Source: https://www.legislation.gov.au/Details/F2018L01071
Timestamp: 2020-04-04 11:09:37
Document Index: 570276734

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 3']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 8) (PB 63 of 2018)
Details: F2018L01071
- F2018L01071
PB 63 of 2018 Lists as made
PB 63 of 2018
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 8)
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 8).
(2) This Instrument may also be cited as PB 63 of 2018.
This Instrument commences on 1 August 2018.
[1] Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
[2] Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]
[3] Schedule 1, entry for Aciclovir in the form Tablet 800 mg
[4] Schedule 1, entry for Aclidinium with formoterol
omit from the column headed "Circumstances": C5763 substitute: C7798
[5] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)
[6] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)
[7] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)
[8] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)
[9] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)
[10] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)
[11] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)
[12] Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)
[13] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 0]
(b) omit from the column headed “Schedule Equivalent” for the brand “Curam”: a
[14] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 1]
(c) omit from the column headed “Brand” for the brand “Curam”: Curam
(d) omit from the column headed “Responsible Person” for the brand “Curam”: SZ
[15] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity:1; Number of Repeats: 0]
[16] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 1]
[17] Schedule 1, entry for Apomorphine in all forms
insert in the column headed “Form” after the word “hydrochloride”: hemihydrate
[18] Schedule 1, entry for Atropine in all forms
insert in the column headed “Form” after the word “sulfate”: monohydrate
[19] Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL
[20] Schedule 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate)
CN6188
[21] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in numerical order in the column headed “Circumstances” for the brand “Clopidogrel Sandoz”: C4165 C4166
[22] Schedule 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL
[23] Schedule 1, entry for Codeine
insert in the column headed “Form” after the word “phosphate”: hemihydrate
[24] Schedule 1, entry for Codeine with paracetamol
[25] Schedule 1, entry for Cyclophosphamide for the form Tablet 50 mg
insert in the column headed “Form” after the word “mg”: (anhydrous)
[26] Schedule 1, entry for Dantrolene in all forms
insert in the column headed “Form” after the word “sodium”: hemiheptahydrate
[27] Schedule 1, entry for Diphenoxylate with atropine
[28] Schedule 1, entry for Diphtheria and tetanus vaccine, adsorbed, diluted for adult use
[29] Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg
Donepezil RBX
[30] Schedule 1, entry for Doxycycline in the form Capsule 50 mg (as hydrochloride) (containing enteric coated pellets)
omit from the column headed "Form": hydrochloride substitute: hyclate
[32] Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hydrochloride)
[33] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)
[34] Schedule 1, entry for Electrolyte replacement, oral in the form Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 [Maximum Quantity: 1; Number of Repeats: 0]
(a) insert in the column headed “Form” after the word “glucose”: monohydrate
C5889 C6786
[35] Schedule 1, entry for Electrolyte replacement, oral in the form Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 [Maximum Quantity: 30; Number of Repeats: 0]
(b) omit from the column headed “Schedule Equivalent” for the brand “restore O.R.S.”: a
[36] Schedule 1, entry for Ezetimibe
C5537 C5538 C5543 C5544 C5562 C5563 C5575 C5576 C5577 C5586 C5594
Ezetimibe GH
C5537 C5538 C5543 C5544 C5562 C5575 C5576 C5577 C5586 C5594
Pharmacor Ezetimibe 10
Zient 10mg
[37] Schedule 1, entry for Ezetimibe with simvastatin
EZETIMIBE/SIMVASTATIN SANDOZ
Zeklen 10/10 mg
Zeklen 10/20 mg
Zeklen 10/40 mg
Zeklen 10/80 mg
[38] Schedule 1, entry for Ferrous sulfate
omit from the column headed “Form”: Oral liquid 30 mg per mL, 250 mL
substitute: Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL
[39] Schedule 1, entry for Flucloxacillin in all forms
insert in the column headed “Form”, in the brackets after the word “sodium”: monohydrate
[40] Schedule 1, entry for Fluconazole in the form Capsule 200 mg
C5978 C5989 C5996 C6002 C6023 C6030
