42Pricing applications in Pricing Pathway A category

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).