Proposal to widen access to cetuximab for bowel cancer

What we’re proposing

We want to hear from you about a proposal to widen access to cetuximab for eligible people with bowel cancer (colorectal cancer) from 1 November 2024 through a provisional agreement with Merck Healthcare Pty Ltd.

The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.

More information: Questions and Answers on the budget increase

We want to hear your feedback about our proposal. Consultation closes at 4pm Friday 23 August 2024. Feedback can be:

• submitted through our online form

• emailed to consult@pharmac.govt.nz

What would the effect be?

Colorectal cancer is the second most common cause of cancer related death in New Zealand.

This proposal would mean that cetuximab would be funded for eligible people with metastatic colorectal cancer (bowel cancer) in combination with chemotherapy at any line of treatment.

We anticipate around 180 people would receive cetuximab in the first year of funding, however, this would reduce to 140 each year after five years as more and more people would receive treatment in the first line setting. We understand there are people currently receiving cetuximab in a private setting. We would intend to enable them to transition to publicly funded treatment if they met the eligibility criteria when they started treatment with cetuximab.

We understand there are people currently receiving cetuximab in a private setting. If this proposal is approved, these people would be eligible to transition to publicly funded treatment if they met the eligibility criteria when they started treatment with cetuximab.

Effects on the health sector

Infusion services

Cetuximab is administered as an intravenous (IV) infusion. The Medsafe approved dosing for cetuximab is once weekly, which means that compared to current treatments, people would need one additional infusion visit each fourteen-day treatment cycle. There would also be more “chair time” needed, that is more time spent receiving infusions, as cetuximab is administered separately from the other chemotherapy infusions. We estimate this would require up to 2,500 additional infusion hours in the first year of funding.

We understand that internationally cetuximab is more commonly administered every two weeks. If this dose regimen was implemented in New Zealand, the impact to infusion services would be lessened substantially.

We understand the supplier has applied to Medsafe with clinical data to support approval of dosing every two weeks, however currently it is not within the Medsafe approved indication. Prescribing off-label would need to follow Section 25 of the Medicines Act 1981(external link).

We seek feedback on the dosing regimen that would likely be implemented for cetuximab if this proposal is approved.

Pathology services

Our clinical advisors told us that people who would benefit most from cetuximab are those whose tumours do not express a RAS or BRAF mutation (RAS and BRAF wildtype).

RAS and BRAF testing would be needed to identify eligible people. We understand these tests are available in New Zealand pathology laboratories and in some centres are routinely undertaken in people with newly diagnosed colorectal cancer. However, we also understand that access to this testing does vary regionally. 

These tests would need to be funded and accessible in all regions to prevent geographical inequities in access to treatment.

We seek feedback on the availability of such testing capabilities across New Zealand to help ensure equitable implementation of this proposal.

Who we think will be interested

• People with colorectal cancer, their whānau, and caregivers
• Oncologists, specialist nurses, hospital pharmacists, radiologists, pathologists, general practitioners, and other health professionals involved in the care of people with colorectal cancer
• Groups who support and advocate for people with colorectal cancer
• Health New Zealand | Te Whatu Ora and the Cancer Control Agency | Te Aho o Te Kahu
• Hospital pharmacies
• Pharmaceutical suppliers, wholesalers, and third-party compounders

About cetuximab and colorectal cancer

Colorectal cancer

Colorectal cancer affects the lower part of the gastrointestinal tract, called the colon and rectum. There are around 3,000 people diagnosed with colorectal cancer in New Zealand each year. Around 20% of people are diagnosed with metastatic disease (where the cancer has spread to other parts of the body). Around 90% of metastatic colon cancer is incurable and its prognosis is poor even when chemotherapy is used.

New Zealanders are often younger at diagnosis compared to adults in the rest of the world. Māori and Pacific people are diagnosed with bowel cancer at a younger age, are more likely to have metastatic disease at diagnosis and more likely to have left-sided disease. Pacific peoples also have significantly poorer survival rates from colorectal cancer compared to non-Pacific peoples.

