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PB 64 of 2021 Arrangements as made
This instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) to add, delete and make changes to drugs, forms, manners of administration, brands, authorised prescribers, maximum quantities and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health
Registered 30 Jun 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 64 of 2021

 

National Health (Highly specialised drugs program) Special Arrangement Amendment (July Update) Instrument 2021

 

National Health Act 1953

___________________________________________________________________________

 

I, MARIANA CRANK, Assistant Secretary (Acting), Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

 

Dated          29 JUNE 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MARIANA CRANK

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1          Name of Instrument

(1)          This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment (July Update) Instrument 2021.

(2)          This Instrument may also be cited as PB 64 of 2021.

2          Commencement

This Instrument commences on 1 July 2021.

3          Amendment of National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

Schedule 1 amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021).

 

 


Schedule 1     Amendments

[1]        Schedule 1, entry for Benralizumab in each of the forms: Injection 30 mg in 1 mL single dose pre‑filled pen; and Injection 30 mg in 1 mL single dose pre‑filled syringe

omit from the column headed “Circumstances”: C9887 C10264 C10281 C11382            substitute: C11841 C11842 C11892 C11893

[2]        Schedule 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled syringe

omit from the column headed “Circumstances”: C11396 C11438 C11448          substitute: C11897 C11924 C11925 C11964

[3]        Schedule 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe

omit from the column headed “Circumstances”: C11383 C11448 C11476 C11493          substitute: C11844 C11901 C11924 C11926

[4]        Schedule 1, entry for Everolimus in each of the forms: Tablet 0.25 mg; and Tablet 0.5 mg

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

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

120

5

[5]        Schedule 1, entry for Everolimus in each of the forms: Tablet 0.75 mg; and Tablet 1 mg

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

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

240

5

[6]        Schedule 1, entry for Mepolizumab in the form Injection 100 mg in 1 mL single dose pre‑filled pen

omit from the column headed “Circumstances”: C9885 C10222 C10280 C10483 C10484 C11428            substitute: C11841 C11842 C11848 C11950

[7]        Schedule 1, entry for Mepolizumab in the form Powder for injection 100 mg

omit from the column headed “Circumstances”: C9885 C10222 C10280 C11428            substitute: C11841 C11842 C11848 C11950

[8]        Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; and Injection (modified release) 20 mg (as acetate), vial and diluent syringe

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

 

 

 

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

 

2

5

[9]        Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

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

 

 

 

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077

 

2

5

[10]      Schedule 1, entry for Omalizumab in each of the forms: Injection 75 mg in 0.5 mL single dose pre‑filled syringe; and Injection 150 mg in 1 mL single dose pre‑filled syringe

(a)        omit from the column headed “Circumstances”: C9855 C10219

(b)        omit from the column headed “Circumstances”: C10279 C11380

(c)        insert in numerical order in the column headed “Circumstances”: C11841 C11846 C11847 C11902

[11]      Schedule 2, entry for Benralizumab

substitute:

Benralizumab

C11841, C11892, C11893

1

Sufficient for 32 weeks of treatment

 

C11842

1

Sufficient for 24 weeks of treatment

[12]      Schedule 2, entry for Dupilumab

substitute:

Dupilumab

C11844, C11897, C11926, C11964

1 pack

Sufficient for 32 weeks of treatment

 

C11901, C11924, C11925

1 pack

Sufficient for 24 weeks of treatment

[13]      Schedule 2, entry for Mepolizumab

substitute:

Mepolizumab

C11841, C11848, C11950

1

Sufficient for 32 weeks of treatment

 

C11842

1

Sufficient for 24 weeks of treatment

[14]      Schedule 2, entry for Omalizumab

substitute:

Omalizumab

C7055

2

2

 

C7046

2

5

 

C10226, C11847

1

Sufficient for 24 weeks of treatment

 

C10223, C10265

1

6

 

C11841, C11846, C11902

1

Sufficient for 32 weeks of treatment

[15]      Schedule 3, entry for Benralizumab

substitute:

Benralizumab

C11841

 

Uncontrolled severe asthma
Balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 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 not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Authority Required procedures

 

C11842

 

Uncontrolled severe 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 the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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

 

C11892

 

Uncontrolled severe 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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 4 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 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

 

C11893

 

Uncontrolled severe 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 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, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
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

[16]      Schedule 3, entry for Dupilumab

substitute:

Dupilumab

C11844

 

Uncontrolled severe 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 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; OR
Patient must have each of: i) 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, ii) 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 received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; 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 Uncontrolled severe asthma - adolescent and adult initial PBS authority application 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); or
(v) the IgE results; and
(vi) 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

 

C11897

 

Uncontrolled severe 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; OR
Patient must have had a total serum human immunoglobulin E greater than or equal to 30 IU/mL with a past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE 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 Uncontrolled severe asthma - adolescent and adult initial PBS authority application 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); or
(v) the IgE results; and
(vi) 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.

