National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 4) (PB 19 of 2018) (Cth)

Case

PB 19 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018
(No. 4)

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 26th of March 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. 4).

(2)        This Instrument may also be cited as PB 19 of 2018.

2          Commencement

This Instrument commences on 1 April 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 in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

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

Abacavir/Lamivudine Mylan AF MP C4527 C4528 60 5 30 D(100)

(b)omit from the column headed “Schedule equivalent” for the brand “Kivexa”:          a

  1. Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:            C4154 C5453 C5521 C6599 C7078 C7100 C7101 C7132

(b)substitute:              C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592

(c)omit from the column headed “Purposes”:   P4154 P5521 P6599 P7100 P7101 P7132

(d)substitute:                   P7536 P7564 P7570 P7571 P7587 P7592

  1. Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:            C4154 C5453 C5521 C6599 C7078 C7100 C7101 C7132

(b)substitute:              C7517 C7536 C7553 C7564 C7570 C7571 C7587 C7592

(c)omit from the column headed “Purposes”:   P5453 P7078

(d)substitute:                   P7517 P7553

  1. Schedule 1, after entry for Atenolol in the form Oral solution 50 mg in 10 mL, 300 mL

insert in the columns in the order indicated:

Atezolizumab Solution concentrate for I.V. infusion 1200 mg in 20 mL Injection Tecentriq RO MP C6999 C7539 C7572 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Budesonide with eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses

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

a DuoResp Spiromax TB MP NP C7527 1 5 1

(b)insert in the column headed “Schedule equivalent” for the brand “Symbicort Turbuhaler 200/6”:     a

  1. Schedule 1, entry for Budesonide with eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

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

a DuoResp Spiromax TB MP NP C7527 C7574 1 5 1

(b)insert in the column headed “Schedule equivalent” for the brand “Symbicort Turbuhaler 400/12”:   a

  1. Schedule 1, entry for Carbomer 974

omit from the column headed “Responsible Person” for the brand “Poly Gel”: NV            substitute: AQ

  1. Schedule 1, after entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0]

insert:

Solution for injection 200 mg in 1 mL pre-filled pen Injection Cimzia UC MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P4606 P4737 P4830 2 2 2
MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P4643 P4764 P4853 P6374 P6423 P6474 2 5 2
MP C4606 C4643 C4737 C4764 C4830 C4853 C6374 C6396 C6398 C6399 C6423 C6455 C6456 C6460 C6474 P6396 P6398 P6399 P6455 P6456 P6460 6 0 2

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

omit:

Clopidogrel RBX RA MP NP C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20 CN5532; Number of Repeats: 5 CN5532]

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

a Cyprone 50 AL MP P5532 20
CN5532 		5
CN5532 		20

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100; Number of Repeats: 5]

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

a Cyprone 50 AL MP 100 5 50

  1. Schedule 1, entry for Dapagliflozin

substitute:

Dapagliflozin Tablet 10 mg (as propanediol monohydrate) Oral Forxiga AP MP C4991 C5629 C7495 C7506 C7528 28 5 28
NP C4991 C5629 C7495 C7506 28 5 28

  1. Schedule 1, entry for Dapagliflozin with metformin

substitute:

Dapagliflozin with metformin Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride Oral Xigduo XR 5/1000 AP MP C5631 C5657 C5739 C5798 C7492 C7498 56 5 56
NP C5631 C5657 C5739 C5798 C7492 56 5 56
Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride Oral Xigduo XR 10/500 AP MP C5631 C5657 C5739 C5798 C7492 C7498 28 5 28
NP C5631 C5657 C5739 C5798 C7492 28 5 28
Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride Oral Xigduo XR 10/1000 AP MP C5631 C5657 C5739 C5798 C7492 C7498 28 5 28
NP C5631 C5657 C5739 C5798 C7492 28 5 28

  1. Schedule 1, entry for Dexamethasone

(a)omit:

Intravitreal injection 700 micrograms Injection Ozurdex AG MP C6506 C7083 1 1 1

(b)substitute:

Intravitreal injection 700 micrograms Injection Ozurdex AG MP C7565 C7566 C7579 P7566 1 0 1
MP C7565 C7566 C7579 P7565 P7579 1 1 1

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

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

a Duloxetine Sandoz 30 SZ MP NP C5650 28 0 28

(b)omit:

a Pharmacor Duloxetine 30 CR MP NP C5650 28 0 28

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

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

a Duloxetine Sandoz 60 SZ MP NP C5650 28 5 28

(b)omit:

a Pharmacor Duloxetine 60 CR MP NP C5650 28 5 28

  1. Schedule 1, entry for Empagliflozin

substitute:

Empagliflozin Tablet 10 mg Oral Jardiance BY MP C4991 C5629 C7495 C7506 C7528 30 5 30
NP C4991 C5629 C7495 C7506 30 5 30
Tablet 25 mg Oral Jardiance BY MP C4991 C5629 C7495 C7506 C7528 30 5 30
NP C4991 C5629 C7495 C7506 30 5 30

  1. Schedule 1, after entry for Empagliflozin

insert:

Empagliflozin with linagliptin Tablet containing 10 mg empagliflozin with 5 mg linagliptin Oral Glyxambi BY MP C7524 C7556 30 5 30
NP C7556 30 5 30
Tablet containing 25 mg empagliflozin with 5 mg linagliptin Oral Glyxambi BY MP C7524 C7556 30 5 30
NP C7556 30 5 30

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride [Authorised Prescriber: MP]

insert in numerical order in the column headed “Circumstances”:        C7492 C7498

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride [Authorised Prescriber: NP]

insert in numerical order in the column headed “Circumstances”:        C7492

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride [Authorised Prescriber: MP]

insert in numerical order in the column headed “Circumstances”:        C7492 C7498

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride [Authorised Prescriber: NP]

insert in numerical order in the column headed “Circumstances”:        C7492

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride [Authorised Prescriber: MP]

insert in numerical order in the column headed “Circumstances”:        C7492 C7498

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride [Authorised Prescriber: NP]

insert in numerical order in the column headed “Circumstances”:        C7492

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride [Authorised Prescriber: MP]

insert in numerical order in the column headed “Circumstances”:        C7492 C7498

  1. Schedule 1, entry for Empagliflozin with metformin in the form Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride [Authorised Prescriber: NP]

insert in numerical order in the column headed “Circumstances”:        C7492

  1. Schedule 1, after entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

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

Fludarabine AMNEAL JU MP See Note 3 See Note  3 1 PB(100)

  1. Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

omit:

a Frusemide RBX RA MP NP 100 1 100

  1. Schedule 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium)

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

GANCICLOVIR SPX HN MP C4972 C4990 C4999 C5025 10 1 5 D(100)

  1. Schedule 1, entry for Gliclazide in the form Tablet 30 mg (modified release)

(a)omit:

Chem mart Gliclazide MR CH MP NP 100 5 100

(b)omit:

Terry White Chemists Gliclazide MR TW MP NP 100 5 100

  1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Bars 81 g, 7 (Camino Pro Complete)

insert:

Bars 81 g, 14 (Tylactin Complete) Oral Tylactin Complete QH MP NP C5533 8 5 1

  1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Oral liquid 250 mL, 30 (Tylactin RTD)

insert:

Sachets containing oral powder 16 g, 60 (PKU Build 10) Oral PKU Build 10 QH MP NP C4295 2 5 1

  1. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 20 g, 60 (PKU Restore)

insert:

Sachets containing oral powder 32 g, 30 (PKU Build 20) Oral PKU Build 20 QH MP NP C4295 4 5 1

  1. Schedule 1, entry for Hydrocortisone in the form Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g

omit from the column headed “Responsible Person” for the brand “Colifoam”: HM          substitute: GO

  1. Schedule 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 15 mL

(a)omit from the column headed “Responsible Person” for the brand “Genteal” (twice occurring): NV  substitute: AQ

(b)omit from the column headed “Responsible Person” for the brand “In a Wink Moisturising” (twice occurring): NM      substitute: IQ

