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

Medicines

Consultation Closed

We are seeking feedback on a proposal to widen funded access to rituximab (Riximyo).

What we’re proposing

We are seeking feedback on a proposal to widen funded access to rituximab (Riximyo) for the treatment of people with newly diagnosed B-cell acute lymphoblastic leukaemia/lymphoma. 

This funding is proposed to start from 1 August 2021.

Consultation closes at 4pm on Wednesday 9 June 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that from 1 August 2021, funded access to rituximab would be widened to include the treatment of people with newly diagnosed B-cell acute lymphoblastic leukaemia/lymphoma (B-cell ALL).

We estimate that approximately 20 patients would benefit from this proposal each year.

Who we think will be interested

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

About rituximab and B-cell ALL

Rituximab is a monoclonal antibody agent currently funded for use in a variety of indications, including cancer, rheumatoid arthritis, autoimmune and haematological conditions (see: Section B(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 the other currently funded indications or for the proposed widening of funded access to include B-cell ALL.

This means that rituximab would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981 when used in these unapproved indications.(external link)

B-cell ALL is an aggressive blood cancer that results in too many immature white blood cells in the bone marrow and blood. It is the most common type of acute lymphoblastic leukaemia (ALL). It is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia.

Rituximab for the treatment of B-cell ALL is given intravenously, for a maximum of 18 doses in combination with chemotherapy. Our clinical advisors have indicated that there would be persistent long-term benefits when rituximab is added on to existing chemotherapy for people with B-cell ALL.

Why we’re proposing this

A funding application for rituximab for the treatment of newly diagnosed B-cell ALL(external link) was reviewed by PHARMAC’s Cancer Treatments Subcommittee of Pharmacology and Therapeutics Advisory Committee (PTAC) (CaTSoP) in August 2017 and in February 2021.

Rituximab (Riximyo) was awarded sole supply as part of a competitive procurement process in 2019 and was subsequently part of a successful biosimilar transition that concluded in 2020. As part of this process, the price and subsidy for rituximab reduced considerably and access was widened to rituximab for multiple cancers and inflammatory conditions, enabling treatment with rituximab for more New Zealanders.

In August 2017(external link), CaTSoP deferred making a recommendation for the funding of rituximab for people with newly diagnosed B-cell ALL due to uncertainty regarding the appropriate dosing regimen and the benefit of targeting funding to a subpopulation of patients.

Recently, at its February 2021 meeting(external link), CaTSoP recommended that rituximab be funded for the treatment of CD20 positive B-cell ALL with a medium priority and for the wider group of patients with B-cell ALL irrespective of CD20 expression with a low priority, subject to eligibility criteria.

We are proposing to fund rituximab for the wider group of patients (B-cell ALL irrespective of CD20 expression). The evidence indicates that the benefit of the proposed dosing regimen may be generalisable to all patients with B-cell ALL and not just those patients with CD20 expression.

Details about our proposal

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

Special Authority for Subsidy

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.

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

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm on Wednesday 9 June 2021.

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

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.