National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 2) (PB 10 of 2015) (Cth)

Case

PB 10 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 2)

National Health Act 1953

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

Dated 23rd February 2015

FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2015 (No. 2).

(2)        This Instrument may also be cited as PB 10 of 2015.

2          Commencement

This Instrument commences on 1 March 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 Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

    (a)omit:

GenRx Amoxycillin and Clavulanic Acid GX PDP C1836 C1837 10 0 10

(b)omit:

GenRx Amoxycillin and Clavulanic Acid GX MP NP C1836 C1837 10 1 10

  1. Schedule 1, entry for Anastrozole

    omit from the column headed “Circumstances” (all instances):           C2213   substitute:          C4795

  2. Schedule 1, after entry for Aripiprazole in the form Tablet 30 mg

    insert in the columns in the order indicated:

Powder for injection 300 mg (as monohydrate) with diluent Injection Abilify Maintena LU MP NP C4246 1 5 1
Powder for injection 400 mg (as monohydrate) with diluent Injection Abilify Maintena LU MP NP C4246 1 5 1

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

    omit from the column headed “Circumstances”:       C4598   substitute:             C4814

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

    (a)omit all codes from the column headed “Circumstances” for the brands “Capecitabine Actavis” and “Capecitabine Alphapharm”

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

Capecitabine AN EA MP 60 2 60

(c)omit all codes from the column headed “Circumstances” for the brands “Capecitabine-DRLA”; “Capecitabine Sandoz”; “Xelabine”; and “Xeloda”

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

    (a)omit all codes from the column headed “Circumstances” for the brands “Capecitabine Actavis” and “Capecitabine Alphapharm”

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

Capecitabine AN EA MP 120 2 120

(c)omit all codes from the column headed “Circumstances” for the brands “Capecitabine Apotex”; “Capecitabine-DRLA”; “Capecitabine GH”; “Capecitabine Sandoz”; “Xelabine”; and “Xeloda”

  1. Schedule 1, entry for Cefalotin

    (a)omit:

Cefalotin Sandoz SZ PDP 10 0 10

(b)omit:

Cefalotin Sandoz SZ MP NP 10 1 10

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

    omit from the column headed “Brand”:      Hospira Pty Limited      substitute:             Hospira Cefazolin Sodium

  2. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

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

Plidogrel FM MP NP C1719 C1720 C1721 C1722 C1723 C1724 C4165 C4166 28 5 28

  1. Schedule 1, after entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL

    insert:

Coal tar Foam 20 mg per g, 100 g Application Scytera RZ MP NP 1 2 1

  1. Schedule 1, entry for Dorzolamide with timolol

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

Cosdor QA MP C4343 1 5 1
AO C4326 1 5 1

  1. Schedule 1, entry for Escitalopram

    omit:

Oral solution 10 mg (as oxalate) per mL, 28 mL Oral Lexapro LU MP NP C4680 C4681 C4707 C4721 C4747 1 5 1

  1. Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 2]

    (a)omit from the column headed “Circumstances”:           C4557  

    (b)insert in numerical order:       C4812

  2. Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 5]

    (a)omit from the column headed “Circumstances”:           C4557

    (b)insert in numerical order:       C4812

    (c)omit from the column headed “Purposes”:      P4557

    (d)insert in numerical order:       P4812

  3. Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats 2]

    (a)omit from the column headed “Circumstances”:           C4557  

    (b)insert in numerical order:       C4812

  4. Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats 5]

    (a)omit from the column headed “Circumstances”:           C4557

    (b)insert in numerical order:       C4812

    (c)omit from the column headed “Purposes”:      P4557

    (d)insert in numerical order:       P4812

  5. Schedule 1, entry for Exemestane

    (a)omit from the column headed “Circumstances” for Authorised Prescriber “MP” (all instances):      C1541 C2457  C4552   
    substitute:  C4796  C4802  C4808

    (b)omit from the column headed “Circumstances” for Authorised Prescriber “NP” (all instances):       C1541 C2457 
    substitute:  C4802  C4808

