Decision to widen access to obinutuzumab for people with relapsed or refractory follicular or marginal zone lymphoma

Medicines Decision

Pharmac are widening access to funded obinutuzumab (Gazyva) for people with relapsed or refractory follicular or marginal zone lymphoma.

What we’re doing

We're pleased to announce a decision to widen access to funded obinutuzumab (Gazyva) for people with relapsed or refractory follicular or marginal zone lymphoma through a new agreement with Roche Products (New Zealand) Limited.

This decision comes following detailed consideration of the extensive and valuable feedback to our consultation on the access criteria for obinutuzumab that we originally proposed.

Who we think will be most interested

  • People with non-Hodgkin lymphoma and their whānau/carers
  • Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their families and whānau, who are affected by non-Hodgkin lymphoma
  • Healthcare professionals who treat patients with non-Hodgkin lymphoma
  • People interested in the funding of medicines for people with cancer
  • Pharmaceutical suppliers
  • Te Whatu Ora hospital pharmacies

What does this mean for people?

From 1 September 2022, people with follicular lymphoma and marginal zone lymphoma that has relapsed after, or is refractory to, a rituximab-containing regimen will be able to access funded obinutuzumab, subject to eligibility criteria.

Obinutuzumab is a targeted cancer therapy called a monoclonal antibody. Monoclonal antibodies work by finding specific proteins on cells. Obinutuzumab recognises the CD20 protein on the surface of lymphoma cells and makes it easier for your immune system to kill these cells.

Obinutuzumab is already funded for the treatment of some people with chronic lymphocytic leukaemia.

We anticipate that around 100 additional people in the first year will be eligible for treatment under the new criteria and around 50 each year after that. We expect that this decision will result in improvements in progression-free and overall survival for these patients.

We understand that incidence of follicular lymphoma is lower for Māori and Pacific peoples compared with non-Māori, non-Pacific peoples. However, the information we have available for other blood cancers, and non-Hodgkin lymphoma more generally (not just follicular lymphoma), suggests that the age-standardised incidence of indolent non-Hodgkin lymphoma may be greater in Māori and Pacific peoples, and outcomes may be worse. We are uncertain of the expected impact of this proposal for Māori and Pacific peoples, however we intend to monitor the uptake to inform future funding decisions for people with indolent non-Hodgkin lymphoma.

We acknowledge that this decision will impact already stretched infusion resources for Te Whatu Ora hospitals, but expect that over time, the wider impact on the health system will decrease due to the benefits associated with the efficacy of treatment. We expect that obinutuzumab will require similar infusion resource to the administration of rituximab. However, obinutuzumab is likely given in the inpatient setting, at least early in a patient’s treatment course.

Obinutuzumab is Medsafe approved for use in indolent non-Hodgkin lymphoma:(external link)

  • in combination with chemotherapy followed by maintenance obinutuzumab for people with previously untreated advanced follicular lymphoma ; and
  • in combination with bendamustine followed by maintenance obinutuzumab for people with indolent non-Hodgkin lymphoma who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

Any changes to the original proposal?

We publicly consulted on a proposal to fund obinutuzumab for non-Hodgkin lymphoma in May 2022, alongside proposals to fund several other medicines.

We have already notified decisions to fund other products included in this consultation. In this notification we indicated that we needed additional time to consider the feedback received in relation to the obinutuzumab proposal in detail to understand the impact of changes requested in the feedback.

We have taken this feedback on board and sought clinical advice in relation to this feedback. We have made two changes to the eligibility criteria as a result, to enable access to obinutuzumab:

  • for those who relapse or are refractory within 12 months of receiving a rituximab containing combined chemo-immunotherapy regimen (increased from six months in the consultation letter)
  • to enable it to be used in combination with chemotherapeutic regimens other than bendamustine.

We consider that these changes better reflect the unmet health need and will align better with clinical practice in New Zealand.

All consultation feedback received in relation to obinutuzumab has been summarised at the end of this notification letter.

Detail about this decision

Access to obinutuzumab will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2022 as follows (new criteria shown only, key changes from consultation indicated in bold):

Special Authority for Subsidy

Initial application – (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist.

Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

  1. Either:
    1. Patient has follicular lymphoma; or
    2. Patient has marginal zone lymphoma; and
  2. Patient is refractory to or has relapsed within 12 months of a rituximab containing combined chemo-immunotherapy regimen*; and
  3. Patient has an ECOG performance status of 0-2; and
  4. Patient has been previously treated with no more than four chemotherapy regimens; and
  5. Obinutuzumab to be administered at a maximum dose of 1000 mg for a maximum of 6 cycles in combination with chemotherapy*

 

Renewal - (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist.

Approvals valid for 24 months for applications meeting the following criteria:

All of the following:

  1. Patient has no evidence of disease progression following obinutuzumab induction therapy; and
  2. Obinutuzumab to be administered at a maximum of 1000 mg every 2 months for a maximum of 2 years; and
  3. Obinutuzumab to be discontinued at disease progression.

