Source: https://www.global-regulation.com/law/australia/220163/national-health-%2528listing-of-pharmaceutical-benefits%2529-amendment-instrument-2014-%2528no.-3%2529---pb-17-of-2014.html
Timestamp: 2018-12-16 17:15:50
Document Index: 99156970

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 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 1', 'art 1', 'art 1', 'art 1']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3) - PB 17 of 2014 (Australia)
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3) - PB 17 of 2014
Link to law: https://www.comlaw.gov.au/Details/F2014L00342
PB 17 of 2014
Dated 21 March 2014
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 3).
(2) This Instrument may also be cited as PB 17 of 2014.
[1] Schedule 1, entry for Abacavir in each of the forms: Tablet 300 mg (as sulfate); and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”: C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
[2] Schedule 1, entry for Abacavir with Lamivudine
omit from the column headed “Circumstances”: C3590 C3591 C3592 C3593 substitute: C4505 C4527 C4528 C4538
[3] Schedule 1, entry for Abacavir with Lamivudine and Zidovudine
omit from the column headed “Circumstances”: C3979 C3980 C3981 C3982 substitute: C4472 C4480 C4495 C4523
[4] Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
C1363 C1366
[5] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
(a) omit from the column headed “Circumstances”: C3520 C3522
(b) omit from the column headed “Circumstances”: C3743 C3744
(c) insert in numerical order: C4492 C4501 C4517 C4518 C4531
[6] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
(d) omit from the column headed “Purposes”: P3520
(e) omit from the column headed “Purposes”: P3743
(f) insert in numerical order: P4492 P4501 P4518
[7] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 4]
[8] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2;
(d) omit from the column headed “Purposes”: P3522
(e) omit from the column headed “Purposes”: P3744
(f) insert in numerical order: P4517 P4531
[9] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
[10] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
[11] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
[12] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2;
[13] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
[14] Schedule 1, entry for Atazanavir in each of the forms: Capsule 100 mg (as sulfate); Capsule 150 mg (as sulfate); Capsule 200 mg (as sulfate); and Capsule 300 mg (as sulfate)
[15] Schedule 1, entry for Azathioprine in the form Tablet 25 mg
[16] Schedule 1, after entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
[17] Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 5]
Optifresh eye gel
[18] Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g [Maximum Quantity: 1; Number of Repeats: 11]
[19] Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30
Optifresh Tears
[20] Schedule 1, entry for Carmellose in the form Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30
Optifresh Plus
[21] Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
[22] Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Maximum Quantity: 10;
[23] Schedule 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg
(a) omit from the column headed “Circumstances”: C3843 C3844 C3903 C3904
(b) insert in numerical order: C4468 C4477 C4511 C4532
[24] Schedule 1, after entry for Clindamycin
Shampoo containing clobetasol propionate 500 micrograms per mL, 125 mL
[25] Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
insert in numerical order in the column headed “Circumstances”: C4504
[26] Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets); Capsule 200 mg (containing enteric coated beadlets); Capsule 250 mg (containing enteric coated beadlets); and Capsule 400 mg (containing enteric coated beadlets)
[27] Schedule 1, after entry for Docosahexaenoic acid with carbohydrate
C4454 C4455 C4469 C4512
[28] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
omit from the column headed “Brand”: Lipodox substitute: Liposomal Doxorubicin SUN
[29] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
omit from the column headed “Brand”: Lipodox 50 substitute: Liposomal Doxorubicin SUN
[30] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1459 substitute: P4485
[31] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (all instances): P1279 substitute: P4514
[32] Schedule 1, entry for Doxycycline in each of the forms: Tablet 50 mg (as monohydrate); Tablet 50 mg (as hydrochloride); and
Capsule 50 mg (as hydrochloride) (containing enteric coated pellets)
omit from the column headed “Circumstances” (all instances): C1346 C1851 C1852 substitute: C4475 C4529 C4539
[33] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0]
[34] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 0]
[35] Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 21; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring): P1459 substitute: P4485
[36] Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity: 28; Number of Repeats: 0]
omit from the column headed “Purposes” (twice occurring): P1279 substitute: P4514
[37] Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
[38] Schedule 1, entry for Emtricitabine
[39] Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and
omit from the column headed “Circumstances”: C4362 C4386 C4387 C4403 C4406 substitute: C4473 C4481 C4525 C4536 C4537
[40] Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
(a) omit from the column headed “Circumstances”: C3524
(b) omit from the column headed “Circumstances”: C3770 C3771
(c) insert in numerical order: C4457 C4458 C4482 C4483 C4503
(d) omit from the column headed “Purposes”: P3524
(e) omit from the column headed “Purposes”: P3770
(f) insert in numerical order: P4458 P4483 P4503
[41] Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
(d) omit from the column headed “Purposes”: P3771
(e) insert in numerical order: P4457 P4482
[42] Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
[43] Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
[44] Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes
solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 3]
[45] Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes
solvent 1 mL [Maximum Quantity: 2; Number of Repeats: 5]
[46] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL
[47] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 400 mg in 200 mL
[48] Schedule 1, entry for Flutamide
Tablet 250 mg, 30
[49] Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
[50] Schedule 1, entry for Gefitinib
omit from the column headed “Circumstances”: C4384 C4387 substitute: C4473 C4474
[51] Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)
[52] Schedule 1, entry for Homatropine
omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP AO
[53] 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”: AS substitute: HM
[54] Schedule 1, entry for Indinavir
[55] Schedule 1, entry for Infliximab
C4524 C4535
[56] Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL;
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; I.V. injection containing irinotecan hydrochloride trihydrate
300 mg in 15 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
omit from the column headed “Circumstances” (all instances): C3184
[57] Schedule 1, entry for Lamivudine in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Circumstances” (all instances): C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
[58] Schedule 1, entry for Lamivudine in the form Oral solution 10 mg per mL, 240 mL
[59] Schedule 1, entry for Lamivudine with Zidovudine
omit from the column headed “Circumstances” (twice occurring): C3586 C3587 C3588 C3589 substitute: C4454 C4455 C4469 C4512
[60] Schedule 1, entry for Leuprorelin in each of the forms: Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set; and Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
omit from the column headed “Responsible Person”: HH substitute: TL
[61] Schedule 1, entry for Linagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4488
[62] Schedule 1, entry for Lopinavir with Ritonavir in each of the forms: Tablet 100 mg-25 mg; Tablet 200 mg-50 mg; and
Oral liquid 400 mg-100 mg per 5 mL, 60 mL
[63] Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
[64] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
[65] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
[66] Schedule 1, entry for Misoprostol
omit from the column headed “Circumstances”: C4266 substitute: C4463
[67] Schedule 1, entry for Morphine
Injection containing morphine sulphate 10 mg in 1 mL (with preservative)
Morphine Sulphate Wockhardt
[68] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Circumstances” (all instances): C3586 C3587 C3588 C3589 substitute C4454 C4455 C4469 C4512
[69] Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”: C3587 C3589 C3994 C3995 substitute: C4454 C4460 C4469 C4526
[70] Schedule 1, entry for Nevirapine in the form Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
[71] Schedule 1, after entry for Nicotine in the form Transdermal patch 35 mg
Transdermal patch 39.4 mg
nicorette 16hr Invisipatch
[72] Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; Powder for I.V. infusion
50 mg; I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL; Solution concentrate for I.V. infusion 100 mg in
20 mL; Powder for I.V. infusion 100 mg; and Solution concentrate for I.V. infusion 200 mg in 40 mL
omit from the column headed “Circumstances” (all instances): C3900 C3901 C3930 C3939
[73] Schedule 1, entry for Oxycodone
Tablet containing oxycodone hydrochloride 5 mg (controlled release)
[74] Schedule 1, after entry for Pancrelipase
[75] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
GenRx Perindopril
[76] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
[77] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
[78] Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
[79] Schedule 1, entry for Rilpivirine
[80] Schedule 1, entry for Ritonavir in each of the forms: Tablet 100 mg; and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
[81] Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30;
and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
[82] Schedule 1, entry for Saquinavir
[83] Schedule 1, entry for Saxagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4520
[84] Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg
(as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
omit from the column headed “Circumstances”: C4350 substitute: C4519
[85] Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; and Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C4325 substitute: C4423
[86] Schedule 1, omit entry for Sitagliptin with simvastatin
[87] Schedule 1, entry for Stavudine in each of the forms: Capsule 20 mg; Capsule 30 mg; and Capsule 40 mg
[88] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C2100
(b) insert in numerical order: C4496
[89] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
(c) omit from the column headed “Purposes” (all instances): P2100 substitute: P4496
[90] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
[91] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
[92] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
[93] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
[94] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
[95] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
[96] Schedule 1, entry for Temozolomide
Astromide
C1736 C1737 C2101 C4496
[97] Schedule 1, entry for Tenofovir
C4454 C4455 C4469 C4476 C4489 C4490 C4499 C4509 C4510 C4512 C4544 C4545
[98] Schedule 1, entry for Tenofovir with Emtricitabine
[99] Schedule 1, entry for Tenofovir with emtricitabine and efavirenz
omit from the column headed “Circumstances”: C3983 C3984 C3985 C3986 substitute: C4470 C4494 C4522 C4533
[100] Schedule 1, entry for Tenofovir with Emtricitabine and Rilpivirine
[101] Schedule 1, entry for Testosterone in the form Subcutaneous implant 200 mg
omit from the column headed “Brand”: Schering-Plough Pty Limited substitute: Merck Sharp & Dohme (Australia) Pty Ltd
[102] Schedule 1, after entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)
Capsule containing powder for oral inhalation 28 mg (for use in podhaler)
C4456 C4513
[103] Schedule 1, entry for Tropisetron
Capsule 5 mg (as hydrochloride)
[104] Schedule 1, entry for Tropisetron in the form I.V. injection 5 mg (as hydrochloride) in 5 mL
[105] Schedule 1, entry for Vildagliptin
omit from the column headed “Circumstances”: C4350 substitute: C4467
[106] 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
[107] Schedule 1, entry for Zidovudine in each of the forms: Capsule 100 mg; Capsule 250 mg; and Syrup 10 mg per mL, 200 mL
