Decision to fund treatments for stage III and IV melanoma and widen access to treatments for immune checkpoint inhibitor-related toxicity

Medicines Decision

What we’re doing

We're pleased to announce a decision to widen access to existing treatments and fund new treatments for people with stage IIIB to stage IV melanoma (malignant skin cancer). We’re also widening access to treatments to support the management of immune checkpoint inhibitor related toxicity.

Melanoma

From 1 June 2025 the following medicines will be funded for stage IIIB to stage IV melanoma, subject to eligibility criteria:

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

Dabrafenib and trametinib will be funded through an agreement with Novartis New Zealand Ltd (Novartis).

Immune checkpoint inhibitor-related toxicity

From 1 June 2025 access will be widened to infliximab (brand name Remicade) and tocilizumab (brand name Actemra) for the management of immune checkpoint inhibitor-related toxicity subject to eligibility criteria.

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 and funding decision has been one of many that we have been working on to put our budget increase into action.

Questions and answers on Pharmac's budget increase

Pembrolizumab, dabrafenib and trametinib for the treatment of stage IIIB to IV melanoma

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 support and advocate for people with melanoma
  • Health New Zealand and The Cancer Control Agency
  • Hospital and community pharmacies
  • Hei Āhuru Mōwai | Māori Cancer Leadership Aotearoa
  • Pharmaceutical suppliers and wholesalers

What does this mean for people?

Pembrolizumab (Keytruda) and dabrafenib (Tafinlar) in combination with trametinib (Mekinist) will be funded for people in the perioperative setting (i.e. around the time of surgery).

Dabrafenib (Tafinlar) with trametinib (Mekinist) will be funded alongside the currently funded immune checkpoint inhibitors (nivolumab, pembrolizumab) in the unresectable or metastatic setting.

We consider that this will provide clinicians and people with melanoma options to use the best treatment for the individual’s clinical circumstances.

We understand that there are people currently accessing these medicines in these settings 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.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 20 March 2025: Proposal to fund treatments for Stage III and IV melanoma. 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.

Overall, feedback was supportive of the proposal and considered that it would have a positive impact on people living with melanoma and their whānau and would provide clinicians with more treatment options to support people. 

It was noted in the consultation letter that this proposal would have a significant impact on the health sector. Most feedback related to how the proposal would be implemented by the health system. We are working collaboratively with Health NZ and the Cancer Control Agency to support implementation of this funding decision.

Key themes in the feedback and our response

Several other points were raised that we sought further clinical advice on, which resulted in amendments from the proposal as originally consulted on. The main changes included:

  • provided additional clarity regarding eligibility for pembrolizumab, dabrafenib and trametinib around the time of surgery through:
    • separation of neoadjuvant criteria and adjuvant criteria for access to pembrolizumab and amendments to Special Authority approval periods to support this
    • reference to specific pathological staging definitions
    • clarity that commencing treatment 13 weeks post-surgery means post-resection of the primary tumour or lymphadenectomy, whichever occurred most recently.
  • updated estimated patient numbers to reflect feedback suggesting there would be a greater number of people referred to medical oncology services for access to treatment around the time of surgery
  • ensuring that people currently accessing treatment would be able to transition to publicly funded treatment through a temporary criterion (will be removed after 6 months on 1 December 2025)
  • widening access to infliximab and tocilizumab to support management of immune checkpoint inhibitor-related toxicity.

We also received feedback requesting changes that unfortunately we are not progressing at this time. A summary of the feedback received and our response to this is detailed below.

Pembrolizumab

Pembrolizumab is currently already funded for eligible people with unresectable or metastatic melanoma. From 1 June 2025, access to pembrolizumab (Keytruda) will be widened to include eligible people with resectable stage IIIB to IV melanoma.

Pembrolizumab will be able to be accessed prior to surgery (‘neoadjuvant’) and/or after surgery (‘adjuvant’). However, the total perioperative treatment course (i.e. before- and after-surgery) would not be able to exceed 12 months’ worth of treatment. This would provide clinicians with flexibility to prescribe pembrolizumab both before and after surgery.

We now estimate that around 130 people would receive pembrolizumab in the perioperative setting for stage IIIB through to stage IV resectable melanoma in the first year of funding.

Dabrafenib in combination with trametinib

From 1 June 2025, dabrafenib (Tafinlar), in combination with trametinib (Mekinist), will be funded:

  • in the adjuvant setting for eligible people with resectable stage IIIB to IV BRAF mutated melanoma after surgery; and
  • in the unresectable or metastatic setting for eligible people with BRAF mutated melanoma.

