Statement of Principles

concerning

NON-MELANOMA MALIGNANT NEOPLASM OF THE SKIN
(Reasonable Hypothesis)

(No. 78 of 2024)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated    18 October 2024.

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 non-melanoma malignant neoplasm of the skin (Reasonable Hypothesis) (No. 78 of 2024).

1.                Commencement

              This instrument commences on 19 November 2024.

1.                Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

1.                Repeal

The Statement of Principles concerning non-melanotic malignant neoplasm of the skin (Reasonable Hypothesis) (No. 7 of 2016) (Federal Register of Legislation No. F2016L00239) made under subsections 196B(2) and (8) of the VEA is repealed.

1.                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.

1.                Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

1.                Kind of injury, disease or death to which this Statement of Principles relates
   1.           This Statement of Principles is about non-melanoma malignant neoplasm of the skin and death from non-melanoma malignant neoplasm of the skin.

Meaning of non-melanoma malignant neoplasm of the skin

1.           For the purposes of this Statement of Principles, non-melanoma malignant neoplasm of the skin:
   1.           means a primary malignant neoplasm arising from the non-melanotic cells of the epidermis of the skin; and
   2.           includes:
      1.             basal cell carcinoma;
      2.          squamous cell carcinoma;
      3.        squamous cell carcinoma in situ (Bowen disease) or basal cell carcinoma in situ; and
      4.         non-melanoma malignant neoplasm of the external aspect of the lip, subungual skin, external auditory canal skin, and anogenital skin; and
   3.           excludes:
      1.             non-melanoma malignant neoplasm mucosa lining the oral (inner) aspects of the lips, conjunctiva, and anogential mucosa;
      2.          malignant melanoma of the skin;
      3.        keratoacanthoma;
      4.         Merkel cell carcinoma;
      5.           mammary and extramammary Paget disease;
      6.         Kaposi sarcoma;
      7.      soft tissue sarcoma;
      8.    carcinoid tumour;
      9.         non-Hodgkin lymphoma; and
      10.           Hodgkin lymphoma.
2.           While non-melanoma malignant neoplasm of the skin attracts ICD‑10‑AM codes: C00.0, C00.1, C00.2, C00.6, C00.8, C00.9, C44, C51.0, C51.1, C51.2, C51.8, C51.9, C60.0, C60.1, C60.2, C60.8, C60.9, C63.2, D04, D07.1, D07.4, in applying this Statement of Principles the meaning of non-melanoma malignant neoplasm of the skin is that given in subsection (2).
3.           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 non-melanoma malignant neoplasm of the skin

1.           For the purposes of this Statement of Principles, non-melanoma malignant neoplasm of the skin, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's non-melanoma malignant neoplasm of the skin.

Note: terminal event is defined in the Schedule 1 – Dictionary.

1.                Basis for determining the factors

The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that non-melanoma malignant neoplasm of the skin and death from non-melanoma malignant neoplasm of the skin 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.

1.                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 non-melanoma malignant neoplasm of the skin or death from non-melanoma malignant neoplasm of the skin with the circumstances of a person's relevant service:

1.           being a prisoner of war of Japan before clinical onset;

1.           having sunlight exposure to unprotected skin for a cumulative period of at least 2,250 latitude equivalent hours before clinical onset;

Note: latitude equivalent hours and unprotected skin are defined in the Schedule 1 - Dictionary.

1.           having at least 5 sunburns at the affected site at least 2 years before clinical onset;

Note: sunburn is defined in the Schedule 1 - Dictionary. 

1.           having ultraviolet radiation exposure from an ultraviolet-emitting tanning device (excluding sunlamps) on at least 10 occasions at the affected site before clinical onset, at least 2 years before clinical onset;
2.           having received a burn from an electric welding device on at least 10 occasions at the affected site, at least 10 years before clinical onset;
3.           having PUVA therapy, where:
   1.           the first PUVA treatment commenced at least 5 years before clinical onset; and
   2.           at least 50 PUVA treatments were administered before clinical onset;

Note: PUVA therapy is defined in the Schedule 1 - Dictionary.

