Proposal to widen access to rituximab and change the funded brand for all funded indications excluding rheumatoid arthritis

A decision has been made

Read the decision to widen access to rituximab and award sole supply – published 5 December 2019

From 1 March 2020, new Special Authority criteria would apply to biosimilar rituximab (Riximyo), based on current rituximab criteria with amendments and additions. The proposed changes are to remove the criteria for rheumatoid arthritis and to include the following new or amended uses (additions in bold and deletions in strikethrough – relevant criteria only shown):Amended criteria

Maintenance treatment in CD20+ low grade or follicular B-cell Non-Hodgkin's Lymphoma

Initial application - indolent, low-grade lymphomas or hairy cell leukaemia*

Applications from any relevant practitioner. Approvals valid for 9 months.

Either:

1.  Both:

1.1   The patient has indolent low grade NHL or hairy cell leukaemia* with relapsed disease following prior chemotherapy; and
1.2   To be used for a maximum of 6 treatment cycles; or

2.  Both :

2.1   The patient has indolent, low grade lymphoma or hairy cell leukaemia* requiring first-line systemic chemotherapy; and
2.2   To be used for a maximum of 6 treatment cycles

Note: 'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia. *Unapproved indication. 'Hairy cell leukaemia' also includes hairy cell leukaemia variant.

Renewal - indolent, low-grade lymphomas or hairy cell leukaemia*

Applications from any relevant practitioner. Approvals valid for 912 months.

Either:

1.  All of the following:

1.1   The patient has indolent, low-grade NHL or hairy cell leukaemia* with relapsed disease following prior chemotherapy; and
1.2   The patient has had a rituximab treatment-free interval of 12 months or more; and\
1.3   To be used for no more than 6 treatment cycles; or

2.  Both:

2.1   Rituximab is to be used for maintenance in CD20+ low grade or follicular B-cell NHL following induction with first-line systemic chemotherapy, and
2.2   Patient is intended to receive rituximab maintenance therapy for 2 years at a dose of 375 mg/m2 every 8 weeks (maximum of 12 cycles).

Note: 'Indolent, low-grade lymphomas' includes follicular, mantle, marginal zone and lymphoplasmacytic/Waldenstrom macroglobulinaemia. *Unapproved indication. 'Hairy cell leukaemia' also includes hairy cell leukaemia variant.

ABO incompatible organ transplant

Initial application – (ABO-incompatible renal organ transplant) from any relevant practitioner only from a nephrologist or Practitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified where patient is to undergo an ABO-incompatible renal solid organ transplant*. Note: Indications marked with * are unapproved indications

Antibody mediated organ transplant rejection

Initial application – (Antibody-mediated renal organ transplant rejection) from any relevant practitioner. only from a nephrologist or Practitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified where patient has been diagnosed with antibody-mediated renal organ transplant rejection*. Note: Indications marked with * are unapproved indications.

New criteria

Severe antisynthetase syndrome

Initial application – (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has confirmed antisynthetase syndrome; and

2. Patient has severe, immediately life or organ threatening disease, including interstitial lung disease; and

3. Either

3.1   Treatment with at least 3 immunosuppressants (oral steroids, cyclophosphamide, methotrexate, mycophenolate, ciclosporin, azathioprine) has not be effective at controlling active disease; or
3.2   Rapid treatment is required due to life threatening complications; and

4. Maximum of four 1000mg infusions of rituximab.

Renewal – (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for 12 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 inflammatory markers, muscle strength and pulmonary function; and
2. The patient has not received rituximab in the previous 6 months; and
3. Maximum of two cycles of 2 x 1000mg infusions of rituximab given two weeks apart.

Graft versus host disease

Initial application – (graft versus host disease) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria.

All of the following:

1. Patient has refractory graft versus host disease following transplant; and
2. Treatment with at least 3 immunosuppressants (oral steroids, ciclosporin, tacrolimus, mycophenolate, sirolimus) has not be effective at controlling active disease; and
3. The total rituximab dose used would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

Severe chronic inflammatory demylelinating neuropathy

Initial application – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or any other 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
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 any other 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.

Anti-NMDA receptor autoimmune encephalitis

Initial application – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or any other 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; 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 other 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 would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).

From 1 September 2020, Riximyo would be awarded Sole Subsidised Supply status in the Pharmaceutical Schedule (the only available brand of rituximab in DHB hospitals) for all funded indications except for rheumatoid arthritis until 30 June 2023.