In the first year of funding we now estimate that:

  • around 25 people would receive dabrafenib in combination with trametinib in the adjuvant setting for stage IIIB through to stage IV resectable melanoma in the first year of funding.
  • around 130 people with unresectable or metastatic melanoma would receive dabrafenib and trametinib in the first year of funding.

Eligibility criteria allow dabrafenib in combination with trametinib to be accessed after surgery irrespective of whether pembrolizumab was used prior to surgery. In addition, dabrafenib in combination with trametinib will be able to be accessed in the unresectable or metastatic setting as a first line systemic treatment, or as a second line treatment in those whose disease has progressed on immunotherapy (nivolumab, pembrolizumab). This would provide the choice of treatment depending on the clinical circumstances of the individual living with melanoma.

Details about our decision 

Dabrafenib and trametinib 

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

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

Both Tafinlar and Mekinist will have subsidy and delisting protection until 31 May 2028.

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

From 1 June 2025, dabrafenib (Tafinlar) and trametinib (Mekinist) will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Resected melanoma

Special Authority for Subsidy

Initial application – (stage III or IV resected melanoma - adjuvant) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

  1. The individual is currently on treatment with [dabrafenib/trametinib] and [dabrafenib/trametinib] and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
    1. Either:
      1. The individual has resected stage IIIB, IIIC, IIID or IV melanoma (excluding uveal) (see note a); or
      2. Both:
      3. The individual has received neoadjuvant treatment with a PD-1/PD-L1 inhibitor; and
      4. Adjuvant treatment with [dabrafenib/trametinib] is required; and
    2. The individual 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 b); and
    5. The individual has a confirmed BRAF mutation; and 
    6. [dabrafenib/trametinib] must be administered in combination with [dabrafenib/trametinib]; and
    7. The individual has ECOG performance score 0-2.

Notes: 

a) Stage IIIB, IIIC, IIID or IV melanoma defined as per American Joint Committee on Cancer (AJCC) 8th Edition

b) Initiating treatment within 13 weeks of complete surgical resection means 13 weeks after resection (primary or lymphadenectomy) 

Renewal – (stage III or IV resected melanoma - adjuvant) from any relevant practitioner. Approvals valid for 4 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 [dabrafenib/trametinib]; 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.

Unresectable or metastatic melanoma

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

Either:

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

Both:

  1. Any of the following:
    1. The individual’s disease has had a complete response to treatment; or
    2. The individual’s disease has had a partial response to treatment; or
    3. The individual 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.

Pembrolizumab

From 1 June 2025, access to pembrolizumab (Keytruda) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

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.

Resectable or resected melanoma

The 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 - neoadjuvant) only from a relevant specialist or from 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 pembrolizumab 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. Treatment must be prior to complete surgical resection; and
    4. Pembrolizumab must be administered as monotherapy; and
    5. The individual has ECOG performance 0-2; and
    6. Pembrolizumab to be administered at a fixed dose of 200 mg every 3 weeks (or equivalent).

Note: Stage IIIB, IIIC, IIID or IV melanoma defined as per American Joint Committee on Cancer (AJCC) 8th Edition

Initial application – (stage III or IV resected melanoma - adjuvant) only from a relevant specialist or from 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 pembrolizumab and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
  3. Either:
    1. The individual has resected stage IIIB, IIIC, IIID or IV melanoma (excluding uveal) (see note a); or
    2. Both:
      1. The individual has received neoadjuvant treatment with pembrolizumab; and
      2. Adjuvant treatment with pembrolizumab is required; and
  4. The individual has not received prior funded systemic treatment in the adjuvant setting for stage IIIB, IIIC, IIID or IV melanoma; and
  5. Treatment must be in addition to complete surgical resection; and
  6. Treatment must be initiated within 13 weeks of complete surgical resection, unless delay is necessary due to post-surgery recovery (see note b); and
  7. Pembrolizumab must be administered as monotherapy; and
  8. The individual has ECOG performance 0-2; and
  9. Pembrolizumab to be administered at a fixed dose of 200 mg every 3 weeks (or equivalent).

