Document ID: chunk:federal_register_of_legislation:F2024C00988:reg:82
Version: federal_register_of_legislation:F2024C00988
Segment Type: reg
Provision Reference: reg 82
Character Range: 143028–144429

82  When weighted average disclosed price is the same as the applicable approved ex‑manufacturer price
  Despite section 81, if all of the following apply, the weighted average disclosed price of the listed brand of the pharmaceutical item for the data collection period is taken to be the amount of the applicable approved ex‑manufacturer price of the listed brand of the pharmaceutical item:
 (a) the total adjusted volume worked out for brands of the pharmaceutical item under section 77:
 (i) is more than zero; and
 (ii) is no more than 10% of the sum of the total adjusted volumes for the brands of each pharmaceutical item with the same drug and manner of administration as the listed brand (including the pharmaceutical item of the listed brand);
 (b) the weighted average percentage difference worked out for brands of the pharmaceutical item under section 78 is not more than 3%;
 (c) there is not a related brand of the listed brand of the pharmaceutical item:
 (i) that is bioequivalent or biosimilar to the listed brand of the pharmaceutical item; and
 (ii) to which paragraphs (a) and (b) do not apply;
 (d) the Pharmaceutical Benefits Advisory Committee has not advised the Minister that the pharmaceutical item does not provide a significant improvement in efficacy or a reduction in toxicity over alternative therapies.

Subdivision C—Information that must not be taken into account