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PB 1 of 2018 Lists 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.
Administered by: Health
Made 22 Jan 2018
Registered 24 Jan 2018
Tabled HR 05 Feb 2018
Tabled Senate 05 Feb 2018
Date of repeal 02 Feb 2018
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

PB 1 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018
(No. 1)

National Health Act 1953

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

Dated                     22 January 2018

 

 

 

 

 

 

 

 

 

 

 

LISA LA RANCE

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 2018 (No. 1).

            (2)        This Instrument may also be cited as PB 1 of 2018.

2          Commencement

This Instrument commences on 1 February 2018.

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, entry for Abacavir with Lamivudine

insert as the first entry in the columns in the order indicated:

 

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg

Oral

 

Abacavir/Lamivudine GH 600/300

GQ

MP

C4527 C4528

 

60

5

30

 

D(100)

[2]           Schedule 1, entry for Acarbose in each of the forms: Tablet 50 mg; and Tablet 100 mg

omit:

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

[3]           Schedule 1, entry for Alendronic Acid

omit:

 

 

 

 

Alendronate AN

EA

MP NP

C6310 C6323 C6327

 

4

5

4

 

 

[4]           Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a)      omit:

 

 

 

a

AmoxyClav GH 875/125

GQ

PDP

C5833 C5894

 

10

0

10

 

 

(b)      omit:

 

 

 

a

AmoxyClav GH 875/125

GQ

MP NP

C5832 C5893

 

10

1

10

 

 

[5]           Schedule 1, entry for Benztropine

omit:

 

Injection containing benztropine mesylate 2 mg in 2 mL

Injection

 

Cogentin

FK

MP NP PDP

 

 

5

0

5

 

 

[6]           Schedule 1, entry for Bortezomib in the form Powder for injection 1 mg

omit from the column headed “Circumstances”:          C6372 C6384 C6466 C6472 C6478             substitute:             C7376 C7377 C7389 C7390 C7402

 

[7]           Schedule 1, entry for Bortezomib in the form Powder for injection 3 mg

omit from the column headed “Circumstances”:          C6372 C6373 C6384 C6452 C6466 C6472 C6478

insert in numerical order in the column headed “Circumstances”:         C7376 C7377 C7389 C7390 C7402 C7414 C7416

[8]           Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg

omit from the column headed “Circumstances”:          C6373 C6452

insert in numerical order in the column headed “Circumstances”:         C7414 C7416

[9]           Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg

omit:

 

 

 

a

Candesartan GH

GQ

MP NP

 

 

30

5

30

 

 

[10]         Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)

(a)      omit:

 

 

 

 

Ozcef

RA

PDP

 

 

10

0

10

 

 

(b)      omit:

 

 

 

 

Ozcef

RA

MP

 

 

10

1

10

 

 

[11]         Schedule 1, after entry for Cefuroxime in the form Tablet 250 mg (as axetil) [Brand: Zinnat; Maximum Quantity: 14; Number of Repeats: 1]

insert in the columns in the order indicated:

 

 

 

 

Zinnat

AS

PDP

 

 

20

0

20

 

 

 

 

 

 

 

 

MP

 

 

20

1

20

 

 

[12]         Schedule 1, entry for Clozapine in the form Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Clozaril 25”:                              NV                          substitute:                GO

[13]         Schedule 1, entry for Clozapine in the form Tablet 100 mg

omit from the column headed “Responsible Person” for the brand “Clozaril 100”:                           NV                          substitute:                GO

[14]         Schedule 1, omit entry for Coal Tar – Prepared

 

 

 

[15]         Schedule 1, entry for Cromoglycic Acid

omit:

 

Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic)

Inhalation by mouth

 

Intal Spincaps

EA

MP NP

 

 

100

5

100

 

 

[16]         Schedule 1, omit entry for Cyproheptadine

[17]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

omit:

 

 

 

a

Procur 100

ED

MP

 

 

50

5

50

 

 

[18]         Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg

omit:

 

 

 

 

Donepezil-GA

ED

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

[19]         Schedule 1, entry for Dorzolamide

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

 

 

 

a

APO-Dorzolamide

TX

MP AO

 

 

1

5

1

 

 

[20]         Schedule 1, entry for Dorzolamide with timolol

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

 

 

 

a

APO-Dorzolamide/Timolol 20/5

TX

MP

C4343

 

1

5

1

 

 

 

 

 

 

 

 

AO

C5038

 

