Commonwealth Numbered Regulations Commonwealth Numbered Regulations(1) An application is in the complex pricing category if:
(a) it includes a claim to which subregulation (2) applies; and
(b) the resulting price for a drug, medicinal preparation or vaccine is higher than the price for an equivalent amount or unit of a listed drug, a special pharmaceutical product or a designated vaccine that:
(i) the applicant nominates in the application as presenting an alternative therapy; or
(ii) the Committee considers is clinically comparable to the drug, medicinal preparation or vaccine the subject of the application.
(2) This subregulation applies if an applicant claims that:
(a) the use of a drug, medicinal preparation or vaccine provides a significant improvement in the efficacy or reduction in toxicity compared to any alternative therapy provided by:
(i) a listed drug; or
(ii) a special pharmaceutical product; or
(iii) a designated vaccine; and
(b) the applicant requests a higher price compared to the alternative therapy; and
(c) the Committee's recommendation is in accordance with the claim.
(3) An application is in the complex pricing category if:
(a) it includes a request for a review of the existing price for a listed drug, a special pharmaceutical product or a designated vaccine and the resulting price is higher; or
(b) the following apply:
(i) when the application was made, it included a claim of cost minimisation;
(ii) the Committee's recommendation or advice to the Minister was not in accord with the claim; or
(c) there is an agreement, between the applicant and the Commonwealth (other than an agreement or arrangement mentioned in paragraph 3.1 (b)), containing risk‑sharing arrangements or other requirements relating to the supply of a drug, medicinal preparation or vaccine.