National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 3) (PB 24 of 2020) (Cth)
Case
PB 24 of 2020
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 3)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 30 March 2020
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 3).
(2)This Instrument may also be cited as PB 24 of 2020.
Commencement
This Instrument commences on 1 April 2020.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Part 1, Division 1, Section 4, definition for ‘medication for the treatment of HIV or AIDS’
substitute:
medication for the treatment of HIV or AIDS means any of the following:
(a) abacavir
(b) abacavir with lamivudine
(c) abacavir with lamivudine and zidovudine
(d) atazanavir
(e) atazanavir with cobicistat
(f) azithromycin
(g) bictegravir with emtricitabine with tenofovir alafenamide
(h) darunavir
(i) darunavir with cobicistat
(j) dolutegravir
(k) dolutegravir with abacavir and lamivudine
(l) dolutegravir with lamivudine
(m) dolutegravir with rilpivirine
(n) doxorubicin - pegylated liposomal
(o) efavirenz
(p) emtricitabine with rilpivirine with tenofovir alafenamide
(q) emtricitabine with tenofovir alafenamide
(r) enfuvirtide
(s) etravirine
(t) fosamprenavir
(u) ganciclovir
(v) lamivudine
(w) lamivudine with zidovudine
(x) lopinavir with ritonavir
(y) maraviroc
(z) nevirapine
(aa) raltegravir
(bb) rifabutin
(cc) rilpivirine
(dd) ritonavir
(ee) saquinavir
(ff) tenofovir
(gg) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat
(hh) tenofovir with emtricitabine
(ii) tenofovir with emtricitabine and efavirenz
(jj) tipranavir
(kk) valganciclovir
(ll) zidovudine
Schedule 1, entry for Atazanavir
omit:
| Capsule 150 mg (as sulfate) | Oral | Reyataz | BQ | EMP | C4454 C4512 | 120 | 5 | D |
Schedule 1, entry for Benralizumab in the form Injection 30 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C9918 C9941 C9982
(b)insert in numerical order in the column headed “Circumstances”: C10264 C10281 C10314
Schedule 1, entry for Benralizumab in the form Injection 30 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9918 C9941 C9982
(b)insert in numerical order in the column headed “Circumstances”: C10264 C10281 C10314
(c)omit from the column headed “Purposes”: P9982 substitute: P10281
Schedule 1, entry for Benralizumab in the form Injection 30 mg in 1 mL single dose pre‑filled syringe [Maximum Quantity: 1; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C9918 C9941 C9982
(b)insert in numerical order in the column headed “Circumstances”: C10264 C10281 C10314
(c)omit from the column headed “Purposes”: P9918 P9941 substitute: P10264 P10314
Schedule 1, after entry for Darunavir with cobicistat
insert:
| Darunavir with cobicistat, emtricitabine and tenofovir alafenamide | Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg | Oral | Symtuza | JC | EMP | C10317 C10324 | 60 | 5 | D |
Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C7594
(b)insert in numerical order in the column headed “Circumstances”: C10268
Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7594
(b)insert in numerical order in the column headed “Circumstances”: C10268
Schedule 1, entry for Glecaprevir with pibrentasvir in the form Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir
[Maximum Quantity: 84; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C7594
(b)insert in numerical order in the column headed “Circumstances”: C10268
(c)omit from the column headed “Purposes”: P7594 substitute: P10268
Schedule 1, entry for Lenalidomide in each of the forms: Capsule 5 mg; Capsule 10 mg; and Capsule 15 mg
insert in numerical order in the column headed “Circumstances”: C10334 C10335
Schedule 1, entry for Mepolizumab in the form Powder for injection 100 mg [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C9853 C9854
(b)omit from the column headed “Circumstances”: C9963
(c)insert in numerical order in the column headed “Circumstances”: C10221 C10222 C10280
(d)insert in numerical order in the column headed “Purposes”: P9885
Schedule 1, entry for Mepolizumab in the form Powder for injection 100 mg [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9853 C9854
(b)omit from the column headed “Circumstances”: C9963
(c)insert in numerical order in the column headed “Circumstances”: C10221 C10222 C10280
(d)insert in numerical order in the column headed “Purposes”: P10280
Schedule 1, entry for Mepolizumab in the form Powder for injection 100 mg [Maximum Quantity: 1; Number of Repeats: 7]
(a)omit from the column headed “Circumstances”: C9853 C9854
(b)omit from the column headed “Circumstances”: C9963
(c)insert in numerical order in the column headed “Circumstances”: C10221 C10222 C10280
(d)insert in numerical order in the column headed “Purposes”: P10221 P10222
Schedule 1, entry for Omalizumab in the forms Injection 75 mg in 0.5 mL single dose pre‑filled syringe
(a)omit from the column headed “Circumstances”: C9849 C9851
(b)omit from the column headed “Circumstances”: C9881 C9882 C9886 C9916
(c)insert in numerical order in the column headed “Circumstances”: C10219 C10223 C10226 C10265 C10279 C10299
Schedule 1, entry for Omalizumab in the form Injection 150 mg in 1 mL single dose pre‑filled syringe
(a)omit from the column headed “Circumstances”: C9849 C9851
(b)omit from the column headed “Circumstances”: C9881 C9882 C9886 C9916
(c)insert in numerical order in the column headed “Circumstances”: C10219 C10223 C10226 C10265 C10279 C10299
Schedule 1, entry for Pegfilgrastim
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Fulphila | AF | EMP | C7822 C7843 C9235 C9303 | 1 | 11 | D |
Schedule 1, entry for Peginterferon alfa‑2a in the form Injection 180 micrograms in 0.5 mL single use pre‑filled syringe
substitute:
| Injection 180 micrograms in 0.5 mL single use pre-filled syringe | Injection | Pegasys | RO | EMP | C5004 C9603 | 8 | 5 | C |
Schedule 1, entry for Sildenafil
omit from the column headed “Responsible Person” for the brand “Revatio”: PF substitute: UJ
Schedule 1, entry for Sofosbuvir with velpatasvir and voxilaprevir
omit from the column headed “Circumstances”: C5969 substitute: C10248
Schedule 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg
omit:
| Truvada | GI | EMP | C6985 C6986 | 60 | 5 | C |
Schedule 2, after entry for Responsible Person TX
insert:
| UJ | 50 629 389 911 |
Schedule 3, entry for Benralizumab
(a)omit:
| C9918 | P9918 | Uncontrolled severe eosinophilic asthma Initial treatment ‑ Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS‑subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS‑subsidised 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 and that is no older than 12 months immediately prior to commencing PBS‑subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ‑5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) eosinophil count and date; and (iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (v) the reason for switching therapy (i.e. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS‑subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ‑5 assessment of the patient's most recent course of PBS‑subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ‑5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS‑subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA‑approved Product Information). A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
