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

Medicines Consultation Closed

What we’re proposing

We are seeking feedback on a proposal to fund two new treatments, called immune checkpoint inhibitors, for locally advanced and metastatic non-small cell lung cancer (NSCLC) through provisional agreements with two suppliers:

  • pembrolizumab (brand name Keytruda), supplied by Merck Sharp and Dohme, for people with advanced NSCLC as first-line treatment, subject to eligibility criteria.
  • atezolizumab (brand name Tecentriq), supplied by Roche, for people with advanced NSCLC as second-line treatment, subject to eligibility criteria.

Consultation closes at 4 pm, 24 January 2023 and feedback can be emailed to consult@pharmac.govt.nz

Immune checkpoint inhibitors for advanced non-small cell lung cancer

What would the effect be?

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

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

Pembrolizumab would be funded as the first medicine in eligible people’s advanced NSCLC treatment journey (called “first-line therapy”), either alone (“monotherapy”) or combined with cancer chemotherapy medicines (“combination therapy”).

Atezolizumab monotherapy (without chemotherapy) would be funded if people needed further treatment following prior chemotherapy (called “second-line therapy”).

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, lung cancer is a Hauora Arotahi (Māori health area of focus) and a priority area in Te Pae Tata. We anticipate that many Māori and Pacific people would benefit from this proposal.

We estimate that over 420 people with advanced NSCLC would begin treatment with pembrolizumab in the first year of funding, and that this would increase to over 650 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 would begin treatment with atezolizumab. This would decrease to around 20 people after three years of funding as more and more people would receive treatment in the first-line setting.

Who we think will be 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, and other health professionals involved in the care of people with lung cancer
  • Groups who advocate for and support people with lung cancer
  • Te Aka Whai Ora - Māori Health Authority and Iwi-Māori Partnership Boards
  • Hospital pharmacists, and wholesalers
  • Te Whatu Ora hospitals
  • Pharmaceutical suppliers
  • Other organisations with an interest in lung cancer and its treatments

About non-small cell lung cancer

There are two main types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer. NSCLC accounts for about 80% of all lung cancers.

People with NSCLC typically have poor quality of life and have a poor prognosis. Most people with NSCLC are diagnosed with locally advanced or with metastatic disease. This is known as Stage III or Stage IV disease. Staging describes where the cancer is located and whether it has spread to other parts of the body. When lung cancer has been diagnosed at Stage III it has not spread to other parts of the body. Stage IV lung cancer means that it has spread to other parts of the body.

About pembrolizumab and atezolizumab

Pembrolizumab and atezolizumab are targeted cancer therapies called immunotherapies (immune checkpoint inhibitors), that work by helping the body’s immune system to fight cancer cells.

Pembrolizumab and atezolizumab inhibit the interaction between receptor PD-1 and its binder(s) PD-L1/PD-L2 on the surface of certain immune cells called T-cells. This results in causes the T-cells to find and kill cancer cells.

Pembrolizumab is currently approved by Medsafe for a number of different uses, including NSCLC. Pharmac currently funds pembrolizumab for people with metastatic melanoma. It is administered as an intravenous infusion, either every three weeks or every six weeks. Further information regarding its use can be found in the Medsafe datasheet(external link).

Atezolizumab is also Medsafe approved for use in multiple types of cancer, including NSCLC. It is administered as an intravenous infusion every three weeks. Further information regarding its use can be found in the Medsafe datasheet(external link).

Why we’re proposing this

We have heard from, and listened to, many stakeholders about the significant unmet need for people with advanced NSCLC. Our advisors and stakeholders have highlighted the benefits that immune checkpoint inhibitors would provide for people with lung cancer. 

We have engaged with many stakeholders, including Te Aho o Te Kahu, the Cancer Society, the Lung Cancer Foundation, healthcare professionals specialising or interested in treatments for lung cancer, and Te Whatu Ora as part of this funding process.

Pembrolizumab clinical advice

We first received a funding application to fund pembrolizumab for the treatment of advanced NSCLC in 2017.

First-line monotherapy

Since receiving an application in 2017, we have sought advice from the Cancer Treatments Advisory Committee (CTAC, previously known as CaTSoP) and PTAC on multiple occasions about the funding of pembrolizumab as first line monotherapy for advanced NSCLC. In 2019, CTAC recommended pembrolizumab be funded for first-line monotherapy for advanced NSCLC with a high priority [PDF, 710 KB].

First-line combination therapy

Since receiving an application for the use of pembrolizumab in combination with chemotherapy in 2018, we have sought advice from CTAC and PTAC on multiple occasions. In 2019, PTAC recommended pembrolizumab be funded for use in first-line combination therapy for advanced NSCLC with a medium priority [PDF, 796 KB].

