Decision to widen access to cetuximab, bendamustine and pemetrexed

10 October 2024

Medicines Decision

What we’re doing

We're pleased to announce that we have made the decision to widen access to cetuximab for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer from 1 November 2024.

We are also making changes to widen access to bendamustine for relapsed or refractory chronic lymphocytic leukaemia (CLL) and open list pemetrexed for any relevant clinical use, both from 1 November 2024.

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 increase covers medicines for both cancer and non-cancer health conditions. This decision is one of many that we’re working on to put our budget increase into action.

Media release: Funding boost means more medicines for more New Zealanders

Who we think will be interested

People with cancer and their whānau and caregivers
Oncologists, haematologists, specialist nurses, hospital pharmacists, radiologists, pathologists, and other health professionals involved in the diagnosis and/or care of people with cancer
Groups who support and advocate for people with cancer
Health New Zealand | Te Whatu Ora and the Cancer Control Agency
Hospital pharmacies
Pharmaceutical suppliers and wholesalers

Cetuximab for metastatic colorectal cancer

What does this mean for people?

From 1 November 2024, cetuximab (branded as Erbitux) will be funded for people with left-sided, RAS and BRAF wild-type, metastatic colorectal cancer subject to eligibility criteria.

We anticipate that about 380 people will benefit from cetuximab in the first year of funding. This includes 140 people who have not received any prior treatments for metastatic disease and 240 people who have received one or more prior treatment. In addition, we understand there are around 60 people privately funding cetuximab who could move into the publicly funded setting. We anticipate the total number of people starting on treatment will reduce to 150 people each year after five years of funding.

This is higher than the numbers we communicated in our consultation. We have removed the requirement for cetuximab to be given in combination with chemotherapy. Based on the feedback we received and changes we have made, we consider uptake will be higher.

Any changes to the original proposal?

This decision was subject to a consultation letter released on 5 August 2024. We received feedback from clinicians, advocacy groups, and consumers.

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback. The feedback received was supportive of the proposal.

Funding cetuximab with chemotherapy or on its own

We received some requests for amendments to eligibility criteria. Based on the feedback, we have made changes so that cetuximab can be used on its own, without chemotherapy. Prescribers will need to determine whether using cetuximab with chemotherapy or on its own is best for those individuals they are treating.

Funding cetuximab for BRAF mutated metastatic colorectal cancer

We also received a lot of feedback from people with colorectal cancer, their whānau and friends, requesting access to cetuximab for BRAF mutated metastatic colorectal cancer. We sought expert advice on this request. Based on the advice, we have not changed the eligibility criteria to include this indication at this time. We need to assess BRAF mutated metastatic colorectal cancer further. We will be working with clinicians and suppliers to develop a funding application that addresses this health need. More details on the advice we received and our decision on this is below.

Other changes based on your feedback

We have also amended the prescriber types for currently funded head and neck cancer indications and made minor amendments to the eligibility criteria for this. These are detailed further below.

A summary of the feedback and our responses to this are detailed below.

Impact on pathology services

This funding decision will require RAS and BRAF testing for all metastatic colorectal cancer. The availability and timeliness of testing is important when identifying who would benefit from cetuximab.

We expect over 1000 people will need testing in the first year of funding, and over 600 people each year after that. This will have a significant impact on pathology services.

We have talked with pathologists, clinicians, Health New Zealand | Te Whatu Ora, the Cancer Control Agency | Te Aho o Te Kahu, and the Ministry of Health | Manatū Hauora to understand the availability and delivery of RAS and BRAF testing. We understand such testing is not currently available across all regions, however work is underway to support increased lab testing capacity and capability.

We will continue to work with our health sector partners to support the equitable implementation of this funding decision.

Details of this decision

The eligibility criteria for cetuximab (branded as Erbitux) in Section B of the Pharmaceutical Schedule will be amended from 1 November 2024 to include the following indication:

Special Authority for Subsidy

Initial application - (colorectal cancer, metastatic) 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:

Patient has metastatic colorectal cancer located on the left side of the colon (see Note); and
There is documentation confirming disease is RAS and BRAF wild-type; and
Patient has an ECOG performance score of 0-2; and
Patient has not received prior funded treatment with cetuximab; and
Either:
1. Cetuximab is to be used in combination with chemotherapy, or
2. Chemotherapy is determined to not be in the best interest of the patient based on clinician assessment.

