National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2022 (Cth)
Case
PB 81 of 2022
National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September 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 25 August 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
Name
(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (September Update) Instrument 2022.
(2)This instrument may also be cited as PB 81 of 2022.
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 September 2022, immediately after the commencement of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022 (PB 80 of 2022). | 1 September 2022 |
Note: This table relates only to the provisions of this instrument as originally made.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)
Schedule 1, entry for Ciclosporin in the form Capsule 10 mg
(a)omit from the column headed “Circumstances”: C6676
(b)omit from the column headed “Circumstances”: C9763
(c)insert in numerical order in the column headed “Circumstances”: C13122 C13168
Schedule 1, entry for Ciclosporin in the form Capsule 25 mg
(a)omit from the column headed “Circumstances” (all instances): C6676
(b)omit from the column headed “Circumstances” (all instances): C9763
(c)insert in numerical order in the column headed “Circumstances”: C13122 C13168
Schedule 1, entry for Ciclosporin in the form Capsule 50 mg
(a)omit from the column headed “Circumstances” (all instances): C6676
(b)omit from the column headed “Circumstances” (all instances): C9763
(c)insert in numerical order in the column headed “Circumstances”: C13122 C13168
Schedule 1, entry for Ciclosporin in the form Capsule 100 mg
(a)omit from the column headed “Circumstances” (all instances): C6676
(b)omit from the column headed “Circumstances” (all instances): C9763
(c)insert in numerical order in the column headed “Circumstances”: C13122 C13168
Schedule 1, entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL
(a)omit from the column headed “Circumstances”: C6676
(b)omit from the column headed “Circumstances”: C9763
(c)insert in numerical order in the column headed “Circumstances”: C13122 C13168
Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; Capsule 10 mg; and Capsule 15 mg
(a)omit from the column headed “Circumstances”: C10334 C10335 C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840
(b)insert in numerical order in the column headed “Circumstances”: C13142 C13143 C13146 C13150 C13190 C13192 C13193 C13194 C13218 C13219
Schedule 1, entry for Lenalidomide in the form Capsule 25 mg
(a)omit from the column headed “Circumstances”: C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840
(b)insert in numerical order in the column headed “Circumstances”: C13142 C13143 C13146 C13190 C13192 C13193 C13194 C13218
Schedule 1, entry for Nusinersen
(a)omit from the column headed “Circumstances”: C13046 C13047
(b)omit from the column headed “Circumstances”: C13089
(c)insert in numerical order in the column headed “Circumstances”: C13198 C13222 C13254 C13270
Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg
omit from the column headed “Circumstances”: C12693 C12698 C12893 C12914 substitute: C13141 C13144 C13145 C13252
Schedule 1, entry for Risdiplam
omit from the column headed “Circumstances”: C12675
Schedule 1, after entry for Selexipag in the form Tablet 1.6 mg
insert:
| Selinexor | Tablet 20 mg | Oral | Xpovio | C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13115 P13229 P13256 | 16 | 2 |
| C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13116 P13118 P13228 | 20 | 2 | ||||
| C13115 C13116 C13118 C13159 C13160 C13161 C13228 C13229 C13256 | P13159 P13160 P13161 | 32 | 2 |
Schedule 2, entry for Lenalidomide
substitute:
| Lenalidomide | C13193 C13194 | 14 tablets | 3 |
| C13142 | 21 tablets | 1 | |
| C12841 | 21 tablets | 2 | |
| C12985 C12997 C13192 | 21 tablets | 3 | |
| C13143 C13146 C13190 C13218 | 21 tablets | 5 | |
| C13150 C13219 | 28 tablets | 2 |
Schedule 2, entry for Nusinersen
substitute:
| Nusinersen | C13064 C13198 C13254 | 1 dose | 0 |
| C12667 C12672 C12676 C13222 C13270 | 1 dose | 3 |
Schedule 2, entry for Pomalidomide
substitute:
| Pomalidomide | C13144 C13145 | 1 pack (21 capsules) | 5 |
| C13141 C13252 | 1 pack (14 capsules) | 2 |
Schedule 2, entry for Risdiplam [Maximum quantity: 1; Maximum repeats: 0]
omit from the column headed “Circumstances”: C12675
Schedule 3, entry for Azacitidine
omit entry for circumstances code “C13029”and substitute:
| C13029 | Chronic Myelomonocytic Leukaemia Initial treatment The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder. The first 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: (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority 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). The following reports must be documented in the patient's medical records: (a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) full blood examination report No more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Ciclosporin
(a)omit:
| C6676 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6676 |
(b)omit:
| C9763 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a dermatologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9763 |
(c)insert in numerical order after existing text:
| C13122 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13122 |
| C13168 | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13168 |
Schedule 3, entry for Lenalidomide
(a)omit:
| C10334 | Multiple myeloma Initial treatment with lenalidomide monotherapy in newly diagnosed disease The treatment must be as monotherapy; AND The condition must be confirmed by a histological diagnosis; AND Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND Patient must not have progressive disease following autologous stem cell transplant (ASCT). The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application ‑ Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, the date the autologous stem cell transplant was performed, and nomination of which disease activity parameters will be used to assess progression. To enable confirmation of eligibility for treatment, the results of current diagnostic reports of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Written Authority Required procedures |
