Proposal to fund rituximab for IgG4-related disease

What we’re proposing

We are seeking feedback on a proposal to fund rituximab for people with a chronic inflammatory condition called IgG4-related disease from 1 July 2023.

Details about this proposal, including how to provide feedback, can be found below.

We welcome your feedback on this proposal. Consultation closes at 4pm on Tuesday 11 April 2023 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 July 2023 access to funded rituximab (Riximyo brand) would be widened to include people who have IgG4-related disease, subject to eligibility criteria.

Who we think will be interested

  • People with IgG4-related disease and their whānau and caregivers
  • Rheumatologists, general practitioners, specialist nurses, and other health professionals involved in the care of people with IgG4-related disease
  • Hospital and community pharmacists, Te Whatu Ora and wholesalers
  • Pharmaceutical suppliers
  • Other organisations with an interest in IgG4-related disease and its treatment

About IgG4-related disease and rituximab

IgG4-related disease, which can also be known as IgG4-related systemic disease, is a chronic inflammatory condition. When someone has IgG4-related disease, different tissues within their body are penetrated by white blood cells known as lymphocytes and IgG4-secreting plasma cells. This causes the tissues to become scarred (fibrosed) and damaged.

IgG4 can affect many organs and body systems, and people with the disease have a wide diverse range of symptoms, signs and severity. IgG4-related disease is uncommon and has only recently been recognised. Its cause is unknown and it can be difficult to diagnose. We have been unable to source information on who is affected by IgG4-related disease in Aotearoa New Zealand, including Māori and Pacific peoples.

Rituximab is a monoclonal antibody medicine currently funded for use in a variety of indications, including cancer, rheumatoid arthritis, and autoimmune and blood conditions. It is administered as an intravenous infusion.

You can find all the indications rituximab is currently funded for in the Pharmaceutical Schedule(external link)

Riximyo is the currently funded brand of rituximab for all indications other than for rheumatoid arthritis. People who are eligible for funded rituximab for rheumatoid arthritis receive the Mabthera brand of rituximab. Riximyo is a biosimilar(external link) rituximab product.

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 IgG4-related disease. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

You can read more about section 25 of the Medicines Act 1981 on the Medsafe website(external link)

Why we’re proposing this

A funding application for rituximab for the treatment of IgG4-related disease was reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) Meeting in May 2021. PTAC recommended that rituximab be funded for IgG4-related disease with a high priority, subject to Special Authority criteria.

You can find the record of the PTAC meeting, along with the information about the application, on the application tracker(external link) on Pharmac’s website.

This advice, in combination with our recent budget uplift, has enabled us to progress this proposal. 

Details about our proposal

Access to rituximab would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2023 as follows (new criteria shown only):

Initial application – Immunoglobulin G4-related disease (IgG4-RD)

Application from any relevant practitioner. Approvals valid for 6 weeks for applications meeting the following criteria:

All of the following:

  1. Patient has confirmed diagnosis of IgG4-RD; and
  2. Either:
    1. Treatment with corticosteroids and/or disease modifying anti-rheumatic drugs for at least 3 months has been ineffective in lowering corticosteroid dose below 5 mg per day (prednisone equivalent) without relapse; or
    2. Treatment with corticosteroids and/or disease modifying anti-rheumatic drugs is contraindicated or associated with evidence of toxicity or intolerance; and
  3. Total rituximab dose used should not exceed a maximum of two 1000 mg infusions of rituximab given two weeks apart. 

Renewal – Immunoglobulin G4-related disease (IgG4-RD)

Application from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

  1. Either:
    1. Treatment with rituximab was previously successful and patient’s disease has demonstrated sustained response, but the condition has relapsed; or
    2. Patient is receiving maintenance treatment; and
  2. Rituximab re-treatment not to be given within 6 months of previous course of treatment; and
  3. Maximum of two 1000 mg infusions of rituximab given two weeks apart.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm on Tuesday 11 April 2023

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.