Decision to fund two new treatments for people with advanced non-small cell lung cancer

Medicines Decision

What we’re doing

We're pleased to announce a decision to fund two new treatments, called immune checkpoint inhibitors, for people with locally advanced and metastatic non-small cell lung cancer (NSCLC) from 1 April 2023. In summary:

  • pembrolizumab (brand name Keytruda), supplied by Merck Sharp and Dohme, will be funded for the treatment of people with advanced NSCLC as first-line treatment.
  • atezolizumab (brand name Tecentriq), supplied by Roche, will be funded for people with advanced NSCLC as second or later line treatment.

This funding decision is the result of a request for proposals, released in July 2022, seeking bids from suppliers of immune checkpoint inhibitors for the treatment of advanced NSCLC in three indications:

  • first-line monotherapy
  • first-line combination therapy
  • second-line monotherapy.

Further information about the RFP can be found in the consultation letter and details about this decision can be found below.

What does this mean for people?

Lung cancer is the leading cause of cancer-related death in Aotearoa New Zealand. Most people with lung cancer are diagnosed with advanced disease, at the locally advanced or metastatic stage.

From 1 April 2023 people with locally advanced or metastatic non-small cell lung cancer (referred to as “advanced NSCLC” in this consultation), who meet the eligibility criteria, will have access to pembrolizumab (Keytruda). It also means that people who have previously received chemotherapy for their advanced NSCLC, who meet the eligibility criteria will have access to atezolizumab (Tecentriq).

The incidence of NSCLC is more than three times higher for Māori and twice as high for Pacific people compared to non-Māori non-Pacific people. Māori and Pacific people are also diagnosed at a younger age, with later stage disease and experience worse outcomes from NSCLC than non-Māori, non-Pacific peoples. Mate Pukupuku Pūkahukahu (lung cancer) is a Hauora Arotahi (Māori health area of focus) and a priority area in Te Pae Tata. By having more effective treatment options for advanced disease, we expect that this decision will contribute to achieving health equity and have significant health benefits, in particular for Māori and Pacific peoples.

We estimate that over 450 people with advanced NSCLC will begin treatment with pembrolizumab in the first year of funding, and that this will increase to over 700 people per year after three years of funding.

We estimate that in the first year, over 300 people with advanced NSCLC who have received prior chemotherapy will begin treatment with atezolizumab and that this will decrease to around 20 people after three years of funding as more people will receive the first-line treatment.

Reducing barriers

Where possible, we have sought to reduce barriers for affected individuals and their whānau, while minimising the impact for the health and disability system. This was considered during the development of the proposal and eligibility criteria for access to immune checkpoint inhibitors, including:

  • the option for a six weekly dosing regimen for pembrolizumab
  • using more flexible criteria to assess tumour burden and response to treatment (moving away from the strict RECIST criteria)
  • including access to treatment for people with PD-L1 expression who can’t have chemotherapy
  • building in flexibility for treatment when not enough tissue can be obtained for biopsy and testing
  • testing will be provided free of charge to the health system for the first 6 months while capacity is increased. 

Sector impact

We know that this funding decision will have a substantial impact on the health and disability system of Aotearoa New Zealand. We have worked, and will continue to work, with our health sector partners to support the equitable implementation of this funding decision.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 16 December 2022. We received a lot of consultation feedback supporting the proposal. We are really grateful to those who took the time to provide feedback. 

As a result of the feedback received, we have made the following changes to the eligibility criteria: 

Both treatments

  • Small changes to clarify the wording in the criteria
  • Increased the initial and renewal approval duration from 3 months to 4 months
  • A temporary criterion will be in place for the first three months to simplify the transition to publicly funded treatment for people currently on privately funded treatment or a compassionate access programme 

Pembrolizumab

  • Amended the criteria for pembrolizumab to enable access to treatment for people with expression of PD-L1 for whom chemotherapy is not considered to be in the person’s best interests.

