Statement of Principles concerning systemic lupus erythematosus (Reasonable Hypothesis) (No. 21 of 2016) (Cth)

Statement of Principles concerning SYSTEMIC LUPUS ERYTHEMATOSUS (Reasonable Hypothesis) (No. 21 of 2016) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 4 March 2016

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 Revocation 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 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 systemic lupus erythematosus (Reasonable Hypothesis) (No. 21 of 2016). 2 Commencement This instrument commences on 4 April 2016. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Revocation The Statement of Principles concerning systemic lupus erythematosus No. 85 of 2007, as amended, made under subsections 196B(2) and (8) of the VEA is revoked. 5 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. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about systemic lupus erythematosus and death from systemic lupus erythematosus. Meaning of systemic lupus erythematosus (2) For the purposes of this Statement of Principles, systemic lupus erythematosus means: (a) a chronic inflammatory autoimmune disease characterised by the presence of antibodies directed against cell nuclei and variable clinical manifestations in multiple systems and organs. Common features include polyarthritis and arthralgia, photosensitivity, rash, serositis, and renal, haematological and neurological disorders; and (b) excludes discoid lupus erythematosus and mixed connective tissue disease. (3) While systemic lupus erythematosus attracts ICD‑10‑AM code M32, L93.1 or L93.2, in applying this Statement of Principles the meaning of systemic lupus erythematosus 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), Ninth Edition, effective date of 1 July 2015, copyrighted by the Independent Hospital Pricing Authority, ISBN 978‑1‑76007‑020‑5. Death from systemic lupus erythematosus (5) For the purposes of this Statement of Principles, systemic lupus erythematosus, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's systemic lupus erythematosus. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that systemic lupus erythematosus and death from systemic lupus erythematosus 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: relevant service is defined in the Schedule 1 – Dictionary. 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 systemic lupus erythematosus or death from systemic lupus erythematosus with the circumstances of a person's relevant service: (1) being exposed to sunlight or ultraviolet light at a level sufficient to induce erythema at least 24 hours, but not more than 30 days, before the clinical onset of systemic lupus erythematosus; (2) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being: (a) produced; (b) excavated; (c) drilled, cut or ground; or (d) used in construction, manufacturing, cleaning or blasting, for a cumulative period of at least 2 000 hours before the clinical onset of systemic lupus erythematosus; (3) where smoking has not ceased before the clinical onset of systemic lupus erythematosus, smoking at least ten pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of systemic lupus erythematosus; Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 – Dictionary. (4) being treated with a drug from the specified list of drugs at the time of the clinical onset of systemic lupus erythematosus; Note: specified list of drugs is defined in the Schedule 1 – Dictionary. (5) being treated with a drug which is associated in the individual with: (a) the development of the symptoms or signs of systemic lupus erythematosus during drug therapy; (b) the cessation of the symptoms or signs of systemic lupus erythematosus within weeks of discontinuing drug therapy; (c) an absence of clinical or laboratory evidence of systemic lupus erythematosus prior to beginning drug therapy; and (d) the development of serological markers which reduce in titre on discontinuing drug therapy; and where treatment with the drug continued for at least the three days before the clinical onset of systemic lupus erythematosus; (6) having hormone replacement therapy with an oestrogen for at least the two years before the clinical onset of systemic lupus erythematosus; (7) being exposed to sunlight or ultraviolet light at a level sufficient to induce erythema at least 24 hours, but not more than 30 days, before the clinical worsening of systemic lupus erythematosus; (8) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being: (a) produced; (b) excavated; (c) drilled, cut or ground; or (d) used in construction, manufacturing, cleaning or blasting, for a cumulative period of at least 2 000 hours before the clinical worsening of systemic lupus erythematosus; (9) where smoking has not ceased before the clinical onset of systemic lupus erythematosus, smoking at least ten pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical worsening of systemic lupus erythematosus; Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 – Dictionary. (10) being treated with a drug from the specified list of drugs at the time of the clinical worsening of systemic lupus erythematosus; Note: specified list of drugs is defined in the Schedule 1 – Dictionary. (11) being treated with a drug which is associated in the individual with: (a) an increase in the symptoms or signs of systemic lupus erythematosus during drug therapy; and (b) a decrease in the symptoms or signs of systemic lupus erythematosus within weeks of discontinuing drug therapy; and where treatment with the drug continued for at least the three days before the clinical worsening of systemic lupus erythematosus; (12) having a clinically symptomatic bacterial, viral or fungal infection at the time of the clinical worsening of systemic lupus erythematosus; (13) being pregnant within the six weeks before the clinical worsening of systemic lupus erythematosus; (14) inability to obtain appropriate clinical management for systemic lupus erythematosus. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9 must be related to the relevant service rendered by the person. (2) The factors set out in subsections 9(7) to 9(14) apply only to material contribution to, or aggravation of, systemic lupus erythematosus where the person's systemic lupus erythematosus was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 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 9 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.