Document ID: chunk:federal_register_of_legislation:F2022L00909:reg:9
Version: federal_register_of_legislation:F2022L00909
Segment Type: reg
Provision Reference: reg 9
Character Range: 3868–6494

9               Factors that must exist
At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting dermatomyositis or death from dermatomyositis with the circumstances of a person's relevant service:
(1)          taking a drug from the specified list of drugs for at least the 4 weeks before the clinical onset of dermatomyositis;
Note: specified list of drugs is defined in the Schedule 1 – Dictionary.
(2)          taking hydroxyurea for at least the 6 months before the clinical onset of dermatomyositis;
(3)          taking an immune checkpoint inhibitor or interferon alfa within the 1 year before the clinical onset of dermatomyositis;
            Note: Examples of immune checkpoint inhibitors include ipilimumab, nivolumab, pembrolizumab and tremelimumab.
(4)          taking a drug which is associated in the individual with the clinical onset of dermatomyositis during drug therapy and either:
(a)          the improvement of dermatomyositis within 2 months of discontinuing or tapering drug therapy; or
(b)          the redevelopment of dermatomyositis on rechallenge with the same drug; and
where taking the drug continued for at least the 7 days before the clinical onset of dermatomyositis;
(5)          having a malignant neoplasm, other than non-melanotic malignant neoplasm of the skin, within 5 years of the clinical onset of dermatomyositis;
(6)          taking a drug from the specified list of drugs for at least the 4 weeks before the clinical worsening of dermatomyositis;
Note: specified list of drugs is defined in the Schedule 1 – Dictionary.
(7)          taking hydroxyurea for at least the 6 months before the clinical worsening of dermatomyositis;
(8)          taking an immune checkpoint inhibitor or interferon alfa within the 1 year before the clinical worsening of dermatomyositis;
            Note: Examples of immune checkpoint inhibitors include ipilimumab, nivolumab, pembrolizumab and tremelimumab.
(9)          taking a drug which is associated in the individual with:
(a)          the clinical worsening of dermatomyositis during drug therapy; and
(b)          the improvement of dermatomyositis within 2 months of discontinuing or tapering drug therapy; and
where taking the drug continued for at least the 7 days before the clinical worsening of dermatomyositis;
(10)      having a malignant neoplasm, other than non-melanotic malignant neoplasm of the skin, within 5 years of the clinical worsening of dermatomyositis;
(11)      inability to obtain appropriate clinical management for dermatomyositis.