Decision to widen access to rituximab for people with B-cell acute lymphoblastic leukaemia/lymphoma

Medicines Decision

We're widening access to rituximab (Riximyo).

What we’re doing

We're widening access to rituximab (Riximyo) to include treatment of people with newly diagnosed B-cell acute lymphoblastic leukaemia/lymphoma (B-cell ALL).

What does this mean for people?

From 1 August 2021, people with B-cell ALL who meet the funding criteria will be eligible for funded access to rituximab.

Rituximab is a monoclonal antibody agent currently funded for use in a variety of indications subject to access critieria, including cancer, rheumatoid arthritis, autoimmune and haematological conditions (see: Section B - rituximab)(external link).

Rituximab is Medsafe approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis. Rituximab is not Medsafe approved for use in B-cell ALL.

This means that rituximab use in this indication would need to be prescribed and used in accordance withsection 25 of the Medicines Act 1981(external link).

We estimate that approximately 20 people will benefit from this decision each year.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 25 May 2021.

We’re grateful for the time people took to respond to this consultation.

Following review of the consultation feedback, we have not made any changes to the proposed Special Authority.

Who we think will be interested

  • People with blood cancers and their whānau
  • Haematologists and oncologists
  • Hospital pharmacists
  • Other organisations with an interest in the treatment of cancer

Detail about this decision

The criteria for funded access to rituximab (Riximyo) will be amended in Section B of the Pharmaceutical Schedule from 1 August 2021 to include people with B-cell ALL (new criteria shown only):

Initial application - (B-cell acute lymphoblastic leukaemia/lymphoma*) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. Patient has newly diagnosed B-cell acute lymphoblastic leukaemia/lymphoma*; and
  2. Treatment must be in combination with an intensive chemotherapy protocol with curative intent; and
  3. The total rituximab dose would not exceed the equivalent of 375 mg/m2 per dose for a maximum of 18 doses.

Note: Indications marked with * are unapproved indications.

Similar restrictions will apply to Part II of Section H of the Pharmaceutical Schedule.

There are no changes to other existing Special Authority criteria or hospital restrictions for rituximab (Riximyo).

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responders were generally supportive of the proposal. All consultation responses received were considered in their entirety in making the decision to widen access to rituximab for B-cell ALL.

A summary of the main theme raised in feedback and our response to the feedback is set out below:



Suggested widening access to rituximab to include patients with relapsed B-cell ALL.

We consider that the use of rituximab in the relapsed setting would be a different indication to the current proposal and would need to be considered as a separate funding application. Further clinical advice would be required to understand the aspects relevant to the Factors for Consideration regarding this widening of access.  

We would be pleased to consider a funding application for the use of rituximab in this setting.

If you have any questions about this decision, you can email us at; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.