| C10335 | Multiple myeloma Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must not have demonstrated progressive disease; AND The treatment must be as monotherapy. 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. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Authority Required procedures |
| C10373 | Multiple myeloma Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must be ineligible for a primary stem cell transplantation; AND Patient must not be receiving concomitant PBS‑subsidised bortezomib, thalidomide or its analogues; AND The treatment must be in combination with dexamethasone. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application ‑ Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and ineligibility for prior stem cell transplant; and nomination of which disease activity parameters will be used to assess response; and (3) a signed patient acknowledgement. To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Written Authority Required procedures |
| C10427 | Multiple myeloma Continuing treatment until progression in patients initiated on dual combination therapy (lenalidomide and dexamethasone), or, in patients initiated on triple therapy (lenalidomide, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond Patient must have previously been authorised with a PBS prescription with this drug for the condition; AND Patient must not have demonstrated progressive disease; AND Patient must not be receiving concomitant PBS‑subsidised bortezomib, thalidomide or its analogues; AND The treatment must be in combination with 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). Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Authority Required procedures |
| C10428 | Multiple myeloma Initial treatment with triple therapy (lenalidomide, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28‑day treatment cycle The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must not be receiving concomitant PBS‑subsidised carfilzomib, thalidomide or its analogues; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application ‑ Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, current pathology results of (for items a, b, c, g), or, a statement that diagnosis was based on (for items d, e, f) at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients and kept on the patient’s records. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be declared to be held on the patient’s medical records. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Written Authority Required procedures |
| C10429 | Multiple myeloma Continuing treatment of triple therapy (lenalidomide, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28‑day treatment cycles) Patient must have received PBS‑subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND Patient must not be receiving concomitant PBS‑subsidised carfilzomib, thalidomide or its analogues; AND The treatment must be in combination with bortezomib and dexamethasone; AND The treatment must not exceed a total of 2 cycles under this restriction. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Authority Required procedures |
| C10452 | Multiple myeloma Continuing treatment of triple therapy (lenalidomide, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21‑day treatment cycles) Patient must have received PBS‑subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND Patient must not be receiving concomitant PBS‑subsidised carfilzomib, thalidomide or its analogues; AND The treatment must be in combination with bortezomib and dexamethasone; AND The treatment must not exceed a total of 4 cycles under this restriction. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Authority Required procedures |
| C10453 | Multiple myeloma Initial treatment with triple therapy (lenalidomide, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21‑day treatment cycle The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must not be receiving concomitant PBS‑subsidised carfilzomib, thalidomide or its analogues; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application ‑ Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, and nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, current pathology results of (for items a, b, c, g), or, a statement that diagnosis was based on (for items d, e, f) at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients and kept on the patient’s records. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be declared to be held on the patient’s medical records. Patients receiving this drug under the PBS listing must be registered in the i‑access risk management program. | Compliance with Written Authority Required procedures |
| C12689 | Multiple myeloma Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease The condition must be confirmed by a histological diagnosis; AND The treatment must be as monotherapy; OR The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a primary 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. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Multiple Myeloma lenalidomide Authority Application ‑ Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and (3) a signed patient acknowledgment. To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided. Patients receiving lenalidomide under the PBS listing must be registered in the i‑access risk management program. | Compliance with Written Authority Required procedures |
