Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:46:p1
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 46 (pt 1/2)
Character Range: 89506–92154

46  Pricing applications in Pricing Pathway D category
 (1) A pricing application is in Pricing Pathway D category if:
 (a) subsection (2), (3), (4) or (5) applies to the pricing application; and
 (b) the pricing application does not seek the entering into of a deed under section 85E of the Act relating to the drugs or medicinal preparations to which the pricing application relates (the new drugs); and
 (c) the pricing application is not in Pricing Pathway A category.
 (2) This subsection applies to the pricing application if:
 (a) it includes one or more of the following claims about the new drugs and an alternative therapy:
 (i) a claim that the effectiveness of specified doses of the new drugs is equivalent to specified doses of the alternative therapy;
 (ii) a claim that the new drugs will provide similar health benefits to those provided by the alternative therapy;
 (iii) a claim that the new drugs may be supplied at the same or a lower price per treatment, or price per unit, as that for the alternative therapy; and
 (b) it notes that the claims are consistent with the Committee's recommendation or advice to the Minister in relation to the new drugs; and
 (c) it suggests a price based on the claims.
 (3) This subsection applies to the pricing application if:
 (a) it claims that the use of the new drugs provides a significant improvement in the efficacy or reduction in toxicity compared to an alternative therapy; and
 (b) it requests for the new drugs a higher price per treatment, or price per unit, than that for:
 (i) the alternative therapy referred to in paragraph (a); or
 (ii) another alternative therapy if, as part of the Committee's recommendation or advice to the Minister in relation to the new drugs, the Committee found that the other therapy is clinically comparable to the new drugs; and
 (c) the claim in paragraph (a) and the request in paragraph (b) are consistent with the Committee's recommendation or advice to the Minister in relation to the new drugs.
 (4) This subsection applies to the pricing application if:
 (a) it includes a request for a review of the existing price for a listed drug; and
 (b) the resulting price requested in the pricing application is consistent with the Committee's recommendation or advice to the Minister in relation to the listed drug.
 (5) This subsection applies to the pricing application if:
 (a) it includes both of the following claims about the new drugs and an alternative therapy:
 (i) a claim that the new drugs will provide similar health benefits to those provided by the alternative therapy;
 (ii) a claim that the new drugs may be supplied at the same