National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 10) (PB 101 of 2015) (Cth)

Case

PB 101 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 10)

National Health Act 1953

I, PAUL CREECH, First Assistant Secretary (Acting), 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    23 October 2015

PAUL CREECH
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2015 (No. 10).

(2)        This Instrument may also be cited as PB 101 of 2015.

2          Commencement

This Instrument commences on 1 November 2015.

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 Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

    omit from the column headed “Circumstances”:        C1314   substitute:             C5534

  2. Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid

    omit from the column headed “Circumstances”:        C1453   substitute:             C5533

  3. Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid

    insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain tryglycerides Oral powder 400 g (Alfamino Junior) Oral Alfamino Junior NT MP NP C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 8 5 1

  1. Schedule 1, entry for Amino acid formula without valine, leucine and isoleucine

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

  2. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 400 g (HCU Anamix infant)

    omit from the column headed “Circumstances”:        C1484   substitute:             C5559

  3. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine in each of the forms: Sachets containing oral powder 24 g, 30 (HCU gel); Sachets containing oral powder 25 g, 30 (HCU express 15); Oral powder 500 g (XMET Maxamaid); Oral powder 500 g (XMET Maxamum); Oral liquid 87 mL, 30 (HCU cooler 10); Oral liquid 125 mL, 30 (HCU Lophlex LQ 20); Oral liquid 130 mL, 30
    (HCU cooler 15); and Oral liquid 174 mL, 30 (HCU cooler 20)

    omit from the column headed “Circumstances”:        C1314   substitute:             C5534

  4. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine in each of the forms: Sachets containing oral powder 25 g, 30 (MMA/PA express 15); Sachets containing oral powder 24 g, 30 (MMA/PA gel); Oral powder 400 g (MMA/PA Anamix infant); Oral powder 500 g (XMTVI Maxamaid); Oral powder 500 g (XMTVI Maxamum); and Oral liquid
    130 mL, 30 (MMA/PA cooler 15)

    omit from the column headed “Circumstances”:        C1225  C1307    substitute:             C5542  C5560

  5. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in each of the forms: Sachets containing oral powder 24 g, 30 (TYR gel); Sachets containing oral powder 25 g, 30 (TYR express 15); and Sachets containing oral powder 29 g, 30 (TYR Anamix Junior)

    omit from the column headed “Circumstances”:        C1453   substitute:             C5533

  6. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in each of the forms: Oral powder 400 g (TYR Anamix infant); Oral powder 500 g (XPhen, Tyr Maxamaid); Oral powder 500 g (XPhen, Tyr Maxamum); Oral liquid 87 mL, 30 (TYR cooler 10); Oral liquid 125 mL, 30 (TYR Lophlex LQ 20); Oral liquid 130 mL, 30 (TYR cooler 15); and Oral liquid 174 mL, 30
    (TYR cooler 20)

    omit from the column headed “Circumstances”:        C1453   substitute:             C5533

  7. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in each of the forms: Sachets containing oral powder 24 g, 30 (MSUD gel); Sachets containing oral powder 25 g, 30 (MSUD express 15); Sachets containing oral powder 29 g, 30 (MSUD Anamix Junior); and Sachets containing oral powder 34 g, 30 (MSUD express 20)

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

  8. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in each of the forms: Oral powder 400 g (MSUD Anamix infant); Oral powder 500 g (MSUD AID III); Oral powder 500 g (MSUD Maxamaid); Oral powder 500 g
    (MSUD Maxamum); Oral liquid 87 mL, 30 (MSUD cooler 10); Oral liquid 125 mL, 30 (MSUD Lophlex LQ 20); Oral liquid 130 mL, 30 (MSUD cooler 15); and Oral liquid 174 mL, 30 (MSUD cooler 20)

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

  9. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

  10. Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

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

Blooms the Chemist Amlodipine IB MP NP 30 5 30

  1. Schedule 1, entry for Amylopectin, modified long chain

    omit from the column headed “Circumstances”:        C3081   substitute:             C5561

  1. Schedule 1, entry for Bacillus Calmette and Guerin, Connaught strain

    omit from the column headed “Circumstances”:        C1419   substitute:             C5578  C5598

  2. Schedule 1, entry for Bacillus Calmette and Guerin, Tice strain

    omit from the column headed “Circumstances”:        C1290   substitute:             C5540  C5597

  3. Schedule 1, entry for Ciprofloxacin in the form Ear drops 3 mg (as hydrochloride) per mL, 5 mL

    omit from the column headed “Circumstances”:        C2615  C3191  C3192    substitute:             C5535  C5551  C5593

  4. Schedule 1, entry for Cystine with carbohydrate

    omit from the column headed “Circumstances”:        C1314   substitute:             C5534

  5. Schedule 1, entry for Desferrioxamine in the form Powder for injection containing desferrioxamine mesylate 500 mg

    omit:

Desferal 500 mg NV MP C1085 C3340 400 5 10 D(100)

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 21; Number of Repeats: 0; Pack Quantity: 21]

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

Doxylin 100 AF MP NP P4485 21 0 21

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole GH GQ MP NP C4988 C5029 C5030 C5039 P4988 30 1 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole GH GQ MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 1]

