National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (January Update) Instrument 2022 (Cth)

Case

PB 123 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (January Update) Instrument 2022

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), 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     22 December 2022                    

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

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

  1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (January Update) Instrument 2022.

(2)This instrument may also be cited as PB 123 of 2022.

  1. 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 January 2023 1 January 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Note:          This table relates only to the provisions of this instrument as originally made.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.

  1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

  1. 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)

  1. Part 1, Division 1, Section 6, definition for “medication for the treatment of HIV or AIDS”

substitute:

medication for the treatment of HIV or AIDS means any of the following:

(a)  abacavir;

(b)  abacavir with lamivudine;

(c)  abacavir with lamivudine and zidovudine;

(d)  atazanavir;

(e)  atazanavir with cobicistat;

(f)  azithromycin;

(g)  bictegravir with emtricitabine with tenofovir alafenamide;

(h)  cabotegravir;

(i)  cabotegravir and rilpivirine;

(j)  darunavir;

(k)  darunavir with cobicistat;

(l)  darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

(m)  dolutegravir;

(n)  dolutegravir with abacavir and lamivudine;

(o)  dolutegravir with lamivudine;

(p)  dolutegravir with rilpivirine;

(q)  doxorubicin ‑ pegylated liposomal;

(r)  efavirenz;

(s)  emtricitabine with rilpivirine with tenofovir alafenamide;

(t)  emtricitabine with tenofovir alafenamide;

(u)  etravirine;

(v)  fosamprenavir;

(w)  ganciclovir;

(x)  lamivudine;

(y)  lamivudine with zidovudine;

(z)  lopinavir with ritonavir;

(aa)  maraviroc;

(bb)  nevirapine;

(cc)  raltegravir;

(dd)  rifabutin;

(ee)  rilpivirine;

(ff)  ritonavir;

(gg)  saquinavir;

(hh)  tenofovir;

(ii)  tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

(jj)  tenofovir with emtricitabine;

(kk)  tenofovir with emtricitabine and efavirenz;

(ll)  valganciclovir;

(mm)  zidovudine.

  1. Schedule 1, entry for Eltrombopag in each of the forms: Tablet 25 mg (as olamine); and Tablet 50 mg (as olamine)

omit from the column headed “Circumstances”: C11199 C11202 C11244 C11262 C11263             substitute: C13325 C13326 C13327 C13395

  1. Schedule 1, entry for Mycophenolic acid in the form Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”

Pharmacor Mycophenolate C5554 C5795 C9691 C9693 2 5

  1. Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg

omit from the column headed “Circumstances” (all instances): C13141 C13144 C13145 C13252   substitute: C13746 C13755 C13757 C13768

  1. Schedule 1, entry for Romiplostim in each of the forms: Powder for injection 375 micrograms; and Powder for injection 625 micrograms

omit from the column headed “Circumstances”: C11205 C11246 C11266 C11267 C11289             substitute: C13329 C13376 C13396 C13399

  1. Schedule 1, omit entry for Tipranavir

  1. Schedule 1, entry for Zoledronic acid

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zoledronic Acid Accord C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 1 11

  1. Schedule 2, entry for Eltrombopag

substitute:

Eltrombopag C13325 C13326 C13327 C13395 1 pack 5

  1. Schedule 2, entry for Pomalidomide

substitute:

Pomalidomide C13757 C13768 1 pack (14 capsules) 2
C13746 C13755 1 pack (21 capsules) 5

  1. Schedule 2, entry for Romiplostim

substitute:

Romiplostim C13399 1 vial 5
C13329 C13376 C13396 Sufficient for treatment for 4 weeks 5

  1. Schedule 3, entry for Eltrombopag

substitute:

Eltrombopag C13325 Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be swapping therapy from romiplostim to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with romiplostim may change to eltrombopag under this restriction. 		Compliance with Authority Required procedures
C13326 Severe thrombocytopenia
Initial treatment - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4 weeks; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form, and
(3) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
The platelet count must be no more than 4 weeks old at the time of application. 		Compliance with Written Authority Required procedures
C13327 Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C13395 Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have swapped treatment from romiplostim to this drug under the Balance of supply or change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Pomalidomide

substitute:

Pomalidomide C13746 Multiple myeloma
Initial treatment - dual therapy in combination with dexamethasone
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND
Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and
(2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) 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
C13755 Multiple myeloma
Continuing treatment - dual therapy in combination with dexamethasone
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). 		Compliance with Authority Required procedures
C13757 Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone)
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy that is either: (i) lenalidomide monotherapy, (ii) contains lenalidomide; AND
Patient must have undergone or be ineligible for a stem cell transplant.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures
C13768 Multiple myeloma
Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Romiplostim

substitute:

Romiplostim C13329 Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have swapped treatment from eltrombopag to this drug under the Balance of supply or change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C13376 Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be swapping therapy from eltrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with eltrombopag, may change to romiplostim under this restriction. 		Compliance with Authority Required procedures
C13396 Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week 		Compliance with Authority Required procedures
C13399 Severe thrombocytopenia
Initial treatment - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4 weeks; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.
Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form, and
(3) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
The platelet count must be no more than 4 weeks old at the time of application. 		Compliance with Written Authority Required procedures

  1. Schedule 3, omit entry for Tipranavir

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