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PB 28 of 2021 Arrangements as made
This instrument amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) to add the listed drug dupilumab, three forms of the listed drug adalimumab and thirteen brands of existing pharmaceutical items. It also provides for the deletion of two brands of pharmaceutical items and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs adalimumab, apomorphine, benralizumab, mepolizumab and omalizumab.
Administered by: Health
Registered 31 Mar 2021

PB 28 of 2021

 

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (April Update) Instrument 2021

 

National Health Act 1953

___________________________________________________________________________

 

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, as delegate of the Minister for Health and Aged Care, make the following Amendment Instrument.

Dated         31 March 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BEN SLADIC

Assistant Secretary

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 (April Update) Instrument 2021.

(2)          This Instrument may also be cited as PB 28 of 2021.

2          Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 April 2021, immediately after the commencement of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021).

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

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]        Part 1, Division 1, Section 6, definition for “CAR drug”

substitute:

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a)           abatacept;

(b)          adalimumab;

(c)           ambrisentan;

(d)          azacitidine;

(e)           benralizumab;

(f)           bosentan;

(g)           dupilumab

(h)          eculizumab;

(i)            eltrombopag;

(j)            epoprostenol;

(k)          etanercept;

(l)            iloprost;

(m)        infliximab;

(n)          ivacaftor;

(o)          lenalidomide;

(p)          lumacaftor with ivacaftor;

(q)          macitentan;

(r)            mepolizumab;

(s)           midostaurin;

(t)            nusinersen;

(u)          omalizumab;

(v)          pasireotide;

(w)         pegvisomant;

(x)          pomalidomide;

(y)          riociguat;

(z)           rituximab;

(aa)       romiplostim;

(bb)      sildenafil;

(cc)       tadalafil;

(dd)      teduglutide;

(ee)       tezacaftor with ivacaftor and ivacaftor;

(ff)        tocilizumab;

(gg)       ustekinumab;

(hh)      vedolizumab.

[2]        Schedule 1, entry for Adalimumab

substitute:

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526

 

2

5

 

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.4 mL pre-filled syringe

Injection

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526

 

2

5

 

 

 

Hadlima

C11526

 

2

5

 

 

 

Hyrimoz

C11526

 

2

5

 

 

 

Idacio

C11526

 

2

5

 

 

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Humira

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C9384 C9417 C10582 C10583 C10619 C11520 C11521

 

See Schedule 2

See Schedule 2

 

 

 

Amgevita

C11526

 

2

5

 

 

 

Hadlima

C11526

 

2

5

 

 

 

Hyrimoz

C11526

 

2

5

 

 

 

Idacio

C11526

 

2

5

[3]        Schedule 1, entry for Apomorphine in each of the forms: Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL; and Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

omit from the column headed “Circumstances”: C4833 C9561                         substitute:  C11385 C11445

[4]        Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

omit from the column headed “Circumstances”: C4833 C9561                         substitute:  C11385 C11445

[5]        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

(a)        omit from the column headed “Circumstances”: C10314

(b)        insert in numerical order in the column headed “Circumstances: C11382

[6]        Schedule 1, entry for Cinacalcet in each of the forms: Tablet 30 mg (as hydrochloride); Tablet 60 mg (as hydrochloride); and Tablet 90 mg (as hydrochloride)

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

 

 

 

Cinacalcet Mylan

C10063 C10067 C10073

 

56

5

[7]        Schedule 1, after entry for Doxorubicin - Pegylated Liposomal

insert:

Dupilumab

Injection 200 mg in 1.14 mL single dose pre-filled syringe

Injection

Dupixent

C11396 C11438 C11448

 

See Schedule 2

See Schedule 2

 

Injection 300 mg in 2 mL single dose pre-filled syringe

Injection

Dupixent

C11383 C11448 C11476 C11493

 

See Schedule 2

See Schedule 2

[8]        Schedule 1, entry for Mepolizumab in each of the forms: Injection 100 mg in 1 mL single dose pre-filled pen; and Powder for injection 100 mg

(a)        omit from the column headed “Circumstances”: C10221

(b)        insert in numerical order in the column headed “Circumstances: C11428

[9]        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”: C10299

(b)        insert in numerical order in the column headed “Circumstances: C11380

[10]      Schedule 1, entry for Rituximab  in the form Solution for I.V. infusion 100 mg in 10 mL

omit:

 

 

 

Mabthera

C7021 C7022 C9344 C9511

 

See Schedule 2

See Schedule 2

[11]      Schedule 1, entry for Rituximab  in the form Solution for I.V. infusion 500 mg in 50 mL

omit:

 

