National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 4) (PB 29 of 2016) (Cth)
PB 29 of 2016
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 4)
National Health Act 1953
I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 29 April 2016
PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 4).
(2) This Instrument may also be cited as PB 29 of 2016.
2 Commencement
This Instrument commences on 1 May 2016.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
After Subsection 11(1)(d)
insert:
(1A) If the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include the words ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ treat as if the words used are ‘Compliance with Authority Required procedures’.
Note: If there is a Streamlined Authority Code section 14 continues to apply.
Subsection 12(1), paragraph (d)
substitute:
(d) the authorised prescriber submits details of the prescription in accordance with subsection 12(4A) to the Chief Executive Medicare,
by means of electronic communication to obtain an electronic authority.After Subsection 12(4)
insert:
(4A) The prescription submitted in accordance with paragraph 12(1)(d) must be:
(a) given to the Chief Executive Medicare in writing; and
(b) by means of an electronic communication; and
(c) encrypted when it is given to the Chief Executive Medicare; and
(d) in accordance with any other requirements that would need to be met in order for the requirements to give the
information in writing to be taken to have been met under the Electronic Transactions Act 1999.
Subsection 13(3)
substitute:
(3) A prescription submitted in accordance with paragraph 12(1)(d) may be authorised by the Chief Executive Medicare sending
his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.(3A) If the prescription submitted is declined for authorisation, the authorised prescriber may seek review of the decision by the Chief Executive Medicare.
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
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]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, omit entry for Aluminium Hydroxide with Magnesium Hydroxide
Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg and Tablet 30 mg
omit from the column headed “Circumstances”: C1589 substitute: C4246
Schedule 1, entry for Auranofin
omit:
| Capsule 3 mg | Oral | Ridaura | GH | MP NP | 60 | 5 | 60 |
Schedule 1, after entry for Beclomethasone in the form Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)
insert:
| Bendamustine | Powder for injection containing bendamustine hydrochloride 25 mg | Injection | Ribomustin | JC | MP | C6075 C6124 | See Note 3 | See Note 3 | 1 | D(100) |
| Powder for injection containing bendamustine hydrochloride 100 mg | Injection | Ribomustin | JC | MP | C6075 C6124 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, after entry for Buprenorphine in the form Transdermal patch 10 mg
insert:
| Transdermal patch 15 mg | Transdermal | Norspan | MF | MP NP | C4951 | 2 | 0 | 2 |
Schedule 1, after entry for Buprenorphine in the form Transdermal patch 20 mg
insert:
| Transdermal patch 25 mg | Transdermal | Norspan | MF | MP NP | C4951 | 2 | 0 | 2 |
| Transdermal patch 30 mg | Transdermal | Norspan | MF | MP NP | C4951 | 2 | 0 | 2 |
| Transdermal patch 40 mg | Transdermal | Norspan | MF | MP NP | C4951 | 2 | 0 | 2 |
Schedule 1, entry for Carmellose
omit:
| Eye drops containing carmellose sodium 5 mg per mL, 15 mL | Application to the eye | Refresh Tears Plus | AG | MP | C1362 C3036 | P1362 | 1 | 5 | 1 |
| NP AO | C1362 | 1 | 5 | 1 | |||||
| MP | C1362 C3036 | P3036 | 1 | 11 | 1 | ||||
| Eye drops containing carmellose sodium 10 mg per mL, 15 mL | Application to the eye | Refresh Liquigel | AG | MP | C1362 C3036 | P1362 | 1 | 5 | 1 |
| NP AO | C1362 | 1 | 5 | 1 | |||||
| MP | C1362 C3036 | P3036 | 1 | 11 | 1 |
substitute:
| Eye drops containing carmellose sodium 5 mg per mL, 15 mL | Application to the eye | Refresh Tears Plus | AG | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||
| NP | C6073 | 1 | 5 | 1 | ||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 | |||
| Eye drops containing carmellose sodium 10 mg per mL, 15 mL | Application to the eye | Refresh Liquigel | AG | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||
| NP | C6073 | 1 | 5 | 1 | ||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Carmellose with glycerin
substitute:
| Carmellose with glycerin | Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL | Application to the eye | Optive | AG | AO | C6097 | 1 | 3 | 1 |
| MP | C6072 C6079 | P6072 | 1 | 3 | 1 | ||||
| NP | C6072 | 1 | 3 | 1 | |||||