Who we think will be most interested

  • People with lung cancer, their whānau, caregivers and communities
  • Māori and Pacific people with lung cancer and their whānau
  • Māori and Pacific health care professionals
  • Oncologists, specialist nurses, hospital pharmacists, radiologists, pathologists and other health professionals involved in the care of people with lung cancer
  • Groups who advocate for and support people with lung cancer
  • Te Aho o Te Kahu
  • Te Aka Whai Ora - Māori Health Authority and Iwi-Māori Partnership Boards
  • Te Whatu Ora hospitals
  • Pharmaceutical suppliers and wholesalers
  • Other organisations with an interest in lung cancer and its treatments 

Detail about this decision

Pembrolizumab for the first line treatment of advanced non-small cell lung cancer

Pembrolizumab will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2023 and the following prices and subsidies will apply: 

Chemical Formulation Brand Pack size Current Price and subsidy New Price and subsidy
Pembrolizumab Inj 25 mg per ml, 4 ml vial Keytruda 1 $4,680.00 $4,680.00
Pembrolizumab Inj 1 mg for ECP Baxter 1 mg $49.14 $47.74

A confidential rebate will apply to Keytruda that will reduce the net price to the Funder.

Keytruda will have Principal Supply Status from 1 April 2023 until 31 March 2026. It will be the only listed immune checkpoint inhibitor for the first line treatment of advanced non-small cell lung cancer during this period.

Keytruda will be listed as a PCT-only pharmaceutical in Section B of the Pharmaceutical Schedule, meaning that only Te Whatu Ora hospitals will be able to make a subsidy claim.

Access to pembrolizumab (Keytruda) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2023, to include the following eligibility criteria (changes to  criteria following consultation are shown with additions in bold, deletions in strikethrough, please note that criterion 1 will be in place for the first three months of listing only):

Initial application - (non-small cell lung cancer first-line monotherapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4 months for applications meeting the following criteria:

Either:

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
    1. Patient has locally advanced or metastatic, unresectable, non-small cell lung cancer; and
    2. Patient has not had chemotherapy for their disease in the palliative setting; and
    3. Patient has not received prior funded treatment with an immune checkpoint inhibitor for NSCLC; and
    4. There is documentation confirming that the disease does not express activating mutations of EGFR or ALK tyrosine kinase unless not possible to ascertain; and
    5. Pembrolizumab to be used as monotherapy; and
    6. Either:
      1. There is documentation confirming the disease expresses PD-L1 at a level greater than or equal to 50% as determined by a validated test unless not possible to ascertain; or
      2. Both:
        1. There is documentation confirming the disease expresses PD-L1 at a level greater than or equal to 1% as determined by a validated test unless not possible to ascertain; and
        2. Chemotherapy is determined to be not in the best interest of the patient based on clinician assessment; and
    7. Patient has an ECOG 0-2; and
    8. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 12 weeks; and
    9. Baseline measurement of overall tumour burden is documented clinically and radiologically. 

Renewal – (non-small cell lung cancer first line monotherapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4 months for applications meeting the following criteria:

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. No evidence of disease progression; and
  4. The treatment remains clinically appropriate and patient is benefitting from treatment; and
  5. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent); and
  6. Pembrolizumab to be discontinued at signs of disease progression; and
  7. Treatment with pembrolizumab to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks). 

Initial application - (non-small cell lung cancer first-line combination therapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4 months for applications meeting the following criteria:

Either:

  1. Patient is currently on treatment with pembrolizumab and met all remaining criteria prior to commencing treatment; or
  2. All of the following:
    1. Patient has locally advanced or metastatic, unresectable, non-small cell lung cancer; and
    2. The patient has not had chemotherapy for their disease in the palliative setting; and
    3. Patient has not received prior funded treatment with an immune checkpoint inhibitor for NSCLC; and
    4. There is documentation confirming that the disease does not express activating mutations of EGFR or ALK tyrosine kinase unless not possible to ascertain; and
    5. Pembrolizumab to be used in combination with platinum-based chemotherapy; and
    6. Patient has an ECOG 0-2; and
    7. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent) for a maximum of 12 weeks; and
    8. Baseline measurement of overall tumour burden is documented clinically and radiologically. 

