Decision to widen access to intravenous trastuzumab and change the funded brand
On this page
What we’re doing
We’re pleased to announce that we have made the decision to widen access to intravenous trastuzumab and change the funded brand to a biosimilar trastuzumab called Herzuma. In summary:
- Herzuma (supplied by Celltrion Healthcare) will be funded from 1 December 2023. It will be the principal funded brand of intravenous trastuzumab from 1 June 2024.
- Funded access to intravenous trastuzumab will be widened from 1 December 2023 to include people with locally advanced or metastatic, HER-2 positive gastric, gastro-oesophageal junction and oesophageal cancer.
- The funding criteria for trastuzumab and pertuzumab will be changed from 1 October 2023 so people receiving these treatments for metastatic breast cancer can take a ‘treatment holiday’. This will allow people pause their treatment. They could then restart if they experience disease progression while treatment is paused.
- Any relevant practitioner will be able to apply for initial and renewal applications for intravenous trastuzumab. This would ensure all relevant prescribers who care for people with cancer can apply for funded intravenous trastuzumab treatment.
This decision results from a competitive process for the Principal Supply of funded intravenous trastuzumab. This decision releases significant funds which we are investing in other medicines for the benefit of New Zealanders.
Any changes to the original proposal?
This decision was subject to a consultation letter dated 8 June 2023. We are grateful for the time people took to provide us with their feedback. Responses were generally supportive of the proposal. We received requests for changes to the proposed timings and to widen access further.
After considering all the feedback we received, we have made some changes to the original proposal:
- Funded access has been widened to include locally advanced or metastatic, HER-2 positive gastro-oesophageal junction or oesophageal cancer, as well as gastric cancer.
- People will be able to take treatment holidays from 1 October 2023 instead of 1 December 2023.
We have also made some changes to streamline the criteria. These changes include:
- Removing reference to treatment regimens for early breast cancer.
- Removing restrictions on prescribing intravenous trastuzumab in combination with lapatinib. Lapatinib has been discontinued by the supplier and has not been supplied since mid-2022.
- Aligning the criteria in Section B and Section H of the Pharmaceutical Schedule to minimise any confusion for applicants.
The full funding criteria are included on the page for each medicine
Who we think will be most interested
- People currently using intravenous trastuzumab and their family, whānau and caregivers
- Groups who advocate for and support people with breast, gastric or oesophageal cancer
- Oncologists, specialist nurses, and other health professionals involved in the care of people with breast, gastric or oesophageal cancer
- Hospital pharmacists and wholesalers
- Te Whatu Ora hospitals
- Third-party compounders
- Pharmaceutical suppliers.
Details about this decision
From 1 December 2023, a new brand of intravenous trastuzumab called Herzuma will be funded. Herzuma will be the principal funded brand from 1 June 2024 until 31 May 2027.
We’re really grateful for the time people took to respond to the consultation on this proposal. The Pharmac Board considered all feedback received during consultation when making this decision. A summary of the main themes raised in feedback, and our responses, are set out in the table below.
Proposed transition to a biosimilar intravenous trastuzumab product
Supportive of the proposal.
Feedback noted the available data which indicates Herzuma is a safe and effective trastuzumab product
Unsupportive of the proposal.
Feedback highlighted Herceptin is an important treatment for people with breast cancer and allows them to live longer lives.
Concern was raised that this proposal would remove treatment for people.
Our clinical advisors have carefully considered the evidence that supports the use of biosimilar trastuzumab. The advice we have received supports the funding of the Herzuma brand as the only listed brand of intravenous trastuzumab.
We understand that some people may be uncertain about transitioning to an alternative brand of a medicine. We have developed a comprehensive implementation plan so people have confidence in the Herzuma brand and understand what this transition means for them. This includes working with consumer groups and healthcare professionals so people can access this information and seek support in whatever way works for them. Consumer groups and healthcare professionals were supportive of this proposed change and have indicated confidence in the Herzuma brand in their feedback.
Some feedback raised concerns that this proposal would be taking away treatment. This proposal includes wider access for more people and would not remove any lines of funded treatment for those receiving intravenous trastuzumab.
Widening funded access to intravenous trastuzumab
Supportive of widening access to gastric cancer.
Feedback noted the high health need in this population, absence of funded targeted medicines and that this treatment is standard of care in many other countries.
We are pleased to be able to widen access to a medicine so more New Zealanders can benefit from trastuzumab. The feedback we received aligns with the advice we received from our advisors.