[108] Schedule 3, after details relevant to Responsible Person code TK
53 162 640 708
[109] Schedule 4, Part 1, entry for Abacavir
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4454
Patient must be antiretroviral treatment naïve; AND
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4512
[110] Schedule 4, Part 1, entry for Abacavir with Lamivudine
The treatment must be in combination with other antiretroviral agents;
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4527
C4528
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4528
[111] Schedule 4, Part 1, entry for Abacavir with Lamivudine and Zidovudine
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4480
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4495
[112] Schedule 4, Part 1, entry for Adalimumab
Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
— cyclosporin at a dose of at least 2 mg/kg per day; and/or
where bDMARD means adalimumab or etanercept; and
(a) 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; and (b) either:
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Juvenile idiopathic arthritis — initial treatment 3
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Juvenile idiopathic arthritis — continuing treatment
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
(a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
a patient who has failed to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; OR
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle, AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction;
Patient must be aged 18 years or older;
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis
For the purposes of this restriction 'biological disease modifying anti-rheumatic drug' and 'bDMARD' mean adalimumab, etanercept or tocilizumab
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; and
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial adalimumab after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle
Initial treatment ― Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply
Patient must have received insufficient adalimumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient adalimumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
Continuing treatment ― balance of supply
Patient must have received insufficient adalimumab therapy under the Continuing treatment restriction to complete 24 weeks treatment; AND
Initial treatment ― Initial 2 (change or recommencement of treatment after break of less than 24 months)
Patient must have received prior PBS-subsidised treatment with adalimumab, etanercept or tocilizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with adalimumab for this condition in the current treatment cycle; AND
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has received PBS-subsidised treatment with adalimumab in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment, within the timeframes specified below
Where the most recent course of PBS-subsidised adalimumab treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised adalimumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with adalimumab
If a patient fails to respond to PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
Patient must have demonstrated an adequate response to treatment with adalimumab; AND
Patient must have received adalimumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction;
Patient must be aged 18 years or older
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response
All applications for continuing treatment with adalimumab must include a measurement of response to the prior course of therapy
This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with adalimumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle
[113] Schedule 4, Part 1, entry for Atazanavir
[114] Schedule 4, Part 1, entry for Calcipotriol with betamethasone
Chronic stable plaque type psoriasis vulgaris
The condition must be on the patient's scalp; AND
The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; AND
Patient must require more than 30 grams of the product per month
[115] Schedule 4, Part 1, entry for Carbomer with Triglyceride Lipids [Circumstances Code: C3036; Purposes Code: P3036]
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: C3036
[116] Schedule 4, Part 1, entry for Cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 3903
Compliance with Authority Required procedures - Streamlined Authority Code 3904
Patient must have KRAS wild-type metastatic colorectal cancer; AND
Compliance with Authority Required procedures - Streamlined Authority Code 4468
Patient must have received an initial authority prescription for cetuximab for treatment of K-RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Compliance with Authority Required procedures - Streamlined Authority Code 4532
[117] Schedule 4, Part 1, after entry for Clindamycin
The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; OR
The condition must be inadequately controlled with combination use of a vitamin D analogue and potent topical corticosteroid
[118] Schedule 4, Part 1, entry for Denosumab
Patient must be one in whom surgical resection is not feasible; OR
Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity;
Patient must be an adult; OR
Patient must be a skeletally mature adolescent
Compliance with Authority Required procedures - Streamlined Authority Code 4504
[119] Schedule 4, Part 1, entry for Didanosine
[120] Schedule 4, Part 1, after entry for Docosahexaenoic acid with carbohydrate
[121] Schedule 4, Part 1, entry for Doxycycline
Patient must be aged 8 years or older
[122] Schedule 4, Part 1, entry for Efavirenz
[123] Schedule 4, Part 1, entry for Emtricitabine
[124] Schedule 4, Part 1, entry for Erlotinib
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less
Patient must have failed prior therapy which included a platinum compound; AND
Patient must have a WHO performance status of 3 or less; AND
Patient must have a contraindication or intolerance to treatment with docetaxel and pemetrexed; AND
Patient must not be able to receive further chemotherapy subsidised by the PBS or from other sources following treatment with erlotinib
C4525
Patient must have previously been issued with an authority prescription for this drug prior to 1 January 2014; AND
C4537