Notes: 

a) Stage IIIB, IIIC, IIID or IV melanoma defined as per American Joint Committee on Cancer (AJCC) 8th Edition

b) Initiating treatment within 13 weeks of complete surgical resection means either 13 weeks after resection (primary or lymphadenectomy) or 13 weeks prior to the scheduled date of the resection (primary or lymphadenectomy)

Renewal – (stage III or IV resected melanoma - adjuvant) 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:

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 (equivalent to 18 cycles at a dose of 200 mg every 3 weeks), including any systemic neoadjuvant treatment.

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

Unresectable or metastatic melanoma

The Special Authority criteria for pembrolizumab for unresectable or metastatic melanoma will also be amended in Section B of the Pharmaceutical Schedule, from 1 June 2025, as follows (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

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. The individual Patient has metastatic or unresectable melanoma (excluding uveal) stage III or IV; and
  2. Baseline measurement of overall tumour burden is documented clinically and radiologically; and
  3. The individual patient has ECOG performance 0-2; and
  4. Either:
    1. The individual Patient has not received funded nivolumab; or
    2. Both:
      1. The individual 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 individual 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. The individual has been diagnosed in the metastatic or unresectable stage III or IV setting; or
    2. The individual did not receive treatment in the perioperative setting with a PD-1/PD-L1 inhibitor; or
    3. All of the following:
      1. The individual received treatment in the perioperative setting with a PD-1/PD-L1 inhibitor; and
      2. The individual did not experience disease recurrence while on treatment with that PD-1/PD-L1 inhibitor; and
      3. The individual 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. Both All of the following:
    1. Any of the following:
      1. The individual’s Patient's disease has had a complete response to treatment; or
      2. The individual’s Patient's disease has had a partial response to treatment; or
      3. The individual 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; or and
    3. The treatment remains clinically appropriate and the patient is benefitting from the treatment; or
  2. All of the following:
    1. The individual Patient has previously discontinued treatment with pembrolizumab for reasons other than severe toxicity or disease progression; and
    2. The individual 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. The individual Patient has been on treatment for more than 24 months; and
  2. Either:
    1. Both All of the following:
      1. Any of the following:
        1. The individual’s Patient’s disease has had a complete response to treatment; or
        2. The individual’s Patient’s disease has had a partial response to treatment; or
        3. The individual 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; or and
      3. The treatment remains clinically appropriate and the patient is benefitting from the treatment; or
    2. All of the following:
      1. The individual Patient has previously discontinued treatment with pembrolizumab for reasons other than severe toxicity or disease progression; and
      2. The individual Patient has signs of disease progression; and
      3. Disease has not progressed during previous treatment with pembrolizumab.

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

Similar changes will also be made to the current nivolumab eligibility criteria for unresectable or metastatic melanoma.  

Infliximab and tocilizumab for treatment of immune checkpoint inhibitor-related toxicity

Who we think will be interested

  • People with cancers treated with immune checkpoint inhibitors, 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 cancers treated with immune checkpoint inhibitors
  • Groups who support and advocate for people with cancers treated with immune checkpoint inhibitors
  • Health New Zealand and The Cancer Control Agency
  • Hospital and community pharmacies
  • Hei Āhuru Mōwai | Māori Cancer Leadership Aotearoa
  • Pharmaceutical suppliers and wholesalers

What does this mean for people?

From 1 June 2025, access to both infliximab (Remicade) and tocilizumab (Actemra) will be widened to enable access for the treatment of immune checkpoint inhibitor-related toxicity, subject to eligibility criteria.  

The immune checkpoint inhibitors, pembrolizumab, nivolumab, ipilimumab, atezolizumab and durvalumab are currently funded for various cancer indications. Despite their clinical benefits, immune checkpoint inhibitors are associated with a spectrum of immune-related adverse events that can affect multiple different organ systems and can range from mild to severe.

We have received feedback that there are an increasing number of New Zealanders experiencing immune checkpoint inhibitor-related toxicity as a result of the increased funded access and use of immune checkpoint inhibitors.

We understand from the feedback on many recent funding proposals that access to infliximab (Remicade) and tocilizumab (Actemra) will help manage people with more severe or refractory adverse events. In addition, since the recent increase in funded access to immune checkpoint inhibitors, the number of applications for access to infliximab or tocilizumab through Pharmac’s exceptional circumstances pathway has increased.

Having sought advice, we understand that widening access to these medicines will provide clinicians and people treated with immune checkpoint inhibitors with more funded treatment options to support the management of immune checkpoint inhibitor-related toxicity and reduce the administrative burden associated with requesting access through Pharmac’s exceptional circumstances pathway.

