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18 Economic assessment fee

When an economic assessment is required (1) A listing application or variation application relating to a medical device requires an economic assessment if: (a) an economic assessment from an expert with health economics expertise in medical devices is necessary to determine whether or not the medical device satisfies the listing criteria set out in either of the following subsections: (i) 12(5); or (ii) 14(3); or (iii) 15(4); or (b) the Minister is satisfied on any other grounds that the application requires an economic assessment.

Note 1: The device must not be listed on the Schedule 1 unless all criteria for listing have been met..

Note 2: The listing criteria for Part A and Part C of Schedule 1 mentioned in paragraph (a) relate to whether the medical device was compared to medical devices listed in Schedule 1 or alternative treatments, and whether the comparison demonstrated that the medical device is no less clinically effective than alternative devices or treatments, and the benefit amount is proportionate to the clinical-effectiveness of the device.

Note 3: The listing criteria for Part D of Schedule 1 mentioned in paragraph (a) relate to whether the medical device was compared to medical devices listed in Schedule 1, and whether the comparison demonstrated that the device is no less clinically effective than alternative devices, and the benefit amount is proportionate to the clinical-effectiveness of the device.

Note 4: Notice must be given of a decision that the Minister is satisfied as mentioned in paragraph (1)(b) of this section that an application requires an economic assessment for reasons other than those stated in paragraph (a) (see subsection 25(1)). Such a decision made by a delegate of the Minister is reviewable (see section 26).

Amount of economic assessment fee (2) The economic assessment fee is: (a) if the simple fee applies (see subsection (3))— $12,150; or (b) if the complex fee applies (see subsection (4))— $23,460; or (c) if the other fee applies (see subsection (5))— $34,770. Simple fee (3) For the purposes of paragraph (2)(a), the simple fee applies if the Minister is satisfied that the economic assessment: (a) will provide cost‑effectiveness advice for one medical device, and one main clinical purpose; and (b) will be a critique of information supplied by the person who made the application relating to the medical device. Complex fee (4) For the purposes of paragraph (2)(b), the complex fee applies if the Minister is satisfied that the economic assessment: (a) will provide cost‑effectiveness advice: (i) for one medical device, for more than one clinical purpose; or (ii) for more than one related medical device; and (b) will be a critique of information supplied by the person who made the application for each medical device referred to in paragraph (a).

Note: For when medical devices are related, see section 4.

Other fee (5) For the purposes of paragraph (2)(c), the other fee applies if the Minister is satisfied that the economic assessment requires the preparation of a fit‑for‑purpose cost‑effectiveness advice that is more complex than a critique of information provided by the person who made the application relating to the medical device.