Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:45
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 45
Character Range: 87008–89506

45  When pricing terms are substantially similar to those appropriate for the new drugs
 (1) This section applies for the purposes of paragraphs 43(1)(b) and 44(1)(b).

When pricing terms are substantially similar to those appropriate for the new drugs
 (2) The pricing terms in an existing deed under section 85E of the Act are substantially similar to the pricing terms (the new pricing terms) that are appropriate for the new drugs if, under the new pricing terms:
 (a) the new drugs can share an existing subsidisation cap with the drugs or medicinal preparations to which the existing deed relates; or
 (b) the new drugs are cost‑minimised to the drugs or medicinal preparations to which the existing deed relates.
 (3) The pricing terms in an existing deed under section 85E of the Act are substantially similar to the pricing terms appropriate for the new drugs if:
 (a) the Committee's recommendation or advice covering the new drugs suggested that the pricing terms in the existing deed would be appropriate for the new drugs; and
 (b) this suggestion relates to claims in the relevant pricing application of the kind referred to in subparagraphs 46(2)(a)(i), (ii) and (iii).

When pricing terms are not substantially similar to those appropriate for the new drugs
 (4) Despite subsections (2) and (3), the pricing terms in an existing deed under section 85E of the Act are not substantially similar to the pricing terms (the new pricing terms) appropriate for the new drugs if:
 (a) the new pricing terms relate to further clinical testing, or to the collection of further clinical data on the effectiveness, of the new drugs; or
 (b) the new pricing terms, to the extent that they provide for reimbursing the Commonwealth, include taking into account the clinical response of patients to the new drugs; or
 (c) the pricing terms in the existing deed include an existing subsidisation cap that cannot be shared with the new drugs; or
 (d) the new pricing terms, to the extent that they provide for reimbursing the Commonwealth, relate to Commonwealth expenditure on a therapy that involves using the new drugs in combination with any of the drugs or medicinal preparations covered by the existing deed.

Circumstances in the above subsections are not exhaustive
 (5) This section does not set out the only circumstances in which the pricing terms in an existing deed under section 85E of the Act are, or are not, substantially similar to the pricing terms appropriate for the new drugs.