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

Esomeprazole GH GQ MP NP C5011 C5021 C5028 P5028 30 1 30

  1. Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Esomeprazole GH GQ MP NP C5011 C5021 C5028 P5011 P5021 30 5 30

  1. Schedule 1, entry for Everolimus in the form Tablet 0.25 mg [Maximum Quantity: 60; Number of Repeats: 3]

    omit from the column headed “Circumstances”:        C2133  C2134    substitute:             C5566  C5579

  2. Schedule 1, entry for Everolimus in the form Tablet 0.25 mg [Maximum Quantity: 120; Number of Repeats: 5]

    omit from the column headed “Circumstances”:        C1650  C1651  C3355  C3356     substitute:             C5554  C5555  C5567  C5599

  3. Schedule 1, entry for Everolimus in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 3]

    omit from the column headed “Circumstances”:        C2133  C2134    substitute:             C5566  C5579

  4. Schedule 1, entry for Everolimus in the form Tablet 0.5 mg [Maximum Quantity: 120; Number of Repeats: 5]

    omit from the column headed “Circumstances”:        C1650  C1651  C3355  C3356     substitute:             C5554  C5555  C5567  C5599

  5. Schedule 1, entry for Everolimus in the form Tablet 0.75 mg [Maximum Quantity: 120; Number of Repeats: 3]

    omit from the column headed “Circumstances”:        C2133  C2134    substitute:             C5566  C5579

  6. Schedule 1, entry for Everolimus in the form Tablet 0.75 mg [Maximum Quantity: 240; Number of Repeats: 5]

    omit from the column headed “Circumstances”:        C1650  C1651  C3355  C3356     substitute:             C5554  C5555  C5567  C5599

  7. Schedule 1, entry for Everolimus in the form Tablet 1 mg [Maximum Quantity: 120; Number of Repeats: 3]

    omit from the column headed “Circumstances”:        C2133  C2134    substitute:             C5566  C5579

  8. Schedule 1, entry for Everolimus in the form Tablet 1 mg [Maximum Quantity: 240; Number of Repeats: 5]

    omit from the column headed “Circumstances”:        C1650  C1651  C3355  C3356     substitute:             C5554  C5555  C5567  C5599

  9. Schedule 1, entry for Ezetimibe

    omit from the column headed “Circumstances”:        C1989  C1991  C2438  C3724  C3725  C3726  C3727  C3728  C3729  C3730  C3731
    substitute:             C5537  C5538  C5543  C5544  C5562  C5563  C5575  C5576  C5577  C5586  C5594

  10. Schedule 1, entry for Flecainide in each of the forms: Tablet containing flecainide acetate 50 mg; and Tablet containing flecainide acetate 100 mg

    omit from the column headed “Circumstances” (all instances):             C1731  C1732    substitute:             C5550  C5584

  11. Schedule 1, entry for Glycomacropeptide and essential amino acids

    omit from the column headed “Circumstances”:        C1286   substitute:             C4295

  12. Schedule 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals in each of the forms: Bars 54 g, 7
    (Camino Pro Complete); and Bars 81 g, 7 (Camino Pro Complete)

    omit from the column headed “Circumstances”:        C1286   substitute:             C4295

  13. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Oral liquid 250 mL, 30 (PKU Glytactin RTD 15)

    insert in the columns in the order indicated:

Oral liquid 250 mL, 30 (Tylactin RTD) Oral Tylactin RTD QH MP NP C5533 4 5 1

  1. Schedule 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)

    omit from the column headed “Circumstances”:        C1286   substitute:             C4295

  2. Schedule 1, entry for Isoleucine with carbohydrate in each of the forms: Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50); and Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000)

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

  3. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 180;
    Number of Repeats: 5]

    insert in the column headed “Section 100/Prescriber Bag only”:         C(100)  

  4. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 180;
    Number of Repeats: 5]

    insert in the column headed “Section 100/Prescriber Bag only”:         C(100)  

  5. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 180;
    Number of Repeats: 5]

    insert in the column headed “Section 100/Prescriber Bag only”:         C(100)  

  6. Schedule 1, after entry for Losartan in the form Tablet containing losartan potassium 50 mg

    insert:

Lurasidone Tablet containing lurasidone hydrochloride 40 mg Oral Latuda SE MP NP C4246 30 5 30
Tablet containing lurasidone hydrochloride 80 mg Oral Latuda SE MP NP C4246 30 5 30

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

    omit:

Hospira Pty Limited HH MP 30 5 30

  1. Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg

    omit:

APO‑
Mycophenolate 		TX MP P1650 P1651 P3355 P3356 600
CN1650 CN1651 CN3355CN3356 		5
CN1650 CN1651 CN3355CN3356 		100 C(100)
CellCept RO MP P1650 P1651 P3355 P3356 600
CN1650 CN1651 CN3355CN3356 		5
CN1650 CN1651 CN3355CN3356 		100 C(100)
Ceptolate AF MP P1650 P1651 P3355 P3356 600
CN1650 CN1651 CN3355CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
Mycophenolate Sandoz SZ MP P1650 P1651 P3355 P3356 600
CN1650 CN1651 CN3355CN3356 		5
CN1650 CN1651 CN3355CN3356 		100 C(100)
Pharmacor Mycophenolate 250 CR MP P1650 P1651 P3355 P3356 600
CN1650 CN1651 CN3355CN3356 		5
CN1650 CN1651 CN3355CN3356 		100 C(100)

substitute:

APO-
Mycophenolate 		TX MP P5580 P5588 P5600 P5601 600
CN5580 CN5588 CN5600CN5601 		5
CN5580 CN5588 CN5600CN5601 		100 C(100)
CellCept RO MP P5580 P5588 P5600 P5601 600
CN5580 CN5588 CN5600CN5601 		5
CN5580 CN5588 CN5600CN5601 		100 C(100)
Ceptolate AF MP P5580 P5588 P5600 P5601 600
CN5580 CN5588 CN5600CN5601 		5
CN5580 CN5588 CN5600CN5601 		50 C(100)
Mycophenolate Sandoz SZ MP P5580 P5588 P5600 P5601 600
CN5580 CN5588 CN5600CN5601 		5
CN5580 CN5588 CN5600CN5601 		100 C(100)
Pharmacor Mycophenolate 250 CR MP P5580 P5588 P5600 P5601 600
CN5580 CN5588 CN5600CN5601 		5
CN5580 CN5588 CN5600CN5601 		100 C(100)

  1. Schedule 1, entry for Mycophenolic acid

    omit:

Tablet containing mycophenolate mofetil 500 mg Oral APO‑
Mycophenolate 		TX MP 150 5 50
CellCept RO MP 150 5 50
Ceptolate AF MP 150 5 50
Mycophenolate Sandoz SZ MP 150 5 50
Pharmacor Mycophenolate 500 CR MP 150 5 50
APO‑
Mycophenolate 		TX MP P1650 P1651 P3355 P3356 300
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
CellCept RO MP P1650 P1651 P3355 P3356 300
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
Ceptolate AF MP P1650 P1651 P3355 P3356 300
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
Mycophenolate Sandoz SZ MP P1650 P1651 P3355 P3356 300
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
Pharmacor Mycophenolate 500 CR MP P1650 P1651 P3355 P3356 300
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		50 C(100)
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL Oral CellCept RO MP 1 5 1
MP P1650 P1651 P3355 P3356 2
CN1650 CN1651 CN3355 CN3356 		5
CN1650 CN1651 CN3355CN3356 		1 C(100)

substitute:

Tablet containing mycophenolate mofetil 500 mg Oral APO-
Mycophenolate 		TX MP 150 5 50
CellCept RO MP 150 5 50
Ceptolate AF MP 150 5 50
Mycophenolate AN EA MP 150 5 50
Mycophenolate Sandoz SZ MP 150 5 50
Pharmacor Mycophenolate 500 CR MP 150 5 50
APO-
Mycophenolate 		TX MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
CellCept RO MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
Ceptolate AF MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
Mycophenolate AN EA MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
Mycophenolate Sandoz SZ MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
Pharmacor Mycophenolate 500 CR MP P5554 P5555 P5567 P5599 300
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		50 C(100)
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL Oral CellCept RO MP 1 5 1
MP P5554 P5555 P5567 P5599 2
CN5554 CN5555 CN5567 CN5599 		5
CN5554 CN5555 CN5567 CN5599 		1 C(100)

  1. Schedule 1, entry for Naproxen in the form Tablet 250 mg

    omit from the column headed “Responsible Person” for the brand “Naprosyn” (twice occurring):                RO          substitute:                IX

  2. Schedule 1, entry for Naproxen in the form Tablet containing naproxen sodium 550 mg

    (a)omit from the column headed “Responsible Person” for the brand “Anaprox 550” (twice occurring):                RO      substitute:             IX

    (b)omit from the column headed “Responsible Person” for the brand “Crysanal” (twice occurring):       MD         substitute:      IY

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

    omit from the column headed “Responsible Person” for the brand “Naprosyn” (twice occurring):                RO          substitute:                IX

  4. Schedule 1, entry for Naproxen in the form Tablet 750 mg (sustained release)

    (a)omit from the column headed “Responsible Person” for the brand “Naprosyn SR750” (twice occurring):         RO      substitute:             IX

    (b)omit from the column headed “Responsible Person” for the brand “Proxen SR 750” (twice occurring):            MD      substitute:             IY

  5. Schedule 1, entry for Naproxen in the form Tablet 1 g (sustained release)

    (a)omit from the column headed “Responsible Person” for the brand “Naprosyn SR1000” (twice occurring):      RO      substitute:             IX

    (b)omit from the column headed “Responsible Person” for the brand “Proxen SR 1000” (twice occurring):          MD      substitute:             IY

  1. Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

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

Ozin ODT 5 DO MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

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

Ozin ODT 10 DO MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating)

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

Olanzapine Sandoz ODT 15 SZ MP NP C1589 C2044 28 5 28

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

Ozin ODT 15 DO MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating)

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

Olanzapine Sandoz ODT 20 SZ MP NP C1589 C2044 28 5 28

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

Ozin ODT 20 DO MP NP C1589 C2044 28 5 28

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

    omit from the column headed “Brand” (twice occurring):         Pantoprazole generichealth       substitute:                Pantoprazole GH

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

    omit from the column headed “Brand”:         Pantoprazole generichealth       substitute:             Pantoprazole GH

  3. Schedule 1, entry for Perhexiline

    omit from the column headed “Circumstances”:        C1023   substitute:             C5592

