National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 13) (PB 110 of 2018) (Cth)

Case

PB 110 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 13)

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   19 December 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. 13).

(2)This Instrument may also be cited as PB 110 of 2018.

  1. Commencement

This Instrument commences on 1 January 2019.

  1. 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 Arsenic

omit from the column headed “Responsible Person”: PL            substitute: FF

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Atorvachol RF MP NP 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Atorvachol RF MP P7598 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Atorvachol RF MP NP 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Atorvachol RF MP P7598 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

a Atorvachol RF MP NP 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

a Atorvachol RF MP P7598 30 11 30

  1. Schedule 1, entry for Benzatropine in the form Injection containing benzatropine mesilate 2 mg in 2 mL

omit from the column headed “Responsible Person”: PL            substitute: FF

  1. Schedule 1, entry for Benzatropine in the form Tablet containing benzatropine mesilate 2 mg

omit from the column headed “Responsible Person”: PL            substitute: FF

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

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

a APO-Bimatoprost TX AO MP 1 5 1

  1. Schedule 1, entry for Cladribine in the form Injection 10 mg in 5 mL

omit from the column headed “Section 100/ Prescriber Bag only”: D(100) substitute: PB(100)

  1. Schedule 1, entry for Cladribine in the form Solution for I.V. infusion 10 mg in 10 mL single use vial

omit from the column headed “Section 100/ Prescriber Bag only”: D(100) substitute: PB(100)

  1. Schedule 1, after entry for Cladribine in the form Solution for I.V. infusion 10 mg in 10 mL single use vial

insert:

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

  1. Schedule 1, entry for Clindamycin in the form Capsule 150 mg (as hydrochloride) [Maximum Quantity: 24; Number of Repeats: 0]

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

a Clindamycin LU LV PDP C5487 24 0 24

  1. Schedule 1, entry for Clindamycin in the form Capsule 150 mg (as hydrochloride) [Maximum Quantity: 48; Number of Repeats: 1]

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

a Clindamycin LU LV MP NP MW C5470 48 1 24

  1. Schedule 1, entry for Crizotinib in each of the forms Capsule 200 mg; and Capsule 250 mg

insert in numerical order in the column headed “Circumstances”: C8281 C8290 C8291

  1. Schedule 1, entry for Everolimus

substitute:

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

  1. Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate) [Maximum Quantity: 24; Number of Repeats: 0]

omit:

a Flucloxacillin GH GQ MP C5414 C6169 P5414 24 0 24
NP MW C5414 24 0 24
PDP C5298 24 0 24

  1. Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate) [Maximum Quantity: 48; Number of Repeats: 1]

omit:

a Flucloxacillin GH GQ MP C5414 C6169 P6169 48 1 24

  1. Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL

(a)omit:

Hospira Pty Limited PF MP C6266 C6297 See Note 3 See Note 3 5 D(100)

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

DBL Fluorouracil Injection BP PF MP C6266 C6297 See Note 3 See Note 3 5 D(100)

  1. Schedule 1, entry for Hydrochlorothiazide

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate)

omit from the column headed “Responsible Person” for the brand “Imatinib-Teva” (all instances):TB substitute: SZ

  1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate)

omit from the column headed “Responsible Person” for the brand “Imatinib-Teva” (all instances):TB substitute: SZ

  1. Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6740

(b)omit from the column headed “Circumstances”: C6754

(c)omit from the column headed “Circumstances”: C6779

(d)omit from the column headed “Purposes”: P6740 P6754

(e)omit from the column headed “Purposes”: P6779

  1. Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6740

(b)omit from the column headed “Circumstances”: C6754

(c)omit from the column headed “Circumstances”: C6779

  1. Schedule 1, entry for Lenvatinib in each of the forms: Capsule 4 mg (as mesilate); and Capsule 10 mg (as mesilate)

omit from the column headed “Circumstances”: C6577

  1. Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

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

a METEX XR RF MP NP 60 5 60

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

omit from the column headed “Responsible Person” for the brand “NARCAN”: PL substitute: FF

  1. Schedule 1, entry for Naloxone in the form Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Naproxen in the form Oral suspension 125 mg per 5 mL, 474 mL