  6. Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (Glucoflex-R)

    insert in the columns in the order indicated:

Test strips, 50 (GluNEO) For external use GluNEO IF MP NP 2 5 1
MP P4241 2 11 1
Test strips, 50 (Healthpro) For external use Healthpro IF MP NP 2 5 1
MP P4241 2 11 1

  1. Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour next)

    insert in the columns in the order indicated:

Test strips, 100 (Dario) For external use Dario UH MP NP 1 5 1
MP P4241 1 11 1

  1. Schedule 1, entry for Goserelin in the form Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe

    omit from the column headed “Circumstances”:       C1377  C1871  C1872  C3228     substitute:             C4799  C4800  C4806  C4807

  2. Schedule 1, entry for Latanoprost

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

Xalaprost QA MP AO 1 5 1

  1. Schedule 1, entry for Latanoprost with timolol

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

Xalamol 50/5 QA MP C4343 1 5 1
AO C4326 1 5 1

  1. Schedule 1, entry for Letrozole

    omit from the column headed “Circumstances” (all instances):           C1608  C2691  C2692    substitute:             C4795  C4801

  2. Schedule 1, entry for Levidopa with Carbidopa in the form Tablet 250 mg-25 mg (anhydrous)

    omit:

Levo/Carbidopa Sandoz SZ MP NP 100 5 100

  1. Schedule 1, entry for Megestrol

    omit from the column headed “Circumstances”:       C1543

  2. Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg

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

Memantine RBX RA MP NP C4214 C4218 C4221 56 5 56

  1. Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 20 mg

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

Memantine RBX RA MP NP C4214 C4218 C4221 28 5 28

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

    insert in the columns in the order indicated:

Oral suspension 20 mg per mL, 100 mL Oral Allmercap LM MP 1 2 1

  1. Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

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

APO-Metformin XR 1000 TX MP NP 60 5 60

  1. Schedule 1, after entry for Peginterferon Alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe

    insert:

Peginterferon beta-1a Pack containing single use injection pens containing 63 micrograms in 0.5 mL and 94 micrograms in 0.5 mL Injection Plegridy BD MP C4798 1 0 1
Single use injection pen containing 125 micrograms in 0.5 mL Injection Plegridy BD MP C4798 C4811 P4798 2 4 2
MP C4798 C4811 P4811 2 5 2

  1. Schedule 1, after entry for Phenytoin in the form Oral suspension 30 mg per 5 mL, 500 mL

    insert:

Phytomenadione Injection 10 mg in 1 mL Injection/oral Konakion MM RO See Note 4 See Note 4 See Note 4 5 D(MP)

  1. Schedule 1, entry for Ranibizumab

    (a)omit from the column headed “Form”:   Solution for intravitreal injection 1.65 mg in 0.165 mL      
    substitute:                       Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe

    (b)omit from the column headed “Circumstances”:           C4607  C4640    substitute:         C4803  C4804

  2. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL

    omit from the column headed “Circumstances”:       C4607  C4640    substitute:             C4803  C4804

  3. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):       
    C4238  C4248

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):       
    P4248

    (c)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):        
    C4248

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

(e)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):   
C4238  C4248

(f)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):       
P4248

(g)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):    
C4248

(h)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238  C4248

(i)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):   
P4248

(j)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4248

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”:   C4238  C4248

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”:             P4238

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

(d)omit from the column headed “Purposes” for the brand “Cavstat”:             P4228 P4248 substitute:             P4225 P4238

(e)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”:        C4238  C4248

(f)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”:  P4238

(g)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:      C4238  C4248

(h)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”:                     P4238

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    C4238  C4248

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    P4248

    (c)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):              
    C4248

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

(e)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):   
C4238  C4248

(f)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):             
P4248

(g)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):    
C4248

(h)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238  C4248

(i)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):   
P4248

(j)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4248

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”:   C4238  C4248

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”:             P4238

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

(d)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”:        C4238  C4248

(e)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”:  P4238

(f)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:      C4238  C4248

(g)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”:                     P4238