  4. Schedule 1, entry for Phenylalanine with carbohydrate

    omit from the column headed “Circumstances”:        C1453   substitute:             C5533

  5. Schedule 1, entry for Pneumococcal Vaccine ─ Polyvalent

    omit from the column headed “Circumstances”:        C1282  C1284  C1385    substitute:             C5595  C5596

  6. Schedule 1, after entry for Pomalidomide in the form Capsule 4 mg

    insert:

Ponatinib Tablet 15 mg (as hydrochloride) Oral Iclusig TS MP C5549 C5572 C5573 C5574 C5589 P5572 C5589 60 2 60
MP C5549 C5572 C5573 C5574 C5589 P5549 C5573 C5574 60 5 60
Tablet 45 mg (as hydrochloride) Oral Iclusig TS MP C5549 C5572 C5573 C5574 C5589 P5572 C5589 30 2 30
MP C5549 C5572 C5573 C5574 C5589 P5549 C5573 C5574 30 5 30

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)

    (a)omit:

Rabeprazole RBX RA MP NP C1177 C1337 C1533 P1177 30 2 30

(b)omit:

Rabeprazole RBX RA MP NP C1177 C1337 C1533 P1337 P1533 30 5 30

  1. Schedule 1, entry for Raloxifene

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

Fixta 60 DO MP NP C4071 28 5 28

  1. Schedule 1, entry for Rifampicin in the form Capsule 300 mg [Maximum Quantity: 10; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C1190  C1297  C1303    substitute:             C5536  C5552  C5585

    (b)omit from the column headed “Purposes”:         P1297 P1303 substitute:P5536 P5585

  2. Schedule 1, entry for Rifampicin in the form Capsule 300 mg [Maximum Quantity: 100; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C1190  C1297  C1303    substitute:             C5536  C5552  C5585

    (b)omit from the column headed “Purposes”:         P1190   substitute:P5552

  3. Schedule 1, entry for Rifampicin in the form Capsule 150 mg [Maximum Quantity: 10; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C1190  C1297  C1303    substitute:             C5536  C5552  C5585

    (b)omit from the column headed “Purposes”:         P1297 P1303 substitute:P5536 P5585

  4. Schedule 1, entry for Rifampicin in the form Capsule 150 mg [Maximum Quantity: 100; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:             C1190  C1297  C1303    substitute:             C5536  C5552  C5585

    (b)omit from the column headed “Purposes”:         P1190   substitute:P5552

  5. Schedule 1, entry for Rifampicin in the form Syrup 100 mg per 5 mL, 60 mL

    omit from the column headed “Circumstances”:        C1297  C1303    substitute:             C5536  C5585

  6. Schedule 1, entry for Sevelamer [Maximum Quantity: 360; Number of Repeats: 5]

    insert in the column headed “Section 100/Prescriber Bag only”:         C(100)  

  7. Schedule 1, entry for Sirolimus

    substitute:

Sirolimus Tablet 0.5 mg Oral Rapamune PF MP 100 3 100
MP P5567 P5599 200
CN5567 CN5599 		5
CN5567 CN5599 		100 C(100)
Tablet 1 mg Oral Rapamune PF MP 100 3 100
MP P5567 P5599 200
CN5567 CN5599 		5
CN5567 CN5599 		100 C(100)
Tablet 2 mg Oral Rapamune PF MP 100 3 100
MP P5567 P5599 200
CN5567 CN5599 		5
CN5567 CN5599 		100 C(100)
Oral solution 1 mg per mL, 60 mL Oral Rapamune PF MP 1 3 1
MP P5567 P5599 2
CN5567 CN5599 		5
CN5567 CN5599 		1 C(100)

  1. Schedule 1, entry for Somatropin

    (a)omit:

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)

substitute:

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)

(b)omit:

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)

substitute:

Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)

(c)omit:

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5154 C5155 C5160 C5161 C5162 C5207 C5208 C5209 C5210 C5243 C5244 C5245 C5274 C5275 C5277 C5278 C5279 C5308 C5309 C5312 C5313 C5314 C5315 C5316 C5317 C5349 C5350 C5351 C5384 C5385 C5386 C5387 C5388 C5389 C5390 C5391 C5392 C5393 C5423 C5424 C5427 C5428 C5429 C5430 C5431 See Note 3 See Note 3 1 D(100)

substitute:

Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen Injection Norditropin FlexPro NO MP C5146 C5147 C5187 C5188 C5189 C5190 C5191 C5192 C5193 C5194 C5195 C5200 C5227 C5228 C5229 C5230 C5231 C5238 C5239 C5269 C5270 C5272 C5273 C5299 C5300 C5301 C5302 C5307 C5343 C5344 C5345 C5347 C5371 C5372 C5373 C5374 C5375 C5381 C5382 C5383 C5416 C5417 C5418 C5421 C5422 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Sucroferric oxyhydroxide [Maximum Quantity: 180; Number of Repeats: 5]

    insert in the column headed “Section 100/Prescriber Bag only”:         C(100)  

  2. Schedule 1, entry for Tacrolimus

    substitute:

Tacrolimus Capsule 0.5 mg Oral Pharmacor Tacrolimus 0.5 CR MP 100 3 100
Prograf LL MP 100 3 100
TACROLIMUS APOTEX TX MP 100 3 100
Tacrolimus Sandoz SZ MP 100 3 100
Pharmacor Tacrolimus 0.5 CR MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Prograf LL MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
TACROLIMUS APOTEX TX MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Tacrolimus Sandoz SZ MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Capsule 1 mg Oral Pharmacor Tacrolimus 1 CR MP 100 3 100
Prograf LL MP 100 3 100
TACROLIMUS APOTEX TX MP 100 3 100
Tacrolimus Sandoz SZ MP 100 3 100
Pharmacor Tacrolimus 1 CR MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Prograf LL MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
TACROLIMUS APOTEX TX MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Tacrolimus Sandoz SZ MP P5569 P5602 200
CN5569 CN5602 		5
CN5569 CN5602 		100 C(100)
Capsule 5 mg Oral Pharmacor Tacrolimus 5 CR MP 50 3 50
Prograf LL MP 50 3 50
TACROLIMUS APOTEX TX MP 50 3 50
Tacrolimus Sandoz SZ MP 50 3 50
Pharmacor Tacrolimus 5 CR MP P5569 P5602 100
CN5569 CN5602 		5
CN5569 CN5602 		50 C(100)
Prograf LL MP P5569 P5602 100
CN5569 CN5602 		5
CN5569 CN5602 		50 C(100)
TACROLIMUS APOTEX TX MP P5569 P5602 100
CN5569 CN5602 		5
CN5569 CN5602 		50 C(100)
Tacrolimus Sandoz SZ MP P5569 P5602 100
CN5569 CN5602 		5
CN5569 CN5602 		50 C(100)
Capsule 0.5 mg (once daily prolonged release) Oral Prograf XL LL MP 30 3 30
MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)
Capsule 1 mg (once daily prolonged release) Oral Prograf XL LL MP 60 3 60
MP P5569 P5602 120
CN5569 CN5602 		5
CN5569 CN5602 		60 C(100)
Capsule 5 mg (once daily prolonged release) Oral Prograf XL LL MP 30 3 30
MP P5569 P5602 60
CN5569 CN5602 		5
CN5569 CN5602 		30 C(100)

  1. Schedule 1, entry for Temozolomide in each of the forms: Capsule 5 mg; Capsule 20 mg; Capsule 100 mg; and Capsule 140 mg

    omit from the column headed “Responsible Person” for the brand “Astromide” (all instances):     ED          substitute:             FR

  2. Schedule 1, entry for Temozolomide in the form Capsule 180 mg

    omit from the column headed “Responsible Person” for the brand “Astromide” (twice occurring):   EA                substitute:             FR

  3. Schedule 1, entry for Temozolomide in the form Capsule 250 mg

    omit from the column headed “Responsible Person” for the brand “Astromide”:   ED          substitute:             FR

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

    insert in numerical order in the column headed “Circumstances”:       C5541

  5. Schedule 1, entry for Tyrosine with carbohydrate

    omit from the column headed “Circumstances”:        C1286   substitute:             C4295

  6. Schedule 1, entry for Valine with carbohydrate in each of the forms: Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50); and Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000)

    omit from the column headed “Circumstances”:        C1220   substitute:             C5571

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

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

Dilart HCT 80/12.5 AF MP NP C4374 28 5 28

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg

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

Dilart HCT 160/12.5 AF MP NP C4374 28 5 28

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

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

Dilart HCT 160/25 AF MP NP C4374 28 5 28

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg

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

Dilart HCT 320/12.5 AF MP NP C4361 28 5 28

  1. Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg

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

Dilart HCT 320/25 AF MP NP C4361 28 5 28

  1. Schedule 3, after details relevant to Responsible Person code IX

    insert:

IY Clinect Pty Ltd  76 150 558 473

  1. Schedule 3

    omit:

MD Roche Products Pty Ltd  70 000 132 865

  1. Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

    substitute:

Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid C5534 Pyridoxine non-responsive homocystinuria

  1. Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid

    substitute:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid C5533 Tyrosinaemia

  1. Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid

    insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides C4305

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae

Initial treatment for up to 6 months

The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4312

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein

Initial treatment for up to 6 months

Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4323

Cows' milk protein enteropathy

Initial treatment for up to 6 months

The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4330

Cows' milk anaphylaxis

Patient must be up to the age of 24 months.
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4337

Cows' milk protein enteropathy

Continuing treatment

The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures
C4338

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae

Continuing treatment

The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4339

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein

Continuing treatment

Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4345

Severe cows' milk protein enteropathy with failure to thrive

Continuing treatment

The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4352

Severe cows' milk protein enteropathy with failure to thrive

Initial treatment for up to 6 months

The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist and the date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C4415

Severe intestinal malabsorption including short bowel syndrome

Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Amino acid formula without phenylalanine

    insert:

Amino acid formula without valine, leucine and isoleucine C5571 Maple syrup urine disease

  1. Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without methionine

    substitute:

Amino acid formula with vitamins and minerals without methionine C5534 Pyridoxine non-responsive homocystinuria
C5559

Pyridoxine non-responsive homocystinuria

Patient must be an infant or a very young child.