| C12840 | Multiple myeloma Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease Patient must have previously received PBS‑subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND The treatment must be as monotherapy; OR The treatment must be in combination with dexamethasone. Patients receiving lenalidomide under the PBS listing must be registered in the i‑access risk management program. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C13142 | Multiple myeloma Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles) Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND The treatment must not exceed a total of 2 cycles under this restriction. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13143 | Multiple myeloma Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND The treatment must be as monotherapy; OR The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone. Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13146 | Multiple myeloma Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond 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). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13150 | Multiple myeloma Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease 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 be as monotherapy. 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. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13190 | Multiple myeloma Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease The condition must be confirmed by a histological diagnosis; AND The treatment must be as monotherapy; OR The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a primary 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. 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 histological report confirming the diagnosis of multiple myeloma; and (2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and (3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and (4) details of the basis of the diagnosis of progressive disease or failure to respond; and (5) nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records. 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). Patients receiving lenalidomide under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures |
| C13192 | Multiple myeloma Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle The condition must be newly diagnosed; AND 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 not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. 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 histological report confirming the diagnosis of multiple myeloma; and (2) nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records. 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures |
| C13193 | Multiple myeloma Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles) Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND The treatment must not exceed a total of 4 cycles under this restriction. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13194 | Multiple myeloma Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle The condition must be newly diagnosed; AND 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 not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. 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 histological report confirming the diagnosis of multiple myeloma; and (2) nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records. 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures |
| C13218 | Multiple myeloma Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must be ineligible for a primary stem cell transplantation; AND The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone. 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 histological report confirming the diagnosis of multiple myeloma, and (2) confirmation of ineligibility for prior stem cell transplant; and (3) nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records. 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures |
| C13219 | Multiple myeloma Initial treatment with lenalidomide monotherapy in newly diagnosed disease The treatment must be as monotherapy; AND The condition must be confirmed by a histological diagnosis; AND Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND Patient must not have progressive disease following autologous stem cell transplant (ASCT). 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 histological report confirming the diagnosis of multiple myeloma; and (2) the date the autologous stem cell transplant was performed; and (3) nomination of which disease activity parameters will be used to assess progression. To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records. 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Nusinersen
(a)omit:
| C13046 | Spinal muscular atrophy (SMA) Initial treatment of symptomatic SMA - Loading doses Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA. The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must have experienced at least two of the defined signs and symptoms of SMA prior to 19 years of age; AND The treatment must not be used in combination with other SMA disease-modifying treatments, including risdiplam, for this condition; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction. Patient must be 19 years of age or older. Defined signs and symptoms of SMA are: (i) Onset before 19 years of age; and (ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or (iii) Proximal weakness; or (iv) Hypotonia; or (v) Absence of deep tendon reflexes; or (vi) Failure to gain weight appropriate for age; or (vii) Any active chronic neurogenic changes; or (viii) A compound muscle action potential below normative values for an age-matched child. Application for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; 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) specification of SMA type; and (ii) sign(s) and symptom(s) that the patient has experienced; and (iii) patient's age at the onset of sign(s) and symptom(s). | Compliance with Written Authority Required procedures |
| C13047 | Spinal muscular atrophy (SMA) Continuing/maintenance treatment of symptomatic spinal muscular atrophy (SMA) Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA. Patient must have previously initiated PBS-subsidised treatment with this drug for this condition at the age of 19 years or older; AND The treatment must not be used in combination with other SMA disease-modifying treatments, including risdiplam, for this condition; AND The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND Patient must demonstrate a clinically meaningful response to treatment, following 2 years of treatment. Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit. Treatment should cease if there is no agreement of benefit. Re-assessments for a clinically meaningful response are to be undertaken and documented every six months. Clinically meaningful response to treatment is defined as improvement, stabilisation or minimal decline in symptoms as demonstrated in the following areas: Maintenance of motor function as assessed using Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) and/or 6-minute walk test (6MWT). Maintenance of patient's quality of life including but not limited to level of independence. This may be informed by completion of the patient reported outcome measures SMA health index (SMA-HI) or SMA functional rating scale (SMAFRS). | Compliance with Authority Required procedures |