Compliance with Written Authority Required procedures

 

C11901

 

Uncontrolled severe asthma
Grandfather 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 received non-PBS-subsidised treatment with this biological medicine for this condition prior to 1 April 2021; AND
Patient must have demonstrated or sustained an adequate response to treatment with this biological medicine if the patient has received at least the week 28 dose of this biological medicine; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; 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 had a documented blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids prior to initiating a biological medicine for this condition; OR
Patient must have had a documented total serum human immunoglobulin E greater than or equal to 30 IU/mL measured no more than 12 months prior to initiating a biological medicine, with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating a biological medicine for this condition; AND
Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to commencement of a biological medicine treatment for severe asthma; AND
Patient must have had a duration of asthma of at least 1 year prior to commencement of this biological medicine; AND
Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating a biological medicine 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.
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 as outlined in the clinical criteria.
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 with optimised asthma therapy and must be declared to have been met at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0 prior to commencement with a biological medicine for severe asthma; AND
(b) while receiving optimised asthma therapy in the 12 months prior to commencing treatment with a biological medicine for severe asthma, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
An Asthma Control Questionnaire (5 item version) assessment and/or an assessment of a reduction in the patient's maintenance oral corticosteroid dose to determine whether the patient has achieved or sustained an adequate response to non-PBS-subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been 28 weeks or greater.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Uncontrolled severe asthma dupilumab initial grandfather PBS authority application form which
seeks details of the following (if not already provided):
(i) prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) a eosinophil pathology report (eosinophil counts and dates) prior to initiating a biological medicine for this condition; or
(iii) IgE results prior to initiating a biological medicine for this condition; and
(iv) ACQ-5 scores including the date of assessment of the patient's symptoms, or details of the maintenance oral corticosteroid dose; and
(v) Date of commencing non-PBS-subsidised treatment with this drug.

Compliance with Written Authority Required procedures

 

C11924

 

Uncontrolled severe 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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.
A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.
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 Uncontrolled severe asthma adolescent and adult continuing PBS authority application 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

 

C11925

 

Uncontrolled severe asthma
Grandfather 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 received non-PBS-subsidised treatment with this biological medicine for this condition prior to 1 April 2021; AND
Patient must have demonstrated or sustained an adequate response to treatment with this biological medicine if the patient has received at least the week 28 dose of this biological medicine; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; 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 had a documented blood eosinophil count greater than or equal to 300 cells per microlitre measured no more than 12 months prior to initiating a biological medicine for this condition; OR
Patient must have had a documented blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids, measured no more than 12 months prior to initiating a biological medicine for this condition; OR
Patient must have had a documented total serum human immunoglobulin E greater than or equal to 30 IU/mL measured no more than 12 months prior to initiating a biological medicine, with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating a biological medicine for this condition; AND
Patient must have had a duration of asthma of at least 1 year prior to commencement of this biological medicine; AND
Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating a biological medicine 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.
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 with optimised asthma therapy and must be declared to have been met at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0 prior to commencement with a biological medicine for severe asthma; AND
(b) while receiving optimised asthma therapy in the 12 months prior to commencing treatment with a biological medicine for severe asthma, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
An Asthma Control Questionnaire (5 item version) assessment and/or an assessment of a reduction in the patient's maintenance oral corticosteroid dose to determine whether the patient has achieved or sustained an adequate response to non-PBS-subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been 28 weeks or greater.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
An adequate response to this biological medicine is defined as:
(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
OR
(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Uncontrolled severe asthma dupilumab initial grandfather PBS authority application form which
seeks details of the following (if not already provided):
(i) prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) a eosinophil pathology report (eosinophil counts and dates) prior to initiating a biological medicine for this condition; or
(iii) IgE results prior to initiating a biological medicine for this condition; and
(iv) ACQ-5 scores including the date of assessment of the patient's symptoms, or details of the maintenance oral corticosteroid dose; and
(v) Date of commencing non-PBS-subsidised treatment with this drug.

Compliance with Written Authority Required procedures

 

C11926

 

Uncontrolled severe asthma
Initial treatment 1 - (New patient; 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 been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND
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; OR
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL with 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 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 as outlined in the clinical criteria.
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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break..
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 4 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 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Uncontrolled severe asthma - adolescent and adult initial PBS authority application 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; or
(iv) the IgE result; and
(v) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

 

C11964

 

Uncontrolled severe asthma
Initial treatment 1 - (New patient; 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; OR
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.
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 4 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 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe asthma - adolescent and adult initial PBS authority application 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; or
(iv) the IgE result; and
(v) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

[17]      Schedule 3, entry for Mepolizumab

substitute:

Mepolizumab

C11841

 

Uncontrolled severe asthma
Balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 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 not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Authority Required procedures

 

C11842

 

Uncontrolled severe 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 the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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

 

C11848

 

Uncontrolled severe 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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 4 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 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

 

C11950

 

Uncontrolled severe 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 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, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
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

[18]      Schedule 3, entry for Omalizumab

(a)        omit:

 

C9855

 

Uncontrolled severe allergic asthma
Balance of supply in a patient aged 12 years or older
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 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 not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Authority Required procedures

 

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

(b)        omit:

 

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

 

C11380

 

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 4 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

(c)        insert in numerical order after existing text:

 

C11841

 

Uncontrolled severe asthma
Balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 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 not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.

Compliance with Authority Required procedures

 

C11846

 

Uncontrolled severe 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 at the time of application; 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 conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 4 biological medicines for severe asthma 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 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 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

 

C11847

 

Uncontrolled severe 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 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.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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

 

C11902

 

Uncontrolled severe 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 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, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the date of assessment. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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