Proposal to widen access to intravenous trastuzumab and change the funded brand

Medicines Consultation Closed

Read the final decision relating to this consultation

What we’re proposing

We want to hear from people about a proposal to change the funded brand of intravenous trastuzumab from Herceptin to a biosimilar trastuzumab called Herzuma from 1 December 2023. Trastuzumab is a biologic medicine that is currently funded for people with breast cancer.

The proposal would also give more New Zealanders funded access to intravenous trastuzumab. From 1 December 2023, people with stomach (gastric) cancer who meet certain funding criteria would be able to access funded intravenous trastuzumab.

We are also seeking feedback on what implementation activities would support the proposed transition to the Herzuma brand of trastuzumab.

If the proposal is approved, the following changes would occur from 1 December 2023:

  • A biosimilar intravenous trastuzumab (Herzuma, supplied by Celltrion Healthcare) would be listed, and would be the principal funded brand from 1 June 2024 until 31 May 2027.
  • Funded access to intravenous trastuzumab would be widened to include locally advanced or metastatic, HER2 positive gastric cancer.
  • The funding criteria would be changed so that people taking intravenous trastuzumab for metastatic breast cancer would be able to take a ‘treatment holiday’. This would allow people to pause their treatment. They could then restart if they experience disease progression while treatment is paused. The funding criteria for pertuzumab would also be changed, for people taking pertuzumab in combination with intravenous trastuzumab.
  • Any relevant practitioner would 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 proposal results from a competitive process for the Principal Supply of funded intravenous trastuzumab. This proposal would release significant funds so Pharmac can invest in other medicines for the benefit of New Zealanders.

Feedback on this consultation will help us to understand if any changes should be made to this proposal. Consultation closes at 4 pm on Friday 30 June 2023. Feedback can be emailed to consult@pharmac.govt.nz.

Who we think will be interested

  • People currently using intravenous trastuzumab and their family, whānau and caregivers
  • Groups who advocate for and support people with breast or gastric cancer
  • Oncologists, specialist nurses, and other health professionals involved in the care of people with breast and gastric cancer
  • Hospital pharmacists, and wholesalers
  • Te Whatu Ora hospitals
  • Third-party compounders
  • Pharmaceutical suppliers.

What would the effect be?

From 1 December 2023, a new brand of intravenous trastuzumab called Herzuma would be funded and would be the principal funded brand from 1 June 2024 until 31 May 2027.

Breast Cancer

Intravenous trastuzumab is currently funded for early and metastatic, HER2 positive breast cancer. Approximately 900 people received intravenous trastuzumab in 2022. Of these, approximately 160 Māori and 100 Pacific peoples received treatment with intravenous trastuzumab in 2022.

Pharmac and the supplier of Herzuma (Celltrion Healthcare) would provide information and resources about biosimilar intravenous trastuzumab to support the transition. It is anticipated that this transition would be prescriber led; however, prescribers, pharmacists and individuals receiving trastuzumab treatment would need to work together to manage the transition from Herceptin to Herzuma. We also plan to work with advocacy and support groups so that people would be able to access information in a way that works for them.

Early breast cancer

Approximately 600 people receive intravenous trastuzumab each year for early breast cancer.

People currently receiving treatment could continue to receive their current brand of intravenous trastuzumab 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 would complete their planned intravenous trastuzumab treatment with the Herceptin brand before this date.

If someone starts treatment before 1 December 2023 and would need ongoing treatment beyond 1 June 2024, they would need to transition to Herzuma. People would be able to transition from 1 December 2023 and everyone would need to transition by 1 June 2024.

People with early breast cancer who start on intravenous trastuzumab from 1 December 2023 would receive Herzuma.

Metastatic breast cancer

Approximately 300 people are currently receiving intravenous trastuzumab for metastatic breast cancer.

People who are currently receiving intravenous trastuzumab and would need ongoing treatment beyond 1 June 2024 would need to transition to Herzuma. We understand this would mostly be people with metastatic breast cancer. People would be able to transition from 1 December 2023 and everyone would need to transition by 1 June 2024.

People with metastatic breast cancer who start on intravenous trastuzumab from 1 December 2023 would receive the Herzuma brand.

Treatment holidays

From 1 December 2023, people receiving intravenous trastuzumab (Herceptin or Herzuma) for metastatic breast cancer would be able to take a ‘treatment holiday’. This would mean that people who have experienced a long-term response could pause their treatment. They could then restart on the Herzuma brand of intravenous trastuzumab if they experience disease progression while treatment is paused. The funding criteria for pertuzumab would also be changed. Pertuzumab is another treatment for breast cancer and is funded for use in combination with intravenous trastuzumab.

We understand that people may choose to take a treatment holiday following discussion with their prescriber. We consider this option would improve the quality of life for people who choose to pause treatment, allowing them to spend less time receiving treatment and more time engaging with their day-to-day activities, friends and whānau.

Our estimates indicate that the impact on healthcare sector resources of this change would be minimal, given the number of people who are likely to choose to take a treatment holiday would be small.

Exceptional Circumstances

Our clinical advisors have told us that if an adverse reaction occurred to an excipient in the biosimilar product, an individual may need to return to their previous brand of intravenous trastuzumab.

Pharmac has secured stock of intravenous trastuzumab (440 mg vials) from Roche Products (New Zealand Limited) for the supply of the Herceptin brand through the Exceptional Circumstances Framework.

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.

More information on the excipients in Herzuma is included in the Medsafe datasheet [PDF](external link).

If a reaction were to occur, an individual’s prescriber would need to apply via Pharmac’s Exceptional Circumstances framework. Applicants would 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. Applications would be different to those of our Named Patient Pharmaceutical Applications (NPPA) and we would include more details on how to apply to our Exceptional Circumstances Framework if this proposal is approved.

If a person experiences disease progression following a transition to Herzuma, they would not be eligible for funded access to Herceptin. Unfortunately, disease progression in breast cancer can happen even when someone is receiving treatment. If this were to occur, people should discuss the available treatment options with their prescriber.

Gastric cancer

From 1 December 2023 people with gastric cancer, who meet the funding criteria, would be able to access intravenous trastuzumab. People with gastric cancer would receive the Herzuma brand from this date.

We estimate that approximately 115 people with gastric cancer would receive intravenous trastuzumab in the first full year of funding, with approximately 100 people receiving treatment for gastric cancer every year after.

We understand Māori and Pacific peoples experience higher incidence and mortality of gastric cancer. Māori are less likely to be diagnosed with HER2 positive gastric cancer compared to other types of gastric cancer than non-Māori, non-Pacific peoples. However Māori with HER2 positive gastric cancer are likely to be diagnosed at a younger age. Pacific peoples are also less likely to be diagnosed with HER2 positive gastric cancer compared to non-Māori, non-Pacific peoples. We are not currently aware of the average age of diagnosis for Pacific peoples and whether this is younger than for non-Māori, non-Pacific peoples.

Our assessment of this proposal indicates that people with gastric cancer would currently be receiving chemotherapy. Therefore, we would expect people to have trastuzumab added to their treatment, which would be an additional 90 minutes of infusion time for the first intravenous trastuzumab infusion, and 30 minutes for subsequent infusions.

Support for people receiving intravenous trastuzumab and healthcare professionals

Pharmac would work alongside the supplier (Celltrion Healthcare), as well as advocacy and support groups for people with cancer and healthcare professionals to provide information to support the proposed transition.

We are interested to hear what activities, in addition to what we have outlined below, would support a smooth transition for people to Herzuma.

Support for people receiving intravenous trastuzumab

Pharmac already has general information on our website about biosimilars. We would have a dedicated webpage about the proposed brand (Herzuma) and where you can find more information.

Pharmac and Celltrion Healthcare would work together to provide specific information about the proposed brand (Herzuma). This would include educational material about Herzuma in English, Māori, Samoan, Tongan and Mandarin, and patient alert cards. We also want to work with advocacy and support groups so that everyone has the information they need to understand what this proposal would mean for them and feel informed about the transition.

Pharmac and Celltrion Healthcare would also provide education materials and resources for healthcare professionals, so healthcare teams can support individuals through this transition and answer any questions people may have.

Support for healthcare professionals

Our contracted clinical education provider, He Ako Hiringa, has useful information for healthcare professionals on biologic and biosimilar medicines. You can find this information on the He Ako Hiringa website(external link).

We would have a dedicated webpage on the Pharmac website for healthcare professionals which would include the key dates for the transition, where to find more information and how to apply to our Exceptional Circumstances Framework if your patient might need to return to Herceptin.

