Herzuma – Listing and access criteria
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About Herzuma brand trastuzumab
Trastuzumab is a type of medicine called a biologic. Biologic medicines are made from living organisms, such as yeast, bacteria or animal cells. Herzuma is a biosimilar medicine. This means it is a very similar version of trastuzumab. Biosimilar medicines are expected to be as safe and effective as the reference biologic medicine.
More information on biologic and biosimilar medicines is on our website
Herzuma is Medsafe-approved for use in New Zealand and is approved for the same uses as Herceptin.
Key dates
We appreciate these changes are complex and may mean different things for different people. We encourage prescribers to start discussing the transition to Herzuma as soon as possible. We are working with the supplier of Herzuma, consumer groups and healthcare professional groups so people can access information in a way that works for them.
We will be adding more information to our website on this transition.
- From 1 October 2023:
- People with metastatic breast cancer who have experienced a long-term response to treatment can take a treatment holiday.
- From 1 December 2023:
- Herzuma will be funded for existing uses (early and metastatic breast cancer) and new uses (gastric, gastro-oesophageal and oesophageal cancer).
- People who are new to trastuzumab treatment will receive Herzuma. Herceptin will not be funded for people new to trastuzumab treatment.
- People who have been on Herceptin previously will need to transition to Herzuma and have until 31 May 2024 to do this.
- From 1 June 2024:
- Only the Herzuma brand of trastuzumab is listed on the Pharmaceutical Schedule. Everyone needs to have transitioned to the Herzuma brand.
- Herceptin will only be available through our Exceptional Circumstances Framework for people who have transitioned to Herzuma and experienced an adverse reaction.
What this decision means for people using trastuzumab prior to 1 December 2023
Transitioning to using Herzuma will need to be discussed between prescribers, individuals receiving treatment and their family, whānau, and caregivers.
Early breast cancer
People currently receiving treatment with the Herceptin brand of trastuzumab can continue with the Herceptin brand until their treatment course is complete, if this is before 1 June 2024. We understand from our clinical advisors that most people with early breast cancer who start treatment with the Herceptin brand will complete their planned intravenous trastuzumab treatment with the Herceptin brand before this date. However, some people may require treatment after 1 June 2024. They will need to transition from Herceptin to Herzuma during this time.
Metastatic breast cancer
People who are currently receiving intravenous trastuzumab and require ongoing treatment beyond 1 June 2024 will need to transition to Herzuma. People will be able to transition from 1 December 2023 and everyone will need to transition before 1 June 2024.
Treatment holidays from 1 October 2023
From 1 October 2023, people receiving intravenous trastuzumab for metastatic breast cancer will be able to take a ‘treatment holiday’. This will mean that people who have experienced a long-term response could pause their treatment. They could then restart their trastuzumab treatment if they experience disease progression while treatment is paused. If they need to restart after 1 December 2023, they will need to restart on the Herzuma brand of trastuzumab.
The funding criteria for pertuzumab will also be changed to allow ‘treatment holidays’. Pertuzumab is another treatment for metastatic breast cancer and is funded for use in combination with intravenous trastuzumab.
We had proposed to allow treatment holidays from 1 December 2023 in our consultation letter. Based on feedback, we have changed this to 1 October 2023. Consultation feedback highlighted this change would improve people’s quality of life. It would allow people to spend less time receiving treatment providing more time for their day-to-day activities, friends and whānau. Feedback from the health sector indicated this change would be easy for the sector to implement.
Exceptional Circumstances
Our clinical advisors have told us that if an adverse reaction occurred to an excipient in the Herzuma brand, an individual may need to return to their previous brand of trastuzumab (Herceptin). Based on evidence from overseas and experience in Aotearoa New Zealand, experiencing a reaction to Herzuma if you have previously received Herceptin is very unlikely. The excipients between the Herceptin brand and the Herzuma brand are very similar. Your prescriber would need to apply for ongoing funded access to the Herceptin brand.
If a person experiences disease progression following a transition to Herzuma, they will not be eligible for funded access to Herceptin. Unfortunately, disease progression in breast cancer can happen while someone is receiving treatment. If this were to occur, people should discuss the available treatment options with their prescriber.
What this decision means for people starting trastuzumab treatment for the first time from 1 December 2023
From 1 December 2023, all people starting trastuzumab treatment will start on the Herzuma brand. This includes people with HER-2 positive gastric, gastro-oesophageal junction or oesophageal cancer who are eligible for funded trastuzumab treatment.
We estimate that approximately 140 people will benefit from widened access to Herzuma in the first year.
We understand that widening access to include oesophageal cancers may reduce the imaging procedures required when someone is diagnosed. This would reduce the barriers to accessing a targeted funded treatment for individuals with a cancer diagnosis. It would also minimise the resource impact on the health sector. We understand that this decision may increase the number of infusions required. The increase is expected to be small, when compared to the overall infusion capacity in New Zealand. We will continue working with our sector partners to support equitable health outcomes for New Zealanders, including those who are eligible for intravenous medicines.
If someone who starts trastuzumab treatment for the first time with the Herzuma brand experiences an adverse reaction, they would need to be considered via our Named Patient Pharmaceutical Assessment pathway(external link).
For prescribers and pharmacists
We anticipate this transition will be led by prescribers; however, prescribers, pharmacists and individuals receiving trastuzumab treatment will need to work together to manage the transition from Herceptin to Herzuma. We encourage prescribers to engage with individuals receiving treatment at their earliest opportunity to discuss continuation of their trastuzumab treatment with Herzuma.
Treatment holidays from 1 October 2023
People with metastatic breast cancer who have experienced a long-term response to treatment can take a ‘treatment holiday’ from 1 October 2023. They can restart treatment if they experience disease progression during this break. If they need to restart trastuzumab treatment after 1 December 2023, they will need to restart with the Herzuma brand.