| MP | C6072 C6079 | P6079 | 1 | 7 | 1 |
Schedule 1, entry for Certolizumab pegol
(a)omit from the column headed “Circumstances”: C4831 C4839 C4842 C4843
(b)omit from the column headed “Circumstances”: C4863
(c)insert in numerical order: C6068 C6109 C6126
Schedule 1, entry for Cromoglycic Acid in the form Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL
omit from the column headed “Circumstances”: C1466 substitute: C6088
Schedule 1, omit entry for Electrolyte Replacement, Solution
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nexazole | RW | MP NP | C4988 C5029 C5030 C5039 | P4988 | 30 | 1 | 30 |
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nexazole | RW | MP NP | C4988 C5029 C5030 C5039 | P5029 P5030 P5039 | 30 | 5 | 30 |
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nexazole | RW | MP NP | C5011 C5021 C5028 | P5028 | 30 | 1 | 30 |
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Nexazole | RW | MP NP | C5011 C5021 C5028 | P5011 P5021 | 30 | 5 | 30 |
Schedule 1, entry for Esomeprazole and Clarithromycin and Amoxycillin
insert as first item in the columns in the order indicated:
| Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | ESOMEPRAZOLE SANDOZ Hp7 | SZ | MP NP | C6118 | 1 | 0 | 1 |
Schedule 1, entry for Esomeprazole and Clarithromycin and Amoxycillin in the form Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)
omit from the column headed “Circumstances”: C5683 substitute: C6118
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
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](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
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](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
(a)omit from the column headed “Brand”: Fludara substitute: Fludarabine ACT
(b)omit from the column headed “Responsible Person”: GZ substitute: EA
(c)omit from the column headed “Pack Quantity”: 5 substitute: 1
Schedule 1, omit entry for Glucose
Schedule 1, omit entry for Glycerol
Schedule 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals
omit:
| Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk) | Oral | Camino Pro Bettermilk | QH | MP NP | C4295 | 4 | 5 | 1 |
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4826 P4840
(e)insert in numerical order: P6069 P6092
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C4826 C4840
(b)omit from the column headed “Circumstances”: C4864
(c)insert in numerical order: C6069 C6081 C6092
(d)omit from the column headed “Purposes”: P4864
(e)insert in numerical order: P6081
Schedule 1, entry for Hypromellose
substitute:
| Hypromellose | Eye drops 3 mg per mL, 15 mL | Application to the eye | a | Genteal | AQ | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||||
| NP | C6073 | 1 | 5 | 1 | ||||||
| a | In a Wink Moisturising | IQ | AO | C6120 | 1 | 5 | 1 | |||
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||||
| NP | C6073 | 1 | 5 | 1 | ||||||
| a | Genteal | AQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | ||
| a | In a Wink Moisturising | IQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | ||
| Eye drops 5 mg per mL, 15 mL | Application to the eye | Methopt | QA | MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |
| NP | C6073 | 1 | 5 | 1 | ||||||
| AO | C6120 | 1 | 5 | 1 | ||||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Hypromellose with Carbomer 980
substitute:
| Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg‑2 mg per g, 10 g | Application to the eye | a | Genteal gel | AQ | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||||
| NP | C6073 | 1 | 5 | 1 | ||||||
| a | HPMC PAA | IQ | AO | C6120 | 1 | 5 | 1 | |||
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||||
| NP | C6073 | 1 | 5 | 1 | ||||||
| a | Genteal gel | AQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | ||
| a | HPMC PAA | IQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Hypromellose with Dextran
substitute:
| Hypromellose with dextran | Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 | Application to the eye | Bion Tears | AQ | AO | C2802 | 3 | 5 | 1 | |
| MP NP | C1359 | 3 | 5 | 1 | ||||||
| Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL | Application to the eye | a | Poly-Tears | IQ | MP | C6073 C6098 | P6073 | 1 | 5 | 1 |
| NP | C6073 | 1 | 5 | 1 | ||||||
| AO | C6120 | 1 | 5 | 1 | ||||||
| a | Tears Naturale | AQ | MP | C6073 C6098 | P6073 | 1 | 5 | 1 | ||
| NP | C6073 | 1 | 5 | 1 | ||||||
| AO | C6120 | 1 | 5 | 1 | ||||||
| a | Poly-Tears | IQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | ||