Renewal – (non-small cell lung cancer first line combination therapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4  months for applications meeting the following criteria:

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. No evidence of disease progression; and
  4. The treatment remains clinically appropriate and patient is benefitting from treatment; and
  5. Pembrolizumab to be used at a maximum dose of 200 mg every three weeks (or equivalent); and
    6. Pembrolizumab to be discontinued at signs of disease progression; and
  6. Treatment with pembrolizumab to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

Atezolizumab for the second or later line treatment of advanced non-small cell lung cancer

Atezolizumab (Tecentriq) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2023, at the following prices and subsidies:

Chemical Formulation Brand Pack size Price and subsidy
Atezolizumab Inj 60 mg per ml, 20 ml vial Tecentriq 1 $9,503.00
Atezolizumab Inj 1 mg for ECP Baxter 1 mg $8.08

A confidential rebate will apply to Tecentriq that will reduce the net price to the Funder.

Tecentriq will have Principal Supply Status from 1 April 2023 to 31 March 2026. It will be the only listed immune checkpoint inhibitor for the second or later line treatment of advanced non-small cell lung cancer during this time.

Tecentriq will be listed as a PCT-only pharmaceutical in Section B of the Pharmaceutical Schedule, meaning that only Te Whatu Ora hospitals will be able to make a subsidy claim.

Atezolizumab will be listed in Section B and Part II of Section H subject to the following eligibility criteria (changes to the criteria following consultation are shown with additions in bold, deletions in strikethrough, please note that criterion 1 will be in place for the first three months of listing only):

Initial application- (non-small cell lung cancer second line monotherapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4 months for applications meeting the following criteria:

Either:

  1. Patient is currently on treatment with atezolizumab and met all remaining criteria below prior to commencing treatment; or
  2. All of the following:
    1. Patient has locally advanced or metastatic non-small cell lung cancer; and
    2. Patient has not received prior funded treatment with an immune checkpoint inhibitor for NSCLC; and
    3. There is documentation confirming that the disease does not express activating mutations of EGFR or ALK tyrosine kinase unless not possible to ascertain; and
    4. Patient has an ECOG 0-2; and
    5. Patient has documented disease progression following treatment with at least two cycles of platinum-based chemotherapy; and
    6. Atezolizumab is to be used as monotherapy at a dose of 1200 mg every three weeks (or equivalent) for a maximum of 12 weeks; and
    7. Baseline measurement of overall tumour burden is documented clinically and radiologically. 

Renewal – (non-small cell lung cancer second line monotherapy) only from a medical oncologist or any relevant practitioner on the recommendation of a medical oncologist. Approvals valid for 3 4 months for applications meeting the following criteria:

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. No evidence of disease progression; and
  4. The treatment remains clinically appropriate and patient is benefitting from treatment; and
  5. Atezolizumab to be used at a maximum dose of 1200 mg every three weeks (or equivalent); and
    6. Atezolizumab to be discontinued at signs of disease progression; and
  6. Treatment with atezolizumab to cease after a total duration of 24 months from commencement (or equivalent of 35 cycles dosed every 3 weeks).

Our response to what you told us

We are grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are available below. 

Theme

Pharmac Comment

Supportive

Many responses were supportive of the proposal, and highlighted that:

  • Lung cancer is the leading cause of cancer deaths globally and it is important to have access to the most effective treatments available.
  • This funding proposal meets the greatest treatment need right now for lung cancer and it will be life changing for people with stage 4 NSCLC.
  • This will make a meaningful difference in the lives of patients and their families.
  • Many Māori and Pacific people would benefit from this proposal.
  • The proposal follows a very robust process led by Pharmac, during which it has consulted with; industry, specialists, healthcare professionals, patients and community.