  1. Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

    substitute:

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine C5542 Propionic acidaemia
C5560 Methylmalonic acidaemia

  1. Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

    (a)omit:

C1453 Tyrosinaemia

(b)insert in numerical order after existing text:

C5533 Tyrosinaemia

  1. Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

    (a)omit:

C1220 Maple syrup urine disease

(b)insert in numerical order after existing text:

C5571 Maple syrup urine disease

  1. Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

    substitute:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid C5571 Maple syrup urine disease

  1. Schedule 4, Part 1, entry for Amylopectin, modified long chain

    substitute:

Amylopectin, modified long chain C5561 Glycogen storage disease

  1. Schedule 4, Part 1, entry for Bacillus Calmette and Guerin, Connaught strain

    substitute:

Bacillus Calmette and Guerin, Connaught strain C5578 Carcinoma in situ of the urinary bladder
C5598 Carcinoma in situ of the urinary bladder

  1. Schedule 4, Part 1, entry for Bacillus Calmette and Guerin, Tice strain

    substitute:

Bacillus Calmette and Guerin, Tice strain C5540 Primary and relapsing superficial urothelial carcinoma of the bladder
C5597 Primary and relapsing superficial urothelial carcinoma of the bladder

  1. Schedule 4, Part 1, entry for Ciprofloxacin

    (a)omit:

C2615 Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older Compliance with Authority Required procedures
C3191 Treatment of chronic suppurative otitis media in a patient less than 18 years of age with perforation of the tympanic membrane Compliance with Authority Required procedures
C3192 Treatment of chronic suppurative otitis media in a patient less than 18 years of age with a grommet in situ Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C5535

Chronic suppurative otitis media

Patient must have a grommet in situ.
Patient must be less than 18 years of age.

 Compliance with Authority Required procedures
C5551

Chronic suppurative otitis media

Patient must have perforation of the tympanic membrane.
Patient must be less than 18 years of age.

 Compliance with Authority Required procedures
C5593

Chronic suppurative otitis media

Patient must be an Aboriginal or a Torres Strait Islander person; AND
Patient must be aged 1 month or older.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Cystine with carbohydrate

    substitute:

Cystine with carbohydrate C5534 Pyridoxine non-responsive homocystinuria

  1. Schedule 4, Part 1, entry for Everolimus

    (a)omit:

C1650

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures
C1651

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures
C2133 Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application Compliance with Authority Required procedures
C2134 Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application Compliance with Authority Required procedures
C3355

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3355
C3356

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3356

(b)insert in numerical order after existing text:

C5554

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

Management of cardiac allograft rejection

Management (initiation, stabilisation and review of therapy)

Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5554
C5555

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

Management of cardiac allograft rejection

Management (initiation, stabilisation and review of therapy)

Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures
C5566

Maintenance of renal transplant

Maintenance therapy (following initiation and stabilisation of treatment with everolimus)

Patient must have undergone a renal transplant; AND
The treatment must be under the supervision and direction of a transplant unit.
The name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application.

 Compliance with Authority Required procedures
C5567

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

Management of renal allograft rejection

Management (initiation, stabilisation and review of therapy)

Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures
C5579

Maintenance of cardiac transplant

Maintenance therapy (following initiation and stabilisation of treatment with everolimus)

Patient must have undergone a cardiac transplant; AND
The treatment must be under the supervision and direction of a transplant unit.
The name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application.

 Compliance with Authority Required procedures
C5599

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

Management of renal allograft rejection

Management (initiation, stabilisation and review of therapy)

The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599

  1. Schedule 4, Part 1, entry for Ezetimibe

    substitute:

Ezetimibe C5537

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5537
C5538

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have peripheral vascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5538
C5543

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have diabetes mellitus.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5543
C5544

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have heterozygous familial hypercholesterolaemia.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5544
C5562

Hypercholesterolaemia

Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; OR
Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of the statin treatment.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.

 Compliance with Authority Required procedures - Streamlined Authority Code 5562
C5563 Homozygous sitosterolaemia Compliance with Authority Required procedures - Streamlined Authority Code 5563
C5575

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have hypertension.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5575
C5576

Hypercholesterolaemia

Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND
Patient must be one in whom treatment with an HMG CoA reductase inhibitor (statin) is contraindicated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5576
C5577

Hypercholesterolaemia

Patient must have homozygous familial hypercholesterolaemia; AND
Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin).

 Compliance with Authority Required procedures - Streamlined Authority Code 5577
C5586

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have a family history of coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5586
C5594

Hypercholesterolaemia

The treatment must be in conjunction with dietary therapy and exercise; AND
The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND
Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND
Patient must have symptomatic cerebrovascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated.