(b)omit:
| C13089 | Spinal muscular atrophy (SMA) Transitioning from non-PBS to PBS-subsided treatment - Grandfather treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 August 2022. Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA. The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must have experienced at least two of the defined signs and symptoms of SMA prior to 19 years of age; AND The treatment must not be used in combination with other SMA disease-modifying treatments, including risdiplam, for this condition; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND The treatment must be given concomitantly with best supportive care for this condition. Patient must be 19 years of age or older at the time of initial treatment with this drug. Defined signs and symptoms of SMA are: (i) Onset before 19 years of age; and (ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or (iii) Proximal weakness; or (iv) Hypotonia; or (v) Absence of deep tendon reflexes; or (vi) Failure to gain weight appropriate for age; or (vii) Any active chronic neurogenic changes; or (viii) A compound muscle action potential below normative values for an age-matched child. Application for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; 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) specification of SMA type; and (ii) sign(s) and symptom(s) that the patient has experienced; and (iii) patient's age at the onset of sign(s) and symptom(s). 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 Continuing treatment criteria. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C13198 | Spinal muscular atrophy (SMA) Continuing/maintenance treatment in an adult where treatment was initiated in adulthood The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; OR The treatment must be occurring within the first 104 weeks from the first administered dose; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug. Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND Patient must be undergoing continuing PBS-subsidised treatment that was initiated through the Initial treatment listing for SMA initiated in adulthood; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response. A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline. PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present. Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient's medical records. In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient's motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient's quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS). | Compliance with Authority Required procedures |
| C13222 | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA) Initial PBS-subsidised treatment in a child The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug. Patient must be of an age that is prior to their 19thbirthday at the time of this authority application; AND Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rdbirthday, but before their 19thbirthday (SMA type IIIB/IIIC). Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); OR Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. 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). Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are: (i) Failure to meet or regression in ability to perform age-appropriate motor milestones, (ii) Proximal weakness, (iii) Hypotonia, (iv) Absence of deep tendon reflexes, (v) Any active denervation or chronic neurogenic changes found on electromyography, (vi) A compound muscle action potential below normative values for an age-matched child. In this authority application, confirm: (1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy, (2) which of the above (i to vi) (at least 1) were present after their 3rdbirthday, but before their 19thbirthday, (3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
| C13254 | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA) Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Patient must be undergoing continuing/maintenance treatment initiated through this drug's Initial treatment listing for SMA type IIIB/IIIC in childhood; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. | Compliance with Authority Required procedures |
| C13270 | Spinal muscular atrophy (SMA) Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug. Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19thbirthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised). Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); OR Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. 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). Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are: (i) Failure to meet or regression in ability to perform age-appropriate motor milestones, (ii) Proximal weakness, (iii) Hypotonia, (iv) Absence of deep tendon reflexes, (v) Failure to gain weight appropriate for age, (vi) Any active denervation or chronic neurogenic changes found on electromyography, (vii) A compound muscle action potential below normative values for an age-matched child. In this authority application, confirm: (1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy, (2) which of the above (i to vii) (at least 1) were present during childhood, (3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Pomalidomide
substitute:
| Pomalidomide | C13141 | 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. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