We estimate that each year around 60 people could need infliximab (Remicade) and around 5 could need tocilizumab (Actemra) for the management of immune checkpoint inhibitor related toxicity.

Infliximab (Remicade) and tocilizumab (Actemra) are not Medsafe approved for the treatment of immune checkpoint inhibitor-related toxicity. Prescribing of these medicines for this use would need to occur in accordance with Section 25 of the Medicines Act 1981.

Infliximab

Access to infliximab (Remicade) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2025 for treatment of immune checkpoint inhibitor-related toxicity.

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

Special Authority for Subsidy

Initial application – (immune checkpoint inhibitor toxicity in malignancy*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

  1. The individual requires treatment for moderate to severe autoimmune toxicity following immune checkpoint inhibitor treatment for malignancy; and
  2. The individual has received insufficient benefit from use of corticosteroids; and
  3. Infliximab is to be administered at up to 5mg/kg for up to four doses.

Renewal (immune checkpoint inhibitor toxicity in malignancy*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Both:

  1. The individual has shown clinical improvement and ongoing treatment is required; and
  2. Infliximab is to be administered at up to 5mg/kg for up to a total of 8 doses.

Note: Indications marked with * are unapproved indications.

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

Infliximab 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.

Tocilizumab

Access to tocilizumab (Actemra) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule also from 1 June 2025 for treatment of immune checkpoint inhibitor-related toxicity.

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

Special Authority for Subsidy

Initial application – (immune checkpoint inhibitor toxicity in malignancy*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

  1. The individual requires treatment for moderate to severe autoimmune toxicity following immune checkpoint inhibitor treatment for malignancy; and 
  2. The individual has received insufficient benefit from use of corticosteroids; and
  3. Tocilizumab is to be administered at a maximum dose of 8 mg/kg fortnightly.

Renewal – (immune checkpoint inhibitor toxicity in malignancy*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Both:

  1. The individual has shown clinical improvement and ongoing treatment is required; and
  2. Tocilizumab is to be administered at a maximum dose of 8 mg/kg fortnightly.

Note: Indications marked with * are unapproved indications.

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

Tocilizumab 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.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. Responses were largely supportive of the proposal.

Theme

Pharmac Staff Comment
General feedback
Supportive of proposal, highlighting the improvement in health outcomes that would be expected. We are pleased to be able to fund more medicines for melanoma that will improve health outcomes of New Zealanders.
Feedback on resectable melanoma
Raised concern that the criterion requiring treatment to start within 13-weeks of resection would mean that some people who have already had their melanoma resected would miss out on treatment.

We note that this timeframe from complete surgical resection includes resection and/or lymphadenectomy, whichever occurred more recently. We have clarified this in the eligibility criteria.

We acknowledge that there will be people who have had surgery earlier. We have received clinical advice that treatment commencing within three months of resection and/or lymphadenectomy aligns with the evidence for the use of these treatments. 

However, we recognise that some people would have had their resection in the three months prior to 1 June 2025 and may not be able to commence treatment within the allowed timeframe for reasons outside of their control. We will be happy to consider Special Authority waivers for this group of people. Details on how clinicians can apply through our waivers process is on the Pharmac website.

Special Authority Waivers

Highlighted the importance of making neoadjuvant treatment available. Considered that it would be beneficial to separate out the neoadjuvant criteria from the adjuvant criteria. 

Highlighted the importance of undertaking sentinel node biopsies to support identification of potential adjuvant patients.

We are pleased to be funding pembrolizumab as a neoadjuvant treatment prior to resection as a treatment option as well as access to either pembrolizumab or BRAF/MEK inhibitors post resection, provided that the total treatment duration was no longer than 12 months.

We have separated the criteria for access into neoadjuvant and adjuvant treatment for pembrolizumab to help clarify this.

We understand the importance of sentinel node biopsies to ensure that those who would benefit from adjuvant treatment are able to be best identified.
Proposed that Pharmac consider funding neoadjuvant ipilimumab and nivolumab for resectable stage IIIB-IV melanoma in line with the NADINA trial(external link)findings. This may also help minimise the overall treatment duration, as those patients with a complete pathological response did not need to go on to have further immunotherapy post-surgery.

We understand that the regimen outlined in the NADINA trial(external link)has the potential to reduce impact on the NZ health system. 

Following publication of the consultation on this proposal, we received a clinician-led funding application. 

We intend on working with the applicant and supplier to support progressing this application through our funding application process.
Requested amendments to the eligibility criteria to specify the number of cycles of pembrolizumab that could be used (18 cycles) instead of a time duration (12 months).

