| 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 |
| C10483 | P10483 | Uncontrolled severe eosinophilic asthma
Grandfather treatment - use in a patient initiated with non-PBS subsidised pre-filled syringe or pen device
Patient must have received non-PBS-subsidised treatment with this biological medicine's pre-filled syringe or pen device for this PBS-indication prior to 1 June 2020; AND
Patient must have demonstrated or sustained an adequate response to treatment with this biological medicine if the patient has received at least the week 28 dose of this biological medicine; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed with severe asthma by a multidisciplinary severe asthma clinic team; AND
Patient must have had, prior to commencement of this drug, a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) Forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have had, prior to commencement of this drug, a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre prior to commencement of a biological medicine treatment for severe asthma; OR
Patient must have had a blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids prior to commencement of a biological medicine treatment for severe asthma; AND
Patient must have had a duration of asthma of at least 1 year prior to commencement of this biological medicine; AND
Patient must have failed to achieve adequate control with optimised asthma therapy prior to commencement of this biological medicine despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the 12 months prior to commencing treatment with a biological medicine for severe asthma, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application (if not already provided).
The following initiation criteria indicate failure to achieve adequate control with optimised asthma therapy and must be declared to have been met at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0 prior to commencement with a biological medicine for severe asthma; AND
(b) while receiving optimised asthma therapy in the 12 months prior to commencing treatment with a biological medicine for severe asthma, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
An Asthma Control Questionnaire (5 item version) assessment and/or an assessment of a reduction in the patient's maintenance oral corticosteroid dose to determine whether the patient has achieved or sustained an adequate response to non-PBS-subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been 28 weeks or greater.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
A Grandfathered 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.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Grandfather PBS Authority Application - Supporting Information Form which seeks details of the following (if not already provided):
(i) prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) eosinophil pathology report (eosinophil counts and dates); and
(iii) ACQ-5 scores including the date of assessment of the patient's symptoms, or details of the maintenance oral corticosteroid dose. | Compliance with Written Authority Required procedures |
| C10484 | P10484 | Uncontrolled severe eosinophilic asthma
Grandfather treatment - use in a patient initiated with non-PBS-subsidised pre-filled syringe or pen device
Patient must have received non-PBS-subsidised treatment with this biological medicine's pre-filled syringe or pen device for this PBS-indication prior to 1 June 2020; AND
Patient must have demonstrated or sustained an adequate response to treatment with this biological medicine if the patient has received at least the week 28 dose of this biological medicine; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed with severe asthma by a multidisciplinary severe asthma clinic team; AND
Patient must have had, prior to commencement of this drug, a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) Forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have had, prior to commencement of this drug, a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre prior to commencement of a biological medicine treatment for severe asthma; OR
Patient must have had a blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids prior to commencement of a biological medicine treatment for severe asthma; AND
Patient must have had a duration of asthma of at least 1 year prior to commencement of this biological medicine; AND
Patient must have failed to achieve adequate control with optimised asthma therapy prior to commencement of this biological medicine despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the 12 months prior to commencing treatment with a biological medicine for severe asthma, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application (if not already provided).
