National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 8) (PB 72 of 2016) (Cth)

Case

PB 72 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 8)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 5 August   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. 8).

(2)        This Instrument may also be cited as PB 72 of 2016.

2          Commencement

This Instrument commences on 1 September 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

  1. Schedule 1, entry for Acarbose in each of the forms: Tablet 50 mg; and Tablet 100 mg

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

a GLYBOSAY RW MP NP 90 5 90

  1. Schedule 1, entry for Alendronic Acid

    omit:

Alendronate‑GA ED MP NP C6310  C6323  C6327 4 5 4

  1. Schedule 1, entry for Artemether with lumefantrine in each of the forms: Tablet 20 mg-120 mg; and Tablet (dispersible) 20 mg‑120 mg

    omit from the column headed “Responsible Person”:                 NV        substitute:             SZ

  2. Schedule 1, entry for Beclomethasone in each of the forms: Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation); and Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

    omit from the column headed “Circumstances”:          C1266   substitute:             C6348

  3. Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg
    in 16 mL

    insert in numerical order in  the column headed “Circumstances”:        C6337  C6338  C6353

  4. Schedule 1, entry for Bicalutamide

    omit:

Bicalutamide‑GA ED MP NP C5729 28 5 28

  1. Schedule 1, entry for Bromocriptine

    omit from the column headed “Responsible Person” for the brand “Parlodel” (twice occurring):                  NV        substitute:                SZ

  2. Schedule 1, entry for Budesonide in each of the forms: Nebuliser suspension 500 micrograms in 2 mL single dose units, 30; and Nebuliser suspension 1 mg in 2 mL single dose units, 30

    omit from the column headed “Circumstances”:          C1351   substitute:             C6340

  3. Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

    omit from the column headed “Circumstances”:          C3209   substitute:             C6358

  4. Schedule 1, entry for Calcitriol

    omit:

a Calcitriol‑GA ED MP NP C5089 C5114 C5255 C5401 C5402 100 3 100

  1. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; and Tablet containing candesartan cilexetil 8 mg

    omit:

a Candesartan-GA ED MP NP 30 5 30

  1. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

    (a)omit:

a Candesartan-GA ED MP NP 30 5 30

(b)omit:

a Candesartan RBX RA MP NP 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

    (a)omit:

a Candesartan HCTZ-GA 16/12.5 ED MP NP C4374 30 5 30

(b)omit:

a Candesartan HCTZ RBX 16/12.5 RA MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

    omit:

a Candesartan HCTZ-GA 32/12.5 ED MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

    omit:

a Candesartan HCTZ-GA 32/25 ED MP NP C4374 30 5 30

  1. Schedule 1, entry for Capecitabine in the form Tablet 150 mg

    omit:

Capecitabine Actavis ED MP 60 2 60

  1. Schedule 1, entry for Capecitabine in the form Tablet 500 mg

    omit:

Capecitabine Actavis ED MP 120 2 120

  1. Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

    omit:

GN‑Carvedilol ED MP NP C5324 C5394 30 0 30

  1. Schedule 1, entry for Carvedilol in each of the forms: Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

    omit:

GN‑Carvedilol ED MP NP C5324 C5394 60 5 60

  1. Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

    omit:

Ciprofloxacin‑GA ED MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)

    omit:

a Citalopram-GA ED MP NP C4755 28 5 28

  1. Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

    omit:

Citalopram-GA EF MP NP C4755 28 5 28

  1. Schedule 1, entry for Clomiphene

    omit:

Serophene SG MP C6221  C6240 10 5 10

  1. Schedule 1, entry for Clomipramine

    omit from the column headed “Responsible Person” for the brand “Anafranil 25”:           NV        substitute:             SZ

  2. Schedule 1, entry for Cyproterone

    omit:

Tablet containing cyproterone acetate 50 mg Oral Androcur BN MP C5532 20 5 20
Cyprocur 50 QA MP C5532 20 5 20
Cyprone AF MP C5532 20 5 20
Cyprostat SY MP C5532 20 5 20
Cyproterone AN EA MP C5532 20 5 20
Cyproterone Sandoz HX MP C5532 20 5 20
GenRx Cyproterone Acetate GX MP C5532 20 5 20
Procur ED MP C5532 20 5 20
Androcur BN MP 100 5 50
Cyprocur 50 QA MP 100 5 50
Cyprone AF MP 100 5 50
Cyprostat SY MP 100 5 50
Cyproterone AN EA MP 100 5 50
Cyproterone Sandoz HX MP 100 5 50
Cyrotone ER MP 100 5 50
GenRx Cyproterone Acetate GX MP 100 5 50
Procur ED MP 100 5 50

substitute:

Tablet containing cyproterone acetate 50 mg Oral Androcur BN MP P5532 20
CN5532 		5
CN5532 		20
Cyprocur 50 QA MP P5532 20
CN5532 		5
CN5532 		20
Cyprone AF MP P5532 20
CN5532 		5
CN5532 		20
Cyprostat SY MP P5532 20
CN5532 		5
CN5532 		20
Cyproterone AN EA MP P5532 20
CN5532 		5
CN5532 		20
Cyproterone Sandoz HX MP P5532 20
CN5532 		5
CN5532 		20
GenRx Cyproterone Acetate GX MP P5532 20
CN5532 		5
CN5532 		20
Androcur BN MP 100 5 50
Cyprocur 50 QA MP 100 5 50
Cyprone AF MP 100 5 50
Cyprostat SY MP 100 5 50
Cyproterone AN EA MP 100 5 50
Cyproterone Sandoz HX MP 100 5 50
Cyrotone ER MP 100 5 50
GenRx Cyproterone Acetate GX MP 100 5 50

  1. Schedule 1, entry for Dantrolene in each of the forms: Capsule containing dantrolene sodium 25 mg; and Capsule containing dantrolene sodium 50 mg

    omit from the column headed “Circumstances”:          C1421   substitute:             C6359

  2. Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

    omit:

Dilzem 60 mg EF MP NP 90 5 90

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)

    (a)omit:

Doxy-100 ED PDP 7 0 7

(b)omit:

Doxy-100 ED MP NP 7 1 7

(c)omit:

Doxy-100 ED MP NP P4485 21 0 7

(d)omit:

Doxy-100 ED MP NP P4514 28 0 7

(e)omit:

a Doxy-100 ED MP P6200 28 5 7

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

    omit:

a Drulox ED MP NP C5650 28 0 28

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

    omit:

a Drulox ED MP NP C5650 28 5 28

  1. Schedule 1, entry for Eformoterol in the form Capsule containing powder for oral inhalation containing eformoterol fumarate dihydrate
    12 micrograms (for use in Foradile Aerolizer)

    (a)omit from the column headed “Responsible Person”:      NV        substitute:             SZ

    (b)omit from the column headed “Circumstances”:               C1752  C1753    substitute:             C6355

  2. Schedule 1, entry for Eformoterol in each of the forms: Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses; and Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses

    omit from the column headed “Circumstances”:          C1752  C1753    substitute:             C6355

  3. Schedule 1, entry for Eprosartan

    substitute:

Eprosartan Tablet 400 mg (as mesylate) Oral Teveten GO MP NP 56 5 28
MP NP P6328 P6329 P6332 P6351 56
CN6328 CN6329 CN6332 CN6351 		5
CN6328 CN6329 CN6332 CN6351 		28
Tablet 600 mg (as mesylate) Oral Teveten GO MP NP 28 5 28
MP NP P6328 P6329 P6332 P6351 28
CN6328 CN6329 CN6332 CN6351 		5
CN6328 CN6329 CN6332 CN6351 		28

  1. Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

    omit:

Escitalopram GA ED MP NP C4755 28 5 28

  1. Schedule 1, entry for Exemestane

    omit:

Exemestane‑GA ED MP C4796 C5522 30 5 30
NP C5522 30 5 30

  1. Schedule 1, after entry for Exenatide in the form Injection solution 10 micrograms per dose in pre‑filled pen, 60 doses

    insert in the columns in the order indicated:

Injection (modified release) 2 mg single dose pre-filled pen Injection Bydureon AP MP NP C6339 C6354 4 5 4

  1. Schedule 1, entry for Famciclovir in each of the forms: Tablet 125 mg; Tablet 250 mg; and Tablet 500 mg

    omit from the column headed “Responsible Person” for the brand “Famvir” (all instances):           NV        substitute:             HX

  2. Schedule 1, entry for Famotidine in the form Tablet 20 mg

    (a)omit:

Chem mart Famotidine CH MP NP 60 5 60

(b)omit:

Terry White Chemists Famotidine TW MP NP 60 5 60

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

    (a)omit:

Chem mart Famotidine CH MP NP 30 5 30

(b)omit:

Terry White Chemists Famotidine TW MP NP 30 5 30

  1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a FLUOTEX RF MP NP C4755 C6277 28 5 28

  1. Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

    omit:

Frusid EA MP NP 100 1 100

  1. Schedule 1, entry for Gliclazide in the form Tablet 30 mg (modified release)

    omit:

Oziclide MR RA MP NP 100 5 100

  1. Schedule 1, entry for Glimepiride in the form Tablet 1 mg

    omit:

Glimepiride GA 1 ED MP NP 30 5 30

  1. Schedule 1, entry for Glimepiride in the form Tablet 2 mg

    omit:

Glimepiride GA 2 ED MP NP 30 5 30

  1. Schedule 1, entry for Glimepiride in the form Tablet 3 mg

    omit:

Glimepiride GA 3 ED MP NP 30 5 30

  1. Schedule 1, entry for Glimepiride in the form Tablet 4 mg

    omit:

Glimepiride GA 4 ED MP NP 30 5 30

  1. Schedule 1, entry for Glucagon

    (a)omit from the column headed “Brand” [Authorised Prescriber MP NP]:    GlucaGen Hypokit

    (b)omit from the column headed “Responsible Person” [Authorised Prescriber MP NP]:           NO

  2. Schedule 1, entry for Glyceryl Trinitrate in each of the forms: Transdermal patch 25 mg; and Transdermal patch 50 mg

    omit from the column headed “Responsible Person”:                 NV        substitute:             SZ

  3. Schedule 1, entry for Hydromorphone

    omit:

Injection containing hydromorphone hydrochloride 500 mg in 50 mL Injection Dilaudid‑HP MF MP NP 1 0 1

  1. Schedule 1, entry for Hydroxychloroquine

    (a)omit:

Hydroxychloroquine Actavis ED MP NP 100 1 100

(b)insert in the column headed “Schedule Equivalent” for all brands:             a

(c)omit from the column headed “Brand”:               Terry White Chemist Hydroxychloroquine       
substitute:   Terry White Chemists Hydroxychloroquine

  1. Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 10 mg

    omit:

Tolerade 10 PQ MP NP 50 2 50

  1. Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg

    omit:

Tolerade 25 PQ MP NP 50 2 50

  1. Schedule 1, entry for Indacaterol in each of the forms: Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler); and Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)

    omit from the column headed “Circumstances”:          C3883   substitute:             C6366

  2. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

    omit:

Indapamide‑GA ED MP NP 90 1 90

  1. Schedule 1, entry for Insect Allergen Extract—Honey Bee Venom

    omit:

Injection set containing 550 micrograms with diluent Injection Hymenoptera Honey Bee Venom DE MP 1 0 1

  1. Schedule 1, entry for Ipratropium in each of the forms: Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous)
    in 1 mL single dose units, 30; and Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30

    omit from the column headed “Circumstances” (all instances):               C1754  C1755    substitute:             C6331  C6341

  2. Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

    omit:

a Irbesartan-GA EF MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

    omit:

a Irbesartan HCTZ-GA 150/12.5 EF MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

    omit:

a Irbesartan HCTZ-GA 300/12.5 EF MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg

    omit:

a Irbesartan HCTZ-GA 300/25 EF MP NP C4374 30 5 30

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

    omit:

Irinotecan Actavis 500 EA MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)

    omit:

Imtrate 60 mg ED MP NP 30 5 30

  1. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

    omit:

Lamotrigine‑GA ED MP NP C5138 56 5 56

  1. Schedule 1, entry for Lignocaine

    omit:

Injection containing lignocaine hydrochloride 50 mg in 5 mL Injection Pfizer Australia Pty Ltd PF MP NP
See Note 4 		See Note 4 See Note 4 1 1 D(MP)
D(NP)

substitute:

Injection containing lignocaine hydrochloride 50 mg in 5 mL Injection Pfizer Australia Pty Ltd PF See Note 4 See Note 4 See Note 4  5  5 PB(MP)
PB(NP)

  1. Schedule 1, entry for Linagliptin

    omit from the column headed “Circumstances”:          C4488   substitute:             C6346  C6363