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    C4238  C4259

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    P4259

    (c)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):              
    C4259

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4227 C4238 C4259 P4227 P4259 30 5 30
NP C4227 C4259 30 5 30

(e)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):   
C4238  C4259

(f)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):             
P4259

(g)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):    
C4259

(h)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):
C4238  C4259

(i)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):   
P4259

(j)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):
C4259

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”:   C4238  C4259

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”:             P4238

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4227 C4238 C4259 P4225 P4238 30 11 30

(d)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”:        C4238  C4259

(e)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”:  P4238

(f)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:      C4238  C4259

(g)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”:                     P4238

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    C4238  C4263

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin” (Authorised Prescriber “MP”):             
    P4263

    (c)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin” (Authorised Prescriber “NP”):              
    C4263

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

(e)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):   
C4238  C4263

(f)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “MP”):             

P4263

(g)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin” (Authorised Prescriber “NP”):    
C4263

(h)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):            
C4238  C4263

(i)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “MP”):   
P4263

(j)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” (Authorised Prescriber “NP”):             
C4263

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (a)insert in numerical order the column headed “Circumstances” for the brand “APO-Rosuvastatin”:   C4238  C4263

    (b)insert in numerical order the column headed “Purposes” for the brand “APO-Rosuvastatin”:             P4238

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

Blooms the Chemist Rosuvastatin IB MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

(d)insert in numerical order the column headed “Circumstances” for the brand “Chem mart Rosuvastatin”:        C4238  C4263

(e)insert in numerical order the column headed “Purposes” for the brand “Chem mart Rosuvastatin”:  P4238

(f)insert in numerical order the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:      C4238  C4263

(g)insert in numerical order the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin”:                     P4238

  1. Schedule 1, entry for Testosterone in each of the forms: Capsule containing testosterone undecanoate 40 mg; Injection containing testosterone enanthate 250 mg in 1 mL; I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL; Transdermal gel 50 mg in 5 g sachet, 30; Transdermal patches 12.2 mg, 60; Transdermal patches 24.3 mg, 30; and Transdermal solution (pump pack) 30 mg per
    1.5 mL dose, 60 doses

    omit from the column headed “Circumstances”:       C1021  C1022  C1226    substitute:             C4815  C4816  C4817  C4818  C4819

  2. Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

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

Topiramate AN EA MP NP C2797 C2799 60 5 60

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

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

Topiramate AN EA MP NP C2797 60 5 60

  1. Schedule 1, entry for Toremifene

    omit from the column headed “Circumstances”:       C1750

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

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

Blooms the Chemist Venlafaxine XR IB MP NP C1211 28 5 28

  1. Schedule 1, entry for Vinorelbine in each of the forms: Solution for I.V. infusion 10 mg (as tartrate) in 1 mL; and Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

    omit from the column headed “Circumstances” (all instances):               C3890  C3907

  2. Schedule 3, after details relevant to Responsible Person code IB

    insert:

IF Infopia Australia Pty Ltd  65 166 458 751

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

    insert:

UH uHealth Australia Pty Limited  86 159 107 258

  1. Schedule 4, Part 1, entry for Anastrozole

    substitute:

Anastrozole C4795

Breast cancer

The condition must be hormone receptor positive

Patient must not be pre-menopausal

  1. Schedule 4, Part 1, entry for Aripiprazole

    insert in numerical order following existing text:

C4246 Schizophrenia Compliance with Authority Required procedures –  Streamlined Authority Code 4246

  1. Schedule 4, Part 1, entry for Bevacizumab

    omit:

C4598

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

 Compliance with Authority Required procedures –  Streamlined Authority Code 4598

substitute:

C4814

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm) only if the patient presents with Stage IIIB or Stage IIIC disease; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4814

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

  2. Schedule 4, Part 1, entry for Everolimus

    (a)omit:

C4557 P4557

Metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane

Patient must be female; AND
Patient must be post-menopausal

 Compliance with Authority Required procedures

(b)insert in numerical order following existing text:

C4812 P4812

Metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND
The treatment must be in combination with exemestane