| a | Tears Naturale | AQ | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mLinsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| IRINOTECAN ACT | ED | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| IRINOTECAN ACT | ED | MP | See Note 3 | See Note 3 | 1 | D(100) |
(b)omit:
| Tecan | ED | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Lapatinib
omit from the column headed “Circumstances”: C5040 substitute: C6105
Schedule 1, after entry for Methotrexate
substitute:
| Methotrexate | Injection 5 mg in 2 mL vial | Injection | Hospira Pty Limited | HH | MP | 5 | 0 | 5 | |
| MP | P3925 | See Note 2 | See Note 2 | 5 | C(100) | ||||
| Injection 50 mg in 2 mL vial | Injection | a | Methaccord | EA | MP | 5 | 5 | 1 | |
| a | Methotrexate MYX | YN | MP | 5 | 5 | 1 | |||
| a | Hospira Pty Limited | HH | MP | 5 | 5 | 5 | |||
| Methaccord | EA | MP | P3925 | See Note 2 | See Note 2 | 1 | C(100) | ||
| Methotrexate MYX | YN | MP | P3925 | See Note 2 | See Note 2 | 1 | C(100) | ||
| Hospira Pty Limited | HH | MP | P3925 | See Note 2 | See Note 2 | 5 | C(100) | ||
| Solution concentrate for I.V. infusion 500 mg in 20 mL vial | Injection | Hospira Pty Limited | HH | MP | C3925 | See Note 3 | See Note 3 | 1 | PB(100) |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Injection | Hospira Pty Limited | HH | MP | C3925 | See Note 3 | See Note 3 | 1 | PB(100) |
| Methaccord | EA | MP | C3925 | See Note 3 | See Note 3 | 1 | PB(100) | ||
| Methotrexate MYX | YN | MP | C3925 | See Note 3 | See Note 3 | 1 | PB(100) | ||
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial | Injection | Methotrexate Ebewe | SZ | MP | C3925 | See Note 3 | See Note 3 | 1 | PB(100) |
| Tablet 2.5 mg | Oral | Methoblastin | PF | MP | 30 | 5 | 30 | ||
| Tablet 10 mg | Oral | Methoblastin | PF | MP | 15 | 3 | 15 | ||
| MP | P5648 | 50 | 2 | 50 |
Schedule 1, after entry for Metoclopramide in the form Injection containing metoclopramide hydrochloride 10 mg in 2 mL
insert in the columns in the order indicated:
| MP NP | P6084 | 40 CN6084 | 0 CN6084 | 10 |
Schedule 1, after entry for Nitrofurantoin in the form Capsule 100 mg
insert:
| Nivolumab | Injection concentrate for I.V. infusion 40 mg in 4 mL | Injection | Opdivo | BQ | MP | C6070 C6083 C6095 C6111 C6116 | See Note 3 | See Note 3 | 1 | D(100) |
| Injection concentrate for I.V. infusion 100 mg in 10 mL | Injection | Opdivo | BQ | MP | C6070 C6083 C6095 C6111 C6116 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Norethisterone in the form Tablets 350 micrograms, 28
omit:
| Micronor | JC | MP NP | 4 | 2 | 4 |
Schedule 1, entry for Oestradiol in each of the forms: Transdermal patches 750 micrograms (as hemihydrate), 8; Transdermal patches
1.5 mg (as hemihydrate), 8; and Transdermal patches 3 mg (as hemihydrate), 8omit from the column headed “Responsible Person” for the brands “Estraderm MX 25, “Estraderm MX 50” and Estraderm MX 100” respectively: NV substitute: JU
Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
(a)omit:
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) |
(b)omit:
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 |
Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
(a)omit:
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) |
(b)omit:
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 |
Schedule 1, entry for Ondansetron in the form Wafer 4 mg
(a)omit:
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 |
| MP | C5743 | 4 | 0 | 4 | C(100) |
(b)omit:
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 |
Schedule 1, entry for Ondansetron in the form Wafer 8 mg
(a)omit:
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 |
| MP | C5743 | 4 | 0 | 4 | C(100) |
(b)omit:
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 |
Schedule 1, entry for Oxycodone with naloxone
insert as first item in the columns in the order indicated:
| Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg | Oral | Targin 2.5/1.25mg | MF | MP NP | C4951 | 28 | 0 | 28 |
Schedule 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg
insert in the columns in the order indicated:
| Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg | Oral | Targin 15/7.5mg | MF | MP NP | C4951 | 28 | 0 | 28 |
Schedule 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg
insert in the columns in the order indicated:
| Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg | Oral | Targin 30/15mg | MF | MP NP | C4951 | 28 | 0 | 28 |
Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
(a)omit from the column headed “Circumstances”: C3955 C3956
(b)insert in numerical order: C6106 C6119
Schedule 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
omit from the column headed “Purposes” (all instances): P3035 substitute: P4894
