Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

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; AND

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

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

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; AND

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)

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

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; AND

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.