Patient must not be pre-menopausal

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Exemestane

    substitute:

Exemestane C4796

Metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
Patient must be receiving PBS-subsidised everolimus concomitantly for this condition

Patient must not be pre-menopausal
C4802

Advanced breast cancer

The condition must be hormone receptor positive; AND
The condition must have progressed following treatment with tamoxifen

Patient must not be pre-menopausal
C4808

Early breast cancer

The condition must be hormone receptor positive; AND
The condition must have previously been treated with tamoxifen for a minimum of 2 years

Patient must not be pre-menopausal

  1. Schedule 4, Part 1, entry for Goserelin

    (a)omit:

C1377 Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months’ uninterrupted therapy Compliance with Authority Required procedures
C1871 Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate Compliance with Authority Required procedures
C1872 Hormone‑dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre‑menopausal women Compliance with Authority Required procedures
C3228 Hormone‑dependent breast cancer as an alternative to adjuvant chemotherapy in peri‑ or pre‑menopausal women. Compliance with Authority Required procedures

(b)insert in numerical order following existing text:

C4799

Endometriosis

The condition must be visually proven; AND
The treatment must be for the short-term (up to 6 months

 Compliance with Authority Required procedures
C4800

Locally advanced (Stage III) or metastatic (Stage IV) breast cancer

The condition must be hormone receptor positive

 Compliance with Authority Required procedures
C4806 Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate Compliance with Authority Required procedures
C4807

Breast cancer

The condition must be hormone receptor positive; AND
The treatment must be an alternative to adjuvant chemotherapy

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Letrozole

    substitute:

Letrozole C4795

Breast cancer

The condition must be hormone receptor positive

Patient must not be pre-menopausal
C4801

Early breast cancer

The condition must be hormone receptor positive; AND
The treatment must be for extended adjuvant treatment of the condition commencing within 6 months of ceasing treatment with tamoxifen

Patient must not be pre-menopausal

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

  2. Schedule 4, Part 1, after entry for Peginterferon Alfa-2a

    insert:

Peginterferon beta-1a C4798 P4798

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)

Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application

 Compliance with Authority Required procedures
C4811 P4811

Multiple sclerosis

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ranibizumab

    substitute:

Ranibizumab C4803

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Must be treated by an ophthalmologist

Authority approval for initial treatment of each eye must be sought

The first authority application for each eye must be made in writing or by telephone

A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorized

Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography

 Compliance with Written or Telephone Authority Required procedures
C4804

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye

Must be treated by an ophthalmologist

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Rituximab [Circumstances Code C4701]

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

Where the patient is receiving treatment at/from a Public Hospital

(b)omit from the column headed “Circumstances and Purposes”:      *Patient   substitute:             Patient

  1. Schedule 4, Part 1, entry for Testosterone

    substitute:

Testosterone C4815

Androgen deficiency

Patient must not have established pituitary or testicular disorders other than ageing

Patient must be male; AND
Patient must be aged 40 years or older

Androgen deficiency is defined as:

(i) testosterone level of less than 8 nmol per litre; OR
(ii) testosterone level between 8 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men)

Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings

 Compliance with Authority Required procedures
C4816

Constitutional delay of growth or puberty

Patient must be male; AND
Patient must be under 18 years of age

 Compliance with Authority Required procedures
C4817

Androgen deficiency

Patient must have an established pituitary or testicular disorder

Patient must be male

 Compliance with Authority Required procedures
C4818

Micropenis

Patient must be male; AND
Patient must be under 18 years of age

 Compliance with Authority Required procedures
C4819

Pubertal induction

Patient must be male; AND
Patient must be under 18 years of age

 Compliance with Authority Required procedures

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

  2. Schedule 4, Part 1, entry for Vinorelbine

    omit:

C3890 Locally advanced or metastatic non‑small cell lung cancer Compliance with Authority Required procedures – Streamlined Authority Code 3890
C3907 Advanced breast cancer after failure of prior therapy which includes an anthracycline Compliance with Authority Required procedures – Streamlined Authority Code 3907
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