Submissions

Joint statement from the National Allergy Council, Allergy & Anaphylaxis Australia and Australasian Society of Clinical Immunology and Allergy (ASCIA), in support of the request by Galderma Australia Pty Ltd for the Pharmaceutical Benefits Scheme (PBS) listing of Nemolizumab (Nemluvio®).

Joint statement from the National Allergy Council and Allergy & Anaphylaxis Australia, in support of the request by Novartis Pharmaceuticals to have a Section 100 (Highly Specialised Drugs Program) Authority Required (Written) listing for the initial treatment and an Authority Required (Telephone/Online) listing for the continuing treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Joint statement from the National Allergy Council and Allergy & Anaphylaxis Australia, in support of the request by Celltrion Healthcare Australia Pty Ltd for the Pharmaceutical Benefits Scheme (PBS) listng of Omlyclo® (omalizumab).

Joint statement from the National Allergy Council and Allergy & Anaphylaxis Australia, in support of the request by Novartis Pharmaceuticals Australia Pty Ltd for the Pharmaceutical Benefits Scheme (PBS) listing of a new strength of Xolair® (omalizumab).

Joint statement from the National Allergy Council and Allergy & Anaphylaxis Australia, in support of the request by Sanofi-Aventis Australia Pty Ltd for the Pharmaceutical Benefits Scheme (PBS) listing of Dupixent® (dupilumab)

Allergy & Anaphylaxis Australia (A&AA) response to the request for comments on allergen labelling.

Draft amendments to the general standard for the labelling of prepackaged foods (CXS 1-1985) – provisions relevant to joint presentation and multipack formats.

Comments on the Guidelines on the Provision of Food Information for Pre-Packaged Foods to be Offered via E-Commerce.

Codex Committee on Food Labelling Electronic Working Group on Allergen Labelling 2nd Consultation Paper.

Allergy & Anaphylaxis Australia (A&AA), the Australasian Society of Clinical Immunology and Allergy (ASCIA) and the National Allergy Council welcome the opportunity to lodge our comments regarding the submission for a new PBS listing for Jext® Jnr and Jext® which is on the July 2024 Pharmaceutical Benefits Advisory Committee (PBAC) meeting agenda.

Jext® Jnr (contains 150 micrograms adrenaline) and Jext® (contains 300 micrograms adrenaline) are single dose syringe autoinjectors. The submission requests a General Schedule Authority Required (Telephone/Online) listing of a new form for the treatment of acute allergic reaction with anaphylaxis.

Proposed Draft Guidelines on the Provision of Food Information for Prepackaged Foods offered via E-commerce.

Allergy & Anaphylaxis Australia (A&AA) has responded to the questions in the EWG 2nd Consultation Request. See PDF for the full response.

1st Consultation Paper – March 2024:  A&AA provided a response to the Codex Committee on Food Labelling Electronic Working Group