  1. Schedule 1, entry for Hypromellose with Carbomer 980 in the form Ocular lubricating gel 3 mg‑2 mg per g, 10 g

(a)omit from the column headed “Responsible Person” for the brand “Genteal gel” (twice occurring): NV       substitute: AQ

(b)omit from the column headed “Responsible Person” for the brand “HPMC PAA” (twice occurring): NM       substitute: IQ

  1. Schedule 1, entry for Hypromellose with dextran in the form Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28

omit from the column headed “Responsible Person” for the brand “Bion Tears”: NV        substitute: AQ

  1. Schedule 1, entry for Hypromellose with dextran in the form Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

(a)omit from the column headed “Responsible Person” for the brand “Poly-Tears” (twice occurring): NM            substitute: IQ

(b)omit from the column headed “Responsible Person” for the brand “Tears Naturale” (twice occurring): NV     substitute: AQ

  1. Schedule 1, entry for Ibandronic acid in each of the forms:  Tablet 50 mg (as ibandronate sodium monohydrate); and Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

omit from the column headed “Responsible Person” for the brand “Bondronat”: RO       substitute: IX

  1. Schedule 1, after entry for Insulin Glargine in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 [Brand: Lantus SoloStar]

insert:

Injections (human analogue), cartridge, 300 units per mL, 1.5 mL, 3 Injection Toujeo Solostar SW MP NP 5 1 1
Injections (human analogue), cartridges, 300 units per mL, 1.5 mL, 5 Injection Toujeo Solostar SW MP NP 5 1 1

  1. Schedule 1, entry for Irbesartan in each of the forms: Tablet 150 mg; and Tablet 300 mg

omit:

a Irbesartan RBX RA MP NP 30 5 30

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

omit:

a Irbesartan/HCTZ RBX 150/12.5 RA MP NP C4374 30 5 30

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

omit:

a Irbesartan/HCTZ RBX 300/25 RA MP NP C4374 30 5 30

  1. Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre‑filled syringe; Injection 90 mg (as acetate) in single dose pre‑filled syringe; and Injection 120 mg (as acetate) in single dose pre‑filled syringe

insert in numerical order in the column headed “Circumstances”:         C7509 C7532

  1. Schedule 1, entry for Linagliptin

substitute:

Linagliptin Tablet 5 mg Oral Trajenta BY MP C6346 C6363 C6376 C7505 C7541 30 5 30
NP C6346 C6363 C6376 C7505 30 5 30

  1. Schedule 1, entry for Linagliptin with metformin

substitute:

Linagliptin with metformin Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride Oral Trajentamet BY MP C6333 C6336 C6344 C6443 C7507 C7530 60 5 60
NP C6333 C6336 C6344 C6443 C7530 60 5 60
Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride Oral Trajentamet BY MP C6333 C6336 C6344 C6443 C7507 C7530 60 5 60
NP C6333 C6336 C6344 C6443 C7530 60 5 60
Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride Oral Trajentamet BY MP C6333 C6336 C6344 C6443 C7507 C7530 60 5 60
NP C6333 C6336 C6344 C6443 C7530 60 5 60

  1. Schedule 1, entry for Loperamide in the form Capsule containing loperamide hydrochloride 2 mg [Maximum Quantity: 12; Number of Repeats: 0]

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

a Gastro-Stop AS MP NP C6343 C6364 P6364 12 0 12

  1. Schedule 1, entry for Loperamide in the form Capsule containing loperamide hydrochloride 2 mg [Maximum Quantity: 60; Number of Repeats: 0]

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

a Gastro-Stop AS MP NP C6343 C6364 P6343 60 0 12

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30

omit from the column headed “Responsible Person” for the brand “Molaxole” (all instances): HM               substitute: GO

  1. Schedule 1, after entry for Methotrexate in the form Injection 5 mg in 2 mL vial [Maximum Quantity: See Note 2; Number of Repeats: See Note 2]

insert:

Injection 7.5 mg in 0.15 mL pre-filled syringe Injection Trexject LM MP C7488 C7518 4 5 1
Injection 10 mg in 0.2 mL pre-filled syringe Injection Trexject LM MP C7488 C7518 4 5 1
Injection 15 mg in 0.3 mL pre-filled syringe Injection Trexject LM MP C7488 C7518 4 5 1
Injection 20 mg in 0.4 mL pre-filled syringe Injection Trexject LM MP C7488 C7518 4 5 1
Injection 25 mg in 0.5 mL pre-filled syringe Injection Trexject LM MP C7488 C7518 4 5 1

  1. Schedule 1, entry for Moclobemide in the form Tablet 150 mg

omit from the column headed “Responsible Person” for the brand “Aurorix”: HM             substitute: GO

  1. Schedule 1, entry for Moclobemide in the form Tablet 300 mg

omit from the column headed “Responsible Person” for the brand “Aurorix 300 mg”: HM              substitute: GO

  1. Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”:            C6996

(b)insert in numerical order in the column headed “Circumstances”:           C7567

  1. Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate)

omit from the column headed “Responsible Person” for the brand “Sevikar 20/5”: MK    substitute: AL

  1. Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate)

omit from the column headed “Responsible Person” for the brand “Sevikar 40/5”: MK    substitute: AL

  1. Schedule 1, entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate)

omit from the column headed “Responsible Person” for the brand “Sevikar 40/10”: MK substitute: AL

  1. Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

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

a Pharmacor Olmesartan HCTZ 20/12.5 CR MP NP C4374 30 5 30

  1. Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

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

a Pharmacor Olmesartan HCTZ 40/12.5 CR MP NP C4374 30 5 30

  1. Schedule 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

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

a Pharmacor Olmesartan HCTZ 40/25 CR MP NP C4374 30 5 30

  1. Schedule 1, entry for Paraffin in the form Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

omit from the column headed “Responsible Person” for the brand “Poly Visc”: NV          substitute: IQ

  1. Schedule 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

omit from the column headed “Responsible Person” for the brand “Poly Visc” (twice occurring): NV          substitute: IQ

  1. Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

omit:

Pemetrexed Juno JU MP C4792 C7195 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Pimecrolimus in the form Cream 10 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Elidel”: HM                       substitute: GO

  1. Schedule 1, entry for Polyethylene Glycol 400 with Propylene Glycol in each of the forms: Eye drops 4 mg‑3 mg per mL, 15 mL; and Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28

omit from the column headed “Responsible Person” for the brand “Systane”: NV             substitute: AQ

  1. Schedule 1, after entry for Potassium Chloride with Potassium Bicarbonate

insert:

Pralatrexate Solution for I.V. infusion 20 mg in 1 mL Injection Folotyn MF MP C7526 C7558 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

(a)insert in the column headed “Schedule equivalent” for all brands:          a

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

a ACQUIN RF MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 1.25 mg

omit:

Chem mart Ramipril CH MP NP 30 5 30
Terry White Chemists Ramipril TW MP NP 30 5 30

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:               C4804 C5050 C5052 C5053 C7081 C7102 C7106 C7115

(b)substitute:  C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562

(c)omit from the column headed “Purposes”:         P4804 P5050 P5053 P7081 P7102 P7106

(d)substitute: P7515 P7551 P7552 P7560 P7561 P7562

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4804 C5050 C5052 C5053 C7081 C7102 C7106 C7115

(b)substitute:  C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562

(c)omit from the column headed “Purposes”:         P5052 P7115

(d)substitute: P7511 P7514

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:               C4804 C5050 C5052 C5053 C7079 C7115 C7118 C7127

(b)substitute:  C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562

(c)omit from the column headed “Purposes”:         P4804 P5050 P5053 P7079 P7118 P7127

(d)substitute: P7515 P7551 P7552 P7560 P7561 P7562

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:               C4804 C5050 C5052 C5053 C7079 C7115 C7118 C7127

(b)substitute:  C7511 C7514 C7515 C7551 C7552 C7560 C7561 C7562

(c)omit from the column headed “Purposes”:         P5052 P7115

(d)substitute: P7511 P7514

  1. Schedule 1, entry for Rivastigmine in the form Transdermal patch 27 mg

(a)insert in the column headed “Schedule Equivalent” for the brand “Exelon Patch 15”: a

