Decision to fund two treatment combinations and widen access to ibrutinib for chronic lymphocytic leukaemia (CLL)

Medicines Decision

What we’re doing

We're pleased to announce a decision to fund two fixed duration combinations therapies and widen access to an existing treatment for people with chronic lymphocytic leukaemia (CLL).

From 1 May 2026, the following changes will be implemented:

  • Venetoclax (Venclexta) in combination with ibrutinib (Imbruvica) – Funded as a first line treatment option
  • Venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) – Funded as a first line treatment option
  • Ibrutinib (Imbruvica) – Widened access as a second line treatment for people with CLL regardless of their specific cancer mutation

This decision was subject to a consultation letter dated 18 February 2026. We received feedback from a wide range of stakeholders including consumers, their whānau and families, clinicians, pharmacists and patient support groups. We’re grateful to everyone for their feedback and have made some changes to the original proposals as a result. A summary of the main feedback themes raised for each part of this proposal, and our responses to these, are detailed further in this document.

Who we think will be most interested

  • People with CLL, their whānau, and caregivers
  • Haematologists, oncologists, and health professionals involved in the care of people with CLL
  • Groups who support and advocate for people with CLL
  • Health New Zealand | Te Whatu Ora
  • Cancer Control Agency | Te Aho o Te Kahu
  • Pharmaceutical suppliers and wholesalers

What does this mean for people?

From 1 May 2026, venetoclax with ibrutinib and venetoclax with obinutuzumab will be funded as first line combination treatments. The funding for ibrutinib will also be widened so it can be used on its own as a second line treatment for people whose CLL has not responded to a previous treatment, has come back, or where earlier treatment caused intolerable side effects. 

We anticipate that around 110 people each year will benefit from one of the combination treatments, and around 30 people each year will benefit from widened access to ibrutinib.

This decision will also help reduce the demand on health sector services as these are oral treatments reduce the need for hospital-based infusions. We anticipate that this decision will save approximately 3,700 infusion hours per year. We acknowledge that obinutuzumab is an infusion and appreciate the significant workload requirements for nursing and hospital staff, especially when people are starting on treatment.

Any changes to the original proposal?

Following consultation, changes have been made to the wording of the Special Authority criteria to improve clarity for clinicians. We have also removed the proposed renewal criteria and set the initial approval period to match the fixed-duration treatments.

We’ve changed the access criteria so that people who have been self‑funding venetoclax or ibrutinib can switch to the funded combination treatment, where it is clinically appropriate. This switch to combination treatment will need to be made within six months of the funding date (before 1 November 2026).

We are also widening access to ibrutinib to be used as a second line treatment for people with CLL who relapse or are intolerant to first line treatment. The funding criteria for rituximab has been amended to ensure people can still access rituximab in combination with venetoclax as a second line treatment option.

While we weren’t able to make every change that was suggested through this proposal, the feedback helped shape this decision and will continue to inform future work.

Detail about this decision

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are in the table below. 

Theme

Pharmac Comment

General support for the proposal

Patients, whānau, clinicians, and advocacy groups

Respondents provided strong support for funding venetoclax‑based first‑line combinations; reduced toxicity, fewer hospital visits, alignment with guidelines, and relief from financial hardship; fixed‑duration therapy improves quality of life and access.

We are pleased to be progressing a proposal that would benefit New Zealanders.

Clinicians and advocacy groups

Highlighted system benefits of oral treatments (reduced infusion and nursing time). In contrast one respondent noted that obinutuzumab administration requires significant nursing time and support in the first 5 weeks.

We note the health system benefits from an oral treatment option for individuals and are pleased to be progressing this proposal.

We acknowledge and appreciate the significant workload requirements for nursing and hospital staff with obinutuzumab infusions, especially when individuals are starting on treatment.  We have shared our estimates of these with HNZ to help with their planning.

Special Authority restrictions

Clinicians, consumer, and supplier

Request to remove the renewals for all treatments because these are fixed‑duration and renewal adds admin with little clinical value.

We are grateful for the feedback and have sought advice on this change. Our clinical advisors are supportive and as such we are removing the renewal criteria and extending the initial approval period to cover the whole treatment course. 

Clinicians

Requested a note be added to the venetoclax criteria to clarify that the maximum duration of 12 cycles refers to the period of time on full dose venetoclax and that this is in addition to the 5 week ramp-up period.

We appreciate the feedback and have included a note in the venetoclax criteria to this effect.

Clinician

Requested additional text be included in the ibrutinib criteria to clarify the usage with venetoclax.

We appreciate the feedback and have amended the criteria accordingly.

Clinicians

Requested a change to the criteria to remove the requirement for prior immunochemotherapy in the initial application for ibrutinib for relapsed or refractory CLL.

We appreciate the feedback and have amended the criteria accordingly.

Supplier

Request to remove the maximum dose of venetoclax from the special authority to align with current criteria.

We sought advice from CTAC on the requested changes to the funding criteria and CTAC considered it was reasonable to retain the maximum dosing.