| C9941 | P9941 | Uncontrolled severe eosinophilic asthma Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for 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 previous 12 months, 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. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. 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. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (c) the eosinophil count and date; and (d) Asthma Control Questionnaire (ACQ‑5) score. | Compliance with Written Authority Required procedures |
| C9982 | P9982 | Uncontrolled severe eosinophilic asthma Continuing treatment Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma. Patient must have demonstrated or sustained an adequate response to PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. 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. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 18 to 22 weeks after the first dose of PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application ‑ Supporting Information Form which includes details of maintenance oral corticosteroid dose; or a completed Asthma Control Questionnaire (ACQ‑5) calculation sheet including the date of assessment of the patient's symptoms. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C10264 | P10264 | Uncontrolled severe eosinophilic asthma Initial treatment - Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised 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 and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) eosinophil count and date; and (iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (v) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information). A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
| C10281 | P10281 | Uncontrolled severe eosinophilic asthma Continuing treatment Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma. Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. 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. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application - Supporting Information Form which includes: (i) details of maintenance oral corticosteroid dose; or (ii) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C10314 | P10314 | Uncontrolled severe eosinophilic asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for 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 previous 12 months, 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. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. 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. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (iii) the eosinophil count and date; and (iv) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
Schedule 3, after entry for Darunavir with cobicistat
insert:
| Darunavir with cobicistat, emtricitabine and tenofovir alafenamide | C10317 | HIV infection Continuing treatment Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner. Patient must have previously received PBS-subsidised therapy for HIV infection; AND The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures - Streamlined Authority Code 10317 |
| C10324 | HIV infection Initial treatment Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner. Patient must be antiretroviral treatment naive; OR Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND The treatment must not be in combination with ritonavir. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity. | Compliance with Authority Required procedures - Streamlined Authority Code 10324 |
Schedule 3, entry for Glecaprevir with pibrentasvir
(a)omit:
| C7594 | P7594 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C10268 | P10268 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND The treatment must be limited to a maximum duration of 16 weeks. The application must include details of the prior treatment regimen containing an NS5A inhibitor. | Compliance with Authority Required procedures |
Schedule 3, entry for Lenalidomide
(a)omit entry for circumstances code "C7383" and substitute:
| C7383 | Multiple myeloma Continuing treatment 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 |
(b)omit entry for circumstances code "C7808" and substitute:
| C7808 | Multiple myeloma Initial PBS‑subsidised treatment 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; AND Patient must not be receiving concomitant PBS‑subsidised bortezomib, carfilzomib or thalidomide or its analogues. 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 Authority Required procedures |
(c)insert in numerical order after existing text:
| 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. | Compliance with Authority Required procedures |
Schedule 3, entry for Mepolizumab
(a)omit:
| C9853 | Uncontrolled severe eosinophilic asthma Continuing treatment Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma. Patient must have demonstrated or sustained an adequate response to PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. 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. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 18 to 22 weeks after the first dose of PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application ‑ Supporting Information Form which includes details of maintenance oral corticosteroid dose; or a completed Asthma Control Questionnaire (ACQ‑5) calculation sheet including the date of assessment of the patient's symptoms. | Compliance with Written Authority Required procedures |
| C9854 | Uncontrolled severe eosinophilic asthma Initial treatment ‑ Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS‑subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS‑subsidised 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 and that is no older than 12 months immediately prior to commencing PBS‑subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ‑5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) eosinophil count and date; and (iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (v) the reason for switching therapy (i.e. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS‑subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ‑5 assessment of the patient's most recent course of PBS‑subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ‑5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS‑subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