The following initiation criteria indicate failure to achieve adequate control with optimised asthma therapy and must be declared to have been met at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0 prior to commencement with a biological medicine for severe asthma; AND
(b) while receiving optimised asthma therapy in the 12 months prior to commencing treatment with a biological medicine for severe asthma, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
An Asthma Control Questionnaire (5 item version) assessment and/or an assessment of a reduction in the patient's maintenance oral corticosteroid dose to determine whether the patient has achieved or sustained an adequate response to non-PBS-subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been 28 weeks or greater.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
A Grandfathered 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.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Grandfather PBS Authority Application - Supporting Information Form which seeks details of the following (if not already provided):
(i) prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) eosinophil pathology report (eosinophil counts and dates); and
(iii) ACQ-5 scores including the date of assessment of the patient's symptoms, or details of the maintenance oral corticosteroid dose. | Compliance with Written Authority Required procedures |
Pharmaceutical items with modified prescription circumstances during COVID-19 pandemic |
Listed drug | Form | Manner of administration |
Abatacept | Powder for I.V. infusion 250 mg | Injection |
Adalimumab | Injection 20 mg in 0.4 mL pre‑filled syringe | Injection |
Adalimumab | Injection 40 mg in 0.8 mL pre‑filled syringe | Injection |
Adalimumab | Injection 40 mg in 0.8 mL pre‑filled pen | Injection |
Ambrisentan | Tablet 5 mg | Oral |
Ambrisentan | Tablet 10 mg | Oral |
Benralizumab | Injection 30 mg in 1 mL single dose pre‑filled syringe | Injection |
Benralizumab | Injection 30 mg in 1 mL single dose pre‑filled pen | Injection |
Bosentan | Tablet 62.5 mg (as monohydrate) | Oral |
Bosentan | Tablet 125 mg (as monohydrate) | Oral |
Dornase alfa | Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL | Inhalation |
Epoprostenol | Powder for I.V. infusion 500 micrograms (as sodium) | Injection |
Epoprostenol | Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL | Injection |
Epoprostenol | Powder for I.V. infusion 1.5 mg (as sodium) | Injection |
Epoprostenol | Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL | Injection |
Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL | Injection |
Etanercept | Injection 50 mg in 1 mL single use auto‑injector, 4 | Injection |
Etanercept | Injections 50 mg in 1 mL single use pre‑filled syringes, 4 | Injection |
Iloprost | Solution for inhalation 20 micrograms (as trometamol) in 2 mL | Inhalation |
Infliximab | Powder for I.V. infusion 100 mg | Injection |
Ivacaftor | Sachet containing granules 50 mg | Oral |
Ivacaftor | Sachet containing granules 75 mg | Oral |
Ivacaftor | Tablet 150 mg | Oral |
Lenalidomide | Capsule 5 mg | Oral |
Lenalidomide | Capsule 10 mg | Oral |
Lenalidomide | Capsule 15 mg | Oral |
Lenalidomide | Capsule 25 mg | Oral |
Lumacaftor with
ivacaftor | Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg | Oral |
Lumacaftor with
ivacaftor | Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg | Oral |
Lumacaftor with
ivacaftor | Tablet containing lumacaftor 100 mg with ivacaftor 125 mg | Oral |
Lumacaftor with ivacaftor | Tablet containing lumacaftor 200 mg with ivacaftor 125 mg | Oral |
Macitentan | Tablet 10 mg | Oral |
Mannitol | Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers | Inhalation by mouth |
Mepolizumab | Powder for injection 100 mg | Injection |
Mepolizumab | Injection 100 mg in 1 mL single dose pre-filled pen | Injection |
Omalizumab | Injection 75 mg in 0.5 mL single dose pre‑filled syringe | Injection |
Omalizumab | Injection 150 mg in 1 mL single dose pre‑filled syringe | Injection |
Pomalidomide | Capsule 3 mg | Oral |
Pomalidomide | Capsule 4 mg | Oral |
Riociguat | Tablet 500 micrograms | Oral |
Riociguat | Tablet 1 mg | Oral |
Riociguat | Tablet 1.5 mg | Oral |
Riociguat | Tablet 2 mg | Oral |
Riociguat | Tablet 2.5 mg | Oral |
Rituximab | Solution for I.V. infusion 500 mg in 50 mL | Injection |
Sildenafil | Tablet 20 mg (as citrate) | Oral |
Tadalafil | Tablet 20 mg | Oral |
Tezacaftor with ivacaftor and ivacaftor | Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg | Oral |
Tocilizumab | Concentrate for injection 80 mg in 4 mL | Injection |
Tocilizumab | Concentrate for injection 200 mg in 10 mL | Injection |
Tocilizumab | Concentrate for injection 400 mg in 20 mL | Injection |
Ustekinumab | Solution for I.V. infusion 130 mg in 26 mL | Injection |
Vedolizumab | Powder for injection 300 mg | Injection |