Mutational status and left sidedness

Some colorectal cancers can have genetic mutations, which can impact the effectiveness of certain medicines. A RAS mutation occurs in about 45% of people with colorectal cancer. A BRAF mutation occurs in about 10% of people with colorectal cancer. A mutation in either of these genes is a predictor of a poor response to treatment with cetuximab. Colorectal cancer is also differentiated into left and right sided, depending on where the primary tumour is located.

Our clinical advisors have told us that cetuximab should be funded for people that do not have RAS and BRAF mutations, and when the tumour is located on the left side of the large bowel. RAS or BRAF status must be determined prior to the start of any EGFR-inhibitors such as cetuximab.

Cetuximab

Cetuximab is a cancer treatment that targets certain proteins (called epidermal growth factor receptors, or EGFR) to prevent the growth and spread of cancers. In bowel cancer, it is given in combination with chemotherapy.

Cetuximab is currently funded for the treatment of locally advanced head and neck cancer(external link).

Cetuximab is approved by Medsafe for the treatment of epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer and head and neck squamous cell carcinoma. It is administered as a 120- or 60-minute intravenous infusion every week. We understand that internationally it can also be administered every two weeks, however this is an unapproved use(external link) in New Zealand.

Medsafe datasheet for cetuximab [PDF](external link)

Why we’re proposing this

A funding application(external link) for cetuximab for the first-line treatment of left-sided metastatic colorectal cancer was considered by the Cancer Treatments Subcommittee of PTAC (CaTSoP, now CTAC) in July 2019.

July 2019 Cancer Treatments Subcommittee meeting record [PDF, 434 KB]

It was also considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2018, and November 2019.

August 2018 PTAC meeting record [PDF, 665 KB]

November 2019 PTAC meeting record [PDF, 559 KB]

Our clinical advisors told us that the evidence shows there is a benefit of cetuximab in treating left-sided metastatic colorectal cancer which do not have RAS and BRAF mutations (wild-type). They considered that cetuximab would improve the survival of people with this cancer.

Our advisors considered that cetuximab would have limited benefit for people with cancer located on the right-side of the colon or if their cancer has RAS or BRAF mutations.

Cetuximab has been previously declined for different groups in the second line setting. However, we understand that those with left-sided metastatic colorectal cancer which does not have RAS and BRAF mutations (wild-type) and who have already been treated with chemotherapy would likely benefit from cetuximab. We have reached an agreement with the supplier that would enable us to widen access to cetuximab for eligible people with newly diagnosed and previously treated colorectal cancer.

We expect the number of people accessing cetuximab in later lines would decrease over time as all newly diagnosed eligible people would receive cetuximab as a first-line treatment.

Details about our proposal

From 1 November 2024 access to cetuximab (Erbitux) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule.

The eligibility criteria would be amended in Section B of the Pharmaceutical Schedule to include the following indication (new criteria shown only):

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

Cetuximab would continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2024. We are proposing to reduce the price and subsidy as we anticipate this proposal would significantly reduce compounding wastage. The following prices and subsidies would apply:

Chemical	Formulation	Brand	Pack size	Current price and subsidy	Proposed price and subsidy
Cetuximab	Inj 5 mg per ml, 20 ml vial	Erbitux	1	$364.00	$364.00
Cetuximab	Inj 5 mg per ml, 100 ml vial	Erbitux	1	$1,820.00	$1,820.00
Cetuximab	Inj 1 mg for ECP	Baxter	1 mg	$3.82	$3.73

Cetuximab is currently listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, and this would not change. This means that only Health New Zealand hospitals would be able to make subsidy claims.

To provide feedback

You can either:

• send us an email: consult@pharmac.govt.nz
• complete the online form

by 4pm Friday 23 August 2024.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.