Proposed changes to the Riximyo access criteria

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (Nneuromyelitis Ooptica Sspectrum Ddisorder (NMOSD)*) only from any relevant practitioner a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria:

BothAll of the following:

1. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m² administered weekly for four weeks Cumulative dose up to 1500 mg/m2 body surface area up to 2000 mg total per cycle; and
2. Either
   1. The pPatient has experienced a severe episode or attack of NMOSD (rapidly progressing symptoms and with supporting supportive clinical investigations supportive of a severe attack of NMOSD); or
   2. All of the following:
      1. The pPatient has experienced a breakthrough attack of NMOSD; and
      2. The pPatient is receiving treatment with mycophenolate unless contraindicated or not tolerated; and
      3. The pPatient  is receiving treatment with corticosteroids unless contraindicated or not tolerated; and
3. Each treatment cycle at least 6 months apart.

Renewal — Neuromyelitis Optica Spectrum Disorder (NMOSD) 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. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m² administered weekly for four weeks; and
2. The patient has responded to the most recent course of rituximab; and
3. The patient has not received rituximab in the previous 6 months.

Note: Indications marked with * are unapproved indications

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (Severe Rrefractory Mmyasthenia Ggravis*) only from a neurologist or medical any relevant practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:

Both:

1. 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; and Cumulative dose up to 1500 mg/m2 body surface area up to 2000 mg total per cycle; and
2. Either
   1. Treatment with corticosteroids and at least one other immunosuppressant for at least a minimum period of 12 months has been ineffective; or
   2. Both:
      1. Treatment with at least one other immunosuppressant for a period of at least 12 months; and
      2. Corticosteroids have been trialled for at least 12 months and have been discontinued due to unacceptable side effects.

Note: Indications marked with * are unapproved indications

Renewal — (Severe Rrefractory Mmyasthenia Ggravis *) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

1. 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; and Cumulative dose up to 1500 mg/m2 body surface area up to 2000 mg total per cycle; and
2. An initial response lasting at least 12 months was demonstrated
3. Either:
   1. The pPatient  has relapsed despite treatment with corticosteroids and at least one other immunosuppressant for a period of at least 12 months; or
   2. Both:
      1. The pPatient’s myasthenia gravis has relapsed despite treatment with at least one immunosuppressant for a period of at least 12 months; and
      2. Corticosteroids have been trialled for at least 12 months and have been discontinued due to unacceptable side effects.

Note: Indications marked with * are unapproved indications

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (Steroid dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS)) only from a nephrologist or any relevant Ppractitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient is a child with SDNS* or FRNS*; and
2. Treatment with corticosteroids, ciclosporin, and mycophenolate for at least a period of 3 months for each agent has been ineffective, not tolerated, or is contraindicated or associated with evidence of steroid toxicity; and
   
   3 Treatment with ciclosporin for at least a period of 3 months has been ineffective and/or discontinued due to unacceptable side effects; and
   
   4 Treatment with mycophenolate for at least a period of 3 months with no reduction in disease relapses; and
3. 5 The total rituximab dose used per cycle would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks; and
4. Subsequent retreatment only for each relapse; and
5. Each treatment cycle at least 6 months apart.

Note: Indications marked with * are unapproved indications.

Renewal — (Steroid dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS)) only from a nephrologist or Practitioner on the recommendation of a nephrologist. Approvals valid for 4 weeks for applications meeting the following criteria:

All of the following:

1. Patient who was previously treated with rituximab for nephrotic syndrome*; and
2. Treatment with rituximab was previously successful and has demonstrated sustained response for greater than 6 months, but the condition has relapsed and the patient now requires repeat treatment; 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.

Note: Indications marked with * are unapproved indications.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (Steroid resistant nephrotic syndrome (SRNS)*) only from a nephrologist or any relevant Ppractitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient is a child with SRNS* where and treatment with corticosteroids, and ciclosporin and tacrolimus for at least 3 months for each agent have has been ineffective, not tolerated, or is contraindicated; and
   
   2. Treatment with tacrolimus for at least 3 months has been ineffective; and
2. 3. Genetic causes of nephrotic syndrome have been excluded; and
3. 4. The total rituximab dose used per cycle would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks; and
4. Subsequent retreatment only for each relapse; and
5. Each treatment cycle at least 6 months apart.

Note: Indications marked with * are unapproved indications.

Renewal — (Steroid resistant nephrotic syndrome (SRNS)*) only from a nephrologist or Practitioner on the recommendation of a nephrologist. Approvals valid for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient who was previously treated with rituximab for nephrotic syndrome*; and
2. Treatment with rituximab was previously successful and has demonstrated sustained response for greater than 6 months, but the condition has relapsed and the patient now requires repeat treatment; 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.

Note: Indications marked with * are unapproved indications.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (thrombotic thrombocytopenic purpura (TTP)*) only from a haematologist or any relevant Ppractitioner on the recommendation of a haematologist. Approvals valid for without further renewal unless notified 8 weeks for applications meeting the following criteria:

BothAll of the following:

1. The total rituximab dose used per cycle would not exceed the equivalent of 375 mg/m2 of body surface area per week for a total of 4 weeks; and
2. Each treatment cycle at least 6 months apart; and
3. Either
   1. Patient has thrombotic thrombocytopenic purpura* and has experienced progression of clinical symptoms or persistent thrombocytopenia despite plasma exchange; or
   2. Patient has acute idiopathic thrombotic thrombocytopenic purpuraTTP* with neurological or cardiovascular pathology.

Note: Indications marked with * are unapproved indications.

