Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 December 2025

1 December 2025

Abrilada

C12120 C14061 C14063 C14064 C14107 C14136

See Schedule 2

See Schedule 2

Abrilada

C12120 C14061 C14063 C14064 C14107 C14136

See Schedule 2

See Schedule 2

MOVAPO POD

C10830 C10863

90

5

Solution for subcutaneous injection 920 mg in 23 mL

Injection

Ocrevus SC

C7386 C7699 C9523 C9635

1

0

C17424

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather 2 (transition from LSDP-funded eculizumab)

Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17427

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase

Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17428

Paroxysmal nocturnal haemoglobinuria (PNH)

Subsequent Continuing Treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C17430

Paroxysmal nocturnal haemoglobinuria (PNH)

Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)

Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND

Patient must have received insufficient quantity to complete the induction treatment phase; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17467

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)

Patient must be planning pregnancy; OR

Patient must be pregnant; AND

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17468

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised pegcetacoplan or iptacopan - induction doses

Patient must have received PBS-subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17472

Paroxysmal nocturnal haemoglobinuria (PNH)

First Continuing Treatment

Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17492

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - initial 1 (new patient) induction doses

Patient must not have received prior treatment with this drug for this condition; AND

Patient must have a diagnosis of PNH established by flow cytometry; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17574

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)

Patient must be planning pregnancy; OR

Patient must be pregnant; AND

Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17602

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather 2 (transition from LSDP-funded eculizumab)

Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17626

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase

Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17630

Paroxysmal nocturnal haemoglobinuria (PNH)

Switching from PBS-subsidised pegcetacoplan or iptacopan - induction doses

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17651

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)

Patient must be planning pregnancy; OR

Patient must be pregnant; AND

Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17673

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)

Patient must be planning pregnancy; OR

Patient must be pregnant; AND

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17675

Paroxysmal nocturnal haemoglobinuria (PNH)

Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)

Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND

Patient must have received insufficient quantity to complete the induction treatment phase; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17684

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - initial 1 (new patient) induction doses

Patient must not have received prior treatment with this drug for this condition; AND

Patient must have a diagnosis of PNH established by flow cytometry; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17693

Paroxysmal nocturnal haemoglobinuria (PNH)

Subsequent Continuing Treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C17697

Paroxysmal nocturnal haemoglobinuria (PNH)

First Continuing Treatment

Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C10061

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10061

C10077

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077

C16056

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 16056

C16133

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 16133

C17635

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17635

C17637

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17637

C17638

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17638

C17696

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17696

C10061

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10061

C10075

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10075

C10077

Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077

C17634

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17634

C17635

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17635

C17637

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 17637

Pegcetacoplan

C17598

Paroxysmal nocturnal haemoglobinuria (PNH)

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First continuing treatment', 'Return' criteria, or 'Grandfather' treatment restrictions; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.

Compliance with Written Authority Required procedures

C17599

Paroxysmal nocturnal haemoglobinuria (PNH)

Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 1 (Complement 5 (C5) inhibitor inexperienced patients)

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND

Patient must not have received any treatment for this condition prior to commencing non-PBS-subsidised treatment with this drug; AND

Patient must have had a diagnosis of PNH established by flow cytometry prior to commencing non-PBS-subsidised treatment with this drug; AND

Patient must have had PNH granulocyte clone size equal to or greater than 10% prior to commencing non-PBS-subsidised treatment with this drug; AND

Patient must have had a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing non-PBS-subsidised treatment with this drug; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have had debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have had a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; OR

Patient must have had recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.

A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.

Compliance with Written Authority Required procedures

C17601

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 1 (new untreated patient)

Patient must not have received prior treatment with any of the PBS-subsidised therapies listed for this condition; AND

Patient must have a diagnosis of PNH established by flow cytometry; AND

Patient must have PNH granulocyte clone size equal to or greater than 10%; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17622

Paroxysmal nocturnal haemoglobinuria (PNH)

Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 2 (Complement 5 (C5) inhibitor experienced patients)

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND

Patient must have had PNH granulocyte clone size equal to or greater than 10% within the last 3 months prior to commencing non-PBS-subsidised treatment with this drug; AND

Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND

The treatment must have been in combination with one C5 inhibitor for a period of 4 weeks during initiation of therapy; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.

A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.

Compliance with Written Authority Required procedures

C17623

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 2 (switching from a Complement 5 (C5) inhibitor)

Patient must not have received prior treatment with this drug for this condition; AND

Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND

Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND

The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17647

Paroxysmal nocturnal haemoglobinuria (PNH)

First continuing treatment

Patient must have received PBS-subsidised treatment with this drug for this condition under 'Initial 1' (new untreated patient) or 'Initial 2' (switching from a Complement 5 (C5) inhibitor); AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17683

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancy

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)' criteria; OR

Patient must have received prior PBS-subsidised treatment with at least one drug listed for this condition and must be returning to pegcetacoplan treatment for reasons other than post pregnancy; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan.

