99ACCPrice reductions for single brands of combination items

#### 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 ex‑manufacturer price of the first listed brand of the combination item; the approved ex‑manufacturer price of the single brand of the combination item is taken to be reduced under subsection (2) to an amount equal to the capped price. (5B) If the approved ex‑manufacturer price mentioned in subparagraph (5A)(b)(i) or (ii) is by reference to a different pricing quantity than the pricing quantity on the reduction day, the approved ex‑manufacturer price mentioned in that subparagraph is taken to be the amount that the approved ex‑manufacturer price would have been had the pricing quantity been the same as the pricing quantity on the reduction day. Ministerial discretion not to apply, or to reduce, statutory price reduction (5C) In relation to the single brand of the combination item, the Minister may, by notifiable instrument, determine that: (a) the approved ex‑manufacturer price, and (if applicable) the claimed price, is not to be reduced under subsection (2) or (5), as the case requires, in relation to a particular reduction day; or (b) the approved ex‑manufacturer price, and (if applicable) the claimed price, is to be reduced by a lower percentage than would otherwise apply under subsection (2) or (5), as the case requires, in relation to a particular reduction day. (5D) In making a determination under subsection (5C): (a) the Minister must take into account what the approved ex‑manufacturer price, and (if applicable) the claimed price, of the single brand of the combination item would otherwise be under this section in relation to the particular reduction day if a determination were not made; and (b) the Minister may take into account: (i) any advice given to the Minister under subsection 101(4AC) in relation to the combination item; and (ii) any other matter the Minister thinks is relevant. (5E) If the Minister makes a determination under subsection (5C), the approved ex‑manufacturer price of the single brand of the combination item is not to be further reduced under this section on any reduction day that occurs after the reduction day specified in the determination made under subsection (5C). Section does not limit Minister’s powers (5F) This section does not limit the Minister’s powers, on or after the reduction day, to make: (a) further price agreements; or (b) determinations under section 85B; for the single brand of the combination item. Subject to statutory price reduction etc. (6) The following provisions have effect: (a) a listed component drug contained in a drug in a combination item becomes subject to statutory price reduction if section 99ACB or 99ACQ or subsection 99ACR(3) or (4) or section 99ADH has applied to a listed brand of a pharmaceutical item that: (i) has the listed component drug; and (ii) has the same manner of administration as the combination item; (b) whichever provision mentioned in paragraph (a) applied, that provision applies to the listed component drug contained in the drug in the combination item in the same way as that provision applies to the listed brand of the pharmaceutical item that: (i) has the listed component drug; and (ii) has the same manner of administration as the combination item; (c) a listed component drug contained in a drug in a combination item becomes subject to statutory price reduction if subsection 99ACF(1) or (2) because of an item in the table in section 99ACF has applied to a listed brand of a pharmaceutical item that has the listed component drug; (d) whichever provision mentioned in paragraph (c) applied, that provision applies to the listed component drug contained in the drug in the combination item in the same way as that provision applies to the listed brand of the pharmaceutical item that has the listed component drug. Modified meaning of the same manner of administration (7) For the purposes of subsection (6), a combination item whose drug contains a listed component drug has the same manner of administration as another pharmaceutical item that has (or whose drug contains) the listed component drug if the manner of administration set out in a determination under subsection 85(5) for the combination item, to the extent that the manner of administration relates to the listed component drug: (a) if the other pharmaceutical item is not a combination item—is the same as the manner of administration set out in a determination under subsection 85(5) for the other pharmaceutical item; or (b) if the other pharmaceutical item is another combination item—is the same as the manner of administration set out in a determination under subsection 85(5) for the other combination item, to the extent that the manner of administration relates to the listed component drug.