National Health (December 2018 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2018 National Health Act 1953 I, SEAN LANE, Acting Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this determination under subsections 99ACF(3AA) and 99ACB(6A) of the National Health Act 1953. Dated 28 November 2018 SEAN LANE Acting Assistant Secretary Pricing and PBS Policy Branch Technology Assessment and Access Division Department of Health 1 Name of Instrument This instrument is the National Health (December 2018 First New Brand statutory price reduction) (Exercise of Ministerial discretion) Determination 2018. 2 Commencement This instrument commences on the day after it is registered. 3 Definitions Note: A number of expressions used in this instrument are defined in Part VII the Act. In this instrument: Act means the National Health Act 1953. 4 Authority This instrument is made under subsections 99ACF(3AA) and 99ACB(6A) of the Act. 5 Brand of pharmaceutical item not subject to a price reduction I determine under subsection 99ACF(3AA) of the Act that, for the purposes of subsection 99ACF(2AB), the approved ex-manufacturer price that comes into force on 1 December 2018 of each brand of pharmaceutical item specified in an item in the table in Part 1 of the Schedule is to be worked out using a reduction of zero %. Note: Subsection 99ACF(3AA) enables the Minister to determine that the reduction to the approved ex-manufacturer price or claimed price of a brand of pharmaceutical item subject to subsection 99ACF(2AB) is to be worked out using a lower percentage, including zero %, than would otherwise be the case. 6 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply (1) I determine under subsection 99ACF(3AA) of the Act that, for the purposes of subsection 99ACF(2AB), the approved ex-manufacturer price that comes into force on 1 December 2018 of the brand of pharmaceutical item specified in item 1 in the table in Part 2 of the Schedule is to be worked out using a reduction of 20%. Note: Subsection 99ACF(3AA) enables the Minister to determine that limit on the maximum agreed price of a new brand of an existing pharmaceutical item subject to subsection 99ACF(2AB) is to be calculated using a lower percentage, including zero %, than would otherwise be the case. (2) I determine under subsection 99ACB(6A) of the Act that, for the purposes of subsection 99ACB(5), the maximum agreed price of the brand of pharmaceutical item specified in item 2 in the table in Part 2 of the Schedule that comes into force on 1 December 2018 is to be worked out using a reduction of 20%. Note: Subsection 99ACB(6A) enables the Minister to determine that limit on the maximum agreed price of a new brand of an existing pharmaceutical item is to be calculated using a lower percentage, including zero %, than would otherwise be the case. Schedule Part 1 — Brands of pharmaceutical items with approved ex-manufacturer price not reduced Column 1 Column 2 Item Brand of Pharmaceutical Item Drug Form Manner of administration Brand 1 Flucloxacillin Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL Oral Flucil 2 Flucloxacillin Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL Oral Flucil Part 2 — Brands of pharmaceutical items with approved ex-manufacturer price reduced by a lower percentage than would otherwise apply Column 1 Column 2 Item Brand of pharmaceutical item Drug Form Manner of administration Brand 1 Tocilizumab Injection 162 mg in 0.9 mL single use pre-filled syringe Injection Actemra Subcutaneous Injection 2 Tocilizumab Injection 162 mg in 0.9 mL single use pre-filled pen Injection Actemra ACTPen