[41] Schedule 1, after entry for Follitropin beta in the form Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
Injection 12 micrograms in 0.36 mL pre-filled multi-dose pen
Injection 36 micrograms in 1.08 mL pre-filled multi-dose pen
Injection 72 micrograms in 2.16 mL pre-filled multi-dose pen
[42] Schedule 1, entry for Furosemide in the form Injection 20 mg in 2 mL
omit from the column headed "Responsible Person" for the brand “Frusemide-Claris”: AE substitute: BX
[43] Schedule 1, entry for Gabapentin in the form Capsule 300 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
Gabapentin generichealth
[44] Schedule 1, entry for Gabapentin in the form Capsule 400 mg
[45] Schedule 1, after entry for Glatiramer in the form Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled syringe
[46] Schedule 1, entry for Golimumab in the form Injection 100 mg in 1 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed "Circumstances": C7662
(b) omit from the column headed "Circumstances": C7675
(c) insert in numerical order for the column headed "Circumstances": C7827 C7853
(d) omit from the column headed "Purposes": P7662 P7675
(e) insert in numerical order in the column headed "Purposes": P7827 P7853
(f) omit from the column headed “Number of Repeats”: 1 substitute: 4
[47] Schedule 1, entry for Golimumab in the form Injection 100 mg in 1 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(c) insert in numerical order in the column headed "Circumstances": C7827 C7853
[48] Schedule 1, entry for Ibrutinib
C7806 C7818 C7858 C7865 C7871
P7858 P7871
P7806 P7818 P7865
[49] Schedule 1, entry for Indacaterol with glycopyrronium
[50] Schedule 1, after entry for Insulin aspart with insulin aspart protamine suspension
[51] Schedule 1, entry for Ipratropium in the form Pressurised inhalation containing ipratropium bromide 21 micrograms per dose, 200 doses (CFC-free formulation)
insert in the column headed “Form” after the word “bromide”: monohydrate
[52] Schedule 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30
omit from the column headed "Form": (anhydrous) substitute: (as monohydrate)
[53] Schedule 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30
[54] Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
[55] Schedule 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg
[56] Schedule 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg
[57] Schedule 1, entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set
omit from the column headed "Responsible Person": TL substitute: MF
[58] Schedule 1, entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set
[59] Schedule 1, entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set
[60] Schedule 1, entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
[61] Schedule 1, entry for Leuprorelin and bicalutamide in the form Pack containing 1 syringe containing leuprorelin 7.5 mg (as acetate) and 28 tablets bicalutamide 50 mg
[62] Schedule 1, entry for Leuprorelin and bicalutamide in the form Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 28 tablets bicalutamide 50 mg
[63] Schedule 1, entry for Leuprorelin and bicalutamide in the form Pack containing 1 syringe containing leuprorelin 22.5 mg (as acetate) and 84 tablets bicalutamide 50 mg
[64] Schedule 1, entry for Levetiracetam in the form Tablet 1 g
[65] Schedule 1, entry for Levodopa with carbidopa
(a) omit from the column headed "Form": Intestinal gel 20 mg-5 mg per mL, 100 mL
substitute: Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL
(b) omit from the column headed "Form": Tablet 100 mg-25 mg (anhydrous)
substitute: Tablet 100 mg-25 mg (as monohydrate)
(c) omit from the column headed "Form": Tablet 200 mg-50 mg (anhydrous) (modified release)
substitute: Tablet (modified release) 200 mg-50 mg (as monohydrate)
(d) omit from the column headed "Form": Tablet 250 mg-25 mg (anhydrous)
substitute: Tablet 250 mg-25 mg (as monohydrate)
[66] Schedule 1, entry for Levodopa with carbidopa and entacapone
(a) omit from the column headed "Form": Tablet 50 mg-12.5 mg-200 mg substitute: Tablet 50 mg-12.5 mg (as monohydrate)-200 mg
(b) omit from the column headed "Form": Tablet 75 mg-18.75 mg-200 mg substitute: Tablet 75 mg-18.75 mg (as monohydrate)-200 mg
(c) omit from the column headed "Form": Tablet 100 mg-25 mg-200 mg substitute: Tablet 100 mg-25 mg (as monohydrate)-200 mg
(d) omit from the column headed "Form": Tablet 125 mg-31.25 mg-200 mg substitute: Tablet 125 mg-31.25 mg (as monohydrate)-200 mg
(e) omit from the column headed "Form": Tablet 150 mg-37.5 mg-200 mg substitute: Tablet 150 mg-37.5 mg (as monohydrate)-200 mg
(f) omit from the column headed "Form": Tablet 200 mg-50 mg-200 mg substitute: Tablet 200 mg-50 mg (as monohydrate)-200 mg