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Nifedipine in the form Tablet 20 mg

omit:

a Adalat 20 BN MP NP 60 5 60

  1. Schedule 1, entry for Oxycodone in the form Suppository 30 mg (as pectinate)

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]

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

a PHARMACY CARE PARACETAMOL SI PDP C5846 C5885 P5846 100 0 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]

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

a PHARMACY CARE PARACETAMOL SI MP NP C5835 C5865 P5835 100 1 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]

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

a PHARMACY CARE PARACETAMOL SI PDP C5846 C5885 P5885 300 0 100

  1. Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]

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

a PHARMACY CARE PARACETAMOL SI MP NP C5835 C5865 P5865 300 4 100
MP P4072 2 11 1

  1. Schedule 1, entry for Paraffin in the form Eye ointment, compound, containing liquid paraffin, light liquid paraffin, wool fat, white soft paraffin and retinol palmitate, 5 g

insert in the column headed “Listed Drug”: Paraffin with retinol palmitate

  1. Schedule 1, entry for Probenecid

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Propylthiouracil

omit from the column headed “Responsible Person”: PL substitute: FF

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

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: TB substitute: SZ

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release) 200 mg
    (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: TB substitute: SZ

  1. Schedule 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: TB substitute: SZ

  1. Schedule 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Tevatiapine XR”: TB substitute: SZ

  1. Schedule 1, entry for Sodium acid phosphate

(a)omit from the column headed “Responsible Person” for the brand “PHOSPHATE PHEBRA”: VU substitute: FG

(b)omit from the column headed “Responsible Person” for the brand “Phosphate Sandoz”: PL substitute: FF

  1. Schedule 1, entry for Somatropin

omit:

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)

  1. Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) 

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

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)

  1. Schedule 1, entry for Sucroferric oxyhydroxide

omit from the column headed “Responsible Person”: FN substitute: VL

  1. Schedule 1, entry for Sulthiame in each of the forms: Tablet 50 mg; and Tablet 200 mg

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

omit:

a Pritor Plus 40/12.5 mg FI MP NP C4374 28 5 28

  1. Schedule 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

omit:

a Pritor Plus 80/12.5 mg FI MP NP C4374 28 5 28

  1. Schedule 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-25 mg

omit:

a Pritor Plus 80/25 mg FI MP NP C4374 28 5 28     

  1. Schedule 1, entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)

omit from the column headed “Responsible Person”: PL substitute: FF

  1. Schedule 1, after entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 5]

insert:

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

  1. Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

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

DEZTRON DZ MP C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 1 11 1 PB(100)

  1. Schedule 3, details relevant to Responsible Person code AE

substitute:

AE AFT Pharmaceuticals (AU) Pty Ltd 29 105 636 413

  1. Schedule 3, after details relevant to Responsible Person code FB

insert:

FF Phebra Pty Ltd  99 059 357 890
FG Phebra Pty Ltd  99 059 357 890

  1. Schedule 3

omit:

FN Fresenius Medical Care Australia Pty Ltd  80 067 557 877

  1. Schedule 3, after details relevant to Responsible Person code LU

insert:

LV Luminarie Pty Ltd  18 601 868 375

  1. Schedule 3

omit:

PL The Trustee for Virgo Unit Trust (trading as Phebra)  77 695 661 635

  1. Schedule 3

omit:

VU The Trustee for Virgo Unit Trust (trading as Phebra)  77 695 661 635

  1. Schedule 4, entry for Cladribine

insert in numerical order after existing text:

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

  1. Schedule 4, entry for Crizotinib

insert in numerical order after existing text:

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

  1. Schedule 4, entry for Everolimus

insert in numerical order after existing text:

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

  1. Schedule 4, entry for Ixekizumab

(a)omit:

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

(b)omit:

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

(c)omit:

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

  1. Schedule 4, entry for Lenvatinib

omit:

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

  1. Schedule 4, entry for Paraffin

omit:

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.

  1. Schedule 4, after entry for Paraffin

insert:

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.

  1. Schedule 4, after entry for Tofacitinib

insert:

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

  1. Schedule 5, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL [GRP-17614]

insert in alphabetical order in the column headed “Brand”: DEZTRON

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