Proposed changes for neurology conditions

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
   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.

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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

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. 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.

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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

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
   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.

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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

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

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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