[67] Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg
[68] Schedule 1, entry for Meloxicam in the form Tablet 15 mg
[69] Schedule 1, entry for Mercaptopurine
(a) omit from the column headed “Form”: Oral suspension 20 mg per mL, 100 mL
substitute: Oral suspension containing mercaptopurine monohydrate 20 mg per mL, 100 mL
(b) omit from the column headed “Form”: Tablet 50 mg
substitute: Tablet containing mercaptopurine monohydrate 50 mg
[70] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
[71] Schedule 1, entry for Methyldopa
omit from the column headed "Form": Tablet 250 mg substitute: Tablet 250 mg (as sesquihydrate)
[72] Schedule 1, entry for Metoclopramide
(a) omit from the column headed "Form": Injection containing metoclopramide hydrochloride 10 mg in 2 mL
substitute: Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL
(b) omit from the column headed "Form": Tablet containing metoclopramide hydrochloride 10 mg
substitute: Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)
[73] Schedule 1, entry for Moclobemide in the form Tablet 150 mg
[74] Schedule 1, entry for Moclobemide in the form Tablet 300 mg
[75] Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
omit from the column headed "Circumstances" (all instances): C6684 substitute: C7781
[76] Schedule 1, entry for Morphine
PDP MP NP MW
C4960 C6168
Morphine MR AN
C4900 C6151
[77] Schedule 1, entry for Moxonidine in the form Tablet 200 micrograms
[78] Schedule 1, entry for Moxonidine in the form Tablet 400 micrograms
[79] Schedule 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)
(b) insert in the column headed “Schedule Equivalent” for the brand “Nebilet”: a
[80] Schedule 1, entry for Nebivolol in the form Tablet 5 mg (as hydrochloride)
[81] Schedule 1, entry for Nebivolol in the form Tablet 10 mg (as hydrochloride)
[82] Schedule 1, entry for Nintedanib in each of the forms: Capsule 100 mg; and Capsule 150 mg
omit from the column headed "Circumstances": C6970
[83] 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) insert in numerical order in the column headed "Circumstances": C6996
(b) omit from the column headed “Circumstances”: C7567
(c) insert in numerical order in the column headed “Circumstances”: C7787 C7802 C7864
[84] Schedule 1, entry for Pegfilgrastim
(a) omit from the column headed "Circumstances" (all brands): C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555
(b) substitute (all brands): C7822 C7823 C7843 C7862
[85] Schedule 1, entry for Peginterferon alfa-2a
Injection 135 micrograms in 0.5 mL single use pre-filled syringe
P5004 P5010 P5016 P5067
CN5004 CN5010 CN5016 CN5067
Injection 180 micrograms in 0.5 mL single use pre-filled syringe
CN6745
[86] Schedule 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL
insert in numerical order in the column headed “Circumstances”: C7773
[87] Schedule 1, entry for Perampanel
C4656 C7815
C4658 C7789
[88] Schedule 1, entry for Periciazine
Tablet 2.5 mg, 84
Tablet 10 mg, 84
[89] Schedule 1, entry for Pirfenidone in the form Capsule 267 mg
omit from the column headed circumstances: C6962
[90] Schedule 1, after entry for Pirfenidone in the form Capsule 267 mg
C6950 C6961 C6975
[91] Schedule 1, entry for Piroxicam in the form Capsule 10 mg [Maximum Quantity: 50; Number of Repeats: 0]
[92] Schedule 1, entry for Piroxicam in the form Capsule 10 mg [Maximum Quantity: 50; Number of Repeats: 3]
[93] Schedule 1, entry for Piroxicam in the form Capsule 20 mg [Maximum Quantity: 25; Number of Repeats: 0]
[94] Schedule 1, entry for Piroxicam in the form Capsule 20 mg [Maximum Quantity: 25; Number of Repeats: 3]
[95] Schedule 1, entry for Pramipexole in all forms
omit from the column headed "Form": hydrochloride substitute: dihydrochloride monohydrate
[96] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]
[97] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]
[98] Schedule 1, entry for Quinine
insert in the column headed “Form” after the word “sulfate”: dihydrate
[99] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
[100] Schedule 1, entry for Ramipril in the form Capsule 2.5 mg
[101] Schedule 1, entry for Ramipril in the form Capsule 5 mg
[102] Schedule 1, entry for Ramipril in the form Capsule 10 mg
[103] Schedule 1, entry for Riociguat
[104] Schedule 1, entry for Tiotropium with olodaterol
[105] Schedule 1, entry for Umeclidinium with vilanterol
[106] Schedule 1, entry for Vinblastine
[107] Schedule 3
[108] Schedule 4, Part 1, entry for Aclidinium with formoterol
Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR
Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR
Patient must have been stabilised on a combination of a LAMA and a LABA.