  2. Schedule 1, entry for Linagliptin with metformin in each of the forms: Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride; Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride; and Tablet containing 2.5 mg linagliptin with
    1000 mg metformin hydrochloride

    omit from the column headed “Circumstances”:          C4423  C4448    substitute:             C6333  C6336  C6344

  3. Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

    omit:

Lisinopril‑GA ED MP NP 30 5 30

  1. Schedule 1, entry for Loperamide

    substitute:

Loperamide Capsule containing loperamide hydrochloride 2 mg Oral a Gastrex CR MP NP C6343 C6364 P6364 12 0 12
a Gastro-Stop Loperamide AS MP NP C6343 C6364 P6364 12 0 12
a Imodium JT MP NP C6343 C6364 P6364 12 0 12
a Gastrex CR MP NP C6343 C6364 P6343 60 0 12
a Gastro-Stop Loperamide AS MP NP C6343 C6364 P6343 60 0 12
a Imodium JT MP NP C6343 C6364 P6343 60 0 12

  1. Schedule 1, entry for Macrogol 3350 in each of the forms: Powder for oral solution 510 g; and Sachets containing powder for oral solution 17 g, 30

    omit from the column headed “Schedule Equivalent”:   a

  2. Schedule 1, entry for Mesna

    substitute:

Mesna Solution for I.V. injection 400 mg in 4 mL ampoule Injection Uromitexan BX MP C5106 15 5 15
MP C5130 15 5 15 C(100)
Solution for I.V. injection 1 g in 10 mL ampoule Injection Uromitexan BX MP C5106 15 5 15
MP C5130 15 5 15 C(100)

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

    omit:

Metformin Ranbaxy RA MP NP 60 5 60

  1. Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg

    omit:

a Metoclopramide Actavis ED MP NP MW PDP 25 0 25

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

    omit:

Metoprolol Actavis ED MP NP 100 5 100

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

    omit:

Metoprolol Actavis ED MP NP 60 5 60

  1. Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g

    omit from the column headed “Brand” (all instances):               Elocon             substitute:             Elocon Alcohol Free

  1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

    omit:

Montair 4 ED MP NP C2617 28 5 28

  1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

    omit:

Montair 5 ED MP NP C2618 C3217 28 5 28

  1. Schedule 1, entry for Oestradiol in each of the forms: Transdermal patches 390 micrograms, 8; Transdermal patches 585 micrograms, 8; Transdermal patches 780 micrograms, 8; Transdermal patches 1.17 mg, 8; and Transdermal patches 1.56 mg, 8

    omit from the column headed “Responsible Person”:                 NV        substitute:             SZ

  2. Schedule 1, entry for Oestradiol and Oestradiol with Norethisterone in each of the forms: Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate; and Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate

    omit from the column headed “Responsible Person”:                 NV        substitute:             SZ

  3. Schedule 1, entry for Oestradiol with Norethisterone in each of the forms: Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8; and Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8

    omit from the column headed “Responsible Person”:                 NV        substitute:             SZ

  4. Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

    omit:

Olanzapine‑GA ED MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)

    omit:

Olanzapine‑GA ODT ED MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olmesartan

    substitute:

Olmesartan Tablet containing olmesartan medoxomil 20 mg Oral Olmetec MK MP NP 30 5 30
MP NP P6328 P6329 P6332 P6351 30
CN6328 CN6329 CN6332 CN6351 		5
CN6328 CN6329 CN6332 CN6351 		30
Tablet containing olmesartan medoxomil 40 mg Oral Olmetec MK MP NP 30 5 30
MP NP P6328 P6329 P6332 P6351 30
CN6328 CN6329 CN6332 CN6351 		5
CN6328 CN6329 CN6332 CN6351 		30

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg

    (a)omit:

Omeprazole‑GA ED MP NP C4074 C4075 C4089 C4152 P4074 30 1 30

(b)omit:

Omeprazole‑GA ED MP NP C4074 C4075 C4089 C4152 P4075 P4089 P4152 30 5 30

  1. Schedule 1, entry for Omeprazole in the form Capsule 20 mg

    (a)omit:

Omepro‑GA EA MP NP C4074 C4075 C4089 C4152 P4074 30 1 30

(b)omit:

Omepro‑GA EA MP NP C4074 C4075 C4089 C4152 P4075 P4089 P4152 30 5 30

  1. Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for
    I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL

    omit:

Plaxel ED MP See Note 3 See
Note 3 		1 D(100)

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

    omit:

Pantoprazole-GA EF MP NP C5444 C5512 C5529 30 5 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

    (a)omit:

Pantoprazole-GA EF MP NP C5444 C5445 C5512 C5529 P5445 30 2 30

(b)omit:

Pantoprazole-GA EF MP NP C5444 C5445 C5512 C5529 P5444 P5512 P5529 30 5 30

  1. Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)

    omit:

Paroxetine Actavis ED MP NP C6219  C6267  C6290 30 5 30

  1. Schedule 1, after entry for Paroxetine in the form Tablet 20 mg (as mesilate)

    insert:

Pasireotide Injection (modified release) 20 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV MP C6347 2 5 1 D(100)
See Note 3 See Note 3 See
Note 3 		1 D(100)
Injection (modified release) 40 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV MP C6347 2 5 1 D(100)
See Note 3 See Note 3 See
Note 3 		1 D(100)
Injection (modified release) 60 mg (as embonate), vial and diluent syringe Injection Signifor LAR NV MP C6347 2 5 1 D(100)
See Note 3 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Phenoxymethylpenicillin

    omit:

Tablet 250 mg phenoxymethylpenicillin (as potassium) Oral Abbocillin‑VK Filmtab QA MP NP PDP 50 0 25
MP NP P5697 50 5 25
Tablet 500 mg phenoxymethylpenicillin (as potassium) Oral Abbocillin‑VK Filmtab QA MP NP PDP 50 0 25

  1. Schedule 1, entry for Phenoxymethylpenicillin in the form Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

    (a)omit:

Abbocillin‑V QA PDP 2 0 1

(b)omit:

Abbocillin‑V QA MP NP 2 1 1

  1. Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

    omit:

a Pioglitazone‑GA ED MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

    (a)omit:

a Pioglitazone‑GA ED MP NP C4363 C4364 C4388 28 5 28

(b)omit:

a Pizaccord RA MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

    omit:

a Pioglitazone‑GA ED MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg

    (a)omit:

Pravastatin‑GA 10 ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

Pravastatin‑GA 10 ED MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg

    (a)omit:

Pravastatin‑GA 20 ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

Pravastatin‑GA 20 ED MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg

    (a)omit:

Pravastatin‑GA 40 ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

Pravastatin‑GA 40 ED MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg

    (a)omit:

Pravastatin‑GA 80 ED MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)omit:

Pravastatin‑GA 80 ED MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

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

a APO-Quetiapine XR TX MP NP C4246 C5611 C5639 60 5 60

  1. Schedule 1, entry for Ramipril in the form Tablet 1.25 mg

    (a)omit:

APO-Ramipril TX MP NP 30 5 30

(b)omit:

Chem mart Ramipril CH MP NP 30 5 30

(c)omit:

Terry White Chemists Ramipril TW MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 2.5 mg

    omit:

Ramipril‑GA EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 5 mg

    omit:

Ramipril‑GA EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 10 mg

    omit:

Ramipril‑GA ED MP NP 30 5 30

  1. Schedule 1, entry for Rifabutin

    omit from the column headed “Circumstances”:          C1299  C1435  C3317  C3415     substitute:             C6349  C6350  C6356  C6361

  2. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

    (a)omit:

a Risperidone Actavis 0.5 ED MP NP C5902 C5903  C5911 C6010 P5902 P5911 P6010 60 2 60

(b)omit:

a Risperidone Actavis 0.5 ED MP NP C5902 C5903  C5911 C6010 P5903 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg

    (a)omit:

a Risperidone Actavis 1 ED MP NP C4246 C5898 C5907 C5916 C5993 P5898 P5916 P5993 60 2 60

(b)omit:

a Risperidone Actavis 1 ED MP NP C4246 C5898 C5907 C5916 C5993 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg

    (a)omit:

a Risperidone Actavis 2 ED MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60

(b)omit:

a Risperidone Actavis 2 ED MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

    omit:

a Risperidone Actavis 3 ED MP NP C4246 C5907 60 5 60

  1. Schedule 1, entry for Salbutamol in the form Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

    omit from the column headed “Circumstances”:          C1266   substitute:             C6367

  2. Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30; and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

(a)omit:

GenRx Salbutamol GX MP NP C1754 C1755 2 5 1

(b)omit from the column headed “Circumstances” (all instances):     C1754  C1755    substitute:             C6331  C6341

  1. Schedule 1, entry for Salmeterol

    omit from the column headed “Circumstances”:          C1752  C1753    substitute:             C6355

  2. Schedule 1, entry for Saxagliptin in each of the forms: Tablet 2.5 mg (as hydrochloride); and Tablet 5 mg (as hydrochloride)

    omit from the column headed “Circumstances”:          C5623  C5679    substitute:             C6346  C6363

  3. 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 “Circumstances”:          C5705  C5761  C5762    substitute:             C6333  C6335  C6344

  4. Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

    (a)omit:

GenRx Sertraline GX MP NP C4755 30 5 30

(b)omit:

Sertraline Actavis ED MP NP C4755 C6277 C6289 30 5 30

  1. Schedule 1, entry for Silver sulfadiazine

    omit from the column headed “Circumstances”:          C1386  C1865  C1866    substitute:             C6345  C6362

  2. Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg (as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)

    omit from the column headed “Circumstances”:          C5655  C5679    substitute:             C6346  C6363

  1. Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; and Tablet (modified release) containing 100 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride

    omit from the column headed “Circumstances”:          C5705  C5709  C5761    substitute:             C6333  C6334  C6344

  2. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

    omit:

Sumatriptan‑GA ED MP NP C5259 4 5 4

  1. Schedule 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate)

    omit:

Tamoxen 20 mg EA MP NP C5621 60 5 60

  1. Schedule 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg

    (a)omit:

Telmigen ED MP NP 28 5 28

(b)omit:

Telmisartan RBX RA MP NP 28 5 28

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

    (a)omit from the column headed “Brand”:               Mizart HCT 40/12.5       substitute:             Mizart HCT 40/12.5 mg

    (a)omit:

Telmigen HCT 40/12.5 ED MP NP C4374 28 5 28

(b)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

    (a)omit from the column headed “Brand”:               Mizart HCT 80/12.5       substitute:             Mizart HCT 80/12.5 mg

(b)omit:

Telmigen HCT 80/12.5 ED MP NP C4374 28 5 28

(c)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg

    (a)omit from the column headed “Brand”:               Mizart HCT 80/25          substitute:             Mizart HCT 80/25 mg

    (b)omit:

Telmigen HCT 80/25 ED MP NP C4374 28 5 28

(c)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Tiotropium in the form Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

    (a)omit from the column headed “Circumstances”:               C3883

    (b)insert in numerical order:       C6352

  2. Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)

    omit from the column headed “Responsible Person” for the brand “Hycamtin”:                 NV        substitute:             SZ

  3. Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

    omit:

GA Tramadol SR 150mg ED MP NP C5822 20 0 20

  1. Schedule 1, entry for Triglycerides—medium chain, formula in the form Oral powder 400 g (Peptamen Junior)

    omit from the column headed “Circumstances”:          C4660

  2. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

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

a APO-Valsartan HCTZ 80/12.5 TX MP NP C4374 28 5 28

(b)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg

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

a APO-Valsartan HCTZ 160/25 TX MP NP C4374 28 5 28

(b)insert in the column headed “Schedule Equivalent” for all brands:             a

  1. Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

    (a)omit:

Vancocin CP AS MP C5716 C5717 C5769 P5717 2 0 1
PDP C5801 2 0 1

(b)omit:

Vancocin CP AS MP C5716 C5717 C5769 P5716 P5769 5 0 1

  1. Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 75 mg (as hydrochloride)

    omit:

Venla RBX RA MP NP C5650 28 5 28

  1. Schedule 1, entry for Vildagliptin

    omit from the column headed “Circumstances”:          C4467   substitute:             C6346  C6363

  2. Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride

    omit from the column headed “Circumstances”:          C4308  C4423    substitute:             C6333  C6344  C6357

  3. Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

    omit from the column headed “Responsible Person” for the brand “Aclasta”:     NV        substitute:             HX

  1. Schedule 4, Part 1, entry for Beclomethasone

    substitute:

Beclomethasone C6348

Asthma

Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.