1

5

1

 

 

 


 

[21]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

omit:

 

 

 

 

Accord Doxorubicin

EA

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

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

omit:

 

 

 

a

Duloxetine GH

GQ

MP NP

C5650

 

28

0

28

 

 

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

omit:

 

 

 

a

Duloxetine GH

GQ

MP NP

C5650

 

28

5

28

 

 

[24]         Schedule 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen

omit from the column headed “Circumstances”: C7329

[25]         Schedule 1, entry for Famotidine in the form Tablet 20 mg

omit:

 

 

 

 

Pepzan

ED

MP NP

 

 

60

5

60

 

 

[26]         Schedule 1, entry for Famotidine in the form Tablet 40 mg

omit:

 

 

 

 

Pepzan

ED

MP NP

 

 

30

5

30

 

 

[27]         Schedule 1, entry for Gemcitabine

(a)      omit:

 

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

 

Gemcitabine Ebewe

SZ

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

(b)      omit:

 

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

Injection

 

Gemcitabine Ebewe

SZ

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

(c)      omit:

 

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL

Injection

 

Gemcitabine Ebewe

SZ

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

(d)      omit:

 

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

 

Gemcitabine Ebewe

SZ

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

(e)      omit:

 

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

Injection

 

Gemcitabine Ebewe

SZ

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

[28]         Schedule 1, entry for Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine

substitute:

Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine

Sachets containing oral powder 27 g, 30 (PKU Sphere15)

Oral

 

PKU Sphere15

VF

MP NP

C4295

 

4

5

1

 

 

 

Sachets containing oral powder 35 g, 30 (PKU Sphere20)

Oral

 

PKU Sphere20

VF

MP NP

C4295

 

4

5

1

 

 

[29]         Schedule 1, entry for Idelalisib in each of the forms: Tablet 100 mg; and Tablet 150 mg

omit from the column headed “Circumstances”:          C7060 C7310

insert in numerical order in the column headed “Circumstances”:         C7387 C7388

[30]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

omit:

 

 

 

a

Irbesartan HCTZ AN 150/12.5

EA

MP NP

C4374

 

30

5

30

 

 

 


 

[31]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

omit:

 

 

 

a

Irbesartan HCTZ AN 300/12.5

EA

MP NP

C4374

 

30

5

30

 

 

[32]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg

omit:

 

 

 

a

Irbesartan HCTZ AN 300/25

EA

MP NP

C4374

 

30

5

30

 

 

[33]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

omit:

 

 

 

b

Microgynon 30 ED

BN

MP NP

 

 

4

2

4

 

 

[34]         Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg [Maximum Quantity: 30; Number of Repeats: 2]

omit from the column headed “Responsible Person” for the brand “Ralovera”:                  KR                          substitute:             FZ

[35]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

 

 

 

a

Metformin‑GA

ED

MP NP

 

 

100

5

100

 

 

[36]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit:

 

 

 

a

Metformin‑GA

ED

MP NP

 

 

60

5

60

 

 

[37]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

omit:

 

 

 

 

Metformin‑GA

ED

MP NP

 

 

90

5

90

 

 

 


 

[38]         Schedule 1, entry for Metronidazole

omit:

 

I.V. infusion 500 mg in 100 mL

Injection

 

Metronidazole Sandoz IV

SZ

MP NP

C6675 C6685

 

10

0

10

 

 

 

 

 

 

 

 

PDP

C6667

 

10

0

10

 

 

[39]         Schedule 1, entry for Milk powder—lactose free formula

omit:

 

Oral powder 900 g (S-26 LF)

Oral

 

S-26 LF

AS

MP NP

C4324

 

5

0

1

 

 

[40]         Schedule 1, entry for Naloxone in the form Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

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

 

 

 

a

NARCAN

PL

See Note 4

 

 

See Note 4

See Note 4

10

10

PB(MP)
PB(NP)

[41]         Schedule 1, after entry for Obinutuzumab

insert:

Ocrelizumab

Solution concentrate for I.V. infusion 300 mg in 10 mL

Injection

 

Ocrevus

RO

MP

C7386 C7398 C7411 C7412

 

2

0

1

 

D(100)

[42]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

omit:

 

 

 

 

Oxaliccord

EA

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

[43]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms

omit:

 

 

 

 

Pramipexole GH

GQ

MP NP

C5363

 

30

0

30

 

 

