Statement of Principles concerning HASHIMOTO THYROIDITIS (Balance of Probabilities) (No. 2 of 2022) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 24 December 2021 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Terence Campbell AM Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Repeal 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 Hashimoto thyroiditis (Balance of Probabilities) (No. 2 of 2022). 2 Commencement This instrument commences on 31 January 2022. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning Hashimoto's thyroiditis No. 32 of 2013 (Federal Register of Legislation No. F2013L00731) made under subsections 196B(3) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004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 Hashimoto thyroiditis and death from Hashimoto thyroiditis. Meaning of Hashimoto thyroiditis (2) For the purposes of this Statement of Principles, Hashimoto thyroiditis: (a) means a chronic, inflammatory, autoimmune disease of the thyroid gland characterised by varying degrees of lymphocytic infiltration and fibrosis of the thyroid gland, and typically presenting with a high titre of circulating antibodies against thyroid peroxidase (TPO) or thyroglobulin (Tg); and (b) includes: (i) goitrous thyroiditis; (ii) atrophic thyroiditis; and (iii) chronic autoimmune thyroiditis with transient thyrotoxicosis (Hashitoxicosis); and (c) excludes: (i) Graves disease; (ii) non-autoimmune chronic thyroiditis; (iii) postpartum thyroiditis; (iv) secondary hypothyroidism; and (v) subacute thyroiditis. Note 1: Presenting features typically include a goitre and hypothyroidism, although some patients may be hyperthyroid during the course of the disease. Note 2: Hashimoto thyroiditis is also known as chronic autoimmune thyroiditis or chronic lymphocytic thyroiditis. Note 3: Hashimoto thyroiditis may present as myxoedema coma. Note 4: myxoedema coma is defined in the Schedule 1 - Dictionary. (3) While Hashimoto thyroiditis attracts ICD‑10‑AM codes E03.4, E03.5 or E06.3, in applying this Statement of Principles the meaning of Hashimoto thyroiditis 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 Hashimoto thyroiditis (5) For the purposes of this Statement of Principles, Hashimoto thyroiditis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's Hashimoto thyroiditis. Note: terminal event is defined in the Schedule 1 - Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that Hashimoto thyroiditis and death from Hashimoto thyroiditis can be related to relevant service rendered by veterans 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. 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, Hashimoto thyroiditis or death from Hashimoto thyroiditis is connected with the circumstances of a person's relevant service: (1) having iodine excess within the 3 months before the clinical onset of Hashimoto thyroiditis; Note 1: Iodine excess may be due to consuming foods, dietary supplements or medications with a high content of iodine. Note 2: iodine excess is defined in the Schedule 1 - Dictionary. (2) taking a drug from the Specified List 1 of drugs within the 1 year before the clinical onset of Hashimoto thyroiditis; Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary. (3) undergoing a course of therapeutic radiation for cancer, where the thyroid gland was in the field of radiation, within the 10 years before the clinical onset of Hashimoto thyroiditis; (4) having received iodine-131 (radioactive iodine) treatment within the 10 years before the clinical onset of Hashimoto thyroiditis; (5) being obese for at least 5 years before the clinical onset of Hashimoto thyroiditis; Note: being obese is defined in the Schedule 1 - Dictionary. (6) having postpartum thyroiditis within the 10 years before the clinical onset of Hashimoto thyroiditis; (7) for Hashimoto thyroiditis first presenting as myxoedema coma only, having an acute precipitating event within the 48 hours before the clinical onset of Hashimoto thyroiditis; Note: acute precipitating event and myxoedema coma are defined in the Schedule 1 - Dictionary. (8) having iodine excess within the 3 months before the clinical worsening of Hashimoto thyroiditis; Note 1: Iodine excess may be due to consuming foods, dietary supplements or medications with a high content of iodine. Note 2: iodine excess is defined in the Schedule 1 - Dictionary. (9) taking a drug from the Specified List 2 of drugs for a continuous period of at least 2 weeks, within the 1 year before the clinical worsening of Hashimoto thyroiditis; Note: Specified List 2 of drugs is defined in the Schedule 1 - Dictionary. (10) undergoing a course of therapeutic radiation for cancer, where the thyroid gland was in the field of radiation, within the 10 years before the clinical worsening of Hashimoto thyroiditis; (11) having received iodine-131 (radioactive iodine) treatment within the 10 years before the clinical worsening of Hashimoto thyroiditis; (12) being obese for at least 5 years before the clinical worsening of Hashimoto thyroiditis; Note: being obese is defined in the Schedule 1 - Dictionary. (13) having postpartum thyroiditis within the 10 years before the clinical worsening of Hashimoto thyroiditis; (14) being pregnant or within the 12 months postpartum at the time of the clinical worsening of Hashimoto thyroiditis; (15) for myxoedema coma only, having an acute precipitating event within the 48 hours before that clinical worsening of Hashimoto thyroiditis; Note: acute precipitating event and myxoedema coma are defined in the Schedule 1 - Dictionary. (16) inability to obtain appropriate clinical management for Hashimoto thyroiditis. 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(8) to 9(16) apply only to material contribution to, or aggravation of, Hashimoto thyroiditis where the person's Hashimoto thyroiditis 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(3) 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 6 1 Definitions In this instrument: acute precipitating event means a physical stimulus or event that causes a sudden, intense physical response. Note: Examples of an acute precipitating event include: (a) abrupt cessation of thyroxine therapy; (b) acute illness including cerebrovascular accident, gastrointestinal bleed, myocardial infarction and pulmonary embolism; (c) acute iodine load including iodine-containing drugs; (d) drugs including sedatives, opioids, antipsychotics, selective serotonin reuptake inhibitors, phenytoin, beta blockers, diuretics and chemotherapeutic agents; (e) hypothermia; (f) infection including pneumonia, urinary tract infections and septicaemia; (g) physical trauma including burns; and (h) surgery. being obese means having a Body Mass Index (BMI) of 30 or greater. Note: BMI is also defined in the Schedule 1 - Dictionary. BMI means W/H2 where: (a) W is the person's weight in kilograms; and (b) H is the person's height in metres. Hashimoto thyroiditis—see subsection 7(2). iodine excess means: (a) an average intake of more than 1,100 micrograms of iodine per day for adults, or more than 900 micrograms per day for those aged 18 years and under, for a continuous period of at least 3 months; or (b) having a urinary iodine concentration of greater than 300 micrograms per litre, or greater than 500 micrograms per litre for pregnant women. MRCA means the Military Rehabilitation and Compensation Act 2004. myxoedema coma means a constellation of severe and life-threatening symptoms of rapid onset in a patient with biochemical evidence of decreased thyroxine level. Characteristic symptoms and signs are decreased mental status and hypothermia, and hypotension, bradycardia, hyponatremia, hypoglycaemia and hypoventilation are typically present. Note 1: Myxoedema coma is also known as decompensated hypothyroidism. Note 2: Myxoedema coma may be the first presentation of undiagnosed Hashimoto thyroiditis, or may complicate existing Hashimoto thyroiditis. relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. Specified List 1 of drugs means: (a) interferon alpha; (b) interleukin-2; or (c) sunitinib. Specified List 2 of drugs means: (a) amiodarone; (b) interferon alpha; (c) interleukin-2; (d) lithium; or (e) sunitinib. 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. VEA means the Veterans' Entitlements Act 1986.