1.           having received a cumulative equivalent dose of at least 0.1 sievert of ionising radiation to the affected site at least 10 years before clinical onset;

Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary.

1.           undergoing a course of radiotherapy for cancer at the affected site, at least 5  years before clinical onset;
2.           undergoing a course of radiotherapy for acne at the affected site, at least 5 years before clinical onset;
3.       being infected by the same human papillomavirus type 16, 18 or 33 for at least 2 consecutive years before clinical onset of squamous cell carcinoma of the penis, vulva or perianal skin;
4.       being infected with human immunodeficiency virus before clinical onset;
5.       undergoing solid organ (excluding corneal transplant) or bone marrow transplantation at least 5 years before clinical onset;
6.       taking one of the following medications within the 10 years before clinical onset:
   1.           acalabrutinib;
   2.           azathioprine;
   3.           ciclosporin;
   4.           elotuzumab;
   5.           fingolimod
   6.            hydroxycarbimide (hydroxyurea);
   7.           ibrutinib;
   8.           methotrexate;
   9.             mycophenolate;
   10.             ruxolitinib;
   11.           siponimod
   12.             sirolimus;
   13.         tacrolimus;
   14.           tofacitinib;
   15.           upadacitinib;
   16.           ustekinumab;
   17.           zanubrutinib;
   18.            tumour necrosis factor-α inhibitors adalimumab, certolizumab, etanercept, golimumab, or infliximab; or
   19.            BRAF kinase inhibitors dabrafenib, encorafenib, vemurafenib.
7.       taking ripretinib within the 10 years before clinical onset of squamous cell carcinoma of the skin;
8.       taking ozanimod or ponesimod within the 10 years before clinical onset of basal cell carcinoma of the skin;
9.       taking voriconazole continuously for at least 3 months, at least 6 months before clinical onset of squamous cell carcinoma of the skin
10.       taking a cumulative dose of at least 25 g of hydrochlorothiazide, at least 6 months before clinical onset of squamous cell carcinoma of the skin;
11.       taking a cumulative dose of at least 50 g of hydrochlorothiazide, at least 6 months before clinical onset of basal cell carcinoma of the skin;
12.       having autoimmune hepatitis at the time of clinical onset;
13.       having inflammatory bowel disease at the time of clinical onset;
14.       having psoriasis at the time of clinical onset;
15.       having rheumatoid arthritis at the time of clinical onset;
16.       having sarcoidosis at the time of clinical onset;
17.       having chronic osteomyelitis with a sinus tract draining to the affected skin site at least 2 years before clinical onset;

Note: sinus tract is defined in the Schedule 1 - Dictionary.

1.       having non-Hodgkin lymphoma before clinical onset;
2.       having mature B-cell lymphoid leukaemia and small lymphocytic lymphoma before clinical onset;

Note: Mature B-cell lymphoid leukaemia and small lymphocytic lymphoma is also known as chronic lymphocytic leukaemia/small cell lymphoma.

1.       having phimosis for a continuous period of at least 2 years before clinical onset of squamous cell carcinoma of the glans penis or prepuce of the penis;

Note: phimosis is defined in the Schedule 1 - Dictionary.

1.       having a scar at the affected site at least 5 years before clinical onset;
2.       having ulceration at the affected site for a cumulative period of at least 6 months, at least 5 years before clinical onset;
3.       having lichen sclerosus at the affected site, at least 5 years before clinical onset of squamous cell carcinoma of the penis, vulva or perianal skin;
4.       having hidradenitis suppurativa at the affected site, at least 5 years before clinical onset of squamous cell carcinoma of the skin;

Note: hidradenitis suppurativa is defined in the Schedule 1 - Dictionary.