Schedule 1, after entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g [Brand: Poly Visc; Maximum Quantity: 1; Number of Repeats: 11]
insert:
| Paritaprevir with ritonavir with ombitasvir and dasabuvir | Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg | Oral | Veikira Pak | VE | MP | C5969 | 1 | 2 | 1 | |
| Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin | Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 56 tablets ribavirin 600 mg | Oral | Viekira Pak-RBV | VE | MP | C6130 C6131 | P6131 | 1 | 2 | 1 |
| MP | C6130 C6131 | P6130 | 1 | 5 | 1 | |||||
| Pack containing 56 tablets paritaprevir 75 mg with ritonavir 50 mg with ombitasvir 12.5 mg and 56 tablets dasabuvir 250 mg and 168 tablets ribavirin 200 mg | Oral | Viekira Pak-RBV | VE | MP | C6130 C6131 | P6131 | 1 | 2 | 1 | |
| MP | C6130 C6131 | P6130 | 1 | 5 | 1 |
Schedule 1, entry for Pembrolizumab
substitute:
| Pembrolizumab | Powder for injection 50 mg | Injection | Keytruda | MK | MP | C5362 C6093 C6094 C6103 C6104 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)
omit:
| a | Pioglitazone generichealth 15 | GQ | MP NP | C4363 C4364 C4388 | 28 | 5 | 28 |
Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)
omit:
| a | Pioglitazone generichealth 30 | GQ | MP NP | C4363 C4364 C4388 | 28 | 5 | 28 |
Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)
omit:
| a | Pioglitazone generichealth 45 | GQ | MP NP | C4363 C4364 C4388 | 28 | 5 | 28 |
Schedule 1, entry for Polyethylene Glycol 400 with Propylene Glycol
omit:
| Eye drops 4 mg‑3 mg per mL, 15 mL | Application to the eye | Systane | AQ | MP | C1362 C3036 | P1362 | 1 | 5 | 1 |
| NP AO | C1362 | 1 | 5 | 1 | |||||
| MP | C1362 C3036 | P3036 | 1 | 11 | 1 |
substitute:
| Eye drops 4 mg‑3 mg per mL, 15 mL | Application to the eye | Systane | AQ | AO | C6120 | 1 | 5 | 1 |
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||
| NP | C6073 | 1 | 5 | 1 | ||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Polyvinyl Alcohol
substitute:
| Polyvinyl alcohol | Eye drops 14 mg per mL, 15 mL | Application to the eye | a | Liquifilm Tears | AG | MP | C6073 C6098 | P6073 | 1 | 5 | 1 |
| NP | C6073 | 1 | 5 | 1 | |||||||
| AO | C6120 | 1 | 5 | 1 | |||||||
| a | PVA Tears | PE | MP | C6073 C6098 | P6073 | 1 | 5 | 1 | |||
| NP | C6073 | 1 | 5 | 1 | |||||||
| AO | C6120 | 1 | 5 | 1 | |||||||
| a | Liquifilm Tears | AG | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | |||
| a | PVA Tears | PE | MP | C6073 C6098 | P6098 | 1 | 11 | 1 | |||
| Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | Vistil | AE | AO | C6120 | 1 | 5 | 1 | |||
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | ||||||
| NP | C6073 | 1 | 5 | 1 | |||||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 | ||||||
| Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | Vistil Forte | AE | AO | C6120 | 1 | 5 | 1 | |||
| MP | C6073 C6098 | P6073 | 1 | 5 | 1 | ||||||
| NP | C6073 | 1 | 5 | 1 | |||||||
| MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
Schedule 1, entry for Prednisolone with Phenylephrine
substitute:
| Prednisolone with phenylephrine | Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL | Application to the eye | Prednefrin Forte | AG | AO | C6087 | 1 | 0 | 1 |
| MP NP | C6080 C6101 | 1 | 2 | 1 |
Schedule 1, entry for Prochlorperazine
omit:
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 | Rectal | Stemetil | SW | PDP | 1 | 0 | 1 |
| MP NP | 1 | 2 | 1 |
Schedule 1, entry for Ramipril
omit:
| Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg | Oral | Tritace Titration Pack | SW | MP NP | 1 | 0 | 1 |
Schedule 1, entry for Risperidone
(a)omit:
| Tablet 0.5 mg (orally disintegrating) | Oral | Risperdal Quicklet | JC | MP NP | C4246 C5897 C5898 C5916 | P5897 P5898 P5916 | 56 | 2 | 28 |
| MP NP | C4246 C5897 C5898 C5916 | P4246 | 56 | 5 | 28 |
(b)omit:
| Tablet 1 mg (orally disintegrating) | Oral | Risperdal Quicklet | JC | MP NP | C4246 C5897 C5898 C5907 C5916 | P5897 P5898 P5916 | 56 | 2 | 28 |
| MP NP | C4246 C5897 C5898 C5907 C5916 | P4246 P5907 | 56 | 5 | 28 |
(c)omit:
| Tablet 2 mg (orally disintegrating) | Oral | Risperdal Quicklet | JC | MP NP | C4246 C5898 C5907 C5916 | P5898 P5916 | 56 | 2 | 28 |
| MP NP | C4246 C5898 C5907 C5916 | P4246 P5907 | 56 | 5 | 28 |
(d)omit:
| Tablet 3 mg (orally disintegrating) | Oral | Risperdal Quicklet | JC | MP NP | C4246 C5907 | 56 | 5 | 28 |
(e)omit:
| Tablet 4 mg (orally disintegrating) | Oral | Risperdal Quicklet | JC | MP NP | C4246 C5907 | 56 | 5 | 28 |
Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
omit:
| MP | C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058 | See Note 3 | See Note 3 | See Note 3 | 2 | PB(100) |