Compliance with Authority Required procedures - Streamlined Authority Code 7798
[109] Schedule 4, Part 1, entry for Budesonide with formoterol
(a) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4380:
Compliance with Authority Required procedures - Streamlined Authority Code 4380
(b) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4394:
Compliance with Authority Required procedures - Streamlined Authority Code 4394
(c) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4397:
Compliance with Authority Required procedures - Streamlined Authority Code 4397
(d) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4404:
Compliance with Authority Required procedures - Streamlined Authority Code 4404
(e) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4689:
Compliance with Authority Required procedures - Streamlined Authority Code 4689
(f) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C7527:
Compliance with Authority Required procedures - Streamlined Authority Code 7527
(g) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C7574:
Compliance with Authority Required procedures - Streamlined Authority Code 7574
[110] Schedule 4, Part 1, entry for Fluticasone furoate with vilanterol
(a) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4689:
(b) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4711:
Compliance with Authority Required procedures - Streamlined Authority Code 4711
(c) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4731:
Compliance with Authority Required procedures - Streamlined Authority Code 4731
[111] Schedule 4, Part 1, entry for Fluticasone with formoterol
insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4395:
Compliance with Authority Required procedures - Streamlined Authority Code 4395
[112] Schedule 4, Part 1, entry for Fluticasone with salmeterol
(b) insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C4930:
Compliance with Authority Required procedures - Streamlined Authority Code 4930
[113] Schedule 4, Part 1, after entry for Follitropin beta
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.
Compliance with Authority Required procedures - Streamlined Authority Code 5027
[114] Schedule 4, Part 1, after entry for Glatiramer
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 8 weeks.
The treatment must be limited to a maximum duration of 16 weeks.
The treatment must be limited to a maximum duration of 12 weeks.
[115] Schedule 4, Part 1, entry for Golimumab
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(iii) the signed patient acknowledgement.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written providing for a loading dose of 200 mg at week 0 and a dose of 100 mg at week 2. This prescription should specify a quantity of 3 injections of 100 mg and no repeats. The second prescription should be for the subsequent doses at weeks 6 and 10. This prescription should specify a quantity of 1 injection of 100 mg and one repeat. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2, 6 and 10 so that there is adequate time for a response to be demonstrated.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with golimumab for this condition in the current treatment cycle.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(i) Mayo clinical assessment (to demonstrate response to prior treatment).
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written providing for a loading dose of 200 mg at week 0 and a dose of 100 mg at week 2. This prescription should specify a quantity of 3 injections of 100 mg and no repeats. The second prescription should be for the subsequent doses at weeks 6 and 10. This prescription should specify a quantity of 1 injection of 100 mg and one repeat.
Application for authorisation of initial treatment must be in writing and must include:
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.
Application for authorisation of change or recommencement treatment must be in writing and must include:
[116] Schedule 4, Part 1, entry for Ibrutinib
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
Patient must be considered unsuitable for treatment or retreatment with a purine analogue.
A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following:
a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles;
b) Age is 70 years or older;
c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen;
d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia;
e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH).
[117] Schedule 4, Part 1, entry for Indacaterol with glycopyrronium
[118] Schedule 4, Part 1, entry for Montelukast
The condition must be exercise-induced; AND
The treatment must be as an alternative to adding salmeterol xinafoate; OR
The treatment must be as an alternative to adding eformoterol fumarate; AND
The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND
Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms.