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

a Rivastigmelon Patch 15 AF MP NP C4219 C4220 C4224 30 5 30

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

omit:

Butamol 2.5 QA MP NP C6815 C6825 2 5 1

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

omit:

Butamol 5 QA MP NP C6815 C6825 2 5 1

  1. Schedule 1, entry for Saxagliptin

substitute:

Saxagliptin Tablet 2.5 mg (as hydrochloride) Oral Onglyza AP MP C6346 C6363 C7505 C7541 28 5 28
NP C6346 C6363 C7505 28 5 28
Tablet 5 mg (as hydrochloride) Oral Onglyza AP MP C6346 C6363 C7505 C7541 28 5 28
NP C6346 C6363 C7505 28 5 28

  1. Schedule 1, after entry for Saxagliptin in the form Tablet 5 mg (as hydrochloride) [Authorised Prescriber: NP]

insert:

Saxagliptin with dapagliflozin Tablet containing saxagliptin 5 mg with dapaglifozin 10 mg Oral Qtern 5/10 AP MP C7524 C7556 28 5 28
NP C7556 28 5 28

  1. Schedule 1, entry for Saxagliptin with metformin

substitute:

Saxagliptin with metformin Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride Oral Kombiglyze XR 2.5/1000 AP MP C6333 C6335 C6344 C7507 C7530 56 5 56
NP C6333 C6335 C6344 C7530 56 5 56
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride Oral Kombiglyze XR 5/500 AP MP C6333 C6335 C6344 C7507 C7530 28 5 28
NP C6333 C6335 C6344 C7530 28 5 28
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride Oral Kombiglyze XR 5/1000 AP MP C6333 C6335 C6344 C7507 C7530 28 5 28
NP C6333 C6335 C6344 C7530 28 5 28

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Ransim RA MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Ransim RA MP P4238 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Ransim RA MP NP 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Ransim RA MP P4238 30 11 30

  1. Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

omit:

Omnitrope SZ 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, after entry for Somatropin in the form Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

insert:

Sonidegib Capsule 200 mg Oral Odomzo RA MP C7491 C7540 C7557 30 3 30

  1. Schedule 1, entry for Tenofovir with emtricitabine

substitute:

Tenofovir with emtricitabine Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg Oral a Tenofovir EMT GH GQ MP NP C7580 30 2 30
MP C6985 C6986 60 5 30 C(100)
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg Oral a Truvada GI MP NP C7580 30 2 30
MP C6985 C6986 60 5 30 C(100)
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg Oral a Tenofovir Disoproxil Emtricitabine Mylan 300/200 AF MP NP C7580 30 2 30
MP C6985 C6986 60 5 30 C(100)

  1. Schedule 1, entry for Tiagabine in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 15 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Gabitril”: OA            substitute: TB

  1. Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

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

a TOBRAMYCIN SUN RA MP C5520 56 2 56

  1. Schedule 1, omit entry for Trifluoperazine

  1. Schedule 1, entry for Verteporfin

(a)omit from the column headed “Circumstances”:                           C6121 C7109 C7130

(b)substitute:   C7577 C7583 C7589

  1. Schedule 1, entry for Vildagliptin

insert in numerical order in the column headed “Circumstances”:        C6376

  1. Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride

insert in numerical order in the column headed “Circumstances”:        C6443

  1. Schedule 1, entry for Vismodegib

(a)omit from the column headed “Circumstances”:                           C6810 C7098 C7129

(b)substitute:   C7491 C7540 C7557

  1. Schedule 1, entry for Zonisamide in each of the forms: Capsule 25 mg ; Capsule 50 mg; and Capsule 100 mg

omit from the column headed “Responsible Person” for the brand “Zonegran”: SA            substitute: EI

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

insert:

AQ Alcon Laboratories (Australia) Pty Ltd 88 000 740 830

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

omit from the column headed “Responsible Person”:                 BGP Products Pty Ltd              substitute:             Mylan Health Pty Ltd

