Decision to widen access to rituximab and award sole supply

From 1 March 2020

• A biosimilar rituximab (Riximyo, supplied by Novartis) will be funded.
• The Riximyo brand will be funded for:
  • all new and existing patients requiring rituximab except patients with rheumatoid arthritis
  • new indications:
    • maintenance for CD20+ low grade or follicular B-cell non-Hodgkin’s lymphoma
    • graft versus host disease
    • antisynthetase syndrome with lung disease
    • anti NMDA receptor encephalitis
    • severe chronic inflammatory demyelinating neuropathy
    • amending existing criteria for transplant indications to allow use for any organ.
• The currently funded brand of rituximab (Mabthera, supplied by Roche) will be funded for:
  • existing patients for all indications except the new indications shown above
  • new and existing patients with rheumatoid arthritis.

From December 2020

• The Riximyo brand will be funded for all indications, including the new indications listed above, except for rheumatoid arthritis, and will be the only funded brand of rituximab for these indications until 30 September 2023.

• The Mabthera brand will be funded for patients with rheumatoid arthritis only.

Special Authority for Subsidy

Initial application – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following

1. Patient has severe chronic inflammatory demyelinating polyneuropathy (CIPD); and
2. Either

2.1   Treatment with at least 3 immunosuppressants (oral and intravenous steroids, cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or
Both

2.1.1   Treatment with steroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling active disease; and
2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or

2.2   Rapid treatment is required due to life threatening complications; and

3. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Renewal – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function compared to baseline; and
2. The patient has not received rituximab in the previous 6 months; and
3. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Initial application – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following

1. Patient has severe anti-NMDA receptor autoimmune encephalitis; and
2. Either

2.1   Treatment with at least 3 immunosuppressants (oral and intravenous steroids, cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease;
Both

2.1.1   Treatment with steroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling active disease; and
2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling active disease; or

2.2   Rapid treatment is required due to life threatening complications; and

3. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Renewal – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or any medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function; and
2. The patient has not received rituximab in the previous 6 months; and
3. The patient has experienced a relapse and now requires further treatment; and
4. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

The same restrictions for the Riximyo brand of rituximab will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).