National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 2) (No. PB 1 of 2011) (Cth)

Case

PB 1 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No. 2)1


National Health Act 1953

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

Dated 20 January 2011

FELICITY McNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 2).

(2)        This Instrument may also be cited as PB 1 of 2011.

2          Commencement

This Instrument commences on 1 February 2011.

3          Amendment of PB 108 of 2010

Schedule 1 amends PB 108 of 2010.

Schedule 1     Amendments

[1] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg (Alprazolam-GA); and Tablet 2 mg (Alprazolam-GA)

omit from the column headed “Responsible Person”: GM         and insert:            GN

[2] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg

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

Ralozam GM MP NP C1975 50 2

[3] Schedule 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

insert in the columns in the order indicated:

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides Oral powder 400 g (Neocate LCP + MCT) Oral Neocate LCP + MCT SB MP NP C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810 8 5

[4] Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

omit from the column headed “Brand”:APO-go                and insert:            Apomine

[5] Schedule 1, entry for Aspirin in the form Tablet 100 mg (DBL Aspirin 100 mg)

omit from the column headed “Responsible Person”: YT          and insert:            GY

[6] Schedule 1, entry for Aspirin in the form Tablet 100 mg

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

Mayne Pharma Aspirin YT MP NP 112 1

[7] Schedule 1, after entry for Aurothiomalate

insert in the columns in the order indicated:

Azacitidine Powder for injection 100 mg Injection Vidaza CJ MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

[8] Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

(a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Zithromax”:

Zitrocin GM MP NP C1405 C1838 C1839 P1838 P1839 2 0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Zithromax”:

Zitrocin GM MP NP C1405 C1838 C1839 P1405 2 2

[9] Schedule 1, entry for Bethanechol

omit from the column headed “Responsible Person”: HA          and insert:            YN

  1. Schedule 1, entry for Cabergoline

omit:

Tablet 500 micrograms Oral Dostinex PF NP C1289 2 0
MP C1289 C2659 C2660 C2661 C2662 P1289 2 0
MP C1289 C2659 C2660 C2661 C2662 P2659 P2660 P2661 P2662 8 5
Tinexa SI MP C2659 C2660 C2661 C2662 P2659 P2660 P2661 P2662 8 5

substitute:

Tablet 500 micrograms Oral Dostan GM NP C1289 2 0
MP C1289 C2659 C2660 C2661 C2662 P1289 2 0
Dostinex PF NP C1289 2 0
MP C1289 C2659 C2660 C2661 C2662 P1289 2 0
Dostan GM MP C1289 C2659 C2660 C2661 C2662 P2659 P2660 P2661 P2662 8 5
Dostinex PF MP C1289 C2659 C2660 C2661 C2662 P2659 P2660 P2661 P2662 8 5
Tinexa SI MP C2659 C2660 C2661 C2662 P2659 P2660 P2661 P2662 8 5

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

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

Cobasol GM MP NP C1255 30 5

  1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

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

DBL Cefepime HH MP NP C1427 10 0

  1. Schedule 1, entry for Doxorubicin ─ Pegylated Liposomal

omit from the column headed “Responsible Person”: SH          and insert:            JC        (twice occurring)

  1. Schedule 1, after entry for Duloxetine

    insert in the columns in the order indicated:

Dutasteride Capsule 500 micrograms Oral Avodart GK MP C3667 30 5

  1. Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate
    10 mg; and Tablet containing enalapril maleate 20 mg

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

Acetec AL MP NP 30 5

(b)        omit:

Enahexal HX MP NP 30 5

  1. Schedule 1, entry for Famotidine

    omit:

Famohexal HX MP NP 60 5

  1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Fluconazole Hexal)

omit from the column headed “Responsible Person”: SZ          and insert:            HX

  1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL

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

Fluconazole Sandoz SZ MP NP

C3613 C3614
C3615 C3616

C3617 C3618

 7 0

  1. Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg

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

Fluvoxamine GA GM MP NP C1211 C1241 30 5

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

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

Gemplan WQ MP
See Note 1 		C1193 C1194 C1740 C2069 C2141 4 2

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

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

Gemplan WQ MP
See Note 1 		C1193 C1194 C1740 C2069 C2141 2 2

  1. Schedule 1, entry for Hydrocortisone

    omit:

Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g Application to the eye Hycor SI AO MP NP 1 0

  1. Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

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

Lercadip GM MP NP 28 5

  1. Schedule 1, entry for Lisinopril in the form Tablet 10 mg

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

Lisinopril Sandoz SZ MP NP 30 5

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

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

APO-Metformin 1000 TX MP NP 90 5

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

Chem mart Metformin 1000 CH MP NP 90 5

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

Terry White Chemists Metformin 1000 TW MP NP 90 5

  1. Schedule 1, entry for Nicotine

    substitute:

Nicotine Transdermal patch 24.9 mg Transdermal Nicorette Patch JT MP NP C3042 C3447 C3448 28 2
Transdermal patch 52.5 mg Transdermal Nicotinell Step 1 NC MP NP C3447 C3448 28 2
Transdermal patch 114 mg Transdermal Nicabate P GC MP NP C3447 C3448 28 2

  1. Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

    (a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA RZ MP NP
See Note 1 		C3050 C3611
See Note 2

P3050
See Note 2

 4
See Note 2 		0
See Note 2

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA RZ MP NP C3050 C3611 P3611 10 1

  1. Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

    (a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA RZ MP NP
See Note 1 		C3050 C3611
See Note 2

