices to clinicians and people with melanoma.

Access to treatment after stage III peri-operative treatment

Our advisors told us that if the cancer recurs there is limited evidence of a benefit from retreatment with the same agent as used in the peri-operative setting. They told us if the same treatment is used after recurrence, the benefit would likely be reduced compared to when the patient has not received that treatment previously (i.e. patient is treatment naïve).

As such, we are proposing to limit access to both immune checkpoint inhibitors and BRAF/MEK inhibitors in the metastatic setting to people whose disease did not recur while on treatment or within six months of completing their perioperative treatment with the same treatment.

We note that similar restrictions are used in Australia to ensure that funding is targeted to those people most likely to benefit from treatment.

Providing treatment choice between immune checkpoint inhibitor and BRAF/MEK inhibitors

We are proposing funding for both pembrolizumab and BRAF/MEK inhibitors (dabrafenib and trametinib) in the perioperative setting and dabrafenib and trametinib alongside the currently funded immune checkpoint inhibitors in the unresectable or metastatic setting. We are proposing this because it would provide clinicians and people with melanoma options to use the best treatment for the individual’s clinical circumstances.

We understand people with a BRAF mutation in need of a rapid response may benefit more from dabrafenib and trametinib. As these medications are taken orally they may be more suitable for people who cannot access an infusion centre.

We are interested to hear feedback on what proportions of eligible people would be treated with pembrolizumab or dabrafenib and trametinib in each setting.

This feedback will help both Pharmac and Health NZ plan for new patient flows, particularly to support greater understanding of the additional infusion hours and resource that would be needed to implement this proposal.

Impacts on the health sector

Pembrolizumab, dabrafenib and trametinib would be the first systemic treatments funded for people with stage IIIB through to D melanoma. Stage III melanoma is currently managed by surgery and monitoring for recurrence or progression, with limited involvement from medical oncology services. If approved, we anticipate that this proposal would have a substantial impact on Health New Zealand services.

Specifically, we consider that this proposal would result in:

  • more people with stage IIIB-D melanoma being referred to medical oncologists for systemic treatment
  • more ‘chair time’ and nursing time to administer pembrolizumab by intravenous infusion in hospitals
  • more radiology assessments including CT scans to monitor response to treatment
  • an impact on pathology services due to the requirement for testing for BRAF While testing is in place for colorectal cancer since the funding of cetuximab, this proposal would have an additive impact.
  • management of unwanted side effects from treatment, including admission to hospital and review in primary care.

We appreciate this proposal would add significant pressure to an already constrained health system, particularly in the initial years of funding. However, over time, this proposal is expected to result in less people having advanced disease, reducing the healthcare resource required to manage this (such as resources needed for hospitalisations, treatments, monitoring, and palliative care).

We are providing information to Health NZ to support implementation of this proposal. We welcome feedback on the feasibility of this proposal to be implemented and how resourcing of its implementation  would be supported.

Details about our proposal

Dabrafenib and trametinib

From 1 June 2025 dabrafenib (Tafinlar) and trametinib (Mekinist) would 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

Dabrafenib

Cap 50 mg 

Tafinlar

120

$6,320.86

Dabrafenib

Cap 75 mg 

Tafinlar

120

$9,481.29

Trametinib

Tab 0.5 mg

Mekinist

30

$2,370.32

Trametinib

Tab 2 mg

Mekinist

30

$9,481.29

A confidential rebate would apply to Tafinlar and Mekinist that would reduce their net price.

Both Tafinlar and Mekinist would have protection from delisting and subsidy reduction until 31 May 2028.

Dabrafenib and trametinib would be listed in Section B of the Pharmaceutical Schedule under their own Special Authority criteria. This means that separate Special Authority applications would need to be submitted in order to access both dabrafenib and trametinib for these indications:

Initial application (stage III or IV resected melanoma) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has resectable or resected stage IIIB, IIIC, IIID or IV melanoma (excluding uveal melanoma); and
  2. Patient has not received prior funded systemic treatment in the adjuvant setting for stage IIIB, IIIC, IIID or IV melanoma; and
  3. Treatment must be adjuvant to complete surgical resection; and
  4. Treatment must be initiated within 13 weeks of surgical resection, unless delay is necessary due to post-surgery recovery (see note); and
  5. The patient has confirmed BRAF mutation; and 
  6. [Dabrafenib/Trametinib] must be administered in combination with [trametinib/dabrafenib]; and
  7. The patient has ECOG performance score 0-2.

Note: Initiating treatment within 13 weeks of complete surgical resection means within 13 weeks after resection.

Renewal (stage III or IV resected melanoma) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of disease recurrence; and
  2. [Dabrafenib/Trametinib] must be administered in combination with [trametinib/dabrafenib]; and
  3. Treatment to be discontinued at signs of disease recurrence or at completion of 12 months’ total treatment course, including any systemic neoadjuvant treatment.

Initial application (unresectable or metastatic melanoma) from any relevant practitioner. Approvals valid for 4 months from applications meeting the following criteria:

All of the following:

  1. Patient has metastatic or unresectable melanoma (excluding uveal melanoma) stage III or IV; and
  2. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
  3. The patient has ECOG performance score 0-2; and
  4. The patient has confirmed BRAF mutation; and
  5. [Dabrafenib/Trametinib] must be administered in combination with [trametinib/dabrafenib]; and
  6. Any of the following:
    1. Patient has been diagnosed in the metastatic or unresectable stage III or IV setting; or
    2. Patient did not receive treatment in the adjuvant setting with a BRAF/MEK inhibitor; or
    3. All of the following:
      1. The patient received treatment in the adjuvant setting with a BRAF/MEK inhibitor; and 
      2. The patient did not experience disease recurrence while on treatment with that BRAF/MEK inhibitor; and
      3. The patient did not experience disease recurrence within six months of completing adjuvant treatment with a BRAF/MEK inhibitor.

Renewal (unresectable or metastatic melanoma) – from any relevant practitioner. Approvals valid for 4 months from applications meeting the following:

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 with treatment; and
  2. Response to treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period; and
  3.  The treatment remains clinically appropriate, and the patient is benefiting from treatment.

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

Pembrolizumab

From 1 June 2025, 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 (new criteria only shown):

Initial application (stage III or IV resectable melanoma) only from a relevant specialist or from 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 resectable or resected stage IIIB, IIIC, IIID or IV melanoma (excluding uveal melanoma); and
  2. Patient has not received prior funded systemic treatment in the adjuvant setting for stage IIIB, IIIC, IIID or IV melanoma; and
  3. Treatment must be in addition to complete surgical resection; and
  4. Treatment must be initiated within 13 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery (see note); and
  5. Pembrolizumab must be administered as monotherapy; and
  6. The patient has ECOG performance 0-2; and
  7. Pembrolizumab to be administered at a fixed dose of 200 mg every 3 weeks (or equivalent).

Note: Initiating treatment within 13 weeks of complete surgical resection means either 13 weeks after resection or 13 weeks prior to the scheduled date of the 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 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of disease recurrence; and
  2. Pembrolizumab must be administered as monotherapy; and
  3. Pembrolizumab to be administered at a fixed dose of 200 mg every three weeks (or equivalent) for a maximum of 12 months total treatment course, including any systemic neoadjuvant treatment; and
  4. Treatment to be discontinued at signs of disease recurrence or at completion of 12 months total treatment course, including any systemic neoadjuvant treatment.

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

The eligibility criteria for pembrolizumab for unresectable or metastatic melanoma would also be amended in Section B of the Pharmaceutical Schedule as follows (additions in bold, deletions in strikethrough):

Initial application (unresectable or metastatic melanoma) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 4 months from applications meeting the following criteria:

All of the following:

  1. Patient has metastatic or unresectable melanoma (excluding uveal melanoma) stage III or IV; and
  2. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
  3. The patient has ECOG performance 0-2; and
  4. Either:
    1. Patient has not received funded nivolumab; or
    2. Both:
      1. Patient has received an initial Special Authority approval for nivolumab and has discontinued nivolumab within 12 weeks of starting treatment due to intolerance; and
      2. The cancer did not progress while the patient was on nivolumab; and
  5. Documentation confirming that the patient has been informed and acknowledges that funded treatment with pembrolizumab will not be continued if their disease progresses Any of the following:
    1. Patient has been diagnosed in the metastatic or unresectable stage III or IV setting; or
    2. Patient did not receive treatment in the perioperative setting with a PD-1/PD-L1 inhibitor; or
    3. All of the following:
      1. The patient received treatment in the perioperative setting with a PD-1/PD-L1 inhibitor; and
      2. The patient did not experience disease recurrence while on treatment with that PD-1/PD-L1 inhibitor; and
      3. The patient did not experience disease recurrence within six months of completing perioperative treatment with a PD-1/PD-L1 inhibitor.

Renewal (unresectable or metastatic melanoma, less than 24 months on treatment) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 4 months for applications meeting the following criteria:

Either:

  1. 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.  Response to treatment in target lesions has been determined by comparable radiologic assessment following the most recent treatment period; and
    3. The treatment remains clinically appropriate and the patient is benefitting from the treatment; or
  2.  All of the following:
    1. Patient has previously discontinued treatment with pembrolizumab for reasons other than severe toxicity or disease progression; and
    2. Patient has signs of disease progression; and
    3. Disease has not progressed during previous treatment with pembrolizumab

Renewal (unresectable or metastatic melanoma, more than 24 months on treatment) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 4 months for applications meeting the following criteria: 

Both:

  1. Patient has been on treatment for more than 24 months; and
  2. Either:
    1. 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. Response to treatment in target lesions has been determined by comparable radiologic or clinical assessment following the most recent treatment period; and
      3. The treatment remains clinically appropriate and the patient is benefitting from the treatment; or
    2. All of the following:
      1. Patient has previously discontinued treatment with pembrolizumab for reasons other than severe toxicity or disease progression; and
      2. Patient has signs of disease progression; and
      3. Disease has not progressed during previous treatment with pembrolizumab.

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

Similar changes would also be made to the current nivolumab eligibility criteria for unresectable or metastatic melanoma(external link). 

Pembrolizumab is listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health NZ hospitals are able to make subsidy claims.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4 pm on Friday 4 April 2025

You can also submit feedback using one of our webforms:(external link)

Webform for people, families and whānau with lived experiences(external link)

Webform for health care professionals(external link)

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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