Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:42
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 42
Character Range: 84169–85099

42  Pricing applications in Pricing Pathway A category
  A pricing application is in Pricing Pathway A category if:
 (a) as part of the Committee's recommendation or advice covering the drugs or medicinal preparations to which the pricing application relates, the Committee found that:
 (i) the drugs or medicinal preparations are expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy; and
 (ii) the drugs or medicinal preparations address a high and urgent unmet clinical need; and
 (iii) it would be in the public interest for a pricing application relating to the drugs or medicinal preparations to be in this category; and
 (b) the pricing application, or the notice of intent (if any) in relation to the proposed pricing application, states that the application is to be in this category.
Note: See subsection 48(6) and paragraph 49(1)(b).