 Compliance with Authority Required procedures - Streamlined Authority Code 5594

  1. Schedule 4, Part 1, entry for Flecainide

    substitute:

Flecainide C5550 Serious ventricular cardiac arrhythmias
The treatment must be initiated in a hospital.
C5584 Serious supra-ventricular cardiac arrhythmias

  1. Schedule 4, Part 1, entry for Glycomacropeptide and essential amino acids

    substitute:

Glycomacropeptide and essential amino acids C4295 Phenylketonuria

  1. Schedule 4, Part 1, entry for Glycomacropeptide and essential amino acids with vitamins and minerals

    (a)omit:

C1286 Phenylketonuria

substitute:

C4295 Phenylketonuria

(b)insert in numerical order after existing text

C5533 Tyrosinaemia

  1. Schedule 4, Part 1, entry for Isoleucine with carbohydrate

    substitute:

Isoleucine with carbohydrate C5571 Maple syrup urine disease

  1. Schedule 4, Part 1, after entry for Lopinavir with Ritonavir

    insert:

Lurasidone C4246 Schizophrenia

 Compliance with Authority Required procedures - Streamlined Authority Code 4246

  1. Schedule 4, Part 1, entry for Mycophenolic Acid

    (a)omit:

P1650 CN1650

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures
P1651 CN1651

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures
P3355 CN3355

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3355
P3356 CN3356

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

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection, where management includes initiation, stabilisation and review of therapy as required

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3356

(b)insert in numerical order after existing text:

P5554 CN5554

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

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5554
P5555 CN5555

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

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures
P5567 CN5567

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures
P5580 CN5580

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5580
P5588 CN5588

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures
P5599 CN5599

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599
P5600 CN5600

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

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5600
P5601 CN5601

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

Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Perhexiline

    substitute:

Perhexiline C5592

Angina

The condition must not be responding to other therapy.

 Compliance with Authority Required procedures - Streamlined Authority Code 5592

  1. Schedule 4, Part 1, entry for Phenylalanine with carbohydrate

    substitute:

Phenylalanine with carbohydrate C5533 Tyrosinaemia

  1. Schedule 4, Part 1, entry for Pneumococcal Vaccine ‑ Polyvalent

    substitute:

Pneumococcal vaccine - polyvalent C5595

Prophylaxis of pneumococcal infection

Patient must have undergone a splenectomy.
Patient must be aged 2 years or older.
C5596

Prophylaxis of pneumococcal infection

Patient must have Hodgkin's disease; OR
Patient must have a high risk of contracting pneumococcal infections.

  1. Schedule 4, Part 1, after entry for Polyvinyl Alcohol

    insert:

Ponatinib C5549 P5549

Chronic Myeloid Leukaemia (CML)

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have demonstrated either a major cytogenetic response, or less than 1% BCR-ABL level in the blood, to ponatinib within 18 months of commencement and at no greater than 12 month intervals thereafter.
Applications for authorisation must be in writing and must include:
1. a completed authority prescription form; and
2. a completed Chronic Myeloid Leukaemia Continuing PBS authority application Supporting information form; and
3. demonstration of continued response to treatment as evidenced by either:
(a) major cytogenetic response [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. Where this has been supplied within the previous 12 months (or 18 months for the initial supply), only the date of the relevant pathology report needs to be provided.

 Compliance with Written Authority Required procedures
C5572 P5572

Acute lymphoblastic leukaemia

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must be expressing the T315I mutation; AND
Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor; AND
Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate).
Failure of treatment is defined as either:
1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor;
2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;
3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.
Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.
The authority application must be made in writing and must include:
1. a completed authority prescription form; and
2. a completed Acute Lymphoblastic Leukaemia - ponatinib Initial PBS authority application form; and
3. a signed patient acknowledgement; and
4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript.; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided

 Compliance with Written Authority Required procedures
C5573 P5573

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have failed an adequate trial of dasatinib; OR
Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND
Patient must have failed an adequate trial of nilotinib; OR
Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR
Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis.
Failure of an adequate trial of dasatinib or nilotinib is defined as:
1. Lack of response to dasatinib or nilotinib therapy, defined as either:
(i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or
(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR
2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR
3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR
4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR
5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.
Accelerated phase is defined by the presence of 1 or more of the following:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
3. Peripheral basophils greater than or equal to 20%; or
4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).
Blast crisis is defined as either:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
2. Extramedullary involvement other than spleen and liver.
The authority application must be made in writing and must include:
1. a completed authority prescription form;
2. a completed Chronic Myeloid Leukaemia - ponatinib Initial PBS authority application form;
3. a signed patient acknowledgement;
4. a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale. (The date of the relevant pathology report, which should be within the previous 6 months, needs to be provided); and
5. where there has been a loss of response to dasatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

 Compliance with Written Authority Required procedures
C5574 P5574

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must be expressing the T315I mutation; AND
Patient must have failed an adequate trial of imatinib; OR
Patient must have failed an adequate trial of dasatinib; OR
Patient must have failed an adequate trial of nilotinib.
Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as:
1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either:
(i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or
(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR
2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR
3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR
4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR
5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.
Accelerated phase is defined by the presence of 1 or more of the following:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
3. Peripheral basophils greater than or equal to 20%; or
4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).
Blast crisis is defined as either:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
2. Extramedullary involvement other than spleen and liver.
The authority application must be made in writing and must include:
1. a completed authority prescription form; and
2. a completed Chronic Myeloid Leukaemia - ponatinib Initial PBS authority application form; and
3. a signed patient acknowledgement; and
4. a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale and evidence of the T315I mutation. (The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided); and
5. where there has been a loss of response to imatinib or dasatinib or nilotinib, a copy of the current confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

 Compliance with Written Authority Required procedures
C5589 P5589

Acute lymphoblastic leukaemia

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have progressive disease.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Rifampicin

    substitute:

Rifampicin C5536 P5536

Meningococcal disease

The treatment must be for prophylaxis; AND
Patient must be a carrier of the disease; OR
Patient must be in close contact with people who have the disease.
C5552 P5552

Leprosy

Patient must be an adult.