 

 

Mabthera

C7021 C7022 C9340 C9344 C9448 C9449 C9450 C9511 C9512

 

See Schedule 2

See Schedule 2

[12]      Schedule 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

 

 

 

Tenofovir Sandoz

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P10362

60

2

[13]      Schedule 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

 

 

 

Tenofovir Sandoz

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P6980 P6982 P6983 P6984 P6992 P6998

60

5

[14]      Schedule 2, entry for Adalimumab

substitute:

Adalimumab

C9417, C10582, C10583, C10619

2 doses

3

 

C9384, C11520, C11521

2 doses

5

[15]      Schedule 2, after entry for Azacitidine

insert:

Benralizumab

C9887, C10264, C10314

1

Sufficient for 32 weeks of treatment

 

C10281

1

Sufficient for 24 weeks of treatment

[16]      Schedule 2, after entry for Bosentan

insert:

Dupilumab

C11383, C11438, C11493, C11396

1 pack

Sufficient for 32 weeks of treatment

 

C11448

1 pack

Sufficient for 24 weeks of treatment

 

C11476

1 pack

5

Eculizumab

C6626

1

Sufficient for 4 weeks of treatment

 

C6642

1

4

 

C6668, C6686, C6687, C6688

1

5

 

C6637

1

6

[17]      Schedule 2, after entry for Infliximab

insert:

Ivacaftor

C9889, C9890

1 pack

Sufficient for 24 weeks of treatment

[18]      Schedule 2, after entry for Lenalidomide

insert:

Lumacaftor with Ivacaftor

C10005, C10007, C9891, C9920, C9857, C9943

1 pack

5

Macitentan

C10228, C10236, C10285, C11229, C11312, C11313, C11314, C11317, C11321

1 pack

5

Mepolizumab

C9885, C10221, C10222

1

Sufficient for 32 weeks of treatment

 

C10280, C10483, C10484

1

5

Midostaurin

C8133, C8177, C8193

1 pack

2

 

C8218

1 pack

1

[19]      Schedule 2, entry for Omalizumab

substitute:

Omalizumab

C7055

2

2

 

C7046

2

5

 

C10226, C10279

1

5

 

C10223, C10265

1

6

 

C9855, C10219, C11380

1

7

[20]      Schedule 2, after entry for Pegvisomant

insert:

Pomalidomide

C7791, C7952

1 pack

5

[21]      Schedule 2, after entry for Tadalafil

insert:

Teduglutide

C9687, C9740, C9793, C9829

1 pack

5

 

C9515, C9569

1 pack

11

Tezacaftor with Ivacaftor and Ivacaftor

C9880, C9961, C10064, C10069

1 pack

5

[22]      Schedule 3, entry for Adalimumab

substitute:

Adalimumab

C9384

 

Severe active juvenile idiopathic arthritis
Continuing treatment - balance of supply
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.

Compliance with Authority Required procedures

 

C9417

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

Compliance with Authority Required procedures

 

C10582

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C10583

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C10619

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count must be no more than 4 weeks old at the time of this application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

 

C11520

 

Severe active juvenile idiopathic arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 5 repeats will be authorised.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C11521

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide sufficient for two doses. Up to a maximum of 5 repeats will be authorised.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Written Authority Required procedures

 

C11526

 

Severe active juvenile idiopathic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count submitted with the initial treatment application.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
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 this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 11526

[23]      Schedule 3, entry for Apomorphine

(a)        omit:

 

C4833

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 4833

 

C9561

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 9561

(b)        insert in numerical order after existing text:

 

C11385

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 11385

 

C11445

 

Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 11445

[24]      Schedule 3, entry for Benralizumab

(a)        omit:

 

C10314

 

Uncontrolled severe eosinophilic asthma
Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long‑acting beta‑2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient’s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS‑subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS‑subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the eosinophil count and date; and
(iv) Asthma Control Questionnaire (ACQ‑5) score.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C11382

 

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 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 Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form, which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the eosinophil count and date; and
(iv) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

[25]      Schedule 3, after entry for Doxorubicin - Pegylated Liposomal

insert:

Dupilumab

C11383

 

Uncontrolled severe eosinophilic or allergic 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 eosinophilic or allergic- 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

 

C11396

 

Uncontrolled severe eosinophilic or allergic 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 eosinophilic or allergic 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

 

C11438

 

Uncontrolled severe eosinophilic or 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 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 eosinophilic or allergic 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

 

C11448

 

Uncontrolled severe eosinophilic or allergic 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 eosinophilic or allergic 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

 

C11476

 

