a

Atorvachol

RF

MP NP

30

5

30

a

Atorvachol

RF

MP

P7598

30

11

30

a

Atorvachol

RF

MP NP

30

5

30

a

Atorvachol

RF

MP

P7598

30

11

30

a

Atorvachol

RF

MP NP

30

5

30

a

Atorvachol

RF

MP

P7598

30

11

30

a

APO-Bimatoprost

TX

AO MP

1

5

1

Tablet 10 mg

Oral

Mavenclad

SG

MP

C8269 C8310 C8311

1

1

1

MP

C8269 C8310 C8311

6

1

6

MP

C8269 C8310 C8311

8

1

4

a

Clindamycin LU

LV

PDP

C5487

24

0

24

a

Clindamycin LU

LV

MP NP MW

C5470

48

1

24

Everolimus

Tablet 0.25 mg

Oral

Certican

NV

MP

60

3

60

MP

P5554 P5555 P5794 P5795

120
CN5554 CN5555 CN5794 CN5795

5
CN5554 CN5555 CN5794 CN5795

60

C(100)

Tablet 0.5 mg

Oral

Certican

NV

MP

60

3

60

MP

P5554 P5555 P5794 P5795

120
CN5554 CN5555 CN5794 CN5795

5
CN5554 CN5555 CN5794 CN5795

60

C(100)

Tablet 0.75 mg

Oral

Certican

NV

MP

120

3

60

MP

P5554 P5555 P5794 P5795

240
CN5554 CN5555 CN5794 CN5795

5
CN5554 CN5555 CN5794 CN5795

60

C(100)

Tablet 1 mg

Oral

Certican

NV

MP

120

3

60

MP

P5554 P5555 P5794 P5795

240
CN5554 CN5555 CN5794 CN5795

5
CN5554 CN5555 CN5794 CN5795

60

C(100)

dispersible tablet 2 mg

Oral

Afinitor

NV

MP

C8262 C8263

30

5

30

Tablet 2.5 mg

Oral

Afinitor

NV

MP

C4351 C7431

30

5

30

dispersible tablet 3 mg

Oral

Afinitor

NV

MP

C8262 C8263

30

5

30

dispersible tablet 5 mg

Oral

Afinitor

NV

MP

C8262 C8263

30

5

30

Tablet 5 mg

Oral

Afinitor

NV

MP

C4351 C4604 C4812 C4837 C4861 C7431 C7432

P4604 P4861

30

2

30

Everolimus Sandoz

SZ

MP

C4837 C4861

P4861

30

2

30

Afinitor

NV

MP

C4351 C4604 C4812 C4837 C4861 C7431 C7432

P4351 P4812 P4837 P7431 P7432

30

5

30

Everolimus Sandoz

SZ

MP

C4837 C4861

P4837

30

5

30

Tablet 10 mg

Oral

Afinitor

NV

MP

C4351 C4604 C4812 C4837 C4861 C7431 C7432

P4604 P4861

30

2

30

Everolimus Sandoz

SZ

MP

C4837 C4861

P4861

30

2

30

Afinitor

NV

MP

C4351 C4604 C4812 C4837 C4861 C7431 C7432

P4351 P4812 P4837 P7431 P7432

30

5

30

Everolimus Sandoz

SZ

MP

C4837 C4861

P4837

30

5

30

a

Flucloxacillin GH

GQ

MP

C5414 C6169

P5414

24

0

24

NP MW

C5414

24

0

24

PDP

C5298

24

0

24

a

Flucloxacillin GH

GQ

MP

C5414 C6169

P6169

48

1

24

Hospira Pty Limited

PF

MP

C6266 C6297

See Note 3

See Note 3

5

D(100)

DBL Fluorouracil Injection BP

PF

MP

C6266 C6297

See Note 3

See Note 3

5

D(100)

a

METEX XR

RF

MP NP

60

5

60

a

Adalat 20

BN

MP NP

60

5

60

a

PHARMACY CARE PARACETAMOL

SI

PDP

C5846 C5885

P5846

100

0

100

a

PHARMACY CARE PARACETAMOL

SI

MP NP

C5835 C5865

P5835

100

1

100

a

PHARMACY CARE PARACETAMOL

SI

PDP

C5846 C5885

P5885

300

0

100

a

PHARMACY CARE PARACETAMOL

SI

MP NP

C5835 C5865

P5865

300

4

100

MP

P4072

2

11

1

Injection 12 mg (36 i.u.) in 1 mL cartridge (with preservative)

Injection

Genotropin

PF

MP

C5146 C5147 C5163 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5196 C5200 C5227 C5228 C5229 C5230 C5231 C5232 C5238 C5239 C5241 C5269 C5270 C5272 C5273 C5280 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 C8121 C8242

See Note 3

See Note 3

1

D(100)

Scitropin A

SA

MP

C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433

See Note 3

See Note 3

1

D(100)

a

Pritor Plus 40/12.5 mg

FI

MP NP

C4374

28

5

28

a

Pritor Plus 80/12.5 mg

FI

MP NP

C4374

28

5

28

a

Pritor Plus 80/25 mg

FI

MP NP

C4374

28

5

28       

Tolvaptan

Pack containing 28 tablets 15 mg and 28 tablets 45 mg

Oral

Jinarc

OS

MP

C8287 C8288

1

5

1

Pack containing 28 tablets 30 mg and 28 tablets 60 mg

Oral

Jinarc

OS

MP

C8287 C8288

1

5

1

Pack containing 28 tablets 30 mg and 28 tablets 90 mg

Oral

Jinarc

OS

MP

C8287 C8288

1

5

1

DEZTRON

DZ

MP

C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736

1

11

1

PB(100)