  1. Schedule 4, Part 1, entry for Bevacizumab

    insert in numerical order after existing text:

C6337

Advanced carcinoma of cervix

Initial treatment

Patient must have a Gynaecologic Oncology Group (GOG) performance status of 0 or 1; AND
The condition must not be amenable to curative treatment with surgery; OR

The condition must not be amenable to curative radiation therapy; AND

The condition must be previously untreated with this drug; AND

Patient must not have received prior chemotherapy; OR

Patient must have received prior chemotherapy with radiation therapy; AND

The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.

Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.

The patient's Gynaecologic Oncology Group (GOG) performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6337
C6338

Advanced carcinoma of cervix

Grandfathering treatment

Patient must have received non-PBS treatment with this drug for this condition prior to 1 September 2016; AND

Patient must not have progressive disease; AND

The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.

Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.

The patient's Gynaecologic Oncology Group (GOG) performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 6338
C6353

Advanced carcinoma of cervix

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease; AND

The treatment must be in combination with platinum-based chemotherapy plus paclitaxel.

Advanced carcinoma of the cervix is defined as persistent carcinoma, recurrent carcinoma or metastatic carcinoma of the cervix.

 Compliance with Authority Required procedures - Streamlined Authority Code 6353

  1. Schedule 4, Part 1, entry for Budesonide

    substitute:

Budesonide C6340

Severe chronic asthma

Patient must require long-term steroid therapy; AND

Patient must not be able to use other forms of inhaled steroid therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 6340

  1. Schedule 4, Part 1, entry for Calcipotriol with betamethasone

    (a)omit:

C3209 Chronic stable plaque type psoriasis vulgaris in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy

(b)insert in numerical order after existing text:

C6358

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled by calcipotriol; OR

The condition must be inadequately controlled by potent topical corticosteroid monotherapy.

  1. Schedule 4, Part 1, entry for Cyproterone

    (a)omit from the column headed “Circumstances Code”:     C5532

    (b)insert in the column headed “Purposes Code”:                 P5532

    (c)insert in the column headed “Conditions Code”:             CN5532

  2. Schedule 4, Part 1, entry for Dantrolene

    substitute:

Dantrolene C6359 Chronic spasticity

  1. Schedule 4, Part 1, entry for Eformoterol

    substitute:

Eformoterol C6355

Asthma

Patient must experience frequent episodes of the condition; AND

Patient must be currently receiving treatment with oral corticosteroids; OR

Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.

  1. Schedule 4, Part 1, after entry for Epoetin lambda

    insert:

Eprosartan P6328 CN6328 Drug interactions expected to occur with all of the base-priced drugs Compliance with Authority Required procedures
P6329 CN6329 Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance Compliance with Authority Required procedures
P6332 CN6332 Drug interactions occurring with all of the base-priced drugs Compliance with Authority Required procedures
P6351 CN6351 Adverse effects occurring with all of the base-priced drugs Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Exenatide

    insert in numerical order after existing text:

C6339

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6339
C6354

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR

The treatment must be in combination with a sulfonylurea; AND

Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR

Patient must not have tolerated a combination of metformin and a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6354

  1. Schedule 4, Part 1, entry for Indacaterol

    substitute:

Indacaterol C6366 Chronic obstructive pulmonary disease (COPD)

  1. Schedule 4, Part 1, entry for Ipratropium

    substitute:

Ipratropium C6331

Asthma

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.
C6341

Chronic obstructive pulmonary disease (COPD)

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.

  1. Schedule 4, Part 1, entry for Linagliptin

    substitute:

Linagliptin C6346

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6346
C6363

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6363

  1. Schedule 4, Part 1, entry for Linagliptin with metformin

    substitute:

Linagliptin with metformin C6333

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6333
C6336

Diabetes mellitus type 2

Continuing

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and linagliptin.

 Compliance with Authority Required procedures - Streamlined Authority Code 6336
C6344

Diabetes mellitus type 2

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea 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 6344

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

    insert:

Loperamide C6343 P6343 Diarrhoea Compliance with Authority Required procedures
C6364 P6364

Diarrhoea

Patient must identify as Aboriginal or Torres Strait Islander.

 Compliance with Authority Required procedures - Streamlined Authority Code 6364

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

    insert:

Olmesartan P6328 CN6328 Drug interactions expected to occur with all of the base-priced drugs Compliance with Authority Required procedures
P6329 CN6329 Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance Compliance with Authority Required procedures
P6332 CN6332 Drug interactions occurring with all of the base-priced drugs Compliance with Authority Required procedures
P6351 CN6351 Adverse effects occurring with all of the base-priced drugs Compliance with Authority Required procedures

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

    insert:

Pasireotide C6347

Acromegaly

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Patient must be aged 18 years or older.