Patient must be aged 6 to 14 years inclusive.
Compliance with Authority Required procedures - Streamlined Authority Code 6684
The treatment must be an alternative to adding formoterol fumarate; AND
Compliance with Authority Required procedures - Streamlined Authority Code 7781
[119] Schedule 4, Part 1, entry for Nintedanib
Initial treatment 1 - new patient
The condition must be diagnosed through a multidisciplinary team; AND
Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND
The treatment must be the sole PBS-subsidised treatment for this condition.
Must be treated by a respiratory physician or specialist physician, or in consultation with a respiratory physician or specialist physician.
A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
Patient must have not have an acute respiratory infection at the time of FVC testing.
b) a completed IPF Authority Application Supporting Information Form; and
c) a signed patient acknowledgement.
Patient must not have an acute respiratory infection at the time of FVC testing.
Initial treatment 3 - Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2017; AND
The condition must have been diagnosed through a multidisciplinary team; AND
Patient must have had a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height at the time treatment with this drug for this condition was initiated; AND
Patient must have had a forced expiratory volume in 1 second (FEV1)/FVC ratio greater than 0.7 at the time treatment with this drug for this condition was initiated; AND
Patient must have had diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30% at the time treatment with this drug for this condition was initiated; AND
[120] Schedule 4, Part 1, entry for Nivolumab
(a) insert in numerical order for the column headed “Circumstances code”:
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Compliance with Authority Required procedures - Streamlined Authority Code 6996
Compliance with Authority Required procedures - Streamlined Authority Code 7567
Compliance with Authority Required procedures - Streamlined Authority Code 7787
Compliance with Authority Required procedures - Streamlined Authority Code 7802
Compliance with Authority Required procedures - Streamlined Authority Code 7864
[121] Schedule 4, Part 1, entry for Pegfilgrastim
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Compliance with Authority Required procedures - Streamlined Authority Code 7822
Compliance with Authority Required procedures - Streamlined Authority Code 7843
[122] Schedule 4, Part 1, entry for Peginterferon alfa-2a
(a) omit from the column headed “Circumstances Code” for Circumstance Code C5004: C5004
(b) insert in the column headed “Conditions Code” for Purpose Code P5004: CN5004
(c) omit from the column headed “Circumstances Code” for Circumstance Code C5010: C5010
(d) insert in the column headed “Conditions Code” for Purpose Code P5010: CN5010
(e) omit from the column headed “Circumstances Code” for Circumstance Code C5016: C5016
(f) insert in the column headed “Conditions Code” for Purpose Code P5016: CN5016
(g) omit from the column headed “Circumstances Code” for Circumstance Code P5067: C5067
(h) insert in the column headed “Conditions Code” for Purpose Code P5067: CN5067
(i) omit from the column headed “Circumstances Code” for Circumstance Code P6745: C6745
(j) insert in the column headed “Conditions Code” for Purpose Code P6745: CN6745
[123] Schedule 4, Part 1, entry for Pembrolizumab
[124] Schedule 4, Part 1, entry for Perampanel
(a) insert in the column headed “Purpose Code” for Circumstance Code C4658: P4568
Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
Compliance with Authority Required procedures - Streamlined Authority Code 7789
The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs; AND
The treatment must be in combination with at least one PBS-subsidised anti-epileptic drug; AND
The treatment must be for dose titration purposes.
Compliance with Authority Required procedures - Streamlined Authority Code 7815
[125] Schedule 4, Part 1, entry for Pirfenidone
Initial treatment 2 - change or re-commencement of treatment
Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
[126] Schedule 4, Part 1, entry for Tiotropium with olodaterol
[127] Schedule 4, Part 1, entry for Trastuzumab
(a) insert in the column headed “Purpose Code” for Circumstance Code C5024: P5024
(b) insert in the column headed “Purpose Code” for Circumstance Code C5032: P5032
(c) insert in the column headed “Purpose Code” for Circumstance Code C5041: P5041
(d) insert in the column headed “Purpose Code” for Circumstance Code C6060: P6060
(e) insert in the column headed “Purpose Code” for Circumstance Code C6061: P6061
(f) insert in the column headed “Purpose Code” for Circumstance Code C6062: P6062
(g) insert in the column headed “Purpose Code” for Circumstance Code C7717: P7717
[128] Schedule 4, Part 1, entry for Umeclidinium with vilanterol
[129] Schedule 4, Part 1, after entry for Ursodeoxycholic acid
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab.