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and
where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
(b) who has demonstrated an adequate response to treatment with etanercept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Patient must have received insufficient etanercept therapy under the Continuing treatment 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 restriction;
Patient must have received no PBS-subsidised bDMARD treatment for at least 5 years if they failed or ceased to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) in their last treatment cycle; AND
If a patient fails to respond to PBS-subsidised bDMARD treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised bDMARD therapy in this treatment cycle. A patient may re-trial etanercept after a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle and the date of the first application under a new treatment cycle
Patient must have demonstrated an adequate response to treatment with etanercept; AND
Patient must have received etanercept as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
All applications for continuing treatment with etanercept must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with etanercept, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept
Patient must not have failed PBS-subsidised therapy with etanercept for this condition in the current treatment cycle; AND
Applications for a patient who has received PBS-subsidised treatment with etanercept in this treatment cycle and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment, within the timeframes specified below
Where the most recent course of PBS-subsidised etanercept treatment was approved under either of the Initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised etanercept treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth
Patient must have received insufficient etanercept therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient etanercept therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
[126] Schedule 4, Part 1, entry for Fosamprenavir
[127] Schedule 4, Part 1, entry for Gefitinib
[128] Schedule 4, Part 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals
[129] Schedule 4, Part 1, entry for Indinavir
[130] Schedule 4, Part 1, after entry for Indomethacin
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital
Patient must be 6 years of age or older
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4524
[131] Schedule 4, Part 1, omit entry for Irinotecan
[132] Schedule 4, Part 1, entry for Lamivudine
[133] Schedule 4, Part 1, entry for Lamivudine with Zidovudine
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4454
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4512
[134] Schedule 4, Part 1, entry for Linagliptin
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 linagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4488
[135] Schedule 4, Part 1, entry for Lopinavir with Ritonavir
[136] Schedule 4, Part 1, entry for Misoprostol
The condition must be an intra-uterine pregnancy of up to 49 days of gestation; AND
The treatment must be in sequential combination with mifepristone 200 mg
[137] Schedule 4, Part 1, entry for Nevirapine
Patient must have been stabilised on nevirapine immediate release; AND
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4512
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4526
[138] Schedule 4, Part 1, omit entry for Oxaliplatin
[139] Schedule 4, Part 1, after entry for Pancrelipase
Compliance with Authority Required procedures - Streamlined Authority Code 4462
Patient must have received an initial authority prescription for panitumumab for treatment of KRAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Compliance with Authority Required procedures - Streamlined Authority Code 4498
[140] Schedule 4, Part 1, entry for Raltegravir
[141] Schedule 4, Part 1, entry for Rilpivirine
[142] Schedule 4, Part 1, entry for Ritonavir
[143] Schedule 4, Part 1, entry for Saquinavir
[144] Schedule 4, Part 1, entry for Saxagliptin
The treatment must be in combination with a sulfonylurea, AND
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 saxagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4520
[145] Schedule 4, Part 1, entry for Sitagliptin
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 sitagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4519
[146] Schedule 4, Part 1, entry for Sitagliptin with metformin
Compliance with Authority Required procedures - Streamlined Authority Code 4325
[147] Schedule 4, Part 1, omit entry for Sitagliptin with simvastatin
[148] Schedule 4, Part 1, entry for Stavudine
[149] Schedule 4, Part 1, entry for Temozolomide
Glioblastoma multiforme concomitantly with radiotherapy
Patient must be undergoing concomitant radiotherapy
[150] Schedule 4, Part 1, entry for Tenofovir
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naïve; AND
Patient must have detectable HBV DNA; AND
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4476
Patient must not have cirrhosis; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4489
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4490
Patient must have detectable HBV DNA
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4510
[151] Schedule 4, Part 1, entry for Tenofovir with Emtricitabine
[152] Schedule 4, Part 1, entry for Tenofovir with emtricitabine and efavirenz
Patient must have previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470
Patient must be antiretroviral treatment naive
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522
[153] Schedule 4, Part 1, entry for Tenofovir with Emtricitabine and Rilpivirine
Tenofovir with Emtricitabine and Rilpivirine
[154] Schedule 4, Part 1, entry for Tobramycin
Proven Pseudomonas aeruginosa infection
Patient must have cystic fibrosis; AND
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result; AND
Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4456
Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s)
Compliance with Authority Required procedures - Streamlined Authority Code 4513
[155] Schedule 4, Part 1, entry for Vildagliptin
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 vildagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4467
[156] Schedule 4, Part 1, entry for Vildagliptin with metformin
[157] Schedule 4, Part 1, entry for Zidovudine