substitute:
| MP | C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058 | See Note 2 | See Note 2 | 2 | PB(100) |
Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
omit:
| MP | C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
substitute:
| MP | C4706 C5980 C5998 C6001 C6009 C6034 C6039 C6040 C6058 | See Note 2 | See Note 2 | 1 | PB(100) |
Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Rizatriptan | TX | MP NP | C5708 | 4 | 5 | 2 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Rizatriptan | CH | MP NP | C5708 | 4 | 5 | 2 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Rizatriptan | TW | MP NP | C5708 | 4 | 5 | 2 |
Schedule 1, omit entry for Sodium Chloride
Schedule 1, omit entry for Sodium Chloride with Glucose
Schedule 1, omit entry for Sodium Lactate Compound
Schedule 1, omit entry for Tiludronic Acid
Schedule 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg
omit from the column headed “Circumstances”: C4987 substitute: C6096 C6129
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a)insert in numerical order in the column headed “Circumstances”: C6067 C6091 C6108 C6125
(b)insert in numerical order in the column headed “Purposes”: P6067 P6125
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C6067 C6091 C6108 C6125
(b)insert in numerical order in the column headed “Purposes”: P6091 P6108
Schedule 1, entry for Verteporfin
omit from the column headed “Circumstances”: C3795 C3860 C3861 substitute: C6099 C6100 C6121
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C4826 | P4826 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4840 | P4840 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
(b)omit:
| C4864 | P4864 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text
| C6069 | P6069 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6081 | P6081 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6092 | P6092 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, omit entry for Aluminium hydroxide with magnesium hydroxide
Schedule 4, Part 1, entry for Aripiprazole
substitute:
| Aripiprazole | C4246 | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 4246 |
Schedule 4, Part 1, after entry for Beclomethasone
insert:
| Bendamustine | C6075 | Previously untreated stage III or IV indolent CD20 positive non-Hodgkin's lymphoma Induction treatment The treatment must be in combination with rituximab; AND | Compliance with Authority Required procedures - Streamlined Authority Code 6075 |
| C6124 | Previously untreated stage III or IV CD20 positive mantle cell lymphoma Induction treatment The treatment must be in combination with rituximab; AND | Compliance with Authority Required procedures - Streamlined Authority Code 6124 |
Schedule 4, Part 1, entry for Carmellose
(a)omit:
| C1362 | P1362 | Severe dry eye syndrome, including Sjogren’s syndrome. |
(b)omit:
| C3036 | P3036 | For use in patients who have severe dry eye syndrome, including Sjogren’s syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements |
(c)insert in numerical order after existing text:
| C6073 | P6073 | Severe dry eye syndrome, including Sjogren's syndrome |
| C6098 | P6098 | Severe dry eye syndrome, including Sjogren's syndrome Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. |
| C6120 | Severe dry eye syndrome, including Sjogren's syndrome |
Schedule 4, Part 1, entry for Carmellose with glycerin
substitute:
| Carmellose with glycerin | C6072 | P6072 | Severe dry eye syndrome, including Sjogren's syndrome |
| C6079 | P6079 | Severe dry eye syndrome, including Sjogren's syndrome Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. | |
| C6097 | Severe dry eye syndrome, including Sjogren's syndrome |
Schedule 4, Part 1, entry for Certolizumab pegol
(a)omit:
| C4831 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) - 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; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4839 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied | Compliance with Written Authority Required procedures |
| C4842 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
| C4843 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
(b)omit:
| C4863 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR The authority application must be made in writing and must include: A patient may qualify for PBS-subsidised treatment under this restriction once only | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text
| C6068 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6109 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6126 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Cromoglycic Acid
