19Full health technology assessment pathway fee

19 Full health technology assessment pathway fee

When a full health technology assessment is required (1) A listing application or variation application relating to a medical device requires a full health technology assessment if: (a) subsection (2) applies; or (b) the Minister is satisfied on any other grounds that the application requires a full health technology assessment.

Note: 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 a full health technology assessment (see subsection 25(1)). Such a decision made by a delegate of the Minister is reviewable (see section 26).

(2) This subsection applies if the application is, or will be, the subject of any of the following requests to MSAC: (a) a request that an item be included in the table (within the meaning of the Health Insurance Act 1973) for a medical service involving the medical device; (b) a request that an item in the table (within the meaning of the Health Insurance Act 1973) be amended to cover a medical service involving the medical device; (c) a request for advice about the cost‑effectiveness or clinical‑effectiveness of the medical device.

Note: The listing application is to identify that a full health technology assessment is required for the purposes of subsection (2).

Amount of full health technology assessment pathway fee (3) The full health technology assessment pathway fee is $3,100. (4) A person is exempt from paying a full health technology assessment pathway fee in relation to an application if the person has paid, or is liable to pay, both a clinical assessment fee and an economic assessment fee in relation to the application.