Atezolizumab clinical advice

We first received a funding application to fund atezolizumab for the second-line treatment of advanced NSCLC in 2017.

Since receiving this application we have sought advice from CTAC and PTAC on multiple occasions. In 2017 both PTAC and CTAC recommended atezolizumab be funded for second line treatment with a low priority(external link).

Subsequent clinical advice

Having received applications for several PD-1/PD-L1 immune checkpoint inhibitors, we sought advice in relation to the similarities between these agents. In July 2020 [PDF, 481 KB] CTAC considered it likely that this class of medicines would provide the same or similar health benefit in some NSCLC indications.

In April 2022 [PDF, 204 KB] CTAC considered that any immune checkpoint inhibitor with a positive funding recommendation would provide similar health benefits for all NSCLC indications referenced in this consultation (first-line monotherapy, first-line combination therapy and second-line monotherapy).

Request for Proposals

As a result of the advice received, and the budget increase announced by government, in May 2022 we indicated our intention to release a request for proposals (RFP). In July 2022, we released an RFP 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.

The RFP also allowed proposals to be submitted for medicines that were not approved by Medsafe, or for which had not received a positive funding recommendation from our clinical advisors. This was on the condition that the proposed agents would require Medsafe approval prior to listing and would also need a positive funding recommendation from our clinical advisors.

We received bids for immune checkpoint inhibitors from several suppliers, including some with immune checkpoint inhibitors that had not yet received positive funding recommendations. The proposed immune checkpoint inhibitors were considered by CTAC at a meeting in October 2022. A record of this meeting is currently in development and should be available in the new year.

We are proposing to fund two immune checkpoint inhibitors subject to eligibility criteria. We considered the following as part of the evaluation process:

  • the bids received from suppliers in response to the RFP
  • the clinical advice we have received from our advisory groups
  • the expert advice we have received from external stakeholders
  • assessment of the bids against our Factors for Consideration, which includes equity considerations.

Medicines availability analysis

The unmet health need for an immune checkpoint inhibitor for the treatment of advanced NSCLC was highlighted in the Te Aho o Te Kahu Medicines Availability Analysis(external link). The analysis determined these treatments would provide substantial clinical benefit. This proposal would provide funded treatments for three of the identified medicines gaps in the analysis.

Sector impacts

We expect that this proposal would contribute to achieving health equity and have significant health benefits, in particular for Māori and Pacific peoples. We also know that this proposal would have a substantial impact on the health system of Aotearoa New Zealand. Some of these impacts are described below:

  • additional doctor appointment and follow-up appointments
  • additional ‘chair time’ and nursing time for administration of these treatments, which are delivered by intravenous injection in hospital outpatient settings
  • increased demand on hospital pharmacy services
  • increased demand for laboratory and pathology services
  • increased demand for radiology services
  • increased demand for supportive care and management of unwanted side effects (including admission to hospital).

This proposal aims to try to reduce barriers for affected individuals and their whānau, while minimising the impact for the health system where possible, and this has been considered in the eligibility criteria proposed.

We have engaged with Te Aho o Te Kahu and Te Whatu Ora to help to support resource planning for the health system given the substantial impact expected.

Details about our proposal

Pembrolizumab for advanced non-small cell lung cancer

Access to pembrolizumab (Keytruda) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2023, to include the following new eligibility criteria:

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 months for applications meeting the following criteria:

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. There is documentation confirming the disease expresses PD-L1 at a level ≥50% as determined by a validated test unless not possible to ascertain; 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 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).

 

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 months for applications meeting the following criteria:

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 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 200mg 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).

Pembrolizumab would 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 would apply:

Chemical Formulation Brand Pack size Current price and subsidy Proposed 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 would apply to Keytruda that would reduce the net price. Keytruda would have Principal Supply Status from 1 April 2023 until 31 March 2026. It would be the only listed immune checkpoint inhibitor for the first line treatment of advanced non-small cell lung cancer during this period.

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

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

Atezolizumab (Tecentriq) would 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 Proposed 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 would apply to Tecentriq that would reduce the net price. Tecentriq would have Principal Supply Status from 1 April 2023 to 31 March 2026. It would be the only listed immune checkpoint inhibitor for the second line treatment of advanced non-small cell lung cancer during this time.

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

Atezolizumab would be listed in Section B and Part II of Section H subject to the following eligibility criteria:

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 months for applications meeting the following criteria:

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 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
  7. Treatment with atezolizumab to cease after a total duration of 24 months from commencement (or equivalent).

Other changes associated with this proposal

Pembrolizumab for metastatic melanoma contractual arrangements changed

Pembrolizumab (Keytruda) is already funded for metastatic melanoma. Keytruda would have protection from delisting and subsidy reduction for this indication until 31 March 2026. No changes are proposed for access to pembrolizumab for metastatic melanoma.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm, Tuesday 24 January 2023

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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