substitute:
| Cromoglycic acid | C6088 | Vernal kerato-conjunctivitis |
Schedule 4, Part 1, entry for Esomeprazole and clarithromycin and amoxycillin
substitute:
| Esomeprazole and clarithromycin and amoxycillin | C6118 | Eradication of Helicobacter pylori The condition must be associated with peptic ulcer disease. |
Schedule 4, Part 1, entry for Etanercept
(a)omit:
| C4826 | P4826 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4840 | P4840 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
(b)omit:
| C4864 | P4864 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C6073 | P6073 | Severe dry eye syndrome, including Sjogren's syndrome |
| C6098 | P6098 | Severe dry eye syndrome, including Sjogren's syndrome Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. |
| C6120 | Severe dry eye syndrome, including Sjogren's syndrome |
Schedule 4, Part 1, entry for Polyvinyl Alcohol
substitute:
| Polyvinyl alcohol | C6073 | P6073 | Severe dry eye syndrome, including Sjogren's syndrome |
| C6098 | P6098 | Severe dry eye syndrome, including Sjogren's syndrome Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. | |
| C6120 | Severe dry eye syndrome, including Sjogren's syndrome |
Schedule 4, Part 1, entry for Prednisolone with Phenylephrine
substitute:
| Prednisolone with phenylephrine | C6080 | Corneal grafts |
| C6087 | Uveitis | |
| C6101 | Uveitis |
Schedule 4, Part 1, entry for Risperidone
omit:
| C5897 | P5897 | Behavioural disturbances The condition must be characterised by psychotic symptoms and aggression; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5897 |
Schedule 4, Part 1, omit entry for Tiludronic Acid
Schedule 4, Part 1, entry for Trastuzumab emtansine
(a)omit:
| C4987 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND Authority applications for initial treatment must be made in writing and must include: Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment Patients who have progressive disease on lapatinib are not eligible to receive PBS-subsidised trastuzumab emtansine Patients who have developed intolerance to lapatinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised trastuzumab emtansine If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C6096 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND | Compliance with Written Authority Required procedures |
| C6129 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Ustekinumab
insert in numerical order after existing text:
| C6067 | P6067 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6091 | P6091 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6108 | P6108 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
| C6125 | P6125 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) Patient must have a documented history of severe active psoriatic arthritis; AND | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Verteporfin
substitute:
| Verteporfin | C6099 | Subfoveal choroidal neovascularisation (CNV) Initial treatment The condition must be predominantly classic (greater than or equal to 50%); AND | Compliance with Written or Telephone Authority Required procedures |
| C6100 | Subfoveal choroidal neovascularisation (CNV) Initial PBS-subsidised treatment The condition must be predominantly classic (greater than or equal to 50%); AND | Compliance with Written or Telephone Authority Required procedures | |
| C6121 | Subfoveal choroidal neovascularisation (CNV) Continuing treatment The condition must be predominantly classic (greater than or equal to 50%); AND | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 3
substitute:
Part 3—General statement for drugs for the treatment of hepatitis C
1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C
The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:
the patient is 18 years or older; and
the patient has been assessed in accordance with paragraph 2 of this Part; and
the patient is:
a.treated by a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and is:
i.a gastroenterologist; or
ii.a hepatologist; or
iii.an infectious diseases physician; or
b.treated in consultation with a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and who is:
i.a gastroenterologist; or
ii.a hepatologist; or
iii.an infectious diseases physician
2 Assessment of patient
For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:
documented the following information in the patient’s medical records:
a.evidence of chronic hepatitis C infection; and
b.evidence of the patient’s hepatitis C virus genotype; and
chosen a regimen in accordance with paragraph 3 of this Part; and