Patient must have been receiving treatment with this drug for this condition prior to 1 May 2016; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have demonstrated a response to treatment as specified in the criteria for continuing PBS-subsidised treatment with this drug; AND
C6469
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more), Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 28 weeks treatment; AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions.
Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) or Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; OR
Continuing treatment, Face, hand, foot
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, ixekizumab, secukinumab or ustekinumab.
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.
Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received PBS-subsidised treatment with a biological agent for at least 5 years, if they have previously received PBS-subsidised treatment with a biological agent for this condition and wish to commence a new Treatment Cycle; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (whole body); AND
(iii) the signed patient and prescriber acknowledgements.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) restriction to complete 28 weeks treatment; AND
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Continuing treatment, Whole body
Patient must have a documented history of severe chronic plaque psoriasis; AND
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle.
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment (face, hand, foot); AND
Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years)
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
Applications for patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years)
Initial PBS-subsidised treatment (Grandfather)
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 September 2017; AND
Patient must be receiving treatment with ustekinumab at the time of application; AND
Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine; AND
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
(b) a completed Crohn Disease Grandfathered PBS Authority Application - Supporting Information Form which includes the following:
(v) the signed patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks
If fewer than the maximum stated repeats in the relevant treatment phase are requested at the time of the application, authority approvals for sufficient repeats to complete the balance of the stated repeats in the relevant treatment phase may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend the relevant treatment phase.
Balance of supply for Initial treatment, Continuing treatment or Grandfathered treatment
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Grandfathered treatment restriction to complete 24 weeks of treatment.
Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services.
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle.
(iv) the details of prior biological disease modifying drug treatment including the details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological disease modifying drug (bDMD) therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS-subsidised bDMD treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of bDMD treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of bDMD.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
(iii) the date of clinical assessment.
If the application is the first application for continuing treatment with this drug, an assessment of the patient's response to the initial course of treatment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more months; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery;
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 2 vials of 45 mg and no repeats.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
This assessment, which will be used to determine eligibility for further continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this course of treatment.
[130] Schedule 4, Part 3, Section 3, Treatment regimen
omit table and substitute:
(a) with Genotype 1; and
(b) who is treatment naïve; and
(c) who is non-cirrhotic
(a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or
(b) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or
(c) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(d) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR for 12 weeks; or
(f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(g) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(h) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(i) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
(b) who is treatment experienced; and
(a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or
(b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(h) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(i) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(j) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or
(k) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or
(l) GLECAPREVIR with PIBRENTASVIR for 16 weeks.
(a) with Genotype 2; and
(a) SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(b) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(c) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
(a) with Genotype 3; and
(a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or
(b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(c) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or
(d) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(e) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
(e) GLECAPREVIR with PIBRENTASVIR for 16 weeks.
(a) with Genotype 4; and
(a) SOFOSBUVIR and PEGINTERFERON ALFA-2A and RIBAVIRIN for 12 weeks; or
(b) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(c) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(d) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
(c) GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks; or
(i) Genotype 5; or
(ii) Genotype 6; and
(c) who is cirrhotic
(b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or
(f) GRAZOPREVIR with ELBASVIR for 12 weeks; or
(g) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(h) GLECAPREVIR with PIBRENTASVIR for 12 weeks.
(a) LEDIPASVIR with SOFOSBUVIR for 24 weeks; or
(b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(c) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks; or
(j) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or
(k) GLECAPREVIR with PIBRENTASVIR for 16 weeks.
(c) GLECAPREVIR with PIBRENTASVIR for 12 weeks.
(a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(d) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or
(e) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 24 weeks; or
(f) SOFOSBUVIR with VELPATASVIR for 12 weeks; or
(g) GLECAPREVIR with PIBRENTASVIR for 12 weeks.
(a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or
(g) GLEC