We are grateful to those who took the time to feedback on this proposal.

We are pleased that this funding decision will improve the health outcomes of New Zealanders, in particular Māori. This feedback is in line with the advice we have received and what we have heard from individuals, their whānau and the sector.

Amendments to Special Authority criteria for immune checkpoint inhibitors

Responders requested that access be widened for those who are contraindicated to chemotherapy with a PD-L1 expression greater than 1%, as this would include many Māori and Pacific people.

We appreciate this feedback and request. We have changed the Special Authority criteria to enable access to treatment for these people. We acknowledge this is a group without alternative treatments and would benefit from treatment with immunotherapy. Clinical advice we have received suggests that this would simplify the process to receive immunotherapy for some patients.

Responders requested access to atezolizumab for those who have experienced multiple relapses of their NSCLC.

The criteria as consulted on do not stop access to atezolizumab for the group of people who have experienced multiple relapses on prior chemotherapy. The intent is to enable access for people who have previously received chemotherapy for their advanced NSCLC.

Responders requested that the initial and renewal approval period for both agents be extended from 3 months to 4 months.

We have made this change to help reduce some of the burden for the health sector and potential barriers to access for people with NSCLC.

Responders requested that treatment with the proposed immune checkpoint inhibitor(s) be allowed for those who have previously received durvalumab.

We appreciate that there may be benefit for people who present in the advanced setting after receiving durvalumab. We consider this requires further assessment, including clinical advice regarding the evidence to support this. This issue was recently discussed by our Cancer Treatments Advisory Committee (CTAC) (14 October 2022) [PDF, 220 KB]. The Committee considered that it should review any new evidence when it is available for immune checkpoint inhibitor retreatment for NSCLC (ie where progression did not occur while on immune checkpoint inhibitor treatment).

Responders requested that the criteria for   PD-L1 testing to access treatment with pembrolizumab monotherapy remove the term “unless not possible to ascertain”.

We appreciate this feedback. This wording is included to enable access for people where it is not possible to obtain sufficient tissue for biopsy after all possible attempts, to ensure that this isn’t a barrier to access. Our criteria are in line with advice we received from CTAC (14 October 2022 [PDF, 220 KB]) to minimise access barriers for people with advanced NSCLC.

Responders requested that treatment with an immune checkpoint inhibitor be continued beyond first progression until a repeat assessment 4-8 weeks later confirms no further progression to remove the risk of treatment cessation due to pseudoprogression.

We note that confirmation of progression to exclude pseudoprogression is not currently funded for people receiving immunotherapy for melanoma.

We also note that all the clinical trials that support this decision have used Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 to establish disease progression and this has informed our assessment. The lung cancer funding criteria were put together to limit the impact on certain hospital services and we have moved away from using the strict RECIST criteria to establish baseline tumour burden and treatment response.

We would be happy to reconsider pseudoprogression in the context of all funded immunotherapy at a future meeting of CTAC and welcome submission of information by the relevant oncology or clinical special interest groups to support this.  

Responders requested that baseline assessment of tumour burden be documented and reassessed clinically or radiologically, rather than both.

We have removed requirements for documentation as per RECIST where possible. Clinical advice we have received confirmed there is a need for radiologic assessment to establish tumour burden and response to treatment. Our understanding is that the absence of radiologic assessment for metastatic NSCLC occurs very infrequently at this time.

Responders considered that access to treatment for people with Eastern Cooperative Oncology Group (ECOG) 0-2 is not evidence based and that this should be adjusted to ECOG 0-1.

We consider that the criteria are a pragmatic way to include the intended NSCLC population and enable treatment decisions at clinician discretion. Our clinical advisors considered that this group would benefit from these treatments and therefore we have not changed this criterion.

Responders requested we clarify what is meant by equivalence to 24 months’ worth of treatment in the renewal criteria.

The intent of this criteria is to account for the variability in a person’s treatment journey, which may result in a treatment delay. This criterion means “equivalent of 35 cycles of treatment if administered every 3 weeks”. We have amended the criteria to clarify this.