collected the following information for the purposes of the authority application:
a.the patient’s hepatitis C virus genotype; and
b.whether the patient is:
i. cirrhotic; or
ii. Non-cirrhotic
In this paragraph, evidence of chronic hepatitis C infection is documentation of:
a.repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and
b.test result showing hepatitis C virus ribonucleic acid (RNA) positive
3 Treatment regimen
For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:
is a kind of patient mentioned for an Item in column 2 of the following table; and
is to receive one of the regimens mentioned in column 3 of the same Item of the following table
| Item | Kind of patient | Regimen |
| 1 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (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 with 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. |
| 2 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with 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. |
| 3 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 4 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 5 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 6 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 12 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 7 | Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic | SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 8 | Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic | SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 9 | Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) LEDIPASVIR with SOFOSBUVIR for 12 weeks; or (b) DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or (c) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks. |
| 10 | Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (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 (d) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks; or (e) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 12 weeks; or (f) PARITAPREVIR with RITONAVIR with OMBITASVIR and DASABUVIR and RIBAVIRIN for 24 weeks. |
| 11 | Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 12 | Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic | SOFOSBUVIR and RIBAVIRIN for 12 weeks. |
| 13 | Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic | Either: (a) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (b) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 14 | Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic | Either: (a) DACLATASVIR and SOFOSBUVIR for 24 weeks; or (b) SOFOSBUVIR and RIBAVIRIN for 24 weeks; or (c) SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 15 | Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic | SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
| 16 | Patient: (a) with: (i) Genotype 4; or (ii) Genotype 5; or (iii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic | SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks. |
Schedule 5, entry for Esomeprazole in each of the forms: Tablet (enteric coated) 20 mg (as magnesium trihydrate); and Tablet (enteric coated) 40 mg (as magnesium trihydrate)
insert in alphabetical order in the column headed “Brand”: Nexazole
Schedule 5, after entry for Esomeprazole
insert:
| Esomeprazole and Clarithromycin and Amoxycillin | GRP-20639 | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | ESOMEPRAZOLE SANDOZ Hp7 |
| Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | Nexium Hp7 |
Schedule 5, entry for Olanzapine in the form Tablet 2.5 mg
omit from the column headed “Brand”: Olanzapine-GA 8170B substitute: Olanzapine-GA
Schedule 5, entry for Olanzapine in the form Tablet 5 mg
(a)omit from the column headed “Brand”: Terry White Chemists Olanzapine 8185T substitute: Terry White Chemists Olanzapine
(b)omit from the column headed “Brand”: Zypine 8185T substitute: Zypine
(c)omit from the column headed “Brand”: Zyprexa 8185T substitute: Zyprexa
Schedule 5, entry for Olanzapine in the form Tablet 10 mg
(a)omit from the column headed “Brand”: Olanzacor 10 8187X substitute: Olanzacor 10
(b)omit from the column headed “Brand”: Olanzapine-GA 8187X substitute: Olanzapine-GA
Schedule 5, entry for Ondansetron in each of the forms: Wafer 4 mg; and Wafer 8 mg
omit from the column headed “Brand”: Ondaz Zydis
Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)
(a)insert in alphabetical order in the column headed “Brand”: APO-Rizatriptan
(b)insert in alphabetical order in the column headed “Brand”: Chem mart Rizatriptan
(c)insert in alphabetical order in the column headed “Brand”: Terry White Chemists Rizatriptan
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