Uncontrolled severe eosinophilic or allergic 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 severe asthma; 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 non-PBS-subsidised treatment with a biological medicine for severe asthma, 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 PBS-subsidised treatment with this drug 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 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
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 eosinophilic or allergic 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 non-PBS-subsidised treatment with this drug; and an eosinophil pathology report (eosinophil counts and dates) no more than 4 weeks old at the time of application; or
(iii) IgE results prior to initiating non-PBS-subsidised treatment with this drug; and IgE results no more than 4 weeks old at the time of application; 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

 

C11493

 

Uncontrolled severe eosinophilic or 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 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 eosinophilic or allergic 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

[26]      Schedule 3, entry for Infliximab

(a)        omit entry for Circumstances Code “C9677” and substitute:

 

C9677

 

Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.

Compliance with Written Authority Required procedures

(b)        omit entry for Circumstances Code “C9759” and substitute:

 

C9759

 

Severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of the most recent clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.
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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

[27]      Schedule 3, entry for Mepolizumab

(a)        omit:

 

C10221

P10221

Uncontrolled severe eosinophilic asthma
Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long‑acting beta‑2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient’s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS‑subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines within the same treatment cycle.
The length of the break in therapy is measured from the date the most recent treatment with a PBS‑subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Eosinophilic Asthma Initial PBS Authority Application ‑ Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the eosinophil count and date; and
(iv) Asthma Control Questionnaire (ACQ‑5) score.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

C11428

 

Uncontrolled severe eosinophilic asthma
Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; OR
Patient must have blood eosinophil count greater than or equal to 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.
A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 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 Eosinophilic Asthma Initial PBS Authority Application - Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the eosinophil count and date; and
(iv) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

[28]      Schedule 3, entry for Omalizumab

(a)        omit:

 

C10299

 

Uncontrolled severe allergic asthma
Initial treatment ‑ Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must be under the care of the same physician for at least 6 months; OR
Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for severe asthma; OR
Patient must have had a break in treatment from the most recently approved PBS‑subsidised biological medicine for severe asthma; AND
Patient must have a diagnosis of asthma confirmed and documented by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma, defined by the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma; AND
Patient must have a duration of asthma of at least 1 year; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE, that is no more than 1 year old; AND
Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 32 weeks of treatment under this restriction; AND
The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for severe asthma.
Patient must be aged 12 years or older.
Optimised asthma therapy includes:
(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long‑acting beta‑2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;
AND
(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
The initial IgE assessment must be no more than 12 months old at the time of application.
The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
(a) an Asthma Control Questionnaire (ACQ‑5) score of at least 2.0, as assessed in the previous month, AND
(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
The Asthma Control Questionnaire (5 item version) assessment of the patient’s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS‑subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
This assessment, which will be used to determine eligibility for the first continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for severe asthma within the same treatment cycle.
A treatment break in PBS‑subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 3 biological medicines for severe asthma within the same treatment cycle.
A treatment break in PBS‑subsidised omalizumab therapy of at least 6 months must be observed in a patient with uncontrolled severe allergic asthma, in whom omalizumab is the only appropriate treatment option, and who has either failed to achieve or sustain a response to the most recent PBS‑subsidised omalizumab therapy.
The length of the break in therapy is measured from the date the most recent treatment with a PBS‑subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA‑approved Product Information) to be administered every 2 or 4 weeks.
A multidisciplinary severe asthma clinic team comprises of:
A respiratory physician; and
A pharmacist, nurse or asthma educator.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Allergic Asthma PBS Authority Application ‑ Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (date of commencement and duration of therapy); and
(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
(iii) the IgE result; and
(iv) Asthma Control Questionnaire (ACQ‑5) score.

Compliance with Written Authority Required procedures

(b)        insert in numerical order after existing text:

 

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

[29]      Schedule 3, entry for Vedolizumab

(a)        omit entry for Circumstances Code “C9683” and substitute:

 

C9683

 

Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where the response assessment is not submitted within this timeframe, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Authority Required procedures

(b)        omit entry for Circumstances Code “C9796” and substitute:

 

C9796

 

Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.

Compliance with Written Authority Required procedures

[30]      Schedule 4, after entry for Rituximab

insert:

Selexipag

Tablet 200 micrograms

Oral

Selexipag

Tablet 400 micrograms

Oral

Selexipag

Tablet 600 micrograms

Oral

Selexipag

Tablet 800 micrograms

Oral

Selexipag

Tablet 1 mg

Oral

Selexipag

Tablet 1.2 mg

Oral

Selexipag

Tablet 1.4 mg

Oral

Selexipag

Tablet 1.6 mg

Oral