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

omit from the column headed “Responsible Person”:                 BGP Products Pty Ltd              substitute:             Mylan Health Pty Ltd

  1. Schedule 3

(a)omit:

HM Meda Pharmaceuticals Pty Ltd  59 155 308 679

(b)substitute:

HN Horizon Hospital Healthcare Pty Ltd 60 148 910 883

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

insert:

IQ Alcon Laboratories (Australia) Pty Ltd 88 000 740 830

  1. Schedule 3

omit:

SA SciGen (Australia) Pty Limited 75 055 016 969

  1. Schedule 4, Part 1, entry for Aflibercept

substitute:

Aflibercept C7517 P7517

Diabetic macular oedema (DMO)

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7536 P7536

Central retinal vein occlusion with macular oedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7553 P7553

Diabetic macular oedema (DMO)

Initial treatment

Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7564 P7564

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7570 P7570

Branch retinal vein occlusion with macular oedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7571 P7571

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7587 P7587

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;

b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7592 P7592

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Atenolol

insert:

Atezolizumab C6999 P6999

Locally advanced or metastatic non-small cell lung cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease.

 Compliance with Authority Required procedures - Streamlined Authority Code 6999
C7539 P7539

Locally advanced or metastatic non-small cell lung cancer

Initial treatment

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 7539
C7572 P7572

Locally advanced or metastatic non-small cell lung cancer

Grandfathering treatment

Patient must have received treatment with this drug for this condition prior to 1 April 2018; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 at the time non PBS-subsidised treatment with this drug for this condition was initiated.
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 Authority Required procedures - Streamlined Authority Code 7572

  1. Schedule 4, Part 1, entry for Budesonide with eformoterol

insert in numerical order after existing text:

C7527

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR
Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.
Patient must be aged 18 years or older.
C7574

Chronic obstructive pulmonary disease (COPD)

Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; AND

Patient must have a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND

The treatment must be for symptomatic treatment.

Patient must be aged 18 years or older.

  1. Schedule 4, Part 1, entry for Dapagliflozin

(a)omit:  

C4983

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug

 Compliance with Authority Required procedures - Streamlined Authority Code 4983

(b)insert in numerical order after existing text:

C7495

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7495
C7506

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with a gliptin and an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 7506
C7528

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a gliptin; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7528

  1. Schedule 4, Part 1, entry for Dapagliflozin with metformin

insert in numerical order after existing text:

C7492

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7492
C7498

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and a gliptin for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7498

  1. Schedule 4, Part 1, entry for Dexamethasone

substitute:

Dexamethasone C7565 P7565

Diabetic macular oedema (DMO)

Continuing treatment

Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.

 Compliance with Authority Required procedures
C7566 P7566

Non-infectious posterior segment uveitis

Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Patient must have documented visual impairment defined as a best corrected visual acuity score of approximate Snellen equivalent 6/12 or worse in the eye proposed for treatment, secondary to vitreous haze or macular oedema; AND
Patient must have unilateral, asymmetric or bilateral flare-up where systemic treatment or further intensification of systemic treatment is not clinically indicated.

 Compliance with Authority Required procedures
C7579 P7579

Diabetic macular oedema (DMO)

Initial treatment

Must be treated by an ophthalmologist or in consultation with an ophthalmologist.Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; OR
Patient must be unsuitable for treatment with VEGF inhibitors; OR
Patient must have failed prior treatment with VEGF inhibitors; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must have had a cataract removed in the treated eye; OR
Patient must be scheduled for cataract surgery in the treated eye.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Empagliflozin

(a)omit:

C4983

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 4983

(b)insert in numerical order after existing text:

C7495

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7495
C7506

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with a gliptin and an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 7506
C7528

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a gliptin; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7528

  1. Schedule 4, Part 1, after entry for Empagliflozin

insert:

Empagliflozin with linagliptin C7524

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a dipeptidyl peptidase 4 inhibitor (gliptin) or a sodium-glucose co-transporter 2 (SGLT2) inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7524
C7556