1.       having chronic lymphoedema at the affected site, at least 5 years before clinical onset of squamous cell carcinoma of the skin;
2.       smoking at least 15 cigarettes per day for at least 5 years, or the equivalent thereof in other tobacco products, at least 5 years before clinical onset of squamous cell carcinoma of the skin, and where smoking has ceased, clinical onset occurred within 20 years of cessation;

Note: One gram of tobacco is considered to be equivalent to one cigarette. 

1.       being exposed to arsenic as detailed below, at least 10 years before clinical onset;
   1.           consuming arsenic containing compounds (for example, Fowler's solution) for a cumulative period of at least 3 months; or
   2.           consuming drinking water with an average arsenic concentration of at least 50 micrograms per litre for a cumulative period of at least 2 years; or
   3.           inhaling, ingesting or having cutaneous contact with a pesticide containing arsenic, or arsenic in copper smelting operations, for a cumulative period of at least 1,000 hours; or
   4.           having clinical evidence of chronic arsenic toxicity.
2.       having cutaneous contact at the affected site with coal-tar distillate, for a cumulative period of at least 1,500 hours, at least 5 years before clinical onset;
3.       having cutaneous contact at the affected site with one of the following polycyclic aromatic hydrocarbons, for a cumulative period of at least 1,500 hours, at least 5 years before clinical onset of non-melanoma malignant neoplasm of the scrotal skin;
   1.           creosote;
   2.           shale oil;
   3.           soot;
   4.           mineral oil.
4.       inability to obtain appropriate clinical management for non-melanoma malignant neoplasm of the skin before clinical worsening.

1.            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 factor set out in subsection 9(37) applies only to material contribution to, or aggravation of, non-melanoma malignant neoplasm of the skin where the person's non-melanoma malignant neoplasm of the skin was suffered or contracted before or during (but did not arise out of) the person's relevant service.
2.            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.

Schedule 1 - Dictionary  

Note:               See Section 6

1               Definitions

In this instrument:

                               cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue. The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect. The unit of equivalent dose is the sievert. For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation-related sources and radiation from nuclear explosions or accidents;

                               hidradenitis suppurativa means a chronic skin disease of the terminal follicular epithelium in the apocrine gland-bearing skin (axillae, groin, and under the breasts), characterised by comedo-like follicular occlusion, chronic relapsing inflammation, mucopurulent discharge, and progressive scarring.

                                latitude equivalent hours means hours of sunlight exposure multiplied by the appropriate latitude weighting factor as follows:

(a)          For tropical latitudes (23.5° South to 23.5° North) multiply by 1.0;

(b)          For subtropical latitudes (23.6° - 35°) multiply by 0.75;

(c)          For warm temperate latitudes (35.1° - 45°)  multiply by 0.5;

(d)          For cool temperate latitudes (45.1° - 65°) multiply by 0.25.

Note: sunlight exposure is calculated as the sum of sunlight exposure in each separate latitude, accounting for the different sunlight intensity in each latitude (weighting factor).

Sum of sunlight exposure = (hours spent in tropical latitude x tropical latitude weighting factor) + (hours spent in subtropical latitude x subtropical latitude weighting factor) + (hours spent in warm temperate latitude x warm temperate latitude weighting factor) + (hours spent in cool temperate latitude x cool temperate latitude weighting factor)

                               MRCA means the Military Rehabilitation and Compensation Act 2004.

                               non-melanoma malignant neoplasm of the skin—see subsection 7(2).

                               phimosis means an inability to retract the penile foreskin over the glans penis.

                               PUVA therapy means a combination treatment consisting of taking oral psoralen (P) (also known as Methoxsalen) and exposing the skin to long-wave ultra-violet light (UVA).

                               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 defined in the Schedule 1 - Dictionary.

                               sinus tract means an infected blind-ending epithelium-lined tract leading from a focus of infection to the surface of the skin.

                               sunburn means painful erythema of the skin of at least 48 hours duration, resulting from exposure to solar ultraviolet radiation.

                               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.

                               unprotected skin means skin that is directly exposed to the sun and is not protected by sunscreen, clothing or other physical barrier.

                               VEA means the Veterans' Entitlements Act 1986.