AE

AFT Pharmaceuticals (AU) Pty Ltd

29 105 636 413

FF

Phebra Pty Ltd

 99 059 357 890

FG

Phebra Pty Ltd

 99 059 357 890

FN

Fresenius Medical Care Australia Pty Ltd

 80 067 557 877

LV

Luminarie Pty Ltd

 18 601 868 375

PL

The Trustee for Virgo Unit Trust (trading as Phebra)

 77 695 661 635

VU

The Trustee for Virgo Unit Trust (trading as Phebra)

 77 695 661 635

C8269

Relapsing remitting multiple sclerosis
Initial treatment
The condition must be diagnosed by a neurologist; AND
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, with 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 multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.

Compliance with Authority Required procedures

C8310

Relapsing remitting multiple sclerosis
Continuing treatment
Must be treated by a neurologist.
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
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
Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.

Compliance with Authority Required procedures

C8311

Relapsing remitting multiple sclerosis
Grandfather 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, with 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
Patient must have received treatment with this drug for this condition prior to 1 January 2019; AND
The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND
Patient must have had at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.

Compliance with Authority Required procedures

C8281

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; 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

C8290

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

C8291

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 January 2019; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
The treatment must be as monotherapy; AND
Patient must have a WHO performance status of 2 or less prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material.
A 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

C8262

Refractory seizures associated with tuberous sclerosis complex
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have maintained a response to the PBS-subsidised treatment with this drug for this condition; AND
The treatment must be in combination with at least one anti-epileptic drug; AND
Patient must not be a candidate for curative surgery.

Compliance with Authority Required procedures - Streamlined Authority Code 8262

C8263

Refractory seizures associated with tuberous sclerosis complex
Initial treatment
Patient must have a confirmed diagnosis of tuberous sclerosis complex (TSC); AND
Patient must be experiencing a minimum of two partial-onset seizures per week; AND
The condition must have failed to be controlled satisfactorily at stable doses of at least two anti-epileptic drugs; AND
The treatment must be in combination with at least one anti-epileptic drug; AND
Patient must not be a candidate for curative surgery.
Patient must be at least 2 years of age.

Compliance with Authority Required procedures

C6740

P6740

Severe chronic plaque psoriasis
Initial treatment – Initial 3, Whole body or Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment, Whole body or Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist.

Compliance with Authority Required procedures

C6754

P6754

Severe chronic plaque psoriasis
Initial treatment – Initial 3, Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have been receiving treatment with this drug for this condition prior to 1 February 2017; AND
Patient must have had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with this drug; AND
Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (whole body); AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
The most recent PASI assessment must be no more than 1 month old at the time of application.
A patient may qualify for PBS-subsidised treatment under this restriction once only.

Compliance with Written Authority Required procedures

C6779

P6779

Severe chronic plaque psoriasis
Initial treatment – Initial 3, Face, hand, foot (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have been receiving treatment with this drug for this condition prior to 1 February 2017; AND
Patient must have had disease, prior to treatment with this drug, classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe; or (ii) the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; AND
Patient must have demonstrated a response to treatment as specified in the criterion included in the restriction for continuing PBS-subsidised treatment with this drug (face, hand, foot); AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug) and the most recent PASI assessment; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
The most recent PASI assessment must be no more than 1 month old at the time of application.
The PASI assessment must be performed on the same affected area as assessed at baseline or prior to initiation of treatment with this drug.
A patient may qualify for PBS-subsidised treatment under this restriction once only.

Compliance with Written Authority Required procedures

C6577

Locally advanced or metastatic differentiated thyroid cancer
Grandfathering treatment
The condition must be refractory to radioactive iodine; AND
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 the sole PBS-subsidised therapy for this condition; AND
Patient must have thyroid stimulating hormone adequately repressed.

Compliance with Authority Required procedures - Streamlined Authority Code 6577

P4072

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

Paraffin with retinol palmitate

P4072

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

Tolvaptan

C8287

Autosomal dominant polycystic kidney disease (ADPKD)
Initial treatment
Must be treated by a nephrologist.
Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min/1.73 m2 at the initiation of treatment with this drug for this condition; AND
Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.
Rapidly progressing disease is defined as either of the following:
A decline in eGFR of greater than or equal to 5 mL/min/1.73 m2 within one year;
OR
an average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2  per year over a five year period.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Autosomal dominant polycystic kidney disease PBS Authority Application - Supporting Information Form which includes the following:
(i) The eGFR at initiation of treatment; and
(ii) Confirmation that the patient has rapidly progressing disease or had rapidly progressing disease at the time treatment with this drug for this condition was initiated as defined as a decline in eGFR of greater than or equal to 5 mL/min/1.73 m2 within one year or an average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2  per year over a five year period.

Compliance with Written Authority Required procedures

C8288

Autosomal dominant polycystic kidney disease (ADPKD)
Continuing treatment
Must be treated by a nephrologist or in consultation with a nephrologist.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have end-stage renal disease defined as an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m2; AND
Patient must not have had a kidney transplant.

Compliance with Authority Required procedures - Streamlined Authority Code 8288