Funded trastuzumab changes from 1 December 2023
People who are receiving funded trastuzumab prior to 1 December 2023 will automatically be issued a new Special Authority number for Herzuma. This means that if a person is receiving trastuzumab and prescribers have discussed transitioning to Herzuma, Herzuma can be prescribed immediately. Special Authority renewal applications can be completed to access ongoing treatment if a person’s circumstances meet the criteria.
Between 1 December 2023 and 31 May 2024, both Herzuma and Herceptin will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule with different funding criteria. From 1 December 2023, Special Authority approvals will not be interchangeable between Herzuma and Herceptin. To dispense and claim a subsidy, the correct brand will need to be prescribed for each patient.
Funded trastuzumab changes from 1 June 2024
Everyone who needs trastuzumab treatment beyond 1 June 2024 will need to transition by this date. From 1 June 2024, Herceptin will be delisted from the Pharmaceutical Schedule.
Exceptional Circumstances
If an adverse reaction to the excipients in Herzuma occurs, an individual’s prescriber will need to apply via Pharmac’s Exceptional Circumstances framework. Applicants will need to demonstrate that an individual has transitioned from Herceptin to Herzuma and experienced an adverse reaction meaning that Herzuma would no longer be a suitable option for the individual. We are currently developing a specific form to minimise the administrative burden on prescribers. This will be available via our website.
Stock of the Herceptin brand of trastuzumab (440 mg vials) has been secured from Roche Products (New Zealand Limited) for supply through the Exceptional Circumstances Framework.
If a person experiences disease progression following a transition to Herzuma, they will not be eligible for funded access to Herceptin.
New listing for Herzuma
From 1 December 2023, Herzuma will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price & Subsidy |
|---|---|---|---|---|
|
Trastuzumab (Herzuma) |
Inj 150 mg vial |
Herzuma |
1 |
$100.00 |
|
Trastuzumab (Herzuma) |
Inj 440 mg vial |
Herzuma |
1 |
$293.35 |
|
Trastuzumab (Herzuma) |
Inj 1 mg for ECP |
Baxter |
1 mg |
$0.70 |
A confidential rebate applies to all presentations of Herzuma that reduces the net price.
From 1 June 2024, Herzuma will have Principal Supply Status. This means it will be the only listed brand of intravenous trastuzumab available in Aotearoa New Zealand until 31 May 2027. It is guaranteed at least 95% of the funded market. Any funded use of an alternative brand requires Pharmac approval via its Exceptional Circumstances Framework. The chemical name will also be changed from ‘Trastuzumab (Herzuma)’ to ‘Trastuzumab’ on 1 June 2024.
The following eligibility criteria will apply to Herzuma:
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Initial application — (early breast cancer)
from any relevant practitioner. Approvals valid for 15 months for applications meeting the following criteria:
Both:
- The patient has early breast cancer expressing HER-2 IHC 3+ or ISH + (including FISH or other current technology); and
- Maximum cumulative dose of 106 mg/kg (12 months’ treatment).
Renewal — (early breast cancer*)
from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Either:
- All of the following:
- The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
- The patient received prior adjuvant trastuzumab treatment for early breast cancer; and
- Any of the following:
- The patient has not previously received lapatinib treatment for HER-2 positive metastatic breast cancer; or
- The patient discontinued lapatinib within 3 months due to intolerable side effects and the cancer did not progress whilst on lapatinib; or
- The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
- Either:
- Trastuzumab will not be given in combination with pertuzumab; or
- All of the following:
- Trastuzumab to be administered in combination with pertuzumab; and
- Patient has not received prior treatment for their metastatic disease and has had a treatment-free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
- The patient has good performance status (ECOG grade 0-1); and
- Trastuzumab to be discontinued at disease progression; or
- All of the following:
- Patient has previously discontinued treatment with trastuzumab in the metastatic setting for reasons other than severe toxicity or disease progression; and
- Patient has signs of disease progression; and
- Disease has not progressed during previous treatment with trastuzumab.
Note: * For patients with relapsed HER-2 positive disease who have previously received adjuvant trastuzumab for early breast cancer.
Initial application — (metastatic breast cancer)
from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
- The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
- Either:
- The patient has not previously received lapatinib treatment for HER-2 positive metastatic breast cancer; or
- The patient discontinued lapatinib within 3 months due to intolerable side effects and the cancer did not progress whilst on lapatinib; and
- Either:
- Trastuzumab will not be given in combination with pertuzumab; or
- All of the following:
- Trastuzumab to be administered in combination with pertuzumab; and
- Patient has not received prior treatment for their metastatic disease and has had a treatment-free interval of at least 12 months between prior (neo)adjuvant chemotherapy treatment and diagnosis of metastatic breast cancer; and
- The patient has good performance status (ECOG grade 0-1); and
- Trastuzumab to be discontinued at disease progression.
Renewal — (metastatic breast cancer)
from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Either:
- All of the following:
- The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
- The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
- Trastuzumab to be discontinued at disease progression; or
- All of the following:
- Patient has previously discontinued treatment with trastuzumab for reasons other than severe toxicity or disease progression; and
- Patient has signs of disease progression; and
- Disease has not progressed during previous treatment with trastuzumab.
Initial application — (gastric, gastro-oesophageal junction and oesophageal cancer)
from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- The patient has locally advanced or metastatic gastric, gastro-oesophageal junction or oesophageal cancer expressing HER-2 IHC 2+ FISH+ or IHC3+ (or other current technology); and
- Patient has an ECOG score of 0-2.
Renewal — (gastric, gastro-oesophageal junction and oesophageal cancer)
from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
- Trastuzumab to be discontinued at disease progression.