Requested widened access to include HER-2 positive, locally advanced or metastatic gastro-oesophageal junction cancer.
The application we assessed and ranked on our Options for Investment list included people with gastro-oesophageal junction cancer. Therefore we have amended the eligibility criteria to explicitly include those with gastro-oesophageal junction cancer.
Requested widened access to include HER-2 positive, locally advanced or metastatic oesophageal cancer.
Based on the feedback received, we are widening access to also include oesophageal cancer. We are pleased to be able to fund intravenous trastuzumab for more New Zealanders.
We understand this may reduce the imaging burden on health sector. It will require additional infusions and testing. We will work with our health sector partners to support wider funded access.
Requested widened access to allow further trastuzumab treatment beyond disease progression for people with metastatic breast cancer.
We appreciate this feedback and intend to seek further clinical advice on widened access at the next available opportunity.
Our advisors recommended declining this application(external link) in January 2023, as they considered it would not address the unmet health need. Our advisors considered the evidence of benefit from trastuzumab in this setting is limited.
The record of this meeting was not available publicly at the time of consultation release. Consultation feedback included additional evidence for this use which will be reviewed by our advisors. If widening access is recommended by our clinical advisors, this proposal would be assessed and ranked against our other Options for Investment.
Removing all eligibility criteria for trastuzumab would reduce administrative burden. Eligibility criteria could be reinstated if this was unsustainable.
Initial assessments suggest removing all eligibility criteria for trastuzumab would result in a substantial financial impact to the pharmaceutical budget. We would welcome a funding application to assess this request in more detail and rank it against our other Options for Investment. Anyone can make a funding application, information on how to do this is on our website(external link).
We have made amendments to the criteria following consultation to significantly simplify the criteria. We expect this will make it simpler and faster for prescribers to complete.
Changes to the proposed dates
Feedback suggested the proposed changes to allow treatment holidays should be implemented earlier.
Feedback indicated the impact would be small and therefore the implementation of this change would be straightforward.
Based on the feedback received, we are changing the eligibility criteria to allow treatment holidays from 1 October 2023. We understand this change would give them more time to engage in daily activities and spend time with whānau and loved ones.
Feedback suggested a preference for an earlier introduction of a transition to Herzuma.
We want to ensure there is time for people receiving treatment and the sector to prepare for this transition. The lead time between notification of any decision and listing of a biosimilar also gives people more time to understand what the change would mean for them and engage with support groups and their healthcare teams. It also ensures the supplier can bring in sufficient stock ahead of the listing of Herzuma.
Impact to the health sector and implementation requirements
Feedback questioned access to HER-2 testing for gastric cancer.
We understand all diagnostic testing in New Zealand is publicly funded and therefore laboratories would have some familiarity with HER-2 testing for gastric, gastro-oesophageal junction and oesophageal cancer.
Based on the consultation feedback and clinical advice received, we intend to work with our sector partners to ensure people have access to HER-2 testing.
Feedback indicated trastuzumab would be initiated by a specialist however general practitioners should still be aware of the advantages, disadvantages and side effects.
Our proposed implementation plan includes communications and materials for all healthcare professionals, including those working in primary care. Our contracted clinical education provider (He Ako Hiringa) already has general resources on biosimilars. We intend to support this with Herzuma specific information. We are working with the supplier to hold a webinar(s) which will be a future resource for healthcare professionals to use.
Funding of other medicines for breast cancer
Feedback highlighted support for the funding of subcutaneous trastuzumab to improve equitable access. Feedback highlighted intravenous medicines can produce access barriers. These barriers are greater for people living rurally and support (eg for travel) is not always consistent.
We understand there is a desire for people to receive treatment closer to home. We have received a funding application for subcutaneous trastuzumab(external link). This has been recommended for funding if cost-neutral to intravenous presentation. It is currently ranked on our cost neutral / cost saving list(external link). This means we would fund it if a commercial proposal could be reached that was cost neutral or cost saving.
This RFP process was specifically for an intravenous presentation and any other presentations of trastuzumab were out of scope.
Highlighted the range of medicines funded in other countries for HER-2 positive breast cancer
We understand the funded medicines in other countries for breast cancer is different to New Zealand.
We welcome funding applications for other treatments and will continue to assess them via our Schedule funding pathway. Some of the medicines highlighted in consultation feedback (eg trastuzumab deruxtecan) are already being assessed. The status of medicine funding applications can be found on our Application Tracker(external link).
If you have any questions about this decision, you can email us at email@example.com; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.