Statement of Principles concerning TRANSVERSE MYELITIS (Reasonable Hypothesis) (No. 71 of 2021) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 21 May 2021 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Nicholas Saunders AO Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Application 5 Definitions 6 Kind of injury, disease or death to which this Statement of Principles relates 7 Basis for determining the factors 8 Factors that must exist 9 Relationship to service 10 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning transverse myelitis (Reasonable Hypothesis) (No. 71 of 2021). 2 Commencement This instrument commences on 21 June 2021. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 5 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 6 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about transverse myelitis and death from transverse myelitis. Meaning of transverse myelitis (2) For the purposes of this Statement of Principles, transverse myelitis: (a) means an acute or subacute immune-mediated, inflammatory disorder of the spinal cord producing symptoms and signs of impaired motor, sensory or autonomic functioning; and (b) excludes myelitis or myelopathy of the spinal cord due to: (i) acute disseminated encephalomyelitis; (ii) atopic myelitis; (iii) intrathecal chemotherapy; (iv) multiple sclerosis; (v) neuromyelitis optica syndrome; (vi) radiation; (vii) spinal cord compression; (viii) trauma; (ix) tumour invasion; and (x) vascular, metabolic or degenerative pathologies. Note 1: Transverse myelitis typically presents with symptoms or signs developing over hours to days. Impaired autonomic functioning may present as bowel or bladder dysfunction. There is usually bilateral sensory alteration with a defined upper sensory level. Note 2: The diagnosis of transverse myelitis can be confirmed by finding evidence of spinal cord inflammation on neuroimaging or by analysis of cerebrospinal fluid. (3) While transverse myelitis attracts ICD‑10‑AM code G37.3, in applying this Statement of Principles the meaning of transverse myelitis is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from transverse myelitis (5) For the purposes of this Statement of Principles, transverse myelitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's transverse myelitis. Note: terminal event is defined in the Schedule 1 - Dictionary. 7 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that transverse myelitis and death from transverse myelitis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 - Dictionary. 8 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 transverse myelitis or death from transverse myelitis with the circumstances of a person's relevant service: (1) having a symptomatic gastrointestinal infection or respiratory tract infection within the 2 months before the clinical onset of transverse myelitis; (2) having an infection with a viral, bacterial, fungal or parasitic organism within the 2 months before the clinical onset of transverse myelitis; (3) having a systemic autoimmune disease at the time of the clinical onset of transverse myelitis; (4) having sarcoidosis at the time of the clinical onset of transverse myelitis; (5) having a malignant neoplasm, other than non-melanotic malignant neoplasm of the skin, at the time of the clinical onset of transverse myelitis; Note: Transverse myelitis may be part of a paraneoplastic syndrome and the malignant neoplasm may be present but not yet diagnosed at the time of the clinical onset of transverse myelitis. (6) taking a drug from the specified list of drugs within the 2 months before the clinical onset of transverse myelitis; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (7) taking heroin within the 7 days before the clinical onset of transverse myelitis; (8) receiving oral polio vaccine within the 2 months before the clinical onset of transverse myelitis; (9) having a bone marrow or stem cell transplant before the clinical onset of transverse myelitis; (10) inability to obtain appropriate clinical management for transverse myelitis. 9 Relationship to service (1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person. (2) The factor set out in subsection 8(10) applies only to material contribution to, or aggravation of, transverse myelitis where the person's transverse myelitis was suffered or contracted before or during (but did not arise out of) the person's relevant service. 10 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 8 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 5 1 Definitions In this instrument: biologic agent means a therapeutic product which is derived from living organisms or which contains components of living organisms. Note: Examples of biologic agents that have been associated with transverse myelitis include tyrosine kinase inhibitors, immune checkpoint inhibitors and dinutuximab. MRCA means the Military Rehabilitation and Compensation Act 2004. relevant service means: (a) operational service under the VEA; (b) peacekeeping service under the VEA; (c) hazardous service under the VEA; (d) British nuclear test defence service under the VEA; (e) warlike service under the MRCA; or (f) non-warlike service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. specified list of drugs means: (a) biologic agents for the treatment of cancer; or (b) tumour necrosis factor-α inhibitors. Note: biologic agent is also defined in the Schedule 1 - Dictionary. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. transverse myelitis—see subsection 6(2). VEA means the Veterans' Entitlements Act 1986.