Decision to fund rituximab for IgG4-related disease

7 June 2023

Medicines Decision

What we’re doing

We're pleased to announce that from 1 July 2023 Pharmac will widen access to rituximab (Riximyo) for people with the chronic inflammatory condition immunoglobulin G4-related disease (IgG4-RD), subject to eligibility criteria.

What does this mean for people and prescribers

From 1 July 2023, people with IgG4 disease who meet certain eligibility criteria will be able to access rituximab (Riximyo).

Rituximab is a monoclonal antibody medicine currently funded for use in a variety of indications, including cancer, rheumatoid arthritis, and autoimmune and haematological conditions (see: Section B of the Pharmaceutical Schedule – rituximab (Riximyo).(external link)

Rituximab, administered as an intravenous infusion is Medsafe approved for the treatment of Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Medsafe datasheet for Riximyo brand rituximab [PDF](external link)

IgG4-related 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-related disease is uncommon and can be difficult to diagnose. The disease can affect many organs and body systems, and people with the disease have a wide diverse range of symptoms, signs and severity.

Rituximab is not Medsafe approved for use in this indication and would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981(external link).

Any relevant practitioner will be able to help people access this product by applying for a Special Authority.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 23 March 2023. We received feedback from consumers, clinicians, and professional societies.

We want to thank everyone who took the time to provide us with their feedback. A summary of the feedback received and our responses to this feedback is included below.

The only change made to the original proposal following consultation was clarification that IgG4-RD is not a Medsafe approved indication. This has been reflected in the Special Authority criteria below.

Who we think will be most 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

Detail about this decision

The listing of rituximab in Section B and Part II of Section H of the Pharmaceutical Schedule will be amended to include the following criteria from 1 July 2023 (new criteria shown only, changes post consultation are indicated in bold):

Initial application – (immunoglobulin G4-related disease (IgG4-RD*)) from any relevant practitioner. Approvals valid for 6 weeks for applications meeting the following criteria:

All of the following:

Patient has confirmed diagnosis of IgG4-RD*; and
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
Total rituximab dose used should not exceed a maximum of two 1000 mg infusions of rituximab given two weeks apart.

Note: Indications marked with * are unapproved indications

Renewal – (immunoglobulin G4-related disease (IgG4-RD*)) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

Either:
1. Treatment with rituximab for IgG4-RD* was previously successful and patient’s disease has demonstrated sustained response, but the condition has relapsed; or
2. Patient is receiving maintenance treatment for IgG4-RD*; and
Rituximab re-treatment not to be given within 6 months of previous course of treatment; and
Maximum of two 1000 mg infusions of rituximab given two weeks apart.

Note: Indications marked with * are unapproved indications

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responders were supportive of the proposal and all responses received were considered in their entirety in making the decision to widen access to rituximab for IgG4-related disease. A summary of the main themes raised in feedback and our responses to the feedback received can be found below:

THEME	COMMENT
Clarification was requested regarding which prescriber types are able to apply for a Special Authority for rituximab for IgG4 related disease, specifically confirming if clinical immunologists would be able to apply	Special Authority applications for rituximab for IgG4-related disease may be applied for by ‘any relevant practitioner’. This means all practitioners acting within their scope of practice (including clinical immunologists) would be able to apply for a Special Authority for rituximab for IgG4-related disease.
Considered that specialty-based prescriber restrictions would be an effective way of ensuring patients most likely to benefit from rituximab would have access.	We consider that eligibility criteria are for funding purposes, and we trust that practitioners would prescribe within their scope of practice. We know that each person’s treatment journey is different, and we want to ensure that there are no unnecessary barriers (prescriber restrictions) in access to treatment for those eligible for funded treatment.
Noted that there is no need to provide information to the Ministry of Health when an approved medicine is used for an unapproved use (Section 25 of the Medicines Act 1981), but that information is required for access to medicines via Special Authority. Requested that an application be made to Medsafe for this indication.	We consider that these are separate issues. Pharmac Special Authority criteria are in place to target funded treatment to those considered by our clinical advisors likely to benefit from treatment and hence are in place for funding purposes. There are numerous examples of medicines with eligibility criteria funded for unapproved indications. Instead, Section 25 of the Medicines Act 1981 relates to exemptions for prescribers working within their scope of practice in relation to medicine supply. As a result of this feedback, for clarity, we have highlighted that IgG4-RD is an unapproved indication, similar to other unapproved indications for which rituximab is funded.

THEME

COMMENT

Clarification was requested regarding which prescriber types are able to apply for a Special Authority for rituximab for IgG4 related disease, specifically confirming if clinical immunologists would be able to apply

Special Authority applications for rituximab for IgG4-related disease may be applied for by ‘any relevant practitioner’. This means all practitioners acting within their scope of practice (including clinical immunologists) would be able to apply for a Special Authority for rituximab for IgG4-related disease.

Considered that specialty-based prescriber restrictions would be an effective way of ensuring patients most likely to benefit from rituximab would have access.

We consider that eligibility criteria are for funding purposes, and we trust that practitioners would prescribe within their scope of practice. We know that each person’s treatment journey is different, and we want to ensure that there are no unnecessary barriers (prescriber restrictions) in access to treatment for those eligible for funded treatment.

Noted that there is no need to provide information to the Ministry of Health when an approved medicine is used for an unapproved use (Section 25 of the Medicines Act 1981), but that information is required for access to medicines via Special Authority. Requested that an application be made to Medsafe for this indication.

We consider that these are separate issues.

Pharmac Special Authority criteria are in place to target funded treatment to those considered by our clinical advisors likely to benefit from treatment and hence are in place for funding purposes. There are numerous examples of medicines with eligibility criteria funded for unapproved indications. Instead, Section 25 of the Medicines Act 1981 relates to exemptions for prescribers working within their scope of practice in relation to medicine supply.

As a result of this feedback, for clarity, we have highlighted that IgG4-RD is an unapproved indication, similar to other unapproved indications for which rituximab is funded.

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.