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7556

  1. Schedule 4, Part 1, entry for Empagliflozin with metformin

insert in numerical order after existing text:

C7492

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7492
C7498

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with a dipeptidyl peptidase 4 inhibitor (gliptin); AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and a gliptin for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7498

  1. Schedule 4, Part 1, entry for Lanreotide

insert in numerical order after existing text:

C7509

Functional carcinoid tumour

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

 Compliance with Authority Required procedures - Streamlined Authority Code 7509
C7532

Acromegaly

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

 Compliance with Authority Required procedures - Streamlined Authority Code 7532

  1. Schedule 4, Part 1, entry for Linagliptin

insert in numerical order after existing text:

C7505

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7505
C7541

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.

The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7541

  1. Schedule 4, Part 1, entry for Linagliptin with metformin

insert in numerical order after existing text:

C7507

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7507
C7530

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7530

  1. Schedule 4, Part 1, entry for Methotrexate

insert in numerical order after existing text:

C7488

Severe active rheumatoid arthritis

Patient must be unsuitable for administration of an oral form of methotrexate for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7488
C7518

Severe psoriasis

The condition must not have adequately responded to topical treatment; AND
Patient must be unsuitable for administration of an oral form of methotrexate for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7518

  1. Schedule 4, Part 1, entry for Nivolumab

(a)omit:

C6996

Locally advanced or metastatic non-small cell lung cancer

Initial treatment

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6996

(b)nsert in numerical order after existing text:

C7567 P7567

Locally advanced or metastatic non-small cell lung cancer

Initial treatment

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 7567

  1. Schedule 4, Part 1, after entry for Posaconazole

insert:

Pralatrexate C7526 P7526

Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma

Continuing treatment

The condition must be relapsed or chemotherapy refractory; AND
Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.

 Compliance with Authority Required procedures
C7558 P7558

Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma

Initial treatment

The condition must be relapsed or chemotherapy refractory; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ranibizumab

substitute:

Ranibizumab C7511 P7511

Diabetic macular oedema (DMO)

Initial treatment

Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7514 P7514

Diabetic macular oedema (DMO)

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7515 P7515

Branch retinal vein occlusion with macular oedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7551 P7551

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7552 P7552

Branch retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7560 P7560

Central retinal vein occlusion with macular oedema

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures
C7561 P7561

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures
C7562 P7562

Central retinal vein occlusion with macular oedema

Initial treatment

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Saxagliptin

insert in numerical order after existing text:

C7505

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7505
C7541

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7541

  1. Schedule 4, Part 1, after entry for Saxagliptin

insert:

Saxagliptin with dapagliflozin C7524

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with metformin; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a dipeptidyl peptidase 4 inhibitor (gliptin) or a sodium-glucose co-transporter 2 (SGLT2) inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7524
C7556

Diabetes mellitus type 2

Continuing treatment

The treatment must be in combination with metformin; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 7556

  1. Schedule 4, Part 1, entry for Saxagliptin with metformin

insert in numerical order after existing text:

C7507

Diabetes mellitus type 2

Initial treatment

The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS-subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 7507
C7530 Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with a sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS-subsidised regimen of oral diabetic medicines which included a sodium-glucose co-transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 7530

  1. Schedule 4, Part 1, after entry for Somatropin

insert:

Sonidegib C7491

Metastatic or locally advanced basal cell carcinoma

Initial treatment or Continuing treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

 Compliance with Authority Required procedures
C7540

Metastatic or locally advanced basal cell carcinoma

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; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and
c) A confirmation statement from the treating doctor that the disease has not progressed; and
d) In patients with locally advanced BCC, a letter from a surgically qualified clinician demonstrating that the condition remains inappropriate for surgery; or a letter from a radiation oncologist demonstrating that the condition remains inappropriate for curative radiotherapy
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC

 Compliance with Written Authority Required procedures
C7557

Metastatic or locally advanced basal cell carcinoma

Initial treatment

The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR
Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and
c) A histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery for patients with locally advanced BCC; and
e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy for patients with locally advanced BCC; and
f) A signed patient acknowledgement.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Tenofovir with emtricitabine

insert in numerical order after existing text:

C7580

Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection

The treatment must be for patients at medium to high risk of HIV infection, as defined by the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) Guidelines; AND
Patient must have a negative HIV test result prior to treatment with PBS-subsidised therapy with this drug.
Patient must be 18 years or older.

