National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 9) (PB 93 of 2019) (Cth)

PB 93 of 2019

National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under paragraph 98C(1)(b) of the National Health Act 1953.

Dated   27^th November 2019

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2019 (No. 9).

(2)This Instrument may also be cited as PB 93 of 2019.

1. Commencement

This Instrument commences on 1 December 2019.

1. Amendments to Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)

Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).

Schedule 1     Amendments

1. Schedule 4, entry for Aciclovir

omit:

Eye ointment 30 mg per g, 4.5 g

1. Schedule 4, entry for Brinzolamide with brimonidine

omit from the column headed “Form (strength, type, size, etc.)”: Eye drops 10 mg brinzolamide and 2 mg brimonidine tartarate per mL, 5 mL
substitute: Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL

1. Schedule 4, omit entry for Buprenorphine

1. Schedule 4, entry for Carmellose

insert as first entry:

Eye drops containing carmellose sodium 5 mg per mL, 10 mL

1. Schedule 4, entry for Clobetasol

omit from the column headed “Form (strength, type, size, etc.)”: Shampoo containing clobetasol propionate 500 micrograms per mL, 125 mL
substitute: Shampoo containing clobetasol propionate 500 microgram per mL, 125 mL

1. Schedule 4, omit entry for Fluticasone

1. Schedule 4, after entry for Fluticasone furoate with vilanterol

insert:

Fluticasone propionate	Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC‑free formulation)
Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC‑free formulation)
Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC‑free formulation)
Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses
Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses
Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses

1. Schedule 4, entry for Fluticasone with formoterol

omit from the column headed “Listed Drug”: Fluticasone with formoterol    substitute: Fluticasone propionate with formoterol

1. Schedule 4, entry for Fluticasone with Salmeterol

omit from the column headed “Listed Drug”: Fluticasone with Salmeterol    substitute: Fluticasone propionate with salmeterol

1. Schedule 4, entry for Hypromellose

insert as first entry:

0.3% w/v eye drops, 10 mL (preservative free)

1. Schedule 4, after entry for Levetiracetam

insert:

Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg
Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

1. Schedule 4, entry for Triamcinolone with Neomycin, Gramicidin and Nystatin

omit from the column headed “Form (strength, type, size, etc.)”: Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL       substitute: Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL