Proposed changes for nephrology (renal) conditions

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.

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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.

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.

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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.

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.

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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.

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.

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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.