| C13144 | 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures | |
| C13145 | 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). Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Written Authority Required procedures | |
| C13252 | 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. Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. | Compliance with Authority Required procedures |
Schedule 3, entry for Risdiplam
omit:
| C12675 | Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA) Transitioning from non‑PBS to PBS subsided treatment ‑ Grandfather treatment The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND Patient must have previously received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 August 2021; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND The treatment must not be in combination with PBS‑subsidised treatment with nusinersen for this condition; AND The treatment must be given concomitantly with best supportive care for this condition; AND Patient must be responding to non‑PBS subsidised risdiplam for this condition at the time of application. Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic. Patient must be untreated with gene therapy. Patient must have been 18 years of age or under at the time non‑PBS subsidised treatment with this drug was initiated for this condition. Application for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; and (b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following: i) specification of SMA type (I, II or IIIa); and (ii) sign(s) and symptom(s) that the patient has experienced; and (iii) patient's age at the onset of sign(s) and symptom(s). Defined signs and symptoms of type I SMA are: i) Onset before 6 months of age; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Hypotonia; or v) Absence of deep tendon reflexes; or vi) Failure to gain weight appropriate for age; or vii) Any active chronic neurogenic changes; or viii) A compound muscle action potential below normative values for an age‑matched child. Defined signs and symptoms of type II SMA are: i) Onset between 6 and 18 months; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Weakness in trunk righting/derotation; or v) Hypotonia; or vi) Absence of deep tendon reflexes; or vii) Failure to gain weight appropriate for age; or viii) Any active chronic neurogenic changes; or ix) A compound muscle action potential below normative values for an age‑matched child. Defined signs and symptoms of type IIIa SMA are: i) Onset between 18 months and 3 years of age; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Hypotonia; or v) Absence of deep tendon reflexes; or vi) Failure to gain weight appropriate for age; or vii) Any active chronic neurogenic changes; or viii) A compound muscle action potential below normative values for an age‑matched child. 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 Continuing treatment criteria. | Compliance with Written Authority Required procedures |
Schedule 3, after entry for Selexipag
insert:
| Selinexor | C13115 | P13115 | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 80 mg or 60 mg per week The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy for this condition; AND Patient must not have previously received this drug for this condition; AND Patient must have demonstrated refractory disease to the following prior treatments for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures |
| C13116 | P13116 | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 100 mg per week The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy for this condition; AND Patient must not have previously received this drug for this condition; AND Patient must have demonstrated refractory disease to the following prior treatments for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures | |
| C13118 | P13118 | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 100 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 | |
| C13159 | P13159 | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 160 mg per week The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy for this condition; AND Patient must not have previously received this drug for this condition; AND Patient must have demonstrated refractory disease to the following prior treatments for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. | Compliance with Authority Required procedures | |
| C13160 | P13160 | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 160 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 | |
| C13161 | P13161 | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 160 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy, prior to initiating non-PBS-subsidised therapy with this drug for this condition; AND Patient must have demonstrated refractory disease to prior treatments, prior to initiating non-PBS-subsidised therapy with this drug for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 | |
| C13228 | P13228 | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 100 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy, prior to initiating non-PBS-subsidised therapy with this drug for this condition; AND Patient must have demonstrated refractory disease to prior treatments, prior to initiating non-PBS-subsidised therapy with this drug for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 | |
| C13229 | P13229 | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 80 mg or 60 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 | |
| C13256 | P13256 | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 80 mg or 60 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least four prior lines of therapy, prior to initiating non-PBS-subsidised therapy with this drug for this condition; AND Patient must have demonstrated refractory disease to prior treatments, prior to initiating non-PBS-subsidised therapy with this drug for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti-CD38 monoclonal antibody; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti-CD38 monoclonal antibody. 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 |
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