Pharmac and Celltrion Healthcare would work together to provide specific information about the proposed brand (Herzuma), including:

  • clinical data about efficacy, safety and immunogenicity
  • practical prescribing information and storage / handling information
  • an online webinar about Herzuma for healthcare professionals.

We know we need to collaborate with several agencies across the sector to successfully implement this proposal. This would include:

  • working with Te Aho o Te Kahu (Cancer Control Agency) and Te Whatu Ora to ensure that Te Whatu Ora staff have the resources required to support this transition.
  • Working with Te Whatu Ora Sector Operations to transition Special Authority applications to the new brand of intravenous trastuzumab (Herzuma) and reduce the potential administrative burden on prescribers.

We want to hear what other information about biologic medicines and Herzuma would help healthcare professionals in supporting this transition.

About intravenous trastuzumab

Trastuzumab is a type of medicine called a biologic. Biological medicines are made from living organisms. Herzuma is a biosimilar medicine. This means it is a very similar version of trastuzumab to Herceptin.

Read more about biologic and biosimilar medicines.

Trastuzumab targets a specific receptor on certain cancer cells, called human epidermal growth factor receptor 2 (HER2). When it binds to these receptors, trastuzumab stops them multiplying.

Herzuma, like Herceptin, would be supplied as a powder which is mixed with sterile water (reconstituted) before administration. It is given by intravenous (IV) infusion, usually over 30 – 90 minutes every three weeks in a Te Whatu Ora hospital outpatient clinic setting. The proposed brand of trastuzumab (Herzuma) would also be supplied as a powder and administered as an infusion with the same dosing as Herceptin.

Further information about intravenous trastuzumab, reconstitution instructions and dosing is in the Medsafe datasheet [PDF](external link).

Compounding

Trastuzumab needs to be mixed with sterile water (reconstitution) to make a solution before it can be administered. This is often done by a non Te Whatu Ora third-party compounder, sometimes called a contract manufacturer. The “Inj 1 mg for ECP” formulation of intravenous trastuzumab listed in Section B of the Schedule allows Te Whatu Ora hospitals to claim a subsidy for the number of milligrams supplied by a third-party compounder.

Why we’re proposing this

Several biosimilar trastuzumab products are now approved by Medsafe for use in Aotearoa New Zealand. The availability of biosimilars provided Pharmac with the opportunity to promote competition and reduce the cost of intravenous trastuzumab. This allows Pharmac to propose wider access to intravenous trastuzumab to include locally advanced or metastatic, HER2 positive gastric cancer. It would also release significant funds so Pharmac can invest in other medicines for the benefit of New Zealanders.

Pharmac released a Request for Proposals (RFP) for the supply of intravenous trastuzumab in Te Whatu Ora hospitals on 8 September 2022. As a result of the RFP, Pharmac has entered into a provisional agreement with Celltrion Healthcare New Zealand Limited for the Principal Supply of trastuzumab (Herzuma) for all funded indications.

We understand there remains unmet health needs for people with breast cancer and gastric cancer. We will continue to assess funding applications for cancer as we do for all medicines, via our Schedule funding assessment pathway.

Read more about the annual tender funding process on the Pharmac website.

We remain committed to implementing changes to introduce biosimilar medicines where they would release additional funds for Pharmac to invest in other medicines for the benefit of New Zealanders.

Clinical advice on a competitive process

In 2019, Pharmac sought advice from its Pharmacology and Therapeutics Advisory Committee (PTAC) and Cancer Treatments Subcommittee of PTAC (now called the Cancer Treatments Advisory Committee) regarding evidence from Celltrion Healthcare for its biosimilar intravenous trastuzumab product. Our advisors told us it was clinically acceptable for a biosimilar intravenous trastuzumab product to be the only intravenous trastuzumab product listed on the Schedule. Our advisors supported Pharmac progressing a competitive procurement process that may result in the listing of a biosimilar intravenous trastuzumab. The full records of the discussions are available on the Application Tracker(external link).

In April 2022, Pharmac also sought advice from the Cancer Treatments Advisory Committee (CTAC) about the options for this process. CTAC supported a competitive process that would result in one funded brand of intravenous trastuzumab being listed on the Pharmaceutical Schedule and welcomed further consideration of applications for the use of intravenous trastuzumab in other indications. The record of the discussion is available on our website [PDF, 846 KB].