[44]         Schedule 1, entry for Pramipexole in each of the forms: Tablet containing pramipexole hydrochloride 250 micrograms; and Tablet containing pramipexole hydrochloride 1 mg

omit:

 

 

 

 

Pramipexole GH

GQ

MP NP

C5363

 

100

5

100

 

 

[45]         Schedule 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

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

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[46]         Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 200 mg (as fumarate); Tablet (modified release) 300 mg (as fumarate); and Tablet (modified release) 400 mg (as fumarate)

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

 

 

 

a

QUEPINE XR

RF

MP NP

C4246 C5611 C5639

 

60

5

60

 

 

[47]         Schedule 1, after entry for Raltegravir in the form Tablet 400 mg (as potassium)

insert:

 

Tablet 600 mg (as potassium)

Oral

 

Isentress HD

MK

MP

C4454 C4512

 

120

5

60

 

D(100)

[48]         Schedule 1, entry for Ramipril in the form Tablet 10 mg

omit:

 

 

 

 

Ramipril Winthrop

WA

MP NP

 

 

30

5

30

 

 

[49]         Schedule 1, entry for Rituximab

substitute:

Rituximab

Solution for I.V. infusion 100 mg in 10 Ml

Injection

 

Mabthera

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

PB(100)

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

 

See Note 3

See Note 3

2

 

PB(100)

 

Solution for I.V. infusion 500 mg in 50 mL

Injection

 

Mabthera

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

 

See Note 3

See Note 3

1

 

PB(100)

 

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL

Injection

 

Mabthera SC

RO

MP

C6011 C6161 C7399 C7400

P7399

1

5

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P7400

1

6

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6011

1

7

1

 

 

 

 

 

 

 

 

MP

C6011 C6161 C7399 C7400

P6161

1

11

1

 

 

[50]         Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30

omit from the column headed “Responsible Person” for the brand “Salbutamol AN”:                       JU                           substitute:                ED

[51]         Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit from the column headed “Responsible Person” for the brand “Salbutamol AN”:                       JU                           substitute:                ED

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

(a)      omit:

 

 

 

 

Simvastatin‑GA 10

ED

MP

C4238 C4263

P4263

30

5

30

 

 

 

 

 

 

 

 

NP

C4263

 

30

5

30

 

 

(b)      omit:

 

 

 

 

Simvastatin‑GA 10

ED

MP

C4238 C4263

P4238

30

11

30

 

 

[53]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg

(a)      omit:

 

 

 

 

Simvastatin‑GA 20

ED

MP

C4238 C4263

P4263

30

5

30

 

 

 

 

 

 

 

 

NP

C4263

 

30

5

30

 

 

(b)      omit:

 

 

 

 

Simvastatin‑GA 20

ED

MP

C4238 C4263

P4263

30

11

30

 

 

[54]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg

(a)      omit:

 

 

 

 

Simvastatin‑GA 40

ED

MP

C4238 C4263

P4263

30

5

30

 

 

 

 

 

 

 

 

NP

C4263

 

30

5

30

 

 

(b)      omit:

 

 

 

 

Simvastatin‑GA 40

ED

MP

C4238 C4263

P4238

30

11

30

 

 

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

(a)      omit:

 

 

 

 

Simvastatin‑GA 80

ED

MP

C4238 C4263

P4263

30

5

30

 

 

 

 

 

 

 

 

NP

C4263

 

30

5

30

 

 

(b)      omit:

 

 

 

 

Simvastatin‑GA 80

ED

MP

C4238 C4263

P4238

30

11

30

 

 

[56]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a)      omit:

 

 

 

a

Sebifin 250

RA

MP NP

C6395 C6404 C6453

P6404 P6453

42

0

42

 

 

(b)      omit:

 

 

 

a

Sebifin 250

RA

MP NP

C6395 C6404 C6453

P6395

42

1

42

 

 

[57]         Schedule 1, entry for Testosterone

omit:

 

Injection containing testosterone enanthate 250 mg in 1 mL

Injection

 

Primoteston Depot

BN

MP

C6324 C6910 C6919 C6933 C6934

 

3

3

3

 

 

[58]         Schedule 1, omit entry for Ticarcillin with Clavulanic Acid

[59]         Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

omit:

 

 

 

 

GA Tramadol SR 100mg

ED

MP NP

C5822

 

20

0

20

 

 

[60]         Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

omit:

 

 

 

 

GA Tramadol SR 200mg

ED

MP NP

C5822

 

20

0

20

 

 


 

[61]         Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

(a)      omit:

 

 

 

 

Vycin IV

EA

MP

C5716 C5717 C5769

P5717

1

0

1

 

 

 

 

 

 

 

 

PDP

C5801

 

1

0

1

 

 

(b)      omit:

 

 

 

 

Vycin IV

EA

MP

C5716 C5717 C5769

P5716 P5769

3

0

1

 

 

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

(a)      omit:

 

C6372

 

 

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 demonstrated progressive disease at the time of application; AND

Patient must not have achieved a best confirmed response to bortezomib at the time of application; AND

Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; 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 will not be approved if there is a gap of more than 6 months between the initial application and this application.

Compliance with Written Authority Required procedures

 

C6373

 

 

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 lenalidomide or pomalidomide; 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

(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of 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.

Compliance with Written Authority Required procedures

 

 

 

 

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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and

(3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided; and

(4) a signed patient acknowledgment.

To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided:

(a) the level of serum monoclonal protein; or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(c) the serum level of free kappa and lambda light chains; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

 

 

 

 

 

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.

Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

 

 

C6384

 

 

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient 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 PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND

Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes 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; and

(3) a signed patient acknowledgement.

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.

Compliance with Written Authority Required procedures

 

 

 

 

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients.

Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.

Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

 

 

C6452

 

 

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 have experienced treatment failure after a trial of at least four (4) weeks of thalidomide at a dose of at least 100 mg daily or have failed to achieve at least a minimal response after eight (8) or more weeks of thalidomide-based therapy for progressive disease; AND

Patient must not be receiving concomitant PBS-subsidised lenalidomide or pomalidomide; 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 of the difference between involved free light chain and uninvolved free light chain; or

(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

Compliance with Written Authority Required procedures

 

 

 

 

Thalidomide treatment failure is defined as:

(1) confirmed disease progression during thalidomide treatment or within 6 months of discontinuing thalidomide treatment; or

(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment.

Severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living.

Toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity.

Failure to achieve at least a minimal response after 8 or more weeks of thalidomide-based therapy for progressive disease is defined as:

(1) less than a 25% reduction in serum or urine M protein; or

(2) in oligo-secretory and non-secretory myeloma patients only, less than a 25% reduction in the difference between involved and uninvolved serum free light chain levels.

If the dosing requirement for thalidomide cannot be met, the application must state the reasons why this criterion cannot be satisfied.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and

(3) duration of thalidomide and daily dose prescribed; and

(4) a signed patient acknowledgment.

 

 

 

 

 

To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:

(a) the level of serum monoclonal protein; or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(c) the serum level of free kappa and lambda light chains; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

 

 

C6466

 

 

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 PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND

The treatment must be in combination with chemotherapy; AND

Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and

(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C6472

 

 

Symptomatic multiple myeloma

Continuing PBS-subsidised treatment

Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and have severe acute renal failure; AND

Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application; AND

The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND

Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; AND

Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and

(3) diagnostic reports demonstrating the patient has achieved at least a partial response.

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 will not be approved if there is a gap of more than 6 months between the initial application and this application.

Compliance with Written Authority Required procedures

 

C6478

 

 

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient must be newly diagnosed; AND

Patient must be ineligible for high dose chemotherapy; AND

Patient must not be receiving PBS-subsidised thalidomide, lenalidomide or pomalidomide; 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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma and ineligibility for high dose chemotherapy; and

(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

(b)      insert in numerical order after existing text:

 

C7376

 

 

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 demonstrated progressive disease at the time of application; AND

Patient must not have achieved a best confirmed response to bortezomib at the time of application; 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 will not be approved if there is a gap of more than 6 months between the initial application and this application.

Compliance with Authority Required procedures

 

C7377

 

 

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient 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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes 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; and

(3) a signed patient acknowledgement.

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 provided for all patients.

Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.

Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

Compliance with Written Authority Required procedures

 

C7389

 

 

Symptomatic multiple myeloma

Initial PBS-subsidised treatment

Patient 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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma and ineligibility for high dose chemotherapy; and

(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C7390

 

 

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; AND

Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma; and

(3) a signed patient acknowledgement.

Compliance with Written Authority Required procedures

 

C7402

 

 

Symptomatic multiple myeloma

Continuing PBS-subsidised treatment

Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and have severe acute renal failure; AND

Patient must have demonstrated at least a partial response at the completion of cycle 4 at the time of application; 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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application Supporting Information form, which includes a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority; and

(3) diagnostic reports demonstrating the patient has achieved at least a partial response.

