Proposal to fund two medicine combinations for chronic lymphocytic leukaemia (CLL)

Medicines Consultation Closes 04 Mar

What we’re proposing

Tell us what you think about our proposal to fund two fixed duration combination therapies for chronic lymphocytic leukaemia (CLL), a type of blood cancer:

  • Venetoclax (Venclexta) in combination with ibrutinib (Imbruvica) from 1 May 2026
  • Venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) from 1 May 2026

Impact of the proposal

If approved, this proposal would widen access to the following treatment combinations for CLL:

  • Venetoclax in combination with ibrutinib
  • Venetoclax in combination with obinutuzumab

Both combinations would be funded ‘first-line’, meaning that people could receive them as their first treatment for CLL, if they meet specific criteria. These criteria are further outlined in the ‘Details about our proposal’ section.

We estimate that between 80 and 90 people would receive one of the two combination therapy regimens per year over the first 5 years.

Evidence suggests that, for many people, these combination therapies are superior to the current standard of care. They can help people achieve longer periods of remission while avoiding traditional chemotherapy and could mean fewer hospital visits - supporting people to continue living well.

Furthermore, this widening of access will allow people with CLL to receive these drugs earlier in the course of their disease, potentially leading to better outcomes.

Eligible people who are receiving (or about to receive) treatment with these medicines in a private facility as at 1 May 2026 for these newly funded indications would be able to receive funded treatment in that facility for up to 12 months. More information about transitional access to cancer medicines is available on the Ministry of Health website.

Transitional access to new funded cancer medicines for patients receiving treatment in private facilities | Ministry of Health website(external link)

Consultation closes at 5pm 4 March 2026 and feedback can be emailed to consult@pharmac.govt.nz or through our online form.

Give feedback through the online form

What would the effect be?

  • From 1 May 2026, access to venetoclax and ibrutinib would be widened allowing these medicines to be used as a fixed duration combination therapy for first line treatment of people with CLL, regardless of their specific cancer mutation.
  • From 1 May 2026, access to venetoclax and obinutuzumab would be widened allowing these medicines to be used as a fixed duration combination therapy for first line treatment of people with CLL, regardless of their specific cancer mutation.

Who we think will be 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 the people with CLL
  • Health New Zealand | Te Whatu Ora
  • Cancer Control Agency | Te Aho o Te Kahu
  • Pharmaceutical suppliers and wholesalers

About CLL and these treatments

About CLL

CLL is a blood cancer that typically occurs in older adults. CLL can be asymptomatic in the early stages and is often detected routinely in annual blood tests or when a person presents to a doctor with swollen lymph nodes without further symptoms (asymptomatic lymphadenopathy).

CLL is a subset of leukaemia which has worse survival rates for Māori compared to Europeans or people of European descent. Data from the NZ Cancer Registry and Te Whatu Ora shows that Māori represented around 10% of CLL cases from 2019 to 2024.

Venetoclax & ibrutinib

Venetoclax is used to treat multiple types of leukaemia by binding to a protein called BCL-2. Ibrutinib is one type of a class of drug called bruton’s tyrosine kinase inhibitors (BTKi) used in the treatment of different types of blood cancer.

Venetoclax is currently funded in combination with rituximab for relapsed or refractory CLL, and as monotherapy for people with previously untreated CLL provided they have a specific cancer mutation. Currently, ibrutinib is funded as a single therapy for people with CLL who have relapsed on, or are refractory to, a venetoclax regimen.

Venetoclax and ibrutinib are not currently funded for use together as a combination therapy.

Venetoclax & obinutuzumab

Obinutuzumab is a monoclonal antibody drug which targets the CD20 antigen. It is used in combination with other drugs for the treatment of some blood cancers.

Obinutuzumab is funded in combination with chlorambucil for a subgroup of people with CLL.

Venetoclax and obinutuzumab are not currently funded for use together as a combination therapy.

Why we’re proposing this

Fixed-dose ibrutinib and venetoclax

We received applications to fund fixed-dose ibrutinib and venetoclax for people with previously untreated CLL with and without TP53 mutations in 2023.

Our clinical advisors noted that the health need for people with CLL remains high, and recommended we fund ibrutinib and venetoclax for these people with a high priority. Further detail on these applications for CLL with TP53 mutation and without TP53 mutation can be found in the application tracker on the Pharmac website.

Application for ibrutinib plus venetoclax chronic lymphocytic leaukaemia (CLL) with TP53 mutation(external link)

Application for ibrutinib plus venetoclax chronic lymphocytic leaukaemia (CLL) without TP53 mutation(external link)

Fixed-dose Obinutuzumab and venetoclax

We received an application to fund fixed-dose obinutuzumab and venetoclax for people with previously untreated CLL in 2020.

Our clinical advisors recommended we fund this treatment combination with a low priority in 2020. However, this was revised to a high priority at a subsequent meeting in 2023. This recommendation was driven by the need for a treatment option for clinically frailer individuals who may not tolerate other funded agents, and the relative efficacy of obinutuzumab and venetoclax combination therapy compared to the current standard of care. Full details of the application can be found in the application tracker(external link) on the Pharmac website.