Based on clinical advice received, all patients who receive intravenous trastuzumab would be able to transition to the Herzuma brand. There is extensive evidence from overseas that shows biosimilar trastuzumab products are safe and effective. Herzuma has been evaluated and approved for use in Aotearoa New Zealand by Medsafe.

Clinical advice on widening access

We received a recommendation from our clinical advisors to amend the criteria for trastuzumab (and pertuzumab) for metastatic breast cancer to allow for treatment holidays to occur. We have heard from our stakeholders that this would benefit long term responders to treatment. We are proposing the change for both trastuzumab and pertuzumab.

We heard from sector stakeholders and advocacy groups that they wanted us to consider widening access to include gastric cancer and to allow further treatment with trastuzumab following disease progression. We sought advice from our Cancer Treatments Advisory Committee (CTAC) alongside our evaluation of the RFP for intravenous trastuzumab.

Our clinical advisors recommended widening access to locally advanced or metastatic, HER2 positive gastric cancer with a high priority, in October 2022. The full record is available on the Application Tracker(external link).

CTAC recommended declining the application for widening access to allow further treatment with trastuzumab following disease progression. In summary, CTAC told us there isn’t strong evidence on the benefit of further treatment and that there are other funded treatments available in New Zealand, such as trastuzumab emtansine. Based on this advice we aren’t proposing to widen access to include further treatment at this point in time. The full record will be available shortly on the Application Tracker(external link).

We know that there remains an unmet health need for people with cancer in Aotearoa New Zealand, including breast and gastrointestinal cancers. You can find out where relevant applications for treatment of these cancers are in our process on the Application Tracker(external link).

Widening the prescriber type for Special Authority applications

We are also proposing to widen the prescriber type in the Special Authority to any relevant practitioner. We know every individual’s treatment journey and interaction with the health system is different. This proposed change would support a wider range of healthcare professionals to prescribe trastuzumab.

Details about our proposal

Listing of Herzuma

From 1 December 2023, Herzuma would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical Formulation Brand Pack size Proposed price and 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 would apply to Herzuma that would reduce the net price.

From 1 June 2024 until 31 May 2027, Herzuma would have Principal Supply Status. This means it would be the only listed brand of intravenous trastuzumab available in Aotearoa New Zealand and would be guaranteed at least 95% of the funded market, with any alternative brand requiring Pharmac approval via its Exceptional Circumstances Framework. The chemical name would also be changed from ‘Trastuzumab (Herzuma)’ to ‘Trastuzumab’ on 1 June 2024.

Herzuma would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (changes from current intravenous trastuzumab criteria in bold and strikethrough):

Special Authority for Subsidy

Initial application — (early breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 15 months for applications meeting the following criteria:

All of the following:

  1. The patient has early breast cancer expressing HER-2 IHC 3+ or ISH + (including FISH or other current technology); and
  2. Maximum cumulative dose of 106 mg/kg (12 months’ treatment); and
  3. Any of the following
    1. 9 weeks’ concurrent treatment with adjuvant chemotherapy is planned; or
    2. 12 months’ concurrent treatment with adjuvant chemotherapy is planned; or
    3. 12 months’ sequential treatment following adjuvant chemotherapy is planned; or
    4. 12 months’ treatment with neoadjuvant chemotherapy is planned; or
    5. Other treatment regimen, in association with adjuvant chemotherapy, is planned.

Renewal  — (early breast cancer*) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following Either:

  1. All of the following:
    1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology): and
    2. The patient received prior adjuvant trastuzumab treatment for early breast cancer; and
    3. Any of the following:
      1. The patient has not previously received lapatinib treatment for HER-2 positive metastatic breast cancer; or
      2. Both:
        1. The patient started lapatinib treatment for metastatic breast cancer but discontinued lapatinib within 3 months of starting treatment due to intolerance intolerable side effects; and
        2. The cancer did not progress whilst on lapatinib; or
      3. The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
    4. Either:
      1. Trastuzumab will not be given in combination with pertuzumab; or
      2. All of the following:
        1. Trastuzumab to be administered in combination with pertuzumab; and
        2. 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
        3. The patient has good performance status (ECOG grade 0-1); and
    5. Trastuzumab not to be given in combination with lapatinib; and
    6. Trastuzumab to be discontinued at disease progression; or
  2. All of the following:
    1. Patient has previously discontinued treatment with trastuzumab in the metastatic setting for reasons other than severe toxicity or disease progression; and
    2. Patient has signs of disease progression; and
    3. 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) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
  2. Either:
    1. The patient has not previously received lapatinib treatment for HER-2 positive metastatic breast cancer; or
    2. Both:
      1. The patient started lapatinib treatment for metastatic breast cancer but discontinued lapatinib within 3 months of starting treatment due to intolerance; and
      2. The cancer did not progress whilst on lapatinib; and
  3. Either:
    1. Trastuzumab will not be given in combination with pertuzumab; or
    2. All of the following:
      1. Trastuzumab to be administered in combination with pertuzumab; and
      2. 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
      3. The patient has good performance status (ECOG grade 0-1); and
  4. Trastuzumab not to be given in combination with lapatinib; and
  5. Trastuzumab to be discontinued at disease progression.

Renewal — (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following Either:

  1. All of the following:
    1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
    2. The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
    3. Trastuzumab not to be given in combination with lapatinib; and
    4. Trastuzumab to be discontinued at disease progression.; or
  2. All of the following:
    1. Patient has previously discontinued treatment with trastuzumab for reasons other than severe toxicity or disease progression; and
    2. Patient has signs of disease progression; and
    3. Disease has not progressed during previous treatment with trastuzumab.

Initial application — (locally advanced or metastatic gastric cancer) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

  1. The patient has locally advanced or metastatic gastric cancer expressing HER-2 IHC 2+ FISH+ or IHC3+; and
  2. Patient has an ECOG score of 0-2.

Renewal — (locally advanced or metastatic gastric cancer) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

  1. The cancer has not progressed at any time point during the previous 12 months whilst on trastuzumab; and
  2. Trastuzumab to be discontinued at disease progression.

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

The listing in Section B would remain PCT only for claiming purposes only – intravenous trastuzumab can only be dispensed in Te Whatu Ora hospitals.

Changes to the listing of Herceptin

From 1 December 2023, the Pharmaceutical Schedule listing for the Herceptin brand of intravenous trastuzumab would be amended as follows (additions in bold):

Chemical Formulation Brand Pack size Price and subsidy
Trastuzumab (Herceptin) Inj 150 mg vial Herceptin 1 $1,350.00
Trastuzumab (Herceptin) Inj 440 mg vial Herceptin 1 $3,875.00
Trastuzumab (Herceptin) Inj 1 mg for ECP Baxter 1 mg $9.36

From 1 December 2023, the current Special Authority criteria for Herceptin would be amended so only existing patients could continue to access funded treatment with the Herceptin brand of intravenous trastuzumab. All new patients would need to commence treatment with Herzuma.

From 1 June 2024, Herceptin would be delisted from the Pharmaceutical Schedule and funded access for those who need to return to their previous brand of intravenous trastuzumab would be managed through the Exceptional Circumstances Framework, as outlined above.

Changes to the listing of Pertuzumab (Perjeta)

People with metastatic breast cancer may be receiving intravenous trastuzumab in combination with another biologic treatment called pertuzumab (brand name Perjeta). Our clinical advisors recommended the pertuzumab eligibility criteria should also be amended to allow treatment holidays.

From 1 December 2023, the eligibility criteria would be amended as follows (changes from current pertuzumab criteria in bold and strikethrough):

Initial application — (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for application meeting the following criteria:

All of the following:

  1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
  2. Either:
    1. Patient is chemotherapy naïve; or
    2. 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
  3. The patient has good performance status (ECOG grade 0-1); and
  4. Pertuzumab to be administered in combination with trastuzumab; and
  5. Pertuzumab maximum first dose of 840 mg, followed by maximum of 420 mg every 3 weeks; and
  6. Pertuzumab to be discontinued at disease progression.

Renewal — (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both Either:

  1. Both:
    1. The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and
    2. The cancer has not progressed at any time point during the previous 12 months whilst on pertuzumab and trastuzumab; and
  2. All of the following:
    1. Patient has previously discontinued treatment with pertuzumab and trastuzumab for reasons other than severe toxicity or disease progression; and
    2. Patient has signs of disease progression; and
    3. Disease has not progressed during previous treatment with pertuzumab and trastuzumab.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4 pm, Friday 30 June 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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