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PB 38 of 2021 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 30 Apr 2021
Tabling HistoryDate
Tabled HR11-May-2021
Tabled Senate11-May-2021
To be repealed 12 Aug 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 38 of 2021

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 4)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

 

Dated    28 April               2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA CONNOLLY

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

1          Name of Instrument

(1)          This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 4).

(2)          This Instrument may also be cited as PB 38 of 2021.

2          Commencement

This Instrument commences on 1 May 2021.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1           Amendments

 

[1]             Schedule 1, Part 1, entry for Aciclovir

                   (a)        omit:

 

Eye ointment 30 mg per g, 4.5 g (Acivision)

Application to the eye

 

AciVision

DZ

MP NP

C5965

 

1

0

1

 

 

 

 

 

 

AO

C5964

 

1

0

1

 

 

                   (b)        insert as first entry:

 

Eye ointment 30 mg per g, 4.5 g

Application to the eye

 

ViruPOS

AE

MP NP

C5965

 

1

0

1

 

 

 

 

 

 

AO

C5964

 

1

0

1

 

 

[2]             Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

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

 

 

 

a

NOUMED AMLODIPINE

VO

MP NP

 

 

30

5

30

 

 

[3]             Schedule 1, Part 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

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

 

 

 

a

Bimprozt

TY

AO MP

 

 

1

5

1

 

 

[4]             Schedule 1, Part 1, after entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

                           insert:

Cannabidiol

Oral liquid 100 mg per mL,
100 mL

Oral

 

Epidyolex

EU

MP

C11681

 

1

5

1

 

 

[5]             Schedule 1, Part 1, entry for Cyclophosphamide in the form Tablet 50 mg (anhydrous)

                           omit from the column headed “Responsible Person”: ZX             substitute: GH

[6]             Schedule 1, Part 1, entry for Doxycycline in the form Tablet 50 mg (as hyclate)

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

 

 

 

 

APX-Doxycycline

TX

MP NP

C4475 C4529 C4539

 

25

5

25

 

 

[7]             Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 7; Number of Repeats: 0]

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

 

 

 

 

APX-Doxycycline

TX

PDP

 

 

7

0

7

 

 

[8]             Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 7; Number of Repeats: 1]

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

 

 

 

 

APX-Doxycycline

TX

MP NP

 

 

7

1

7

 

 

[9]             Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 21; Number of Repeats: 0]

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

 

 

 

 

APX-Doxycycline

TX

MP NP

 

P4485

21

0

7

 

 

 

 

 

 

 

 

MP NP

 

P4485

21

0

21

 

 

[10]           Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 28; Number of Repeats: 0]

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

 

 

 

 

APX-Doxycycline

TX

MP NP

 

P4514

28

0

7

 

 

[11]           Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 28; Number of Repeats: 5]

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

 

 

 

 

APX-Doxycycline

TX

MP

 

P6200

28

5

7

 

 

[12]           Schedule 1, Part 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

                           omit:

 

 

 

a

Andepra

EL

MP NP

C5650

 

28

0

28

 

 

[13]           Schedule 1, Part 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

                           omit:

 

 

 

a

Andepra

EL

MP NP

C5650

 

28

5

28

 

 

[14]           Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

                           omit:

 

 

 

 

Epirubicin ACT

JU

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[15]           Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

                           omit:

 

 

 

 

Epirubicin ACT

JU

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[16]           Schedule 1, Part 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and Tablet 150 mg (as hydrochloride)

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

 

 

 

a

Erlotinib APOTEX

TX

MP

C4473 C4600 C7446

 

30

3

30

 

 

                   (b)        insert in the column headed “Schedule Equivalent” for the brand “Erlotinib Sandoz”: a

[17]           Schedule 1, Part 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

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

 

 

 

a

Levetiracetam GH

GQ

MP NP

C11077

 

1

5

1

 

 

[18]           Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

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

 

 

 

a

Lurasidone Sandoz

SZ

MP NP

C4246

 

30

5

30

 

 

[19]           Schedule 1, Part 1, entry for Mesalazine in the form Tablet 800 mg (enteric coated)

                           omit from the column headed “Maximum Quantity”: 180             substitute: 90

[20]           Schedule 1, Part 1, after entry for Mesalazine in the form Tablet 1.2 g (prolonged release)

                           insert:

 

Tablet 1.6 g (enteric coated)

Oral

 

Asacol

EU

MP NP

C9444

 

120

4

60

 

 

[21]           Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

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

 

 

 

b

NOUMED METOPROLOL

VO

MP NP

 

 

100

5

100

 

 

[22]           Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

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

 

 

 

b

NOUMED METOPROLOL

VO

MP NP

 

 

60

5

60

 

 

[23]           Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

                           insert in the column headed “Schedule Equivalent” (all instances): a

[24]           Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol

                           omit:

 

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP

Oral

 

Pirmella 1/35

DZ

MP NP

 

 

4

2

3

 

 

[25]           Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

                           omit:

 

 

 

 

NOUMED PERINDOPRIL

VO

MP NP

 

 

30

5

30

 

 

[26]           Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

                           omit:

 

 

 

 

NOUMED PERINDOPRIL

VO

MP NP

 

 

30

5

30

 

 

[27]           Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

                           omit:

 

 

 

 

NOUMED PERINDOPRIL

VO

MP NP

 

 

30

5

30

 

 

[28]           Schedule 1, Part 1, entry for Rasagiline

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

 

 

 

a

Rasazil

GQ

MP NP

C5339

 

30

5

30

 

 

[29]           Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg

                   (a)        omit:

 

 

 

a

Ransim

RA

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Ransim

RA

MP

 

P7598

30

11

30

 

 

[30]           Schedule 1, Part 1, entry for Simvastatin in the form Tablet 80 mg

                   (a)        omit:

 

 

 

a

Ransim

RA

MP NP

 

 

30

5

30

 

 

                   (b)        omit:

 

 

 

a

Ransim

RA

MP

 

P7598

30

11

30

 

 

[31]           Schedule 1, Part 1, entry for Sotalol in each of the forms: Tablet containing sotalol hydrochloride 80 mg; and Tablet containing sotalol hydrochloride 160 mg

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

 

 

 

a

APX-Sotalol

TY

MP NP

C5664

 

60

5

60

 

 

[32]           Schedule 1, Part 1, entry for Stiripentol in each of the forms: Capsule 250 mg; Capsule 500 mg; Powder for oral suspension 250 mg; and Powder for oral suspension 500 mg

                           omit from the column headed “Circumstances”: C10632             substitute: C11642

[33]           Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

                           substitute:

 

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

 

CIPLA TENOFOVIR + EMTRICITABINE 300/200

LR

MP NP

C11143

 

30

2

30

 

 

 

 

 

 

Tenofovir/Emtricitabine 300/200 APOTEX

TX

MP NP

C11143

 

30

2

30

 

 

 

 

 

 

CIPLA TENOFOVIR + EMTRICITABINE 300/200

LR

MP NP

C6985 C6986

 

60

5

30

 

C(100)

 

 

 

 

Tenofovir/Emtricitabine 300/200 APOTEX

TX

MP NP

C6985 C6986

 

60

5

30

 

C(100)

[34]           Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

                           omit from the column headed “Circumstances”: C10273

[35]           Schedule 1, Part 2, omit entry for Codeine

[36]           Schedule 1, Part 2, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

omit:

 

 

 

a

Cyprocur 50

AS

MP

 

P5532

20
CN5532

5
CN5532

20

 

 

 

 

 

 

 

 

MP

 

 

100

5

50

 

 

[37]           Schedule 1, Part 2, entry for Cyproterone

omit:

 

Tablet containing cyproterone acetate 100 mg

Oral

a

Cyprocur 100

AS

MP

 

 

50

5

50

 

 

[38]           Schedule 1, Part 2, omit entry for Paracetamol

[39]           Schedule 3

omit:

ZX

Zenex Pharmaceuticals Pty Ltd

51 603 281 509


 

[40]           Schedule 4, Part 1, entry for Bortezomib

substitute:

Bortezomib

C7938

 

 

Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) must be documented in the patient's medical records. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7938

 

C7939

 

 

Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

Compliance with Authority Required procedures - Streamlined Authority Code 7939

 

C7940

 

 

Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of prescribing; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months.

Compliance with Authority Required procedures - Streamlined Authority Code 7940

 

C7941

 

 

Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for newly diagnosed symptomatic multiple myeloma; AND
Patient must have severe acute renal failure; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
A copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority and diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months.

Compliance with Authority Required procedures - Streamlined Authority Code 7941

 

C7960

 

 

Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

Compliance with Authority Required procedures - Streamlined Authority Code 7960

 

C7961

 

 

Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7961

 

C7962

 

 

Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

Compliance with Authority Required procedures - Streamlined Authority Code 7962

 

C7974

 

 

Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart.

Compliance with Authority Required procedures - Streamlined Authority Code 7974

 

C10338

 

 

Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10338

 

C10426

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response must be documented in the patient's medical records. Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be documented in the patient's medical records for all patients.
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10426

 

C10454

 

 

Multiple myeloma
Triple combination therapy (bortezomib, lenalidomide and dexamethasone)
The condition must be newly diagnosed; AND
The treatment must be in combination with lenalidomide and dexamethasone; AND
The treatment must not be in combination with PBS-subsidised thalidomide, pomalidomide or carfilzomib; AND
The treatment must not be changing from dual combination therapy with lenalidomide and dexamethasone for symptomatic multiple myeloma to triple therapy with lenalidomide, bortezomib and dexamethasone; AND
Patient must not receive more than 8 cycles of treatment with bortezomib under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10454

 

C10455

 

 

Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10455

 

C11099

 

 

Multiple myeloma

 

[41]           Schedule 4, Part 1, after entry for Candesartan with hydrochlorothiazide

                           insert:

Cannabidiol

C11681

 

 

Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.

Compliance with Authority Required procedures

[42]           Schedule 4, Part 1, after entry for Leflunomide

insert:

Lenograstim

C6502

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 6502

 

C6507

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures - Streamlined Authority Code 6507

 

C6516

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures - Streamlined Authority Code 6516

 

C6522

 

 

Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 6522

 

C6523

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 6523

 

C6532

 

 

Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 6532

 

C6535

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures - Streamlined Authority Code 6535

 

C6634

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 6634

 

C6644

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 6644

 

C6653

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 6653

 

C6654

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 6654

 

C6657

 

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 6657

 

C6673

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures - Streamlined Authority Code 6673

 

C6682

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 6682

 

C9226

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9226

 

C9227

 

 

Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9227

 

C9229

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9229

 

C9230

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9230

 

C9231

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 9231

 

C9263

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours.

Compliance with Authority Required procedures - Streamlined Authority Code 9263

 

C9264

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade).

Compliance with Authority Required procedures - Streamlined Authority Code 9264

 

C9265

 

 

Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9265

 

C9266

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9266

 

C9314

 

 

Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation.

Compliance with Authority Required procedures - Streamlined Authority Code 9314

 

C9324

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia.

Compliance with Authority Required procedures - Streamlined Authority Code 9324

 

C9325

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9325

 

C9326

 

 

Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned.

Compliance with Authority Required procedures - Streamlined Authority Code 9326

 

C9327

 

 

Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma.

Compliance with Authority Required procedures - Streamlined Authority Code 9327

[43]           Schedule 4, Part 1, entry for Obinutuzumab

(a)        omit entry for Circumstances Code “C7935” and substitute:

Obinutuzumab

C7935

 

 

Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated grandfather restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures


 

(b)        omit entry for Circumstances Code “C7950” and substitute:

 

C7950

 

 

Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory grandfather restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

(c)        omit entry for Circumstances Code “C7959” and substitute:

 

C7959

 

 

Follicular lymphoma
Re-induction treatment
Patient must not have previously received PBS-subsidised obinutuzumab; AND
The condition must be CD20 positive; AND
The condition must be refractory to treatment with rituximab for this condition; AND
The condition must be symptomatic; AND
The treatment must be for re-induction treatment purposes only; AND
The treatment must be in combination with bendamustine; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction.

Compliance with Authority Required procedures

[44]           Schedule 4, Part 1, entry for Stiripentol

                           substitute:

Stiripentol

C11642

 

 

Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.

Compliance with Authority Required procedures - Streamlined Authority Code 11642

[45]           Schedule 4, Part 1, entry for Trastuzumab emtansine

                           omit:

 

C10273

 

 

Early HER2 positive breast cancer
Grandfather adjuvant treatment
Patient must have received non-PBS-subsidised treatment with this drug as adjuvant treatment of early HER2 positive breast cancer prior to 1 April 2020; AND
The treatment must have been prescribed within 12 weeks after surgery prior to commencing treatment with this drug; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration using non-PBS-subsidised and PBS-subsidised drug supply obtained under the grandfather restriction and the continuing treatment restrictions combined.
Authority applications for grandfather treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery and the number of non-PBS-subsidised cycles of treatment received by the patient.

Compliance with Written Authority Required procedures

[46]           Schedule 5, entry for Adalimumab

                           substitute:

Adalimumab

GRP-25058

Injection 40 mg in 0.4 mL pre-filled syringe

Injection

Humira

 

 

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita
Hadlima
Humira
Hyrimoz
Idacio

 

GRP-25059

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

 

 

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita
Humira

 

GRP-25060

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

 

 

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita
Hadlima
Humira
Hyrimoz
Idacio


 

[47]           Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [GRP-14639]

                           insert in alphabetical order in the column headed “Brand”: APX-Doxycycline

[48]           Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]

                           insert in alphabetical order in the column headed “Brand”: APX-Doxycycline

[49]           Schedule 5, omit entry for Norethisterone with ethinylestradiol

[50]           Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]

                           omit from the column headed “Brand”: NOUMED PERINDOPRIL

[51]           Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]

                           omit from the column headed “Brand”: NOUMED PERINDOPRIL

[52]           Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]

omit from the column headed “Brand”: NOUMED PERINDOPRIL

[53]           Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [GRP-21638]

                           insert in alphabetical order in the column headed “Brand”: CIPLA TENOFOVIR + EMTRICITABINE 300/200