Compliance with Written Authority Required procedures

C17415

Paroxysmal nocturnal haemoglobinuria (PNH)

First Continuing Treatment

Patient must have received PBS-subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17420

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dose

Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND

Patient must have a diagnosis of PNH established by flow cytometry prior to LSDP-funded treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP-funded treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP-funded treatment with eculizumab; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP-funded treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP-funded treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP-funded treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP-funded treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17423

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 1 (new patient) induction dose

Patient must not have received prior treatment with this drug for this condition; AND

Patient must have a diagnosis of PNH established by flow cytometry; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17463

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather (transition from non-PBS-subsidised treatment)

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2022; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; AND

Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17464

Paroxysmal nocturnal haemoglobinuria (PNH)

Subsequent Continuing Treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

Compliance with Written Authority Required procedures

C17469

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised eculizumab - induction dose

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)' criteria; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long-term continuing PBS-subsidised treatment with this drug is planned, a 'Returning' patient may proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17493

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised pegcetacoplan or iptacopan - induction dose

Patient must have received PBS-subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17605

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 1 (new patient) induction dose

Patient must not have received prior treatment with this drug for this condition; AND

Patient must have a diagnosis of PNH established by flow cytometry; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17606

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised eculizumab - induction dose

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)' criteria; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long-term continuing PBS-subsidised treatment with this drug is planned, a 'Returning' patient may proceed under the 'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17609

Paroxysmal nocturnal haemoglobinuria (PNH)

Subsequent Continuing Treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; OR

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

Compliance with Written Authority Required procedures

C17610

Paroxysmal nocturnal haemoglobinuria (PNH)

Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dose

Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND

Patient must have a diagnosis of PNH established by flow cytometry prior to LSDP-funded treatment with eculizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP-funded treatment with eculizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP-funded treatment with eculizumab; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP-funded treatment with eculizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP-funded treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP-funded treatment with eculizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP-funded treatment with eculizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C17629

Paroxysmal nocturnal haemoglobinuria (PNH)

First Continuing Treatment

Patient must have received PBS-subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

Compliance with Written Authority Required procedures

C17630

Paroxysmal nocturnal haemoglobinuria (PNH)

Switching from PBS-subsidised pegcetacoplan or iptacopan - induction doses

Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND

Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria.

Compliance with Written Authority Required procedures

C17631

Paroxysmal nocturnal haemoglobinuria (PNH)

Grandfather (transition from non-PBS-subsidised treatment)

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2022; AND

Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; AND

Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; AND

Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; AND

Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND

Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; OR

Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; OR

Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; OR

Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR

Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR

Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Must be treated by a haematologist; OR

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x109/L)

(iii) White Cell Count (x109/L)

(iv) Reticulocytes (x109/L)

(v) Neutrophils (x109/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5

Compliance with Written Authority Required procedures

C16217

Moderate to severe chronic pouchitis

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 December 2024; AND

Patient must be receiving treatment with this drug for this condition at the time of application; AND

Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis at least one year prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND

The condition must be confirmed based on the patient's symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); AND

Patient must have had a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5 at the time of initiating treatment with this drug for this condition; AND

Patient must have had a minimum endoscopic mPDAI sub-score of at least 2 at the time of initiating treatment with this drug for this condition; AND

Patient must have had at least 3 recurrent episodes of pouchitis within the year prior to initiating treatment with this drug for this condition, each of which was treated with at least 2 weeks of antibiotic or other prescription therapy; OR

The condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

The treatment must have been initiated in combination with standard of care antibiotic; AND

Patient must have demonstrated a partial or complete response to treatment with this drug as determined by the treating clinician, for this condition if the patient has received non-PBS-subsidised treatment for the first three doses of induction.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

The assessment of a patient's response to this course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.

The application for authorisation of treatment must be in writing and must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:

(i) the patient's baseline Modified Pouchitis Disease Activity Index (mPDAI) score and minimum endoscopic mPDAI sub-score; and

(ii) details of prior drug therapy for the condition [dosage, date of commencement and duration of therapy]; and

(iii) the date of commencement of this drug for this condition.

The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient's condition at baseline must have been performed no more than 4 weeks prior to initiation with non-PBS-subsidised treatment with this drug.

The prescriber must have excluded secondary causes of pouchitis, for example:

(a) Ischaemia;

(b) Crohn's disease (CD) or CD of the pouch;

(c) Irritable pouch syndrome;

(d) Predominant cuffitis;

(e) Pouch stricture or pouch fistula;

(f) Active infection;

(g) NSAIDs;

(h) Coeliac disease.

Compliance with Written Authority Required procedures