 Compliance with Authority Required procedures - Streamlined Authority Code 7580

  1. Schedule 4, Part 1, entry for Verteporfin

substitute:

Verteporfin C7577

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be predominantly classic (greater than or equal to 50%).

Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
Patient must have a baseline visual acuity equal to or better than 6/60 (20/200).
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram.

 Compliance with Written Authority Required procedures
C7583

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

The condition must be predominantly classic (greater than or equal to 50%); AND
The condition must be due to macular degeneration; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 7583
C7589

Subfoveal choroidal neovascularisation (CNV)

Initial PBS-subsidised treatment

The condition must be predominantly classic (greater than or equal to 50%); AND
The condition must be due to macular degeneration; AND
Patient must have been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the MBS Visudyne Therapy Program; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
(a) a completed authority prescription form; and
(b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form, which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and
(c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram.

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Vildagliptin

insert in numerical order after existing text:

C6376

Diabetes mellitus type 2

The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitatzone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 6376

  1. Schedule 4, Part 1, entry for Vildagliptin with metformin

insert in numerical order after existing text:

C6443

Diabetes mellitus type 2

The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 6443

  1. Schedule 4, Part 1, entry for Vismodegib

substitute:

Vismodegib C7491

Metastatic or locally advanced basal cell carcinoma

Initial treatment or Continuing treatment – balance of supply

Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.

 Compliance with Authority Required procedures
C7540

Metastatic or locally advanced basal cell carcinoma

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; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; and
c) A confirmation statement from the treating doctor that the disease has not progressed; and
d) In patients with locally advanced BCC, a letter from a surgically qualified clinician demonstrating that the condition remains inappropriate for surgery; or a letter from a radiation oncologist demonstrating that the condition remains inappropriate for curative radiotherapy
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.

Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC

 Compliance with Written Authority Required procedures
C7557

Metastatic or locally advanced basal cell carcinoma

Initial treatment

The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR
Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made in writing and must include:
a) A completed authority prescription form; and
b) A completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; and
c) A histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
d) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery for patients with locally advanced BCC; and
e) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy for patients with locally advanced BCC; and
f) A signed patient acknowledgement.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Inappropriate for surgery is defined as:
i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
ii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
iii/ Medical contraindication to surgery
Inappropriate for curative radiotherapy is defined as:
i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
ii/ Limitations due to location of tumour; or
iii/ Limitations due to cumulative prior radiotherapy dose; or
iv/ Progressive disease despite prior irradiation of locally advanced BCC.

 Compliance with Written Authority Required procedures

  1. Schedule 5, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg
    [GRP-21981]

insert in alphabetical order in the column headed “Brand”:    Abacavir/Lamivudine Mylan

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]

omit from the column headed “Brand”:       Clopidogrel RBX

  1. Schedule 5, after entry for Fentanyl

insert:

Ganciclovir GRP-22142 Powder for I.V. infusion 500 mg (as sodium) Injection Cymevene
GANCICLOVIR SXP

  1. Schedule 5, entry for Ramipril in the form Capsule 1.25 mg [GRP-15640]

(a)omit from the column headed “Brand”:           Chem mart Ramipril

(b)omit from the column headed “Brand”:           Terry White Chemists Ramipril

  1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]

omit from the column headed “Brand”:       Butamol 2.5

  1. Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]

omit from the column headed “Brand”:       Butamol 5

  1. Schedule 5, after entry for Tenofovir with emtricitabine in the form Tenofovir with emtricitabine [GRP-21638]

insert:

GRP-22144 Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg Oral Tenofovir EMT GH
Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg Oral Truvada
Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg Oral Tenofovir Disoproxil Emtricitabine Mylan 300/200
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