Decision to brand change bortezomib through the 2024/25 Invitation to Tender and widen access to bortezomib for the treatment of Waldenström’s macroglobulinemia
What we’re doing
We’re pleased to announce a decision to widen access to bortezomib for the treatment of Waldenström’s macroglobulinemia (WM) in both the first line and relapsed/refractory setting from 1 February 2026.
This decision is a result of including bortezomib in our annual invitation to tender (ITT) process.
We estimate that around 50 people would benefit from bortezomib in the first year of funding, increasing to 70 in year five.
We understand that even with these changes there remains a significant unmet health need for people with Waldenström’s macroglobulinemia and its subtype Bing-Neel syndrome.
We're also announcing a decision to change the funded brand of bortezomib inj 3.5 mg vial through our annual Invitation to Tender. This decision will secure ongoing supply of bortezomib injection.
The decision comes as a result of Pharmac’s 2024/25 Invitation to Tender and means that:
- Bortezomib Eugia, supplied by Eugia Pharma (Australia) Pty Ltd, will be listed on the Pharmaceutical Schedule on 1 April 2026 and will be awarded Principal Supply Status from 1 September 2026 until 30 June 2028.
- Awarding Principal Supply Status to a brand of a medicine means it will be the main funded brand available, and will be supplied to at least 95% of the New Zealand market.
The currently funded brand, DBL Bortezomib, will be delisted on 1 September 2026.
Any changes to the original proposal?
The decision to widen access was subject to a consultation letter dated 2 December 2025.
Proposal to widen access to bortezomib for the treatment of Waldenström’s macroglobulinemia
We are grateful to the health care professionals, consumers and advocacy groups who provided feedback to our consultation. This decision includes a minor change to the wording of the renewal criteria.
Who may be most interested
- People with Waldenström’s macroglobulinemia, their family, whānau, friends and caregivers
- Healthcare professionals involved in the care of people with Waldenström’s macroglobulinemia
- Health New Zealand – Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by Waldenström’s macroglobulinemia
- People or groups with an interest in treatments for Waldenström’s macroglobulinemia
- Pharmacies and wholesalers
- Pharmaceutical suppliers
Details about this decision
From 1 February 2026, access to bortezomib will be widened to include people with Waldenström’s macroglobulinemia. This will mean that people could receive bortezomib as a first line treatment or in the relapsed or refractory setting.
It is estimated that the currently funded treatment, bendamustine with rituximab, is not clinically suitable for approximately 40% of people with Waldenström’s macroglobulinemia. Bortezomib will become available as a first-line treatment for these people, as well as a second-line treatment for those with Waldenström’s macroglobulinemia who relapse or are refractory to bendamustine and rituximab.
Patient advocates and clinicians have advised us that there are other, more effective, treatments that they would like funded. This includes both ibrutinib and zanubrutinib for which Pharmac has received funding applications for the treatment of Waldenström’s macroglobulinaemia.
This notification also includes a decision to change to the funded brand of bortezomib injection, with Bortezomib Eugia being listed from 1 April 2026. Bortezomib Eugia contains the same excipients and has the same shelf life and storage conditions as the currently funded DBL Bortezomib.
Schedule changes
Widened access
From 1 February 2026 bortezomib will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows (new criteria shown only):
Special Authority for Subsidy
Initial application — (Waldenström Macroglobulinaemia) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- The patient has Waldenström Macroglobulinaemia/Lymphoplasmacytic Lymphoma requiring treatment; and
- The patient has not received prior bortezomib treatment
Renewal — (Waldenström Macroglobulinaemia) from any relevant practitioner. Approvals valid for 12 months where there is no evidence of clinical disease progression during bortezomib use.
Bortezomib is Medsafe approved for multiple myeloma. Other uses have not been approved by Medsafe. Prescribing bortezomib outside of the Medsafe approved indications will need to follow Section 25 of the Medicines Act 1981(external link).
Brand change
The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.
|
Chemical name |
Presentation; |
Current pack price |
New pack price |
Principal Supply brand |
Date of subsidy change |
Principal Supply date |
Brand (Supplier) affected by delisting |
|---|---|---|---|---|---|---|---|
|
Bortezomib |
Inj 3.5 mg vial; 1 vial |
$74.93 |
$23.99 |
Bortezomib Eugia (Eugia) |
1 April 2026 |
1 September 2026 |
DBL Bortezomib (Pfizer) |
In Section B of the Pharmaceutical Schedule, the price and subsidy of bortezomib inj 1 mg for ECP (Baxter) will decrease from $22.26 per 1 mg to $7.13 per 1 mg from 1 September 2026.
This decision allows people to potentially access a different brand if their prescriber considers Bortezomib Eugia to be clinically unsuitable for their health needs. The funding of this would be managed via Pharmac’s Exceptional Circumstances framework. This would require an individual’s prescriber to provide information about why the funded brand (Bortezomib Eugia) is not clinically appropriate.
What you told us
Widened Access
Thank you to the people who took time to respond to this consultation. A summary of the main themes raised in feedback and our responses to the feedback can be seen in the table below.
|
Theme |
Pharmac Comment |
|---|---|
|
Support for the proposal |
|
|
Supportive, as this will provide people with Waldenström’s macroglobulinaemia with an additional effective treatment option. Bortezomib may be particularly useful for patients whose WM has relapsed soon after chemoimmunotherapy. WM has multiple causes and presents differently in different patients. Bortezomib is particularly useful in certain patients and circumstances |
We are pleased to be able to progress a decision that supports access to medicines and provides people with Waldenström’s macroglobulinaemia an additional treatment option. |
|
Unmet need remains |
|
|
Bortezomib delivers limited clinical value and does not adequately address the highest unmet need for people living with Waldenström’s macroglobulinaemia in New Zealand There remains an unmet need for a funded BTK inhibitor for WM. BTK inhibitors have very high activity as monotherapy, excellent CNS penetration (relevant to Bing Neel syndrome), and are once daily oral medications. Expanding access to older therapies, without corresponding progress on BTKi funding, risks reinforcing less optimal treatment pathways rather than improving long-term outcomes for patients. Fully support this proposal as long as it does not come at the expense of further funding for other more suitable and effective medicines such as Ibrutinib and Zanubrutinib We hope Pharmac will soon fund BTK inhibitors for WM, so other WM patients will also be able to benefit from their low toxicity and superior efficacy. Zanubrutinib has been found to have significantly less side effects than ibrutinib, and it works better for those with certain WM mutations. |
As a result of including bortezomib in the FY24/25 Invitation to Tender process, we have had a reduction in the price of bortezomib. This means we no longer need to target treatment as we have done in the past to only those with plasma cell dyscrasia, and as a result we have been able to propose widening access to bortezomib for people with Waldenström’s macroglobulinemia. We acknowledge that even with these changes to the bortezomib criteria there remains a significant unmet health need for people with WM and its subtype, Bing-Neel syndrome. Patient advocates & clinicians have advised us that there are other, more effective treatments that they would like funded. This includes both ibrutinib and Zanubrutinib for which Pharmac has received funding applications for the treatment of WM. These applications are awaiting assessment before being ranked on our Options for Investment (OFI) list. The proposal to fund bortezomib does not prevent us from considering BTKIs for funding in the future. |
|
Ranking of other proposals for Waldenström’s macroglobulinaemia |
|
|
BTKi applications for Waldenström’s macroglobulinaemia were submitted to Pharmac in 2018 and 2023 and received positive clinical advice in 2021 and 2023 respectively yet remain unranked on the Options for Investment list more than four years later. Bortezomib is no longer considered an appropriate or preferred therapy for WM due to limited efficacy and significant toxicity. Prior to the availability of BTK inhibitors, bortezomib was used in WM only when no other options were available. It is disappointing that Zanubrutinib remains unranked for WM and that we were not engaged prior to the development of this proposal. |
We understand the frustration in the assessment of these BTKi proposals being delayed, especially as the outcome directly affects treatment options for people with Waldenström’s macroglobulinaemia. We are committed to progressing applications as efficiently and equitably as possible; however, we are unable to provide a specific timeframe for these assessments. Each quarter, we triage proposals for economic evaluation. This process considers the priority assigned by our clinical advisors, the Factors for Consideration, and the capacity required to complete the assessment. We have recently expanded our team of health economists, which we hope will enable us to increase the number of applications assessed each quarter moving forward. Pharmac is committed to engaging with consumer advocacy groups and the suppliers of these BTKi treatments to provide insight into our assessment process. |
|
Other requests |
|
|
Please consider removing the special authority restriction altogether given low cost of generic bortezomib |
Pharmac is only widening access to Waldenström’s macroglobulinaemia at this time based on the funding application received. This is in line with the clinical advice we have received. We will undertake further analysis to assess the impact of open listing bortezomib. |
Brand change
To improve transparency around our annual tender process, we introduced an additional step in 2024/25. In May and July 2025, Pharmac consulted on potential brand changes through the annual tender. We engaged with medical professionals, patient advocacy groups, consumers, suppliers, and professional bodies to get their feedback on support required for any brand changes to funded medicines. We received over 30 responses, including one response specific to bortezomib.
The feedback received was considered as part of the decision-making process. It has also informed how Pharmac will support people through the upcoming brand changes. We want to thank everyone who took the time to share their feedback. We heard from a range of people including healthcare professionals, advocacy groups and users of medicines. You provided feedback about:
- packaging and labelling considerations
- the resources and communications needed to support a brand change
- the people who may need additional support when undergoing a brand change
Please see the July 2025 Tender Notification II for a summary of the key themes identified in annual tender brand change consultations. We did not receive any feedback specific to bortezomib that raised new themes beyond those already outlined in the July 2025 Tender Notification. Key themes from both rounds of consultation, including general, and specific, brand change considerations, have been considered for this brand change.
Who to contact
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.