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 will not be approved if there is a gap of more than 6 months between the initial application and this application.

Compliance with Authority Required procedures

 

C7414

 

 

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 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 of 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.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form which includes details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and

(3) diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously provided; and

(4) a signed patient acknowledgment.

To enable confirmation of eligibility for treatment current diagnostic reports of at least one of the following must be provided:

(a) the level of serum monoclonal protein; or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(c) the serum level of free kappa and lambda light chains; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided.

Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

Compliance with Written Authority Required procedures

 

C7416

 

 

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 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 of the difference between involved free light chain and uninvolved free light chain; or

(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Multiple Myeloma bortezomib Authority Application - Supporting Information Form, which includes details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response; and

(3) a signed patient acknowledgment.

To enable confirmation of eligibility for treatment, current diagnostic reports of at least one of the following must be provided:

(a) the level of serum monoclonal protein; or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(c) the serum level of free kappa and lambda light chains; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be provided.

Compliance with Written Authority Required procedures


 

[63]         Schedule 4, Part 1, omit entry for Cyproheptadine

[64]         Schedule 4, Part 1, entry for Evolocumab

omit:

 

C7329

 

 

Familial homozygous hypercholesterolaemia

Grandfathering treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND

The treatment must be in conjunction with dietary therapy and exercise; AND

The condition must have been confirmed by genetic testing; OR

The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after at least 3 months of treatment at a maximum tolerated dose of an HMG CoA reductase inhibitor (statin), in conjunction with dietary therapy and exercise, prior to initiation of treatment with this drug; OR

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after having developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of statin treatment, prior to initiation of treatment with this drug; OR

Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre prior to initiation of treatment with this drug, and must be contraindicated to treatment with an HMG CoA reductase inhibitor (statin).

Must be treated by a consultant physician or in consultation with a consultant physician.

The date of the consultation with a consultant physician must be no more than 6 months prior to the application for a PBS authority. The full name of the consultant physician consulted and the date of consultation are to be provided at the time of application.

The qualifying LDL cholesterol level prior to initiation of treatment with this drug must be provided at the time of application. With the exception of patients contraindicated to a statin, the agent, dose and duration of statin treatment must be provided at the time of application.

A clinically important product-related adverse event is defined as follows:

(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or

(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.

The authority application must be made in writing and must include:

a) A completed authority prescription form; and

b) A completed Familial homozygous hypercholesterolaemia Initial PBS 'Grandfather' Authority Application - Supporting Information Form; and

c) The date of consultation and the full name of the consultant physician; and

d) A copy of the qualifying Dutch Lipid Clinic Network Score or a copy of the result of genetic testing; and

e) The result of LDL cholesterol level and one of the following where appropriate: statin treatment details including agent, dose and treatment duration; or details of adverse event or contraindication to treatment with a statin as defined in the TGA-approved Product Information.

Compliance with Written Authority Required procedures

[65]         Schedule 4, Part 1, entry for Idelalisib

(a)      omit:

 

C7060

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Continuing treatment

The treatment must be in combination with rituximab; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

 

C7310

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Initial treatment

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with rituximab; AND

The condition must have relapsed or be refractory to at least one prior therapy; AND

The condition must be CD20 positive; AND

Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND

Patient must be inappropriate for chemo-immunotherapy.

A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced:

1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or

2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or

3. Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).

Full blood count results must be no more than 1 month old at the time of application.

The authority application must be made in writing and must include:

a) A completed authority prescription form;

b) A completed CLL/SLL PBS Authority Application - Supporting information form; and

c) Pathology report indicating that the patient can be considered inappropriate for chemo-immunotherapy due to one or more of the following:

1) Recent severe neutropenia; or

2) Recent severe thrombocytopenia; or

3) Presence of 17p chromosomal deletion using fluorescence in situ hybridisation (FISH).

Compliance with Written Authority Required procedures

(b)      insert in numerical order after existing text:

 

C7387

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Initial treatment

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with rituximab for up to a maximum of 8 doses, followed by monotherapy; AND

The condition must have relapsed or be refractory to at least one prior therapy; AND

The condition must be CD20 positive; AND

Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND

Patient must be inappropriate for chemo-immunotherapy.

A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced:

1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or

2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or

3. Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).

