Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99acc:p1
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ACC (pt 1/3)
Character Range: 331257–333963

99ACC  Price reductions for single brands of combination items

When section applies
 (1) This section applies if:
 (a) subsection 85AB(5) applies to the drug in a combination item; and
 (b) there is only one listed brand (the single brand) of the combination item; and
 (c) there is an approved ex‑manufacturer price for the single brand of the combination item; and
 (d) any of the following apply:
 (i) if the drug in the combination item contains only one listed component drug—that listed component drug becomes subject to a statutory price reduction on a day (the reduction day); or
 (ii) if the drug in the combination item contains 2 or more listed component drugs—one of the listed component drugs becomes subject to a statutory price reduction on a day (the reduction day); or
 (iii) if the drug in the combination item contains 2 or more listed component drugs—2 or more of the listed component drugs become subject to a statutory price reduction on the same day (the reduction day); and
 (e) on the reduction day, or on the day before that day, no listed brand of another combination item that has a drug that contains the same component drugs as the combination item:
 (i) is bioequivalent or biosimilar to the single brand of the combination item; and
 (ii) has the same manner of administration as the single brand of the combination item.

Price reduction
 (2) Subject to subsections (5A), (5C) and (5E), on the reduction day, the approved ex‑manufacturer price of the single brand of the combination item is taken to be reduced in accordance with a method prescribed by the regulations.
 (3) Different methods may be prescribed by the regulations for different classes of combination items.
 (4) Subsection (3) does not limit subsection 33(3A) of the Acts Interpretation Act 1901.
 (5) Subject to subsections (5A) and (5C), if the approved ex‑manufacturer price of the single brand of the combination item is reduced under subsection (2), then, on the reduction day, the claimed price (if any) of the single brand of the combination item is taken to be reduced by a percentage equal to the percentage by which the approved ex‑manufacturer price of the single brand of the combination item is reduced under subsection (2).

Reduction cap
 (5A) If:
 (a) the approved ex‑manufacturer price of the single brand of the combination item is to be reduced under subsection (2); and
 (b) apart from this subsection, the reduced approved ex‑manufacturer price would be less than the amount (the capped price) equal to:
 (i) 40% of the approved ex‑manufacturer price of a listed brand of the combination item on 1 January 2016; or
 (ii) if subparagraph (i) does not apply—40% of the original approved