P3050
See Note 2

 4
See Note 2 		0
See Note 2

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA RZ MP NP C3050 C3611 P3611 10 1

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

Reaptan 5/5 RX MP NP C3307 C3308 30 5

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

Reaptan 5/10 RX MP NP C3307 C3308 30 5

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

Reaptan 10/5 RX MP NP C3307 C3308 30 5

  1. Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

Reaptan 10/10 RX MP NP C3307 C3308 30 5

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

    (a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone-GA”:

Risperidone Sandoz SZ MP NP C1589 C2061 C3083 P2061 P3083 60 2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone-GA”:

Risperidone Sandoz SZ MP NP C1589 C2061 C3083 P1589 60 5

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

    (a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:

Risperidone Sandoz SZ MP NP C1589 C2061 C2272 C3083 P2061 P3083 60 2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:

Risperidone Sandoz SZ MP NP C1589 C2061 C2272 C3083 P1589 P2272 60 5

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

    (a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:

Risperidone Sandoz SZ MP NP C1589 C2272 C3083 P3083 60 2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:

Risperidone Sandoz SZ MP NP C1589 C2272 C3083 P1589 P2272 60 5

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

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

Risperidone Sandoz SZ MP NP C1589 C2272 60 5

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

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

Risperidone Sandoz SZ MP NP C1589 C2272 60 5

  1. Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

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

Sertracor 50 MI MP NP C1211 30 5

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

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

Sertracor 100 MI MP NP C1211 30 5

  1. Schedule 1, entry for Stavudine

    omit:

Powder for oral solution 1 mg per mL, 200 mL Oral Zerit BQ MP
See Note 1 		C3586 C3587 C3588 C3589 24 5 D

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

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

Sumatriptan-GA GM MP NP C3233 4 5

  1. Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

omit from the column headed “Brand”:         Tramahexal SR and insert:            Tramadol Sandoz SR

  1. Schedule 1, entry for Trastuzumab

insert as first entry in the columns in the order indicated:

Powder for I.V. infusion 60 mg Injection Herceptin RO MP
See Note 1 		See Note 3 See Note 3 See Note 3 See Note 3 D

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)

(a)        insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Valtrex”:

Zelitrex RE MP NP C3622 C3631 C3632 C3633 P3632 20 0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Valtrex”:

Zelitrex RE MP NP C3622 C3631 C3632 C3633 P3633 30 5

(c)        insert in the columns in the order indicated, and in alphabetical order after the third instance of the brand “Valtrex”:

Zelitrex RE MP NP C3622 C3631 C3632 C3633 P3622 P3631 42 0

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

    (a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Vancocin CP”:

Vancomycin Alphapharm AF MP C1091 C1302 C1464 P1302 2 0
PDP C1302 2 0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Vancocin CP”:

Vancomycin Alphapharm AF MP C1091 C1302 C1464 P1091 P1464 5 0

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

    (a)        insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Hospira Pty Limited”:

Vancomycin Alphapharm AF MP C1091 C1302 C1464 P1302 1 0
PDP C1302 1 0

(b)        insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Hospira Pty Limited”:

Vancomycin Alphapharm AF MP C1091 C1302 C1464 P1091 P1464 3 0

  1. Schedule 1, entry for Varenicline

omit:

Tablet 1 mg (as tartrate) Oral Champix PF MP NP C2776 112 0

substitute:

Tablet 1 mg (as tartrate) Oral Champix PF MP NP C3670 C3671 P3671 56 2
MP NP C3670 C3671 P3670 112 0

  1. Schedule 3, after details relevant to Responsible person code GX

insert:

GY Mayne Pharma International Pty Ltd  88 007 870 984

  1. Schedule 3, details relevant to Responsible person code PL

omit:

Virgo Unit Trust

insert:

The Trustee for Virgo Unit Trust (trading as Phebra)

  1. Schedule 3, after details relevant to Responsible person code RD

insert:

RE GlaxoSmithKline Australia Pty Ltd  47 100 162 481

  1. Schedule 3, after details relevant to Responsible person code RO

insert:

RX Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

  1. Schedule 4, Part 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

    insert in the columns in the order indicated:

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides C1687 Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed Compliance with Authority Required procedures
C1688 Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition Compliance with Authority Required procedures
C2805 Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is 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, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures
C2806 Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures
C2807 Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures
C2808 Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures
C2809 Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures
C2810 Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application Compliance with Authority Required procedures

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

    insert in the columns in the order indicated:

Dutasteride C3667 Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment is initiated by a urologist Compliance with Authority Required procedures - Streamlined Authority Code 3667

  1. Schedule 4, Part 1, entry for Nicotine

    substitute:

Nicotine C3042 Nicotine dependence in an Aboriginal or a Torres Strait Islander person as the sole PBS-subsidised therapy Compliance with Authority Required procedures
C3447 Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the initial authority application Compliance with Authority Required procedures
C3448 Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the initial authority application Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Varenicline

    substitute:

Varenicline C2774 Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application Compliance with Authority Required procedures
C2775 Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application Compliance with Authority Required procedures
C3670 P3670 Continuation of short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program Compliance with Authority Required procedures
C3671 P3671 Completion of short-term sole PBS-subsidised therapy as an aid to achieving long-term abstinence after completion of an initial 12-week PBS-subsidised course in a patient who has ceased smoking, and who is enrolled in a comprehensive support and counselling program Compliance with Authority Required procedures

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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