(b)insert in the column headed “Purposes Code” for the circumstance code “C9885”: P9885
(c)omit:
| C9963 | Uncontrolled severe eosinophilic asthma Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for 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 previous 12 months, 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. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. 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. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (c) the eosinophil count and date; and (d) Asthma Control Questionnaire (ACQ‑5) score. | Compliance with Written Authority Required procedures |
(d)insert in numerical order after existing text:
| C10221 | P10221 | Uncontrolled severe eosinophilic asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for 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 previous 12 months, 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. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. 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. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (iii) the eosinophil count and date; and (iv) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C10222 | P10222 | Uncontrolled severe eosinophilic asthma Initial treatment - Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count greater than or equal to 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised 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 and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma (mepolizumab/benralizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) eosinophil count and date; and (iv) the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (v) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
| C10280 | P10280 | Uncontrolled severe eosinophilic asthma Continuing treatment Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma. Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. 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. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made at around 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Eosinophilic Asthma Continuing PBS Authority Application - Supporting Information Form which includes: (i) details of maintenance oral corticosteroid dose; or (ii) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Omalizumab
(a)omit:
| C9849 | Uncontrolled severe allergic asthma Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE, that is no more than 1 year old; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for 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 previous 12 months, 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. The initial IgE assessment must be no more than 12 months old at the time of application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. 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 severe asthma 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 for severe asthma within the same treatment cycle. A treatment break in PBS‑subsidised omalizumab therapy of at least 6 months must be observed in a patient with uncontrolled severe allergic asthma, in whom omalizumab is the only appropriate treatment option, and who has either failed to achieve or sustain a response to the most recent PBS‑subsidised omalizumab therapy. 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. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information) to be administered every 2 or 4 weeks. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Allergic Asthma PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (c) the IgE result; and (d) Asthma Control Questionnaire (ACQ‑5) score. | Compliance with Written Authority Required procedures |
| C9851 | Uncontrolled severe allergic asthma Continuing treatment Patient must have a documented history of severe allergic asthma; AND Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. An adequate response to omalizumab treatment is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ‑5) or ACQ‑IA 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 or ACQ‑IA score from baseline, OR (c) a reduction in the time‑adjusted exacerbation rates compared to the 12 months prior to baseline. All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ‑IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time‑adjusted exacerbation rate must be made at around 18 to 22 weeks after the first dose of PBS‑subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information), sufficient for 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application ‑ Supporting Information form which includes details of maintenance oral corticosteroid dose; and (c) Asthma Control Questionnaire (ACQ‑5) score or the Asthma Control Questionnaire interviewer administered version (ACQ‑IA) score. | Compliance with Written Authority Required procedures |
(b)omit:
| C9881 | Uncontrolled severe allergic asthma Initial treatment Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 6 to less than 12 years. Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must be under the care of the same physician for at least 6 months. Optimised asthma therapy includes: (i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long‑acting beta‑2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative; AND (ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3‑5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in 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. The initial IgE assessment must be no more than 12 months old at the time of application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) An Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version ‑ the ACQ‑IA be used), AND (b) while receiving optimised asthma therapy in the previous 12 months, 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. The Asthma Control Questionnaire (5 item version) or ACQ‑IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS‑subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS‑subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information) to be administered every 2 or 4 weeks. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application ‑ Supporting Information form, which includes the following: (i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (c) the IgE result; and (d) Asthma Control Questionnaire (ACQ‑5) score or the Asthma Control Questionnaire interviewer administered version (ACQ‑IA) score. | Compliance with Written Authority Required procedures |
| C9882 | Uncontrolled severe allergic asthma Balance of supply in a patient aged 6 to 12 years Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction. | Compliance with Authority Required procedures |