Details about our proposal

Venetoclax

From 1 May 2026, Venetoclax would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (new criteria and amended criteria shown only, additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application - (previously untreated chronic lymphocytic leukaemia in combination with obinutuzumab) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

Either:

  1. Person is currently on treatment with venetoclax and obinutuzumab and met all of the following criteria prior to commencing treatment; or
  2. All of the following:
    1. Person has previously untreated chronic lymphocytic leukaemia; and
    2. Venetoclax is to be administered with obinutuzumab; and
    3. Venetoclax is to be used to a maximum dose of 400mg and for a total of 12 (28 day) cycles 

Renewal - (previously untreated chronic lymphocytic leukaemia in combination with obinutuzumab) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of clinical disease progression; and
  2. The treatment remains appropriate and the person is benefiting from treatment; and
  3. Venetoclax is to be administered in combination with obinutuzumab; and
  4. Venetoclax is to be discontinued after a maximum of 12 (28 day) cycles

Initial application - (previously untreated chronic lymphocytic leukaemia in combination with ibrutinib) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

Either:

  1. Person is currently on treatment with venetoclax and ibrutinib and met all of the following criteria prior to commencing treatment; or
  2. Both of the following:
    1. Person has previously untreated chronic lymphocytic leukaemia; and
    2. Venetoclax is to be administered in combination with ibrutinib 

Renewal - (previously untreated chronic lymphocytic leukaemia in combination with ibrutinib) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of clinical disease progression; and
  2. The treatment remains appropriate and the person is benefiting from treatment; and
  3. Venetoclax is to be administered in combination with ibrutinib; and
  4. Venetoclax is to be discontinued after a maximum of 12 (28 day) cycles

Initial application - (relapsed/refractory chronic lymphocytic leukaemia) Applications from any relevant practitioner. Approvals valid for 8 months for applications meeting the following criteria:

All of the following:

  1. Individual has chronic lymphocytic leukaemia requiring treatment; and
  2. Individual has received at least one prior therapy for chronic lymphocytic leukaemia; and
    3 Individual has not previously received funded venetoclax; and
  3. 4. The individual’s disease has relapsed; and
  4. 5. Venetoclax to be used in combination with six 28-day cycles of rituximab commencing after the 5-week dose titration schedule with venetoclax; and
  5. 6. Individual has an ECOG performance status of 0-2.

Renewal - (relapsed/refractory chronic lymphocytic leukaemia) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Treatment remains clinically appropriate, and the individual is benefitting from and tolerating treatment; and
  2. Venetoclax is to be discontinued after a maximum of 24 months of treatment following the titration schedule unless earlier discontinuation is required due to disease progression or unacceptable toxicity.

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

Ibrutinib

From 1 May 2026 Ibrutinib would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (new criteria and amended criteria shown only, additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application - (previously untreated chronic lymphocytic leukaemia in combination with venetoclax) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

  1. Person is currently on treatment with ibrutinib and venetoclax and met all of the following criteria prior to commencing treatment; or
  2. Both of the following:
    1. Person has previously untreated CLL; and
    2. Ibrutinib is to be administered at a maximum dose of 420 mg daily for 3 (28 day) cycles

Renewal - (previously untreated chronic lymphocytic leukaemia) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of clinical disease progression; and
  2. The treatment remains appropriate and the person is benefiting from treatment; and
  3. Ibrutinib to be administered in combination with venetoclax; and
  4. Ibrutinib is to be discontinued after a maximum of 15 (28 day cycles) of treatment.

Initial application - (chronic lymphocytic leukaemia (CLL)) from any relevant practitioner.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Individual has chronic lymphocytic leukaemia (CLL) requiring therapy; and
    2 Individual has not previously received funded ibrutinib; and
  2. 3. Ibrutinib is to be used as monotherapy; and
  3. 4. Any of the following Either:
    1. 4.1Both:
      1. 4.1.1 There is documentation confirming that the individual has 17p deletion or TP53 mutation; and
      2. 4.1.2 Individual has experienced intolerable side effects or is relapsed or refractory following with venetoclax monotherapy; or
    2. 4.2 All of the following:
      1. 4.2.1 Individual has received at least one prior immunochemotherapy for CLL; and
      2. 4.2.2 Individual’s CLL has relapsed; and
      3. 4.2.3 Individual has experienced intolerable side effects or is relapsed or refractory following  with venetoclax in combination with rituximab regimen; or

        4.3 Individual’s CLL is refractory to or has relapsed following a venetoclax regimen.

Renewal - (chronic lymphocytic leukaemia(CLL)) from any relevant practitioner.

Approvals valid for 12 months where there is no evidence of disease progression.

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

Obinutuzumab

From 1 May 2026 Obinutuzumab would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria (new criteria shown only):

Initial application - (previously untreated chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. Person is currently on treatment with obinutuzumab and venetoclax and met all of the following criteria prior to commencing treatment; or
  2. Both of the following:
    1. Person has previously untreated chronic lymphocytic leukaemia; and
    2. Obinutuzumab to be administered at a maximum cumulative dose of 8,000mg and in combination with venetoclax for a maximum of 6 cycles 28-day cycles of treatment.

Renewal - (previously untreated chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. No evidence of clinical disease progression; and
  2. The treatment remains appropriate and the person is benefiting from treatment; and
  3. Obinutuzumab to be administered in combination with venetoclax; and
  4. Obinutuzumab is to be discontinued after a maximum cumulative dose of 8,000mg and after a maximum of six cycles 28-day cycles of treatment.

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

To provide feedback

Send us an email to consult@pharmac.govt.nz or fill out our online form by 5pm 4 March 2026.

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.

Your feedback may be shared

When you give feedback on a consultation, your feedback becomes official information that Pharmac holds. Pharmac has legal responsibilities for how we manage this official information, under laws such as the Official Information Act and Privacy Act.

Pharmac may receive a request from people for official information, which could include your feedback. Legally, Pharmac must consider whether your feedback should be released.

We will consider your views when assessing whether the feedback has to be released. Tell us if there is anything about your feedback that you would prefer wasn’t released.

If your feedback is proposed for release, then Pharmac will contact you, unless there is a legal reason that we can't.

Note that Pharmac collects and holds your information in line with our Privacy Statement.