Renewal - (colorectal cancer, metastatic) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications where there is no evidence of disease progression.

Note: Left-sided colorectal cancer comprises of the distal one-third of the transverse colon, the splenic flexure, the descending colon, the sigmoid colon, or the rectum.

The eligibility criteria for cetuximab for head and neck cancer will also be amended in Section B of the Pharmaceutical Schedule from 1 November 2024 as follows (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application – (head and neck cancer, locally advanced) only from a medical oncologist relevant specialist or medical any relevant practitioner on the recommendation of a relevant specialist medical oncologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Patient has locally advanced, non-metastatic, squamous cell cancer of the head and neck; and
Patient is contraindicated to, or is intolerant of, cisplatin Cisplatin is contraindicated or has resulted in intolerable side effects; and
Patient has good performance status an ECOG performance score of 0-2; and
To be administered in combination with radiation therapy

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

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 Comment
Supportive. Funding cetuximab for metastatic colorectal cancer would extend the lives of people living with colorectal cancer.	We appreciate this feedback and are pleased to be funding a proposal that benefits New Zealanders. The advice we have received is that funding cetuximab for metastatic colorectal cancer will provide substantial benefits to individuals, their families, and the wider health system.
Consensus that two weekly dosing would be preferred and is supported by best evidence	The funding criteria allow prescribers and individuals to choose the best dosing regimen for their circumstances. We note the biweekly dosing regimen is now included in the Medsafe datasheet.(external link)
Requested that access be enabled for those with BRAF mutated metastatic colorectal cancer.	We understand there is a high health need for people with colorectal cancers who have BRAF mutations. We have sought further expert advice on this type of cancer. Our clinical advisors have told us the current evidence of benefit for cetuximab, with chemotherapy or on its own, is for those with BRAF wild type metastatic colorectal cancer only. We are aware that there are new studies that have been published for cetuximab used in combination with another medicine called encorafenib (a BRAF inhibitor) for people who have BRAF mutations. We are aware that this combination is funded overseas for BRAF mutated cancer. We have not received a funding application for cetuximab in combination with encorafenib and understand that encorafenib is not approved by Medsafe. We would welcome a funding application for cetuximab in combination with encorafenib, alongside a submission for Medsafe approval. This means we could assess these medicines and prioritise them against other funding options. We have also shared this feedback with the supplier of encorafenib. Information about how to submit a funding application is located here(external link).
Requested for wider access to cetuximab monotherapy for: people who have been previously treated with chemotherapy for their metastatic colorectal cancer people for whom first line chemotherapy is inappropriate people who stop chemotherapy during treatment ongoing access to cetuximab monotherapy through the renewal criteria	We appreciate this feedback and have sought further expert advice on these requests. In summary, our clinical advisors have told us that: there are people who have received chemotherapy previously and that further treatment with chemotherapy may not provide clinically meaningful benefit there is evidence of benefit from cetuximab monotherapy for people whose clinical circumstances mean that chemotherapy is inappropriate or who have to stop chemotherapy during treatment. We also understand that it would be preferable to provide cetuximab in combination with chemotherapy. The evidence of benefit from cetuximab treatment is greater when used in combination with chemotherapy. Therefore, we anticipate people will receive cetuximab with chemotherapy where possible. Based on this advice we have amended the eligibility criteria in line with the requests to enable cetuximab monotherapy in such circumstances where chemotherapy is not considered to be in the best interest of the patient.
RAS and BRAF testing is available in some centres but in others it must be privately funded. Nationally available testing would be required to prevent geographic inequities in access. The volumes of tests would increase and the cost for this need to be accounted for.	We understand that access to RAS and BRAF testing is not currently consistently available nationally. We have shared the feedback about the importance of testing capacity and reimbursement with Health NZ and the Cancer Control Agency (Te Aho o Te Kahu) to inform the Cancer Medicines Implementation Planning programme. Inclusion of RAS and BRAF mutational status in eligibility criteria have been recommended by our clinical advisors to ensure that treatment is targeted to those who are expected to receive the greatest benefit.
Concerns about the proposal having an impact on infusion capacity, which is already constrained and under-resourced.	We have provided our health sector partners with our estimates of patient numbers and additional infusion hours that would be needed. We will continue to support Health NZ to understand the implementation requirements of this, and other, funding proposals.
Requested that the eligible age for public bowel cancer screening programmes be lowered.	Pharmac does not manage eligibility for bowel screening programmes in New Zealand. We appreciate this feedback and will share this with Health NZ.