| C9886 | Uncontrolled severe allergic asthma Continuing treatment Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction; 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. An adequate response to omalizumab treatment 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, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction). All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate must be made at around 18 to 22 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of maintenance oral corticosteroid dose; or (c) a completed Asthma Control Questionnaire (ACQ-5) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber; for patients transitioned from the paediatric to the adolescent/adult restrictions an exacerbation calculation sheet may be submitted. | Compliance with Written Authority Required procedures |
| C9916 | Uncontrolled severe allergic asthma Initial treatment - Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Allergic Asthma (omalizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) the IgE results; and (iv) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 26 to 30 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 26 to 30 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C10219 | Uncontrolled severe allergic asthma Initial treatment - Initial 2 (Change of treatment) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Allergic Asthma (omalizumab) Initial PBS Authority Application - Supporting Information Form, which includes the following: (i) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment; and (iii) the IgE results; and (iv) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. | Compliance with Written Authority Required procedures |
| C10223 | Uncontrolled severe allergic asthma Balance of supply in a patient aged 6 to 12 years Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction. | Compliance with Authority Required procedures |
| C10226 | Uncontrolled severe allergic asthma Continuing treatment Patient must have a documented history of severe allergic asthma; AND Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. An adequate response to omalizumab treatment is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA 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 or ACQ-IA score from baseline, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline. All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application - Supporting Information form which includes details of: (i) maintenance oral corticosteroid dose; and (ii) Asthma Control Questionnaire (ACQ-5) score; or (iii) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score. | Compliance with Written Authority Required procedures |
| C10265 | Uncontrolled severe allergic asthma Initial treatment Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 6 to less than 12 years. Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must be under the care of the same physician for at least 6 months. Optimised asthma therapy includes: (i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative; AND (ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in 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. The initial IgE assessment must be no more than 12 months old at the time of application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used), AND (b) while receiving optimised asthma therapy in the previous 12 months, 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. The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form, which includes the following: (i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (iii) the IgE result; and (iv) Asthma Control Questionnaire (ACQ-5) score; or (v) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score. | Compliance with Written Authority Required procedures |
| C10279 | Uncontrolled severe allergic asthma Continuing treatment Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction; 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. An adequate response to omalizumab treatment 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, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction). All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate must be made at around 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Allergic Asthma PBS Authority Application and Supporting Information Form which includes details of: (i) maintenance oral corticosteroid dose; or (ii) Asthma Control Questionnaire (ACQ-5) score including the date of assessment of the patient's symptoms; or (iii) for patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the exacerbation rate has reduced. | Compliance with Written Authority Required procedures |
| C10299 | Uncontrolled severe allergic asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) 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 under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have 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 a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE, that is no more than 1 year old; AND Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for 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 previous 12 months, 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. The initial IgE assessment must be no more than 12 months old at the time of application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, 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. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug. 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 severe asthma 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 for severe asthma within the same treatment cycle. A treatment break in PBS-subsidised omalizumab therapy of at least 6 months must be observed in a patient with uncontrolled severe allergic asthma, in whom omalizumab is the only appropriate treatment option, and who has either failed to achieve or sustain a response to the most recent PBS-subsidised omalizumab therapy. 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. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks. A multidisciplinary severe asthma clinic team comprises of: A respiratory physician; and A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Allergic Asthma PBS Authority Application - Supporting Information Form, which includes the following: (i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and (ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (iii) the IgE result; and (iv) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
Schedule 3, entry for Peginterferon alfa‑2a
(a)omit from the column headed “Purposes Code” for circumstances code “C5004”: P5004
(b)omit:
| C6745 | P6745 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures |
(c)omit from the column headed “Purposes Code” for circumstances code “C9603”: P9603
Schedule 3, entry for Pomalidomide
substitute:
| Pomalidomide | C7791 | Multiple myeloma Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patient must not have progressive disease; AND The treatment must be in combination with dexamethasone; AND Patient must not be receiving concomitant PBS‑subsidised bortezomib, carfilzomib or thalidomide or its analogues. 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 |
| C7952 | Multiple myeloma Initial treatment The treatment must be in combination with 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; AND Patient must not be receiving concomitant PBS‑subsidised bortezomib, carfilzomib or thalidomide or its analogues. 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. If treatment with either bortezomib or lenalidomide is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication. If intolerance to either bortezomib or lenolidomide treatment develops during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance. 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 pomalidomide Authority Application Supporting Information form; and (3) reports demonstrating the patient has failed treatment with, providing details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide; and (4) reports demonstrating the patient has failed treatment with, providing details of the contraindication to or details of the nature and severity of the intolerance to bortezomib. 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 Sofosbuvir with velpatasvir and voxilaprevir
substitute:
| Sofosbuvir with velpatasvir and voxilaprevir | C10248 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND The treatment must be limited to a maximum duration of 12 weeks. The application must include details of the prior treatment regimen containing an NS5A inhibitor. | Compliance with Authority Required procedures |
Schedule 3, Part 1 - General statement for drugs for the treatment of hepatitis C
substitute:
Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C
1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C
The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:
(1)the patient has been assessed in accordance with paragraph 2 of this Part; and
(2)the patient is:
(a)treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or
(b)treated by a medical practitioner or an authorised nurse practitioner in consultation with:
(i)a gastroenterologist; or
(ii)a hepatologist; or
(iii)an infectious diseases physician.
2 Assessment of patient
For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:
(1)documented the following information in the patient’s medical records:
(a)evidence of chronic hepatitis C infection; and
(b)where possible, evidence of the patient’s hepatitis C virus genotype; and
(2)chosen a regimen in accordance with paragraph 3 of this Part; and
(3)collected the following information for the purposes of the authority application:
(a)whether the patient is:
(i)cirrhotic; or
(ii)non-cirrhotic
(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).
(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:
(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and
(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.
3 Treatment regimen
For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:
(1)is a kind of patient mentioned for an Item in column 2 of the following table; and
(2)is to receive one of the regimens mentioned in column 3 of the same Item of the following table.
| Item | Kind of patient | Regimen |
| 1 | Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is non-cirrhotic. | Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 8 weeks. |
| 2 | Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is non-cirrhotic. | Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or (d) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR 16 weeks. |
| 3 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic. | Either: (a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (d) GRAZOPREVIR with ELBASVIR for 12 weeks. |
| 4 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic. | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) GRAZOPREVIR with ELBASVIR for 12 weeks; or (e) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks. |
| 5 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic. | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 6 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic. | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 7 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic. | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks. |
| 8 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic. | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks. |
| 9 | Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is non-cirrhotic. | GRAZOPREVIR with ELBASVIR for 12 weeks. |
| 10 | Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is non-cirrhotic. | Either: (a) GRAZOPREVIR with ELBASVIR for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks. |
| 11 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic. | Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens). |
| 12 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic. | Refer to item 1 above (pan-genotypic, treatment experienced and non-cirrhotic regimens). |
| 13 | Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is cirrhotic. | Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 12 weeks. |
| 14 | Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is cirrhotic. | Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (d) GLECAPREVIR with PIBRENTASVIR 16 weeks. |
| 15 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic. | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) GRAZOPREVIR with ELBASVIR for 12 weeks. |
| 16 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic. | Either: (a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d) GRAZOPREVIR with ELBASVIR for 12 weeks; or (e) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks. |
| 17 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic. | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 18 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic. | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 19 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic. | Either: (a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks. |
| 20 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic. | Either: (a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks. |
| 21 | Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is cirrhotic. | GRAZOPREVIR with ELBASVIR for 12 weeks. |
| 22 | Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is cirrhotic. | Either: (a) GRAZOPREVIR with ELBASVIR for 12 weeks; or (b) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks. |
| 23 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic. | Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens). |
| 24 | Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic. | Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens). |
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