Responders requested that people who have already commenced treatment with an immune checkpoint inhibitor be enabled to transition onto funded immune checkpoint inhibitor treatment.

We appreciate that there are many people who are currently receiving treatment in a private health setting or through a compassionate access programme. We have included a temporary criterion for the first three months from the list date on 1 April 2023 to enable a simple transition onto publicly funded treatment for people who met all remaining criteria at the time of commencing treatment with an immune checkpoint inhibitor.

Responders requested the removal of the requirement to receive at least two cycles of platinum-based chemotherapy prior to eligibility for atezolizumab.

We appreciate that some people are not able to receive two cycles of chemotherapy. The intent of this criterion is to define a population who are not receiving first line treatment. We would consider a Special Authority waiver application for people who wish to receive atezolizumab and have not been able to receive two prior cycles of platinum based chemotherapy due to toxicity and their disease has progressed.

Aseptic compounding

A responder requested that the previous Extemporaneously Compounded Preparations (ECP) price for pembrolizumab be retained for this funding decision.

We consider the change in ECP price is appropriate given the flat dosing (same dose for everyone) that is used in clinical practice for pembrolizumab in its currently funded indication and is specified in the NSCLC Special Authority criteria. We continue to engage with Te Whatu Ora in relation to this issue to understand any impact of this change on the health sector.

Removal of requirement for treatment to be dispensed in a Te Whatu Ora hospital

A responder requested that Pharmac consider removal of the ‘PCT only’ criteria from these new fundings (and all other IV cancer treatments in general). Removal would provide people the option of having their intravenous cancer treatments administered in the private hospital or clinic setting.

We consider that the most appropriate means of claiming for dispensed immune checkpoint inhibitors remains through Te Whatu Ora hospitals.

If there is a clinical need for these treatments to be delivered in another setting, we would work with our sector partners to ensure that this can work logistically, and that reimbursement could occur. We understand that there are already mechanisms in place where compounded pharmaceuticals are administered at sites contracted to Te Whatu Ora hospitals. We remain responsive to requests from the Sector to support implementation of this funding decision.

Funding of other medicines for people with NSCLC

A responder requested funding of entrectinib for ROS1 NSCLC. Noted that people with ROS1 NSCLC would be eligible for the proposed funding of pembrolizumab and that the cost of funding entrectinib would be offset by pembrolizumab if this proposal is progressed.

Entrectinib for people with ROS1 advanced NSCLC has been ranked as an option for investment(external link).

We intend to update our assessment of entrectinib to reflect the funding of immune checkpoint inhibitors for this group of people. We also appreciate the suitability advantages of entrectinib for the small group of people with ROS1 advanced NSCLC. This would be considered as part of an updated assessment under Pharmac’s Factors for Consideration.

A responder requested that access to infliximab and tocilizumab be widened for the treatment of adverse effects of checkpoint inhibitors.

 

 

 

We appreciate that these monoclonal antibodies are  in clinical guidelines as later line treatments for people who experience certain immune related adverse events to treatment with immune checkpoint inhibitors. We understand this use is very rare and has been previously managed on a case-by-case basis through Pharmac’s Exceptional Circumstances Framework for the currently funded immune checkpoint inhibitors. We consider that Pharmac’s Exceptional Circumstances Framework remains the best way to access these treatments if required and this is in line with the clinical advice received. We are open to reconsidering this if there is new information and this mechanism is no longer appropriate.

Funding of immune checkpoint inhibitors for other uses

A small number of people with head and neck cancer would also benefit from these treatments. Their needs are equally important, and their voices need to be heard in this consultation process.

We appreciate there are other uses of pembrolizumab that are at different stages of Pharmac’s funding process. Pembrolizumab for people with head and neck cancer was recommended for funding by CTAC for people with a Combined Positive Score (CPS) >1 in November 2021. This application is currently under assessment (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.