National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 4) (No. PB 27 of 2014) (Cth)

Case

PB 27 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 4)


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    9 April 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. 4).

(2)        This Instrument may also be cited as PB 27 of 2014.

2          Commencement

This Instrument commences on 1 May 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

  1. Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg

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

Acitretin Actavis GN MP C1363 C1366 100 2 100

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) 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-Amoxycillin TX PDP 1 0 1

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) 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-Amoxycillin TX MP NP 1 1 1

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) 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-Amoxycillin TX PDP 1 0 1

  1. Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) 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-Amoxycillin TX MP NP 1 1 1

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [MaximumQuantity: 10; Number of Repeats: 0]

omit from the column headed “Brand”:         Amoxycillin/ Clavulanic Acid 875/125 generichealth     substitute:            AmoxyClav GH 875/125

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [MaximumQuantity: 10; Number of Repeats: 1]

omit from the column headed “Brand”:         Amoxycillin/ Clavulanic Acid 875/125 generichealth     substitute:            AmoxyClav GH 875/125

  1. Schedule 1, entry for Atazanavir

omit:

Capsule 100 mg (as sulfate) Oral Reyataz BQ MP
See Note 1 		C4454 C4455 C4469 C4512 120 5 60 D(100)

  1. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

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

APO-Azathioprine TX MP NP 100 5 100

  1. Schedule 1, entry for Carbamazepine in the form Tablet 100 mg [Maximum Quantity: 200; Number of Repeats: 0]

omit:

Carbamazepine Sandoz SZ PDP 200 0 200

substitute:

Carbamazepine Sandoz SZ PDP 200 0 100
PDP 200 0 200

  1. Schedule 1, entry for Carbamazepine in the form Tablet 100 mg [Maximum Quantity: 200; Number of Repeats: 2]

omit:

Carbamazepine Sandoz SZ MP NP 200 2 200

substitute:

Carbamazepine Sandoz SZ MP NP 200 2 100
MP NP 200 2 200

  1. Schedule 1, entry for Carbomer with Triglyceride Lipids

omit:

Eye gel 2 mg‑10 mg per g, 10 g Application to the eye Artelac BU MP C1362 C3036 P1362 1 5 1
NP AO C1362 1 5 1
MP C1362 C3036 P3036 1 11 1

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]

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

APO-Cephalexin TX PDP 20 0 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]

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

APO-Cephalexin TX MP NP MW 20 1 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]

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

APO-Cephalexin TX MP C4243 40 2 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]

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

APO-Cephalexin TX PDP 20 0 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]

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

APO-Cephalexin TX MP NP MW 20 1 20

  1. Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)

omit:

Kefzol AS MP NP C1169 C1846 C1847 C3132 10 0 10

  1. Schedule 1, entry for Dapagliflozin

omit from the column headed “Responsible Person”:                 BQ       substitute:          AP

  1. Schedule 1, entry for Docetaxel

omit:

Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent Injection AS-Docetaxel AF MP C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

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

Doxorubicin MYX YN MP See Note 3 See
Note 3 		1 D(100)

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

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

Duloxetine RBX RA MP NP C1211 28 0 28

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

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

Duloxetine RBX RA MP NP C1211 28 5 28

  1. Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg

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

Enalapril Actavis UA MP NP 30 5 30

  1. Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

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

Cilopam-S ER MP NP C1211 28 5 28

  1. Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre‑filled pen, 60 doses; and
    Injection solution 10 micrograms per dose in pre‑filled pen, 60 doses

omit from the column headed “Responsible Person”:                 BQ       substitute:          AP

  1. Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg

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

Gabacor NJ MP NP C2664 100 5 100

  1. Schedule 1, entry for Glucose Indicator—Blood

omit:

Test strips, 50 (Omnitest EZ) For external use Omnitest EZ BR MP NP 2 5 1
MP P4241 2 11 1

  1. Schedule 1, entry for Latanoprost with timolol

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

Latanoprost/ Timolol Sandoz 50/5 SZ MP C4343 1 5 1
AO C4326 1 5 1

  1. Schedule 1, entry for Letrozole

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

Gynotril ER MP NP C1608 C2691 C2692 30 5 30

  1. Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

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

Levactam ER MP NP C2664 60 5 60

  1. Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
    7 inert tablets

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

Micronelle 30 ED TX MP NP 4 2 4

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

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

Molaxole HM MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 P3643
See Note 2 		2
See Note 2 		0
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 P3642
See Note 2 		2
See Note 2 		3
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 P1263 P1613 P2693 P2823
See Note 2 		1
See Note 2 		5
See Note 2 		1

  1. Schedule 1, omit entry for Methysergide

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

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

Mistrom ER MP NP 100 5 100

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

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

Mistrom ER MP NP 60 5 60

  1. Schedule 1, entry for Metronidazole in the form I.V. infusion 500 mg in 100 mL

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

Metronidazole Sandoz IV SZ MP NP C4167 C4168 C4169 10 0 10
PDP C4169 10 0 10

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

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

APO-Mirtazapine TX MP NP C1211 30 5 30

  1. Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

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

Olanzapine GH GQ MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

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

Panthron ER MP NP C1337 C1476 C1533 30 5 30

  1. Schedule 1, omit entry for Pergolide

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

Perindopril Actavis 2 UA MP NP 30 5 30

(b)omit:

Perindopril‑DP GN MP NP 30 5 30
Perindopril‑GA UA MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

Perindopril Actavis 4 UA MP NP 30 5 30

(b)omit:

Perindopril‑DP GN MP NP 30 5 30
Perindopril‑GA UA MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

Perindopril Actavis 8 UA MP NP 30 5 30

(b)omit:

Perindopril‑DP GN MP NP 30 5 30
Perindopril‑GA UA MP NP 30 5 30

  1. Schedule 1, after entry for Pizotifen

insert:

Plerixafor Injection 24 mg in 1.2 mL Injection Mozobil GZ MP
See Note 1 		C4549 C4550 1 1 1 D(100)

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

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

Pharmacor Quetiapine 25 CR MP NP C4385 C4391 C4396 60 0 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

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

Pharmacor Quetiapine 100 CR MP NP C1589 C2044 C2765 90 5 90

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

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

Pharmacor Quetiapine 200 CR MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

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

Pharmacor Quetiapine 300 CR MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, after entry for Salmeterol

insert:

Sapropterin Tablet (soluble) containing sapropterin dihydrochloride 100 mg Oral Kuvan SG MP C4547 C4548 P4547 180 0 30
MP C4547 C4548 P4548 180 5 30

  1. Schedule 1, entry for Saxagliptin

omit from the column headed “Responsible Person”:                 BQ       substitute:          AP

  1. Schedule 1, entry for Saxagliptin with metformin in each of the forms: Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with
    500 mg metformin hydrochloride; and Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

omit from the column headed “Responsible Person”:                 BQ       substitute:          AP

  1. Schedule 1, after entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride

insert in the columns in the order indicated:

Tablet (modified release) containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride Oral Janumet XR MK MP NP C4309 C4423 56 5 56
Tablet (modified release) containing 100 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride Oral Janumet XR MK MP NP C4309 C4423 28 5 28

  1. Schedule 1, after entry for Tenofovir with Emtricitabine and Rilpivirine

insert:

Tenofovir with emtricitabine, elvitegravir and cobicistat Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Stribild GI MP
See Note 1 		C4470 C4494 C4522  C4533 60 5 30 D(100)

  1. Schedule 1, entry for Timolol

omit:

Eye drops 2.5 mg (as maleate) per mL, 5 mL Application to the eye Tenopt QA MP AO 1 5 1

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 0]

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

Tramadol Actavis UA MP NP C1497 C1615 P1497 20 0 20
PDP C1497 C1615 20 0 20

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 2]

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

Tramadol Actavis UA MP NP C1497 C1615 P1615 20 2 20

  1. Schedule 1, entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL

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

Tramadol ACT GN MP NP PDP C1378 5 0 5

  1. Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

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

Venlafaxine Actavis XR UA MP NP C1211 28 0 28

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

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

Venlafaxine Actavis XR UA MP NP C1211 28 5 28

  1. Schedule 1, entry for Verapamil in the form Tablet containing verapamil hydrochloride 40 mg

omit:

Isoptin AB MP NP 100 5 100

  1. Schedule 1, entry for Verapamil

omit:

Tablet containing verapamil hydrochloride 120 mg Oral Isoptin AB MP NP 100 5 100

  1. Schedule 4, Part 1, entry for Carbomer with Triglyceride Lipids

(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

  1. Schedule 4, Part 1, omit entry for Pergolide

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

insert:

Plerixafor C4549

Where the patient is receiving treatment at/from a public hospital

Mobilisation of haematopoietic stem cells

The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg

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 4549
C4550

Where the patient is receiving treatment at/from a private hospital

Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per microlitre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg

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

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

insert:

Sapropterin C4547 P4547

Hyperphenylalaninaemia

Initial treatment

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured

The authority application must be made in writing

 Compliance with Written Authority Required procedures
C4548 P4548

Hyperphenylalaninaemia

Continuing treatment

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have demonstrated a 30% or greater reduction in blood phenylalanine levels in response to treatment with sapropterin; OR
Patient must have accessed non-PBS-subsidised treatment prior to 1 May 2014

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured

The authority application must be made in writing

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, after entry for Tenofovir with Emtricitabine and Rilpivirine

insert:

Tenofovir with emtricitabine, elvitegravir and cobicistat C4470

Where the patient is receiving treatment at/from a public hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4470
C4494

Where the patient is receiving treatment at/from a private hospital

HIV infection
Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection

 Compliance with Written or Telephone Authority Required procedures
C4522

Where the patient is receiving treatment at/from a public hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naive

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4522
C4533

Where the patient is receiving treatment at/from a private hospital

HIV infection
Initial treatment

Patient must be antiretroviral treatment naive

 Compliance with Written or Telephone Authority Required procedures
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