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Inquiries Into Allergies and Anaphylaxis Submission Improving Inquiries into allergies and anaphylaxis submission Improving access to treatment and support for Australian patients with Jack Jumper (Hopper) Ant Allergy Clinical Immunology/Allergy Unit Royal Adelaide Hospital October 2019 Applicable terms of reference: 1. The potential and known causes, prevalence, impacts and cost of anaphylaxis in Australia 4. Access to and cost of services, including diagnosis, testing, management, treatment and support JJA venom allergy submission October 2019 1 Background – Nature and prevalence of the problem – Effectiveness and benefits of treatment Allergy to Jack Jumper Ant (JJA) (AKA the ‘hopper ant’; scientific name Myrmecia pilosula) is a uniquely localised problem, as the ants are found only in Australia and are widely distributed in the cooler areas of south-western and south-eastern Australia. It appears to be a major problem across wide areas of southern Australia with "hotspots" in the Adelaide Hills, rural and semi-rural areas around Melbourne and widely spread throughout Tasmania, where up to 2-3% of residents may be allergic to its venom. 1-4 Allergy to hopper ant venom can cause life-threatening anaphylaxis and is a major cause of insect sting anaphylaxis in southern and south-eastern Australia, second only to honey bee venom allergy. In 1149 consecutive cases presenting with anaphylaxis to Royal Hobart Hospital it was dominant amongst all potential causes of anaphylaxis, including penicillin and nut allergy.5 In South Australia, a state with the highest prevalence of hospitalisation for allergy to honey bee stings in Australia, it accounts for around 30% of insect sting allergy referrals, far outnumbering the combined total for "European" wasps, paper wasps and other stinging ants. There have been at least 4 deaths in Australia due to JJA anaphylaxis prior to the introduction of JJA venom immunotherapy treatment.6 Venom immunotherapy (VIT) for treatment of stinging insect anaphylaxis involves the administration of increasing doses of purified insect venom with the aim of inducing clinical tolerance. JJA VIT has been shown to be highly effective at preventing JJA sting anaphylaxis, with a randomised double-blinded, placebo-controlled trial of JJA VIT demonstrating an objective systemic sting reaction rate in those who were on treatment of < 5% vs 70% for those receiving placebo.7,8 The adverse reaction rates to JJA VIT are similar to those observed in honey bee VIT. Since the introduction of the Tasmanian Jack Jumper Allergy Program in 2001, responsible for the manufacture of JJA VIT, aside from one suspected (but unconfirmed) case in the Adelaide Hills, there have been no further deaths due to JJA venom allergy. Aside from preventing potential anaphylactic reactions and deaths, VIT has consistently been shown to improve quality of life.9 In comparison, the alternative to JJA VIT is reliance on adrenaline auto-injectors (Epipens), which may be inadequate for the management more severe reactions, and the carriage of which can be associated with anxiety and reduced quality of life.10 Current treatment availability – Cost and resources involved – Barriers to access Although JJA VIT is highly effective at preventing anaphylaxis to JJA stings, it requires a prolonged course of therapy (minimum 5 year course to indefinite duration) and its applicability and accessibility is limited by multiple factors including: (1) Venom availability. JJA pharmaceutical grade venom extract is manufactured and supplied by the Tasmanian Health Service, Jack Jumper Allergy Program. Venom is collected by venom sac dissection of ants harvested from wild nests, with inherent OH&S risks. While the Tasmanian Jack Jumper Ant Allergy Program is funded, funding has remained static and the program is underfunded relative to the cost of manufacture. Furthermore, the number JJA venom allergy submission October 2019 2 of patients requiring treatment continues to grow due to both new patients being started (18 new patients in SA and 33 new patients in Tasmania started in 2017/2018 financial year) and the cumulative effects of requirement to provide existing patients with a minimum of 5 years duration of therapy. (2) Venom costs. JJA venom is supplied by Tasmanian Jack Jumper Allergy Program Including pharmacy preparation costs, a standard maintenance dose costs $240. Per patient the cost of venom is approximately $3,500 in the first year and $2,500 in subsequent years. Unlike commercial honey bee VIT (which is clinically less effective), JJA VIT is not PBS listed. Tasmania and Victoria have state funding support for venom costs, but South Australia does not. South Australian patients were therefore previously required to cover the cost of their venom. Due to the significant cost of VIT to the individual and concerns regarding equitability of access, the Royal Adelaide Hospital now covers the cost of treatment for South Australian patients via Individual Patient Use applications. (3) Dependence on hospital resources. Currently JJA VIT is administered at the following hospitals: Royal Hobart Hospital Royal Adelaide Hospital Monash Medical Centre North West Regional Hospital (NWRH)(outreach clinic for Tasmanian patients) As patients cannot receive treatment outside of these settings, there is a significant cumulative burden to the Medical Day Treatment Units of these hospitals, which limits the number of new patients who can be started on therapy. South Australia is currently exploring the setup of a satellite clinic in the Adelaide Hills, similar to the existing NWRH and planned Launceston General Hospital clinics in Tasmania. Patients living in NSW and the ACT are unable to receive JJA VIT. (4) Medical and nursing expertise Due to specialized nature of the treatment and risk of allergic side effects, a clinical immunologist/allergist is required to supervise the treatment of patients receiving VIT. Nursing staff with experience in administration of allergen immunotherapy and anaphylaxis management is also a minimum requirement. Currently only Victoria and Tasmania have specific FTE for a clinical immunologist and nurse to manage JJA therapy. (5) Need for improved awareness and education. Despite the fact that JJA venom allergy is the second most common cause of insect related anaphylaxis in south eastern Australia, knowledge of JJA venom allergy and the availability of effective treatment is lacking in residents and GPs, even in areas where the ant is endemic. Raising public awareness has been ad hoc, through local news media outlets and availability of information via the ASCIA website. JJA venom allergy submission October 2019 3 Recommendations (1) Enquiry into establishing a nationwide funding model for the cost of JJA VIT, to enable equitable access to treatment and to relieve patients and individual hospitals of the significant cost burden (2) Support for dedicated consultant and nursing FTE (3) Support for measures that facilitate de-centralising of JJA treatment, such that administration of longer term maintenance therapy is not solely reliant on attendance to tertiary level hospitals (4) Support for measures to raise public awareness of JJA venom allergy nationwide (5) Commensurate financial and resource support to the Jack Jumper Allergy Program to ensure manufacture of adequate venom supply for patients Australia wide. This includes adequate funding of the increasing costs of TGA licensing and quality control requirements. Thank you for your consideration of our submission. Clinical Immunology/Allergy Department, Royal Adelaide Hospital Dr Adriana Le, Clinical Immunologist/Allergist Dr Pravin Hissaria, Senior Immunologist and Immunopathologist Dr William Smith, Head of Clinical Immunology/Allergy Unit Emeritus Professor Bob Heddle References 1) Douglas R, Weiner J, Abrahamson M, O'Hehir R (1998). Prevalence of severe ant venom allergy in South-Eastern Australia. J Allergy Clin Immunol;101 :129-31. 2) Brown SGA, Franks RW, Baldo BA, Heddle R.J., (2003). Prevalence, severity and natural history of jack jumper ant venom in Tasmania. J Allergy Clin Immunol;111:187-92. 3) Heddle R., Hudson Pamela, MacDonald E, Brown Simon. Jack Jumper Ant (JJA)sting anaphylaxis in South Australia. Internal Medicine Journal. 38 Supplement 6:A153, November 2008. [191 Australasian Society of Clinical Immunology and Allergy( ASCIA). Annual Scientific Meeting. Park Hyatt Hotel. Melbourne, Australia 12-14 November 2008: Allergic Disease Poster]. 4) Brown S.G.A., van Eeden P, Wiese M.D., Mullins R.J., Solley G.O., Puy R., Taylor R.W., Heddle R.J., (2011) Causes of ant sting anaphylaxis in Australia: the Australian Ant Venom Allergy Study. Med J Aust;195:69-73. 5) Brown SGA. Clinical features and severity grading of anaphylaxis. J Allergy Clin Immunol. 2004,Aug;114(2):371-6. 6) Brown SG, Wu QX, Kelsall GR, Heddle RJ, Baldo BA. Fatal anaphylaxis following jack jumper ant sting in southern Tasmania. Med J Aust. 2001 Dec 3-17;175(11-12):644-7. 7) Brown SGA, Wiese MD, Blackman KE, Heddle R.J., (2003). Ant venom immunotherapy: a double- blind placebo-controlled crossover trial. Lancet 361:1001-06 8) Brown S.G.A., Wiese M.D., van Eeden P., Stone S.F. ,Chuter .L., Gunner J., Wanandy T., Phillips M., Heddle R.J., (2012) Ultrarnsh versus Semirush initiation of insect venom immunotherapy: A randomised controlled trial. J Allergy Clin. Immunol.130(1):162-8. 9) Oude-Elberink JNG, deMonchy JGR, vanderHeide S, Guyatt GH, Dubois AEJ (2002). Venom immunotherapy improves health-related quality of life in yellow jacket allergic patients. J Allergy Clin Immunol;110: 174-82. 10) Brown SGA, Blackman KE, Stenlake V, Heddle R.J., (2004). Insect sting anaphylaxis; prospective evaluation of treatment with intravenous adrenaline and volume resuscitation. Emergency Medicine Journal;21:149-54 JJA venom allergy submission October 2019 4.
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