 Compliance with Authority Required procedures
C5585 P5585

Haemophilus influenzae type B

The treatment must be for prophylaxis; AND
Patient must be in contact with people who have the disease.

  1. Schedule 4, Part 1, entry for Sirolimus

    substitute:

Sirolimus P5567 CN5567

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit.

 Compliance with Written or Telephone Authority Required procedures
P5599 CN5599

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

Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5599

(j)omit:

C5423

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth

Initial treatment

Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome , hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must be male, have a chronological age of at least 12 years and a growth velocity above the 25th percentile for bone age and sex measured over a 6 month interval; OR
Patient must be male, have a bone age of at least 10 years and a growth velocity above the 25th percentile for bone age and sex measured over a 6 month interval; OR
Patient must be female, have a chronological age of at least 10 years and a growth velocity above the 25th percentile for bone age and sex measured over a 6 month interval; OR
Patient must be female, have a bone age of at least 8 years and a growth velocity above the 25th percentile for bone age and sex measured over a 6 month interval; OR
Patient must have a growth velocity above the 25th percentile for bone age and sex measured over both 12 and 6 month intervals; OR
Patient must have a bone age of 2.5 years or less and an annual growth velocity of greater than 8 cm per year; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
8. Confirmation that the patient has hypothalamic obesity; AND
9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced

 Compliance with Written Authority Required procedures
C5424

Short stature associated with Turner syndrome

Initial treatment

Patient must have a current height at or below the 95th percentile for age on the Turner syndrome growth curve for girls; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a bone age of 2.5 years or less; AND
Patient must not have a height greater than or equal to 155.0cm; AND
Patient must not have a bone age of 13.5 years or greater.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written

 Compliance with Written Authority Required procedures
C5427

Growth retardation secondary to an intracranial lesion, or cranial irradiation

Recommencement of treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written

 Compliance with Written Authority Required procedures
C5428

Short stature associated with chronic renal insufficiency

Recommencement of treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2 ; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2 prescribers should seek reclassification to the indication short stature and slow growth

 Compliance with Written Authority Required procedures
C5429

Growth retardation secondary to an intracranial lesion, or cranial irradiation

Recommencement of treatment as a reclassified patient

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
Patient must have had an intracranial lesion and have undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
Patient must have had an intracranial lesion, have received medical advice that it is unsafe to treat the intracranial lesion, and have undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and have undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome , hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10mU/L in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
Patient must be male, had a chronological age of at least 12 years at commencement of growth hormone treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 6 month interval immediately prior to commencement of growth hormone treatment; OR
Patient must be male, had a bone age of at least 10 years at commencement of growth hormone treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 6 month interval immediately prior to commencement of growth hormone treatment; OR
Patient must be female, had a chronological age of at least 10 years at commencement of growth hormone treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 6 month interval immediately prior to commencement of growth hormone treatment; OR
Patient must be female, had a bone age of at least 8 years at commencement of growth hormone treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 6 month interval immediately prior to commencement of growth hormone treatment; OR
Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over both the 12 month and 6 month interval immediately prior to commencement of growth hormone treatment; OR
Patient must have had a bone age of 2.5 years or less at commencement of growth hormone treatment and an annual growth velocity of 8cm per year or less in the 12 month period immediately prior to commencement of growth hormone treatment; AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight) from immediately prior to commencement of growth hormone treatment, at intervals no greater than six months, and a bone age result performed within the 12 months immediately prior to commencement of growth hormone treatment; OR
(b) If the patient was an older child (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over) at the time of commencement of growth hormone treatment, a minimum of 6 months of growth data (height and weight) from immediately prior to commencement of growth hormone treatment, and a bone age result performed within the 12 months immediately prior to commencement of growth hormone treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion and has undergone a 12 month period of observation following completion of treatment for the intracranial lesion (all treatment); OR
(b) Confirmation that the patient has had an intracranial lesion, has received medical advice that it is unsafe to treat the intracranial lesion, and has undergone a 12 month period of observation since initial diagnosis of the intracranial lesion; OR
(c) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion, and has undergone a 12 month period of observation following completion of treatment for the condition for which cranial irradiation was received; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written

 Compliance with Written Authority Required procedures
C5430

Short stature and slow growth

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written

 Compliance with Written Authority Required procedures
C5431

Short stature associated with biochemical growth hormone deficiency

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have diabetes mellitus; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written

 Compliance with Written Authority Required procedures

  1. Schedule 4, Part 1, entry for Tacrolimus

    substitute:

Tacrolimus P5569 CN5569

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

Management of rejection in patients following organ or tissue transplantation

The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5569
P5602 CN5602

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

Management of rejection in patients following organ or tissue transplantation

The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Triglycerides — medium chain, formula

    insert in numerical order after existing text:

C5541

Dietary management of conditions requiring a source of medium chain triglycerides

Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders.

  1. Schedule 4, Part 1, entry for Tyrosine with carbohydrate

    substitute:

Tyrosine with carbohydrate C4295 Phenylketonuria

  1. Schedule 4, Part 1, entry for Valine with carbohydrate

    substitute:

Valine with carbohydrate C5571 Maple syrup urine disease
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