Access changes for pemetrexed and bendamustine

What does this mean for people?

From 1 November 2024, bendamustine will be funded for relapsed or refractory chronic lymphocytic leukaemia (CLL), subject to eligibility criteria, while the eligibility criteria for pemetrexed will be removed.

We anticipate these changes will impact a small number of people and overall make them more accessible to people. We anticipate around 20 to 30 people, including around 5 people with relapsed or refractory CLL, will benefit from wider access to these treatments each year.

Any changes to the original proposal

This decision was subject to a consultation letter released on 12 July 2024. We received feedback from clinicians, advocacy groups, and consumers.

We want to thank everyone for their feedback. Overall, feedback was supportive of the proposal. Some feedback noted the very small number of people that would be impacted and the continued wider need for targeted CLL treatments.

We have not made any changes to the criteria that were proposed in consultation, however we have aligned the prescriber types for both Hodgkin and non-Hodgkin lymphomas with the changes we have made for bendamustine.

When we consulted on these medicines, we also asked about three other medicines, lanreotide, sunitinib, and pazopanib. We have not made a decision on these other medicines yet. We will notify of a decision for these separately, in the future.

Details of this decision

The eligibility criteria for pemetrexed will be removed from Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2024. This means that funded pemetrexed will be open-listed and can be prescribed for any relevant clinical use.

The eligibility criteria for bendamustine in Section B of the Pharmaceutical Schedule will be amended from 1 November 2024 to as follows (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application — (treatment naive CLL*) only from a relevant specialist or medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

The patient has Binet stage B or C, or progressive stage A chronic lymphocytic leukaemia requiring treatment; and
The patient is chemotherapy treatment naive; and
The patient is unable to tolerate toxicity of full-dose FCR; and
Patient has ECOG performance status of 0-2; and
Patient has a Cumulative Illness Rating Scale (CIRS) score of < 6; and
Bendamustine is to be administered at a maximum dose of 100 mg/m² on days 1 and 2 every 4 weeks for a maximum of 6 cycles.

Notes: Indication marked with a * includes indications that are unapproved.

'Chronic lymphocytic leukaemia (CLL)' includes small lymphocytic lymphoma (SLL). Chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

Initial application — (Indolent, Low-grade lymphomas) only from a relevant specialist or medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

The patient has Indolent low grade NHL requiring treatment; and
The patient has ECOG a WHO performance status of 0-2; and
Any of the following:
1. Both
  1. Patient is treatment naïve; and
  2. Bendamustine is to be administered for a maximum of 6 cycles (in combination with rituximab when CD20+); or
2. Both:
  1. Patient is refractory to or has relapsed within 12 months of a rituximab containing combined chemo-immunotherapy regimen; and
  2. Bendamustine is to be administered in combination with obinutuzumab for a maximum of 6 cycles; or
3. All of the following:
  1. The patient has not received prior bendamustine therapy; and
  2. Bendamustine is to be administered for a maximum of 6 cycles in relapsed patients (in combination with rituximab when CD20+); and
  3. Patient has had a rituximab treatment-free interval of 12 months or more; pr
4. Bendamustine is to be administered as monotherapy for a maximum of 6 cycles in rituximab refractory patients.

Renewal — (Indolent, Low-grade lymphomas) only from a relevant specialist or medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

Either:

Both:
1. Patient is refractory to or has relapsed within 12 months of rituximab in combination with bendamustine; and
2. Bendamustine is to be administered in combination with Obinutuzumab for a maximum of 6 cycles; or
Both:
1. Patients have not received a bendamustine regimen within the last 12 months; and
2. Either:
  1. Both:
    1. Bendamustine is to be administered for a maximum of 6 cycles in relapsed patients (in combination with rituximab when CD20+); and
    2. Patient has had a rituximab treatment-free interval of 12 months or more; or
  2. Bendamustine is to be administered as a monotherapy for a maximum of 6 cycles

Note: ‘Indolent, low-grade lymphomas’ include follicular, mantle cell, marginal zone and lymphoplasmacytic/Waldenstroms macroglobulinaemia.