We acknowledge the request for clarification around the number of cycles received. In response, we have enabled neoadjuvant treatment as an option, provided that the total treatment duration in the perioperative setting does not extend beyond 12 months. We have amended the renewal criteria for access to pembrolizumab as adjuvant treatment to clarify this.
Requested amendments to the eligibility criteria to enable treatment with BRAF/MEK inhibitors only if the person did not receive pembrolizumab in the neoadjuvant setting.

We acknowledge this request. However, we consider that it would be beneficial for clinicians and patients to be able to decide which treatment they receive after neoadjuvant pembrolizumab and resection. We are pleased to be able to offer the option of a BRAF/MEK inhibitor should it be deemed in the best interests of the patient. We anticipate that most people who receive perioperative treatment will receive pembrolizumab.
Requested that the treatments proposed for funding (especially pembrolizumab) be funded for all people with Stage III melanoma. 

Unfortunately, we are not able to include those with Stage IIIA melanoma as part of this funding decision. The population eligible for access is in line with the clinical advice received. Our advisors have told us that those with stage IIIB-IV would benefit the most from treatment with pembrolizumab or BRAF/MEK inhibitors around the time of resection. Full details of the advice we received for the treatment of resectable melanoma is available here: 

Application for pembrolizumab | Application Tracker(external link)

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

We operate with a fixed budget, which means we must make difficult choices about which treatments to fund, and for who, from within this budget. Given the large number of people with Stage IIIA melanoma, and the potential budget impact from funding this group of people, we would need to consider funding for this group against other options for investment. 

While we are not able to include funding for people with Stage IIIA melanoma at this point in time, this does not prevent us from considering it in the future. If there is new information that has not yet been considered by our clinical advisors that would support progression for people with Stage IIIA melanoma, we welcome this and would be happy to consider this in the future. 
Feedback on health system impacts
Feedback highlighted the significant additional pressure that would be placed on frontline services.

We acknowledge this and appreciate this feedback. We are working with our health sector partners to support implementation of this funding decision in the New Zealand health system.
Indicated that in some regions a skin cancer multidisciplinary meeting (MDM) has been established to support implementation.

We appreciate this feedback and acknowledge the multidisciplinary approach that would be required for successful implementation of this proposal. We have shared this with Health NZ and the Cancer Control Agency for consideration alongside its implementation activities.

Highlighted the increased patient management and involvement of general practice in the ongoing management of people with melanoma, in particular highlighting the need to consider:

  • support for the management of adverse effects
  • to support coordination between primary and secondary care providers and the need for clear referral pathways and shared care protocols outlining their roles and responsibilities in the management of patients receiving these therapies
  • education and training on the indications, administration, and potential adverse effects of these new treatments
  • community infusion centres
  • while melanoma is less common in Māori, Pacific, and Asian populations, they may have a higher risk of developing more aggressive melanomas with a poorer prognosis and therefore implementation needs to consider this to avoid perpetuating existing health inequity.

We acknowledge and appreciate the substantial impact on the New Zealand health system that will arise with this funding decision. 

We have discussed this and shared this feedback with Health NZ and the Cancer Control Agency for further consideration.

We understand the importance of both primary and secondary care in the implementation of this proposal. If necessary and supported by the Health NZ and the Cancer Control Agency led implementation planning programme we would:

  • support development of a melanoma pathway, possibly through engaging HealthPathways
  • consider commissioning and developing further resources from education providers for health professionals who have patients using these treatments.

We also intend to commission an update to Healthify(external link) to provide consumer facing relevant information about these medicines and their side effects, alongside the suppliers’ intended activities.

We have sponsored a Goodfellow webinar(external link)‘Recognising immune-related adverse events associated with immune checkpoint inhibitors’ held 11 March 2025. We are widening access to infliximab and tocilizumab for the treatment of immune checkpoint inhibitor-related toxicity as part of this decision to support management of these adverse events. We would consider additional activities in relation to the management of immune checkpoint inhibitor-related toxicity as required in the future.

We understand that Māori, Pacific and Asian populations are less likely to experience melanoma but experience worse health outcomes when they do. We would seek to ensure that our implementation activities do not perpetuate inequities for these populations. We will consider consumer facing educational resources translated into te reo Māori and other languages. 

