National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 1) (Cth)
PB 1 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 1)
National Health Act 1953
I, FELICITY McNEILL, 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 8 January 2014
FELICITY McNEILL
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 2014 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2014.
2 Commencement
This Instrument commences on 1 February 2014.
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
Schedule 1, after entry for Alogliptin in the form Tablet 25 mg (as benzoate)
insert:
| Alogliptin with metformin | Tablet containing 12.5 mg alogliptin (as benzoate) and 500 mg metformin hydrochloride | Oral | Nesina Met 12.5/500 | TK | MP NP | C4423 C4427 | 56 | 5 | 56 |
| Tablet containing 12.5 mg alogliptin (as benzoate) and 850 mg metformin hydrochloride | Oral | Nesina Met 12.5/850 | TK | MP NP | C4423 C4427 | 56 | 5 | 56 | |
| Tablet containing 12.5 mg alogliptin (as benzoate) and 1 g metformin hydrochloride | Oral | Nesina Met 12.5/1000 | TK | MP NP | C4423 C4427 | 56 | 5 | 56 |
Schedule 1, entry for Alprazolam in each of the forms: Tablet 250 micrograms; and Tablet 500 micrograms
omit:
| Xanax | PF | MP NP | C1975 | 50 | 0 | 50 |
Schedule 1, entry for Alprazolam in the form Tablet 1 mg
omit:
| Xanax | PF | MP NP | C1975 | 50 | 2 | 50 |
Schedule 1, entry for Alprazolam in the form Tablet 2 mg
omit:
| Xanax Tri‑Score | PF | MP NP | C1975 | 50 | 2 | 50 |
Schedule 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses
insert in the columns in the order indicated:
| Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2 | Rectal | Budenofalk | OA | MP NP | 1 | 3 | 1 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
[Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor | TX | PDP | 1 | 0 | 1 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
[Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor | TX | MP | 1 | 1 | 1 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
[Maximum Quantity: 1; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor | TX | PDP | 1 | 0 | 1 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
[Maximum Quantity: 1; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Cefaclor | TX | MP | 1 | 1 | 1 |
Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in numerical order after existing codes in the column headed “Circumstances” for the brand “Piax”: C4165 C4166
Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit:
| Paclitaxel Pfizer | PF | MP | C3186 C3890 C3902 C3917 C3955 C3956 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 15 mg in 5 mL
[Maximum Quantity: 4; Number of Repeats: 0]
omit from the column headed “Circumstances”: C3256 substitute: C4422
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 15 mg in 5 mL
[Maximum Quantity: 4; Number of Repeats: 2]
omit from the column headed “Circumstances”: C1500 C3341 substitute: C4430 C4433
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Circumstances”: C3256 substitute: C4420
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 2]
omit from the column headed “Circumstances”: C1500 C3341 substitute: C4424 C4425
Schedule 1, entry for Pamidronic Acid in the form Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Authorised Prescriber”: MP MP NP substitute: MP NP
(b)omit from the column headed “Circumstances”: C3256 substitute: C4420
Schedule 1, entry for Pamidronic Acid in the form Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL [Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”: C1500 C3341 substitute: C4424 C4425
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances”: C3256 substitute: C4422
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”: C1500 C3341 substitute: C4430 C4433
Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL
omit from the column headed “Circumstances”: C1035 C1233 C1500 C3341 C3342 C3343
substitute: C4421 C4426 C4428 C4429 C4431 C4432
Schedule 1, entry for Pamidronic Acid in the form Injection set containing 1 vial powder for I.V. infusion containing disodium pamidronate 90 mg and 1 ampoule solvent 10 mL
omit from the column headed “Circumstances”: C1035 C1233 C1500 C3341 C3342 C3343
substitute: C4421 C4426 C4428 C4429 C4431 C4432
Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 0]
omit from the column headed “Brand”: Paracetamol Sandoz substitute: Paracetamol (Sandoz)
Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 1]
omit from the column headed “Brand”: Paracetamol Sandoz substitute: Paracetamol (Sandoz)
Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 0]
omit from the column headed “Brand”: Paracetamol Sandoz substitute: Paracetamol (Sandoz)
Schedule 1, entry for Paracetamol in the form Tablet 500 mg [Maximum Quantity: 300; Number of Repeats: 4]
omit from the column headed “Brand”: Paracetamol Sandoz substitute: Paracetamol (Sandoz)
Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
omit:
| Quinapril generichealth | GQ | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
(a)omit:
| Chem mart Risedronate | CH | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
(b)omit:
| Terry White Chemists Risedronate | TW | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 5 | ZP | MP | C4225 C4228 C4238 C4248 | P4228 P4248 | 30 | 5 | 30 |
| NP | C4228 C4248 | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 5 | ZP | MP | C4225 C4228 C4238 C4248 | P4225 P4238 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 10 | ZP | MP | C4225 C4228 C4238 C4248 | P4228 P4248 | 30 | 5 | 30 |
| NP | C4228 C4248 | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 10 | ZP | MP | C4225 C4228 C4238 C4248 | P4225 P4238 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 20 | ZP | MP | C4225 C4227 C4238 C4259 | P4227 P4259 | 30 | 5 | 30 |
| NP | C4227 C4259 | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 20 | ZP | MP | C4225 C4227 C4238 C4259 | P4225 P4238 | 30 | 11 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 40 | ZP | MP | C4225 C4226 C4238 C4263 | P4226 P4263 | 30 | 5 | 30 |
| NP | C4226 C4263 | 30 | 5 | 30 |
Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Crosuva 40 | ZP | MP | C4225 C4226 C4238 C4263 | P4225 P4238 | 30 | 11 | 30 |
Schedule 1, entry for Sitagliptin with simvastatin in each of the forms: Tablet 100 mg (as phosphate monohydrate)-10 mg; Tablet 100 mg (as phosphate monohydrate)-20 mg; and Tablet 100 mg (as phosphate monohydrate)-40 mg
omit from the column headed “Circumstances”: C4183 substitute: C4419
Schedule 1, entry for Sotalol in each of the forms: Tablet containing sotalol hydrochloride 80 mg; and Tablet containing sotalol hydrochloride 160 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Sotalol | TX | MP NP | C1350 | 60 | 5 | 60 |
Schedule 1, entry for Temozolomide in the form Capsule 180 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Orion Temozolomide | ON | MP | C1736 C1737 C2101 | 5 | 5 | 5 |
Schedule 3, details relevant to Responsible Person Code ZP
omit: Spirit Pharmaceuticals Pty Ltd substitute: Medis Pharma Pty Ltd
Schedule 4, Part 1, after entry for Alogliptin
insert:
| Alogliptin with metformin | C4423 | Diabetes mellitus type 2 Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination | Compliance with Authority Required procedures – Streamlined Authority Code 4423 |
| C4427 | Diabetes mellitus type 2 Continuing treatment Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and alogliptin | Compliance with Authority Required procedures – Streamlined Authority Code 4427 |
Schedule 4, Part 1, entry for Pamidronic Acid
substitute:
| Pamidronic Acid | C4420 | Symptomatic Paget disease of bone | Compliance with Authority Required procedures – Streamlined Authority Code 4420 |
| C4421 | Where the patient is receiving treatment at/from a public hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4421 | |
| C4422 | Symptomatic Paget disease of bone | Compliance with Authority Required procedures – Streamlined Authority Code 4422 | |
| C4424 | Where the patient is receiving treatment at/from a private hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures | |
| C4425 | Where the patient is receiving treatment at/from a public hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4425 | |
| C4426 | Where the patient is receiving treatment at/from a public hospital Bone metastases The condition must be due to breast cancer | Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4426 | |
| C4428 | Where the patient is receiving treatment at/from a private hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures | |
| C4429 | Where the patient is receiving treatment at/from a private hospital Bone metastases The condition must be due to breast cancer | Compliance with Written and Telephone Authority Required procedures | |
| C4430 | Where the patient is receiving treatment at/from a private hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures | |
| C4431 | Where the patient is receiving treatment at/from a private hospital Multiple myeloma | Compliance with Written and Telephone Authority Required procedures | |
| C4432 | Where the patient is receiving treatment at/from a public hospital Multiple myeloma | Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4432 | |
| C4433 | Where the patient is receiving treatment at/from a public hospital Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy | Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4433 |
Schedule 4, Part 1, entry for Rivaroxaban [Circumstances Code C4098]
insert in the column headed “Purposes Code”: P4098
Schedule 4, Part 1, entry for Sitagliptin with simvastatin
substitute:
| Sitagliptin with simvastatin | C4419 | Diabetes mellitus type 2 and hypercholesterolaemia Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs, The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4419 |
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