Initial application — (Hodgkin’s lymphoma*) only from a relevant specialist or medical practitioner any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

Patient has Hodgkin’s lymphoma requiring treatment; and
Patient has a ECOG performance status of 0-2; and
Patient has received on prior line of chemotherapy; and
Patient’s disease relapsed or was refractory following prior chemotherapy; and
Bendamustine is to be administered in combination with gemcitabine and vinoreline (BeGeV) at a maximum dose of no greater than 90 mg/m2 twice per cycle, for a maximum of four cycles

Note: Indications marked with * are unapproved indications.

Similar changes will also apply to the eligibility criteria for bendamustine in Part II of Section H of the Pharmaceutical Schedule.

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 Comment
Welcomed wider access for pemetrexed and bendamustine. Some responses noted the very small number of people that would be impacted	We are pleased to be able to make medicines more widely available wherever we can. We can make these changes due to the lower medicine costs we have achieved through our Annual Tender process. Following our budget uplift in July 2024, we continue to work to make more treatments available to more people with both cancer and non-cancer conditions.
Suggested that eligibility criteria for bendamustine could be removed.	We appreciate there may be further benefits in removing the eligibility criteria for bendamustine. However, we consider further advice and assessment is needed, particularly to understand the impacts this could have on the use of bendamustine to treat Hodgkin and non-Hodgkin Lymphoma. We intend to seek this advice at a future Cancer Treatments Advisory Committee meeting.
Widening access to bendamustine does not address the wider health need for funding targeted CLL treatments, such as BTK inhibitors or Bcl-2 inhibitors.	We appreciate that there is still an unmet health need for people with CLL. We have received a number of applications for consideration of other treatments for people with newly diagnosed or previously treated CLL. Our clinical advisors have provided advice on these applications, which include the use of BTK inhibitors and venetoclax. Following the advice we received on these, the following applications have been ranked on our Options for Investment list: Ibrutinib for previously untreated (17p deletion) CLL and relapsed/refractory patients for whom ibrutinib is a more appropriate option(external link) BTK inhibitors as first line monotherapy for CLL with TP53 mutation(external link) These applications are currently under assessment before being ranked as on our Options for Investment list: Fixed duration ibrutinib plus venetoclax for previously untreated CLL or SLL without TP53 mutation(external link) BTK inhibitor for first-line CLL treatment without TP53 mutation(external link) Fixed duration ibrutinib plus venetoclax for previously untreated CLL with TP53 mutation(external link) Fixed duration venetoclax with obinutuzumab for previously untreated CLL(external link) A full list of these are available on our Application Tracker(external link).

Theme

Pharmac Comment

Welcomed wider access for pemetrexed and bendamustine. Some responses noted the very small number of people that would be impacted

We are pleased to be able to make medicines more widely available wherever we can. We can make these changes due to the lower medicine costs we have achieved through our Annual Tender process.

Following our budget uplift in July 2024, we continue to work to make more treatments available to more people with both cancer and non-cancer conditions.

Suggested that eligibility criteria for bendamustine could be removed.

We appreciate there may be further benefits in removing the eligibility criteria for bendamustine. However, we consider further advice and assessment is needed, particularly to understand the impacts this could have on the use of bendamustine to treat Hodgkin and non-Hodgkin Lymphoma. We intend to seek this advice at a future Cancer Treatments Advisory Committee meeting.

Widening access to bendamustine does not address the wider health need for funding targeted CLL treatments, such as BTK inhibitors or Bcl-2 inhibitors.

We appreciate that there is still an unmet health need for people with CLL. We have received a number of applications for consideration of other treatments for people with newly diagnosed or previously treated CLL. Our clinical advisors have provided advice on these applications, which include the use of BTK inhibitors and venetoclax.

Following the advice we received on these, the following applications have been ranked on our Options for Investment list:

These applications are currently under assessment before being ranked as on our Options for Investment list:

A full list of these are available on our 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.