The expansion of funded treatment options will significantly increase the number of patients requiring systemic therapy, placing additional strain on existing oncology services. The most direct impact of funding is extending waiting times for first specialist appointments, which is particularly important given the benefit or treating early in melanoma and this could have impacts on the treatment of other tumour streams. 

This impact would be worst on the day of funding, as patients currently receiving care in the private sector will transfer to public and the those with surgery in the prior 13 weeks will all be eligible on the first day of funding, highlighting the urgency.

There is a need to increase funding for internal medicine recruitment. 

We acknowledge and appreciate the substantial impact this funding decision will have on the New Zealand health system. We also understand that the impact will be felt as soon as this decision is implemented.

We have shared our assessment of the impact of this funding decision on the health system with Health NZ and the Cancer Control Agency to inform implementation planning considerations, as has occurred routinely throughout this budget uplift.

We have discussed this feedback and shared it directly with Health NZ and the Cancer Control Agency for further consideration, to inform implementation at a regional level.

The patient estimates provided underestimate the number of potential referrals. It is estimated that there would be a 20-30% increase on that estimated.

We acknowledge that there may be more identifiable people who would potentially be eligible for treatment. 

We also note that we have applied uptake assumptions of for pembrolizumab, given the experience with uptake of immune checkpoint inhibitors across a range of indications. Our patient number estimates take this into account.

However, after considering this feedback, which was provided by a range of stakeholders, we have amended our estimate of the number of people who could be anticipated to receive treatment in the resectable setting accordingly.

This has increased the total number of people that we anticipate will receive treatment in this setting.

To support the management of immune checkpoint inhibitor-related toxicity:

  • Requested funding of supportive medications (infliximab, tocilizumab and tacrolimus) accessed via special authority criteria, to effectively manage toxicity
  • Requested support and resource for a national immunotherapy complications service 

We appreciate this feedback and are happy to be able to widen access to infliximab and tocilizumab for the treatment of immune checkpoint inhibitor-related toxicity as part of this decision. 

We will continue to work to ascertain the need and administrative requirements for access to other treatments (eg. tacrolimus) should this be necessary.

We have shared the request for support for a national immunotherapy complications service with Health NZ and the Cancer Control Agency, for consideration. We understand that such a service is not part of the implementation planning group’s plans at this time.

Noted that BRAF mutation testing needs to be universally available from the date of funding. A national approach to universal BRAF testing for high-risk melanomas will be required to ensure equitable and timely access to therapy.

We have discussed this with Health NZ and understand that there is funding to ensure sufficient capacity for BRAF testing from 1 June 2025 for melanoma. We understand that there would be sufficient capacity and capability to support implementation from 1 June 2025 and will continue to engage with Health NZ in the lead up to the implementation date.
  • Request to allow patients with private insurance to receive Pharmac-funded medication in private clinics to allow care to be provided closer to patient’s homes.
  • Requested that the PCT-only designation be removed for pembrolizumab, so as to enable it to be administered from a community centre or private clinic.

We understand that there is a broader piece of work being undertaken by sector stakeholders (Ministry of Health, Pharmac and Health NZ) to consider the use of Pharmac-funded cancer treatments in private clinics. 

We consider that this is a broader piece of work that, while relevant to this funding decision, will not be implemented as part of this funding decision.
Feedback specific to dabrafenib and trametinib
Noted that the availability of an all-oral option that could be taken at home (i.e. dabrafenib and trametinib) would ease congestion at hospitals.

We appreciate this feedback and are happy that the availability of an all-oral option could help alleviate some of the impacts on Health NZ hospitals associated with this proposal.
Questioned why a competitive process for BRAF/MEK inhibitors was not undertaken. 

We have been working with urgency to address the unmet need for people with BRAF mutated melanoma. We note that no exclusivity has been offered for dabrafenib and trametinib which are currently Medsafe approved for use in both the resectable and unresectable setting. 

The listing of other combination BRAF/MEK inhibitors alongside dabrafenib and trametinib in the future would not be prohibited. 
Feedback specific to pembrolizumab
Requested urgent prioritisation of the funding application for pembrolizumab in high-risk early-stage triple negative breast cancer.

This feedback was not of direct relevance to the funding decision (being the melanoma setting). However, we have received a funding application for pembrolizumab for people with high-risk early-stage triple negative breast cancer. This application has been recommended for funding by the Cancer Treatments Advisory Committee and is now under assessment.

We acknowledge and appreciate the high unmet need for treatment for people with high-risk early-stage triple negative breast cancer. You can follow the progress of this application on the application tracker(external link).

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.