Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A submission is in Category 1 if:
(a) the submission includes a request that the Committee recommend to, or advise, the Minister to exercise a power referred to in an item of the table in Schedule 1; and
(b) subsection (2), (3), (4) or (5) applies in relation to the request or the submission.
Drug, medicinal preparation or vaccine first in class for new population or disease
(2) This subsection applies to a request if it relates to:
(a) a drug or medicinal preparation the intended effect of which is achieved by a distinct pharmacological, chemical, immunological or metabolic means that has not been considered before by the Committee; or
(b) a vaccine the intended effect of which is achieved by a distinct immunological means that has not been considered before by the Committee; or
(c) a drug, medicinal preparation, or vaccine, that is for the treatment or prevention of a disease or disorder that has not been considered before by the Committee.
Drug, medicinal preparation or vaccine covered by a provisional determination
(3) This subsection applies to a request if it relates to a drug, medicinal preparation, or vaccine, that is a medicine, within the meaning of the Therapeutic Goods Act 1989 , in relation to which a provisional determination under section 22D of that Act is in force when the submission including the request is received by the Department.
Co - dependent submission relating to testing
(4) This subsection applies to a submission relating to a drug, medicinal preparation or vaccine if:
(a) determining the existence of:
(i) the proposed circumstances for writing a prescription for supply of the drug or medicinal preparation under Part VII of the Act; or
(ii) the proposed circumstances for provision of the vaccine under section 9B of the Act;
will depend on provision of a medical service using technology before administration of the drug, medicinal preparation or vaccine starts or is continued; and
(b) it is proposed that there be an item of the table, within the meaning of the Health Insurance Act 1973 , for the medical service; and
(c) the submission includes a request for MSAC to recommend that such an item be included in the table (as well as the request referred to in paragraph (1)(a) of this section for the Committee); and
(d) in considering their respective requests, both the Committee and MSAC will need to do a cost - effectiveness test (whether or not the Committee or MSAC will need to assess anything else).
Co - dependent submission relating to administration
(5) This subsection applies to a submission relating to a drug or medicinal preparation if:
(a) administration of the drug or medicinal preparation proposed to be provided under the Act will involve the provision of a medical service; and
(b) it is proposed that there be an item of the table, within the meaning of the Health Insurance Act 1973 , for the medical service; and
(c) the submission includes a request for MSAC to recommend that such an item be included in the table (as well as the request referred to in paragraph (1)(a) for the Committee); and
(d) in considering the request for the Committee, the Committee will need to do a cost - effectiveness test (whether or not the Committee will need to assess anything else); and
(e) in considering the request for MSAC, MSAC will need to assess the cost of the therapy proposed in the submission for a disease or disorder relative to the cost of any alternative therapy for the disease or disorder (whether or not MSAC will need to assess anything else).