Document ID: chunk:federal_register_of_legislation:F2022L00916:reg:9
Version: federal_register_of_legislation:F2022L00916
Segment Type: reg
Provision Reference: reg 9
Character Range: 3851–6460

9               Factors that must exist
At least one of the following factors must exist before it can be said that, on the balance of probabilities, dermatomyositis or death from dermatomyositis is connected 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.