National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2023 (Cth)
PB 14 of 2023
National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2023
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 27 February 2023
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021) 2
Name
(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (March Update) Instrument 2023.
(2)This instrument may also be cited as PB 14 of 2023.
Commencement
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 March 2023 | 1 March 2023 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)
Part 2, Division 3, Subsection 24(1)
omit table and substitute:
| Special patient contribution for certain HSD pharmaceutical benefits | |||||||
| Item | Drug | Form | Manner of administration | Brand | Pack quantity | Claimed price ($) | |
| 1 | Lamivudine | Tablet 100 mg | Oral | Zeffix | 28 | 28.09 | |
| 2 | Valaciclovir | Tablet 500 mg (as hydrochloride) | Oral | Valtrex | 100 | 42.70 | |
Schedule 1, entry for Adalimumab in each of the forms: Injection 40 mg in 0.4 mL pre-filled pen; and Injection 40 mg in 0.4 mL pre-filled syringe
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Yuflyma | C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 | See Schedule 2 | See Schedule 2 |
Schedule 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cinacalcet Viatris | C10063 C10067 C10073 | 56 | 5 |
Schedule 1, entry for Eculizumab
(a)omit from the column headed “Circumstances”: C13461
(b)omit from the column headed “Circumstances”: C13619
(c)insert in numerical order in the column headed “Circumstances”: C13845 C13857
Schedule 1, entry for Ravulizumab in each of the forms: Solution concentrate for I.V. infusion 300 mg in 3 mL; and Solution concentrate for I.V. infusion 1,100 mg in 11 mL
(a)omit from the column headed “Circumstances”: C13466
(b)insert in numerical order in the column headed “Circumstances”: C13844
Schedule 1, entry for Zoledronic acid
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Zoledronate-DRLA 4 | C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 | 1 | 11 |
Schedule 2, entry for Eculizumab
substitute:
| Eculizumab | C6626 | 1 | Sufficient for 4 weeks of treatment |
| C13857 | 1 | 0 | |
| C6642 | 1 | 4 | |
| C6668 C6686 C6687 C6688 | 1 | 5 | |
| C6637 | 1 | 6 | |
| C13464 C13660 C13661 C13684 C13845 | 6 | 5 | |
| C13458 C13459 C13560 | 8 | 0 |
Schedule 2, entry for Ravulizumab [Maximum quantity: 1 dose; Maximum repeats: 2]
(a)omit from the column headed “Circumstances”: C13466
(b)insert in numerical order in the column headed “Circumstances”: C13844
Schedule 3, entry for Eculizumab
(a)omit:
| C13461 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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) a completed authority prescription form; 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) must be at least 1.5 | Compliance with Written Authority Required procedures |
(b)omit:
| C13619 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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) a completed authority prescription form; 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 |
(c)insert in numerical order after existing text:
| C13845 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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) a completed authority prescription form; 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 |
| C13857 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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) a completed authority prescription form; 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 |
Schedule 3, entry for Ravulizumab
(a)omit:
| C13466 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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 in writing and must include: (1) a completed authority prescription form; 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 |
(b)insert in numerical order after existing text:
| C13844 | 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 not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan. 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 in writing and must include: (1) a completed authority prescription form; 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 |
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