Renewal — (thrombotic thrombocytopenic purpura (TTP)*) \only from a haematologist or Practitioner on the recommendation of a haematologist. Approvals valid for 8 weeks for applications meeting the following criteria.

All of the following:

1. Patient was previously treated with rituximab for thrombotic thrombocytopenic purpura*; and
2. An initial response lasting at least 12 months was demonstrated; and
3. Patient now requires repeat treatment; and
4. 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

Note: Indications marked with * are unapproved indications.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (treatment refractory systemic lupus erythematosus (SLE)*) only from a rheumatologist, nephrologist or any relevant Ppractitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid without further renewal unless notified for 7 months for applications meeting the following criteria:

All of the following:

1. The pPatient has severe, immediately life- or organ-threatening SLE*; and
2. The disease condition has been proved refractory to treatment with corticosteroids at a dose of at least 1 mg/kg unless contraindicated; and
3. The disease condition has relapsed following prior treatment for at least 6 months with maximal tolerated doses of azathioprine, mycophenolate mofetil, and high dose cyclophosphamide, or cyclophosphamide is contraindicated; and
4. Initial treatment Mmaximum of four 1000 mg infusions of rituximab; and
5. Treatment for relapse following initial partial response to rituximab up to a maximum of two 1000 mg infusions every 6 months.

Note: Indications marked with * are unapproved indications.

Renewal — (treatment refractory systemic lupus erythematosus (SLE)*) only from a rheumatologist, nephrologist, or Practitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s SLE* achieved at least a partial response was achieved from to the previous round of prior rituximab treatment; and
2. The disease has subsequently relapsed.; and
3. Maximum of two 1000 mg infusions of rituximab

Note: Indications marked with * are unapproved indications.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for without further renewal unless notified 12 months for applications meeting the following criteria.

All of the following:

1. Patient has confirmed antisynthetase syndrome; and

1. 2. Patient has severe, immediately life- or organ-threatening disease, including interstitial lung disease; and
2. 3. Either:
   1. 3.1 Treatment with at least 3 immunosuppressants (oral corticosteroids, cyclophosphamide, methotrexate, mycophenolate, ciclosporin, azathioprine) has not be been ineffective at controlling active disease; or
   2. 3.2 Rapid treatment is required due to for life threatening complications.; and
3. 4. Maximum of four two 1,0001000 mg infusions of rituximab every 6 months.

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 × 1,000mg infusions of rituximab given two weeks apart

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application – (anti-NMDA receptor autoimmune encephalitis*) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria.

All of the following:

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

1. 2 Either:
   1. 2.1.  Both:
      1. 2.1.1 Treatment with corticosteroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling has been ineffective controlling active disease, is not tolerated or is contraindicated; and
      2. 2.1.2  At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling has been ineffective controlling active disease, is not tolerated or is contraindicated; or
   2. 2.2 Rapid treatment is required due to for life threatening complications; and
2. 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 1,000mg doses given two weeks apart Cumulative dose up to 1500 mg/m2 body surface area up to 2000 mg total per cycle; and
3. Each treatment cycle at least 6 months 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.

Note: Indications marked with * are unapproved indications

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application — (Mmembranous nephropathy) only from a nephrologist or any relevant practitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified for 6 weeks for applications meeting the following criteria.

All of the following:

1. Either:
   1. Patient has biopsy-proven primary/idiopathic membranous nephropathy*; or
   2. Patient has PLA2 antibodies with no evidence of secondary cause, and an eGFR of >60 ml/min/1.73m²; and
2. Patient remains at high risk of progression to end-stage kidney disease despite more than 3 months of treatment with conservative measures (see Note) that include (unless contraindicated or the patient has experienced intolerable side effects) renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents; and
3. The total rituximab dose per cycle would not exceed the equivalent of 375mg/m2 of body surface area per week for a total of 4 weeks; and
4. Subsequent retreatment only for disease relapse or after partial response; and
5. Each treatment cycle at least 6 weeks apart.

Renewal — (Membranous nephropathy) only from a nephrologist or any relevant practitioner on the recommendation of a nephrologist. Approvals valid for 6 weeks for applications meeting the following criteria.

1. Patient was previously treated with rituximab for membranous nephropathy*; and
2. Either:
   1. Treatment with rituximab was previously successful, but the condition has relapsed, and the patient now requires repeat treatment; or
   2. Patient achieved partial response to treatment and requires repeat treatment (see Note); 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

Note:

a) Indications marked with * are unapproved indications.

b) High risk of progression to end-stage kidney disease defined as >5 g/day proteinuria.

c) Conservative measures include renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents unless contraindicated or the patient has experienced intolerable side effects.

d) Partial response defined as a reduction of proteinuria of at least 50% from baseline, and between 0.3 grams and 3.5 grams per 24 hours.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

Initial application – (severe chronic inflammatory demyelinating polyneuropathy (CIPD)*) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria.

All of the following:

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

1. Either:
   1. 2.1  Both:
      1. 2.1.1  Treatment with corticosteroids and intravenous immunoglobulin and/or plasma exchange has not been ineffective at controlling active disease, is not tolerated, or is contraindicated; and
      2. 2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) is not tolerated or has not been ineffective at controlling active disease. If an immunosuppressant is contraindicated, a trial has occurred of one of those which is not contraindicated (unless all are contraindicated); or
   2. 2.2  Rapid treatment is required due to for life threatening complications; and
2. 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. Cumulative dose up to 1500 mg/m2 body surface area up to 2000 mg total per cycle; and
3. Each treatment cycle at least 6 months apart.

Renewal – (severe chronic inflammatory demyelinating polyneuropathy) 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 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.

Note: Indications marked with * are unapproved indications