Note: * includes unapproved indications

As part of this decision, the eligibility criteria for bendamustine will be amended as below, to enable its use in combination with obinutuzumab (new criteria shown only).

Special Authority for Subsidy

Initial application — (Indolent, Low-grade lymphomas) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist.

Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

  1. The patient has indolent low grade NHL requiring treatment; and
  2. Patient has a WHO performance status of 0-2; and
  3. Any of the following:
    1. Both:
      1. Patient is treatment naive; and
      2. Bendamustine is to be administered for a maximum of 6 cycles (in combination with rituximab when CD20+); or
    2. Both:
      1. Patient is refractory to or has relapsed within 12 months of a rituximab containing combined chemo-immunotherapy regimen; and
      2. Bendamustine is to be administered in combination with obinutuzumab for a maximum of 6 cycles; or
    3. All of the following:
      1. The patient has not received prior bendamustine therapy; and
      2. Bendamustine is to be administered for a maximum of 6 cycles in relapsed patients (in combination with rituximab when CD20+); and
      3. Patient has had a rituximab treatment-free interval of 12 months or more; or
    4. Bendamustine is to be administered as monotherapy for a maximum of 6 cycles in rituximab refractory patients.

 

Renewal — (Indolent, Low-grade lymphomas) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist.

Approvals valid for 9 months for applications meeting the following criteria:

Either:

  1. Both:
    1. Patient is refractory to or has relapsed within 12 months of rituximab in combination with bendamustine; and
    2. Bendamustine is to be administered in combination with obinutuzumab for a maximum of 6 cycles; or
  2. Both:
    1. Patients have not received a bendamustine regimen within the last 12 months; and
    2. Either:
      1. Both:
        1. Bendamustine is to be administered for a maximum of 6 cycles in relapsed patients (in combination with rituximab when CD20+); and
        2. Patient has had a rituximab treatment-free interval of 12 months or more; or
      2. Bendamustine is to be administered as a monotherapy for a maximum of 6 cycles in rituximab refractory patients.

Note: 'indolent, low-grade lymphomas' include follicular, mantle cell, marginal zone and lymphoplasmacytic/ Waldenstrom's macroglobulinaemia.

Our response to what you told us

We’re really 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 summarised below. 

Theme

Comment

Support for the widening access to obinutuzumab

We are pleased to be funding a treatment that will have a positive effect on patients with follicular lymphoma or marginal zone lymphoma.

Request for removal of “in combination with bendamustine” criterion in the proposed Special Authority criteria as bendamustine in combination with rituximab is now standard of care in first line. Noted that repeated courses of bendamustine can induce marrow toxicity and lymphopenia.

We appreciate this feedback. In light of the feedback received and the subsequent clinical advice, we have amended the criteria. We consider this aligns with NZ clinical practice to better address the unmet need enabling use of this agent in combination with other chemotherapeutic regimens.

Request to rename ‘relapsed or refractory follicular lymphoma’ as ‘refractory’ only, as patients must have relapsed within 6 months after treatment with rituximab.

Request to modify the time frame for determination of refractoriness to 12 or 24 months, as this is the accepted definition of refractoriness and the important consideration for identifying those patients at higher risk.

We appreciate this feedback. In light of the feedback received and the subsequent clinical advice, we have amended the criteria to indicate that those patients who relapse after treatment with, or are refractory to, rituximab within 12 months of a rituximab containing chemoimmunotherapeutic regimen will be eligible for obinutuzumab. We also note that this will better align with the approval duration for rituximab.

Concerns about capacity and staffing resource to provide new cancer treatments

We appreciate the impact on clinical services to initiate and support patients on this treatment. Pharmac staff acknowledge that there is likely to be an impact associated with this proposal.

We note that these patients would receive maintenance rituximab if responding well in prior lines, and this proposal provides a treatment option for those patients who would likely receive chemotherapy only, with poorer outcomes expected.

While initially we expect that this will have an impact on infusion resource capacity, over time we anticipate that the proposal would result in health sector savings from a resource perspective due to the benefits that are expected from treatment.

Request for a change to the obinutuzumab criteria to enable patients who relapse following rituximab (within 6 months) to receive treatment.

Our clinical advisors consider that the greatest unmet need is those people who relapse early or are refractory to treatment. This would not include those patients who relapse after maintenance rituximab.

The amended criteria include patients who relapse within 12 months of a rituximab combined chemoimmunotherapeutic regimen.

The criteria for bendamustine would need to be amended to enable access to obinutuzumab in combination with bendamustine.

We are aware of this requirement and have included the amendments to the bendamustine eligibility criteria in this notification, which enable the use of bendamustine use in combination ith obinutuzumab.

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.