In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.

Biochemical evidence of remission is defined as:

1) Growth hormone (GH) levels of less than 2.5 mcg/L; and

2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)

In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Rifabutin

    substitute:

Rifabutin C6349

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

Mycobacterium avium complex infection

Patient must be human immunodeficiency virus (HIV) positive.

 Compliance with Authority Required procedures
C6350

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

Mycobacterium avium complex infection

Patient must be human immunodeficiency virus (HIV) positive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6350
C6356

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures - Streamlined Authority Code 6356
C6361

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

Mycobacterium avium complex infection

The treatment must be for prophylaxis; AND

Patient must be human immunodeficiency virus (HIV) positive; AND

Patient must have CD4 cell counts of less than 75 per cubic millimetre.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Salbutamol

    substitute:

Salbutamol C6331

Asthma

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.
C6341

Chronic obstructive pulmonary disease (COPD)

Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.
C6367

Bronchospasm

Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.

  1. Schedule 4, Part 1, entry for Salmeterol

    substitute:

Salmeterol C6355

Asthma

Patient must experience frequent episodes of the condition; AND

Patient must be currently receiving treatment with oral corticosteroids; OR

Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.

  1. Schedule 4, Part 1, entry for Saxagliptin

    substitute:

Saxagliptin C6346

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6346
C6363

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6363

  1. Schedule 4, Part 1, entry for Saxagliptin with metformin

    substitute:

Saxagliptin with metformin C6333

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6333
C6335

Diabetes mellitus type 2

Continuing

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin.

 Compliance with Authority Required procedures - Streamlined Authority Code 6335
C6344

Diabetes mellitus type 2

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea 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 6344

  1. Schedule 4, Part 1, entry for Silver sulfadiazine

    substitute:

Silver sulfadiazine C6345 Stasis ulcers
C6362

Infection

Prevention and treatment

The condition must be in partial or full skin thickness loss due to burns; OR

The condition must be in partial or full skin thickness loss due to epidermolysis bullosa.

  1. Schedule 4, Part 1, entry for Sitagliptin

    substitute:

Sitagliptin C6346

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6346
C6363

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6363

  1. Schedule 4, Part 1, entry for Sitagliptin with metformin

    substitute:

Sitagliptin with metformin C6333

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6333
C6334

Diabetes mellitus type 2

Continuing

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin.

 Compliance with Authority Required procedures - Streamlined Authority Code 6334
C6344

Diabetes mellitus type 2

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea 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 6344

  1. Schedule 4, Part 1, entry for Tiotropium

    (a)omit:

C3883 Chronic obstructive pulmonary disease

(b)insert in numerical order after existing text:

C6352 Chronic obstructive pulmonary disease (COPD)

  1. Schedule 4, Part 1, entry for Vildagliptin

    substitute:

Vildagliptin C6346

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6346
C6363

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 6363

  1. Schedule 4, Part 1, entry for Vildagliptin with metformin

    substitute:

Vildagliptin with metformin C6333

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 6333
C6344

Diabetes mellitus type 2

The treatment must be in combination with a sulfonylurea; AND

Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR

Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.

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:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or

(b) Had red cell transfusion within the previous 3 months.

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 or a sulfonylurea 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 6344
C6357

Diabetes mellitus type 2

Continuing

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin.

 Compliance with Authority Required procedures - Streamlined Authority Code 6357

  1. Schedule 5, after entry for Hydroxocobalamin

    insert:

Macrogol 3350 GRP-17024 Powder for oral solution 510 g Oral OsmoLax
Sachets containing powder for oral solution 17 g, 30 Oral Herron ClearLax

  1. Schedule 5, entry for Olanzapine in the form Tablet 2.5 mg

    omit from the column headed “Brand”:       Olanzapine-GAOzin 2.5            substitute:             Ozin 2.5

  2. Schedule 5, entry for Olanzapine in each of the forms: Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

    omit from the column headed “Brand”:       Olanzapine-GA

  3. Schedule 5, entry for Ramipril in the form Capsule 10 mg

    omit from the column headed “Brand”:       Ramipril-GA

  4. Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

    omit from the column headed “Brand”:       Sumatriptan-GA

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