Full blood count results must be no more than 1 month old at the time of application.

The authority application must be made in writing and must include:

a) A completed authority prescription form;

b) A completed CLL/SLL PBS Authority Application - Supporting information form; and

c) Pathology report indicating that the patient can be considered inappropriate for chemo-immunotherapy due to one or more of the following:

1) Recent severe neutropenia; or

2) Recent severe thrombocytopenia; or

3) Presence of 17p chromosomal deletion using fluorescence in situ hybridisation (FISH).

A Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2017 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. 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.

Compliance with Written Authority Required procedures

 

C7388

 

 

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

[66]         Schedule 4, Part 1, entry for Metronidazole

omit:

 

C6667

 

 

Acute anaerobic sepsis

Must be treated in a hospital.

 

 

C6675

 

 

Acute anaerobic sepsis

Must be treated in a hospital.

 

 

C6685

 

 

Prophylaxis to prevent infection

Patient must be undergoing large bowel surgery.

 

[67]         Schedule 4, Part 1, entry for Milk powder — lactose free formula

omit:

 

C4324

 

 

Acute lactose intolerance

Patient must be up to the age of 12 months

The date of birth of the patient must be included in the authority application

Compliance with Authority Required procedures

[68]         Schedule 4, Part 1, after entry for Obinutuzumab

insert:

Ocrelizumab

C7386

 

 

Multiple sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Must be treated by a neurologist.

Compliance with Authority Required procedures - Streamlined Authority Code 7386

 

C7398

 

 

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND

Patient must be ambulatory (without assistance or support).

Must be treated by a neurologist.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures

 

C7411

 

 

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND

Patient must be ambulatory (without assistance or support).

Must be treated by a neurologist.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 7411

 

C7412

 

 

Multiple sclerosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Must be treated by a neurologist.

Compliance with Authority Required procedures

[69]         Schedule 4, Part 1, entry for Rituximab

(a)      omit:

 

C5998

P5998

 

Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 5998

 

C6008

P6008

 

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6008

 

C6009

 

 

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6009

(b)      omit:

 

C6034

 

 

Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

The treatment must be maintenance therapy; AND
Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application; AND
Patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6034

 

C6039

P6039

 

Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma

Re-induction treatment

The treatment must be for re-induction treatment purposes only; AND
The condition must have relapsed or be refractory to treatment; AND
Patient must not receive more than 4 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 3 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 4 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6039

(c)      omit:

 

C6162

P6162

 

Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6162

 

C6309

 

 

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6309

 

C6317

P6317

 

Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6317

 

C7040

 

 

Chronic lymphocytic leukaemia (CLL)

The condition must be CD20 positive; AND
The treatment must be in combination with chemotherapy or idelalisib.

Compliance with Authority Required procedures - Streamlined Authority Code 7040

(d)      insert in numerical order after existing text:

 

C7399

P7399

 

Previously untreated or Relapsed/refractory CD20 positive acute lymphoblastic leukaemia

Maintenance therapy

The treatment must be maintenance therapy; AND

The treatment must be in combination with chemotherapy; AND

Patient must be in complete remission; AND

Patient must not receive more than 6 doses in total under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 7399

 

C7400

P7400

 

Previously untreated or relapsed/refractory CD20 positive lymphoid cancer

Induction or re-induction therapy

The treatment must be for induction or re-induction for CD20 positive lymphoma; OR

The treatment must be for induction or re-induction for CD20 positive chronic lymphocytic leukaemia; OR

The treatment must be for induction or consolidation for CD20 positive acute lymphoblastic leukaemia; AND

The treatment must be in combination with chemotherapy; AND

Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.

An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab.

No more than 8 doses in total as per course of treatment will be allowed for lymphoma or chronic lymphocytic leukaemia.

No more than 12 doses in total as per course of treatment will be allowed for acute lymphoblastic leukaemia for induction course (including consolidation course).

Compliance with Authority Required procedures - Streamlined Authority Code 7400


 

[70]         Schedule 4, Part 1, omit entry for Ticarcillin with clavulanic acid

[71]         Schedule 5

insert as first entry:

Abacavir with lamivudine

GRP-21981

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg

Oral

Abacavir/Lamivudine GH 600/300

 

 

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

Oral

Kivexa

[72]         Schedule 5, entry for Ramipril in the form Tablet 10 mg [GRP-15431]

omit from the column headed “Brand”:         Ramipril Winthrop