We note that maximum dosing is included for all treatments in this proposal as they are fixed duration.

Clinicians and advocacy group

Request to amend the criteria for venetoclax and ibrutinib to allow patients who are self-funding one treatment to move to the fixed duration combination treatment.

We have amended the criteria to allow people who have self-funded one treatment, a time-limited period, to switch to the funded combination treatment. This ensures that these people can access first line treatment with combination therapy along with others who have CLL.

We note that switching from single treatment to the combination would need to be a decision made based on clinician judgement between a person and their clinician.

Clinicians and advocacy group

Request to allow venetoclax to be funded in combination with any BTK inhibitor. This would allow patients the choice to self-fund an alternative to ibrutinib.

We acknowledge the desire to have options for alternative BTK inhibitors. When CTAC reviewed the combination treatment they acknowledged that there may be benefit for other BTK inhibitors to be used with venetoclax, but there is not currently evidence to support this. Until evidence of efficacy of other BTK inhibitors is available in this context, their recommendation for funding is only for ibrutinib.

As such, we are not proposing to change the criteria to allow any BTK inhibitor to be used.

Clinicians and advocacy group

Highlighted that there may be some patients who get side effects from either of these combination treatments. It would be essential to understand if a Named Patient Pharmaceutical Assessment (NPPA) would be option for these people to access a second generation BTK inhibitor.

We recognise that not all people will tolerate these treatment combinations. Where an individual experiences clinically significant adverse side effects, clinicians may consider submitting a NPPA application to Pharmac for an alternative treatment. Any successful application would need to demonstrate that the principles of the NPPA policy are met, including consideration of why ibrutinib would not be appropriate, noting the proposal now includes funding ibrutinib monotherapy second line. 

Making a NPPA application

Clinicians and advocacy group

Requested that Pharmac fund both combination treatments as second-line options for people who have relapsed on chemotherapy under the current treatment paradigm.

We recognise there is an unmet health need for people who have relapsed on first line treatment options. We have not received a funding application for these combinations in a second line setting.

Funding these treatments in the relapsed/refractory setting would require further assessment on the evidence and cost effectiveness and we have therefore not actioned this request. We would welcome a funding application for these treatments in second line. More information about how to submit a funding application is available on our website.

Make a medicine funding application

Other funding requests

Patients, whānau, and clinicians

Highlighted the unmet need for second generation BTK inhibitors (zanubrutinib, acalabrutinib).

We acknowledge the unmet need for these treatments and funding applications for these have been assessed and are ranked on our Options for Investment list. This means they are treatments we would like to fund if we have available budget.

Scientist

Request for a nationwide monitoring protocol to ensure the effectiveness of these treatments.

We recognise the importance of monitoring. While ongoing clinical monitoring is outside Pharmac’s scope, we work with Health New Zealand to understand wider system impacts of funding decisions, including laboratory testing.

Patients, clinicians

Requested first‑line funded ibrutinib monotherapy, irrespective of mutational status, for people currently self‑funding to avoid switching to combination therapy.

The proposal was to fund combination treatment in the first line setting. We acknowledge some people may be self-funding ibrutinib as monotherapy currently and there would be 6 months for those people to change to funded combination treatment if clinically appropriate.

Pharmac has applications for two first‑line monotherapy BTK inhibitors ranked on the Options for Investment list and these are medicines we would like to fund when we have budget to do so.

Patients, clinicians

Requested second line funded ibrutinib monotherapy for people who relapse or are intolerant to a first line treatment.

We appreciate the feedback and understand that there is a health need for funded second‑line ibrutinib monotherapy.

As a result of the feedback, and additional clinical advice, we are widening access to ibrutinib to allow this to be used in second line.

This also ensures that people who received chemotherapy as first line treatment can access ibrutinib as their next treatment.

Clarity on proposal

Individual

Requested clarification on what “fixed duration" will mean.

For these treatments, the ‘fixed duration’ refers to the length of time treatment was used in the clinical trials. This is based on the clinical advice we received from our expert clinical advisors CTAC, the maximum doses and durations for each treatment align with the clinical trial evidence and international guidelines. More details about the clinical advice we received on treatment duration are available in the record of the Oct 2023 meeting.

Record of October 2023 meeting of the Cancer Treatment Advisory Committee [PDF, 991 KB]

Pharmacist

Requested clarity on the application of the transitional access policy.

If an individual received the first doses of obinutuzumab as an inpatient in a public hospital, would they be able to receive the rest of the treatment funded in a private clinic.

If cycle 1, day 1 is the accepted date for transitional access eligibility, regardless of public administration.

The transitional access policy was implemented by the government.

If a person is receiving treatment in a private setting at the time of funding (regardless of where the first dose was given), they would be eligible for funded treatment. All other situations are outside of the policy.

If a person starts treatment after the transition period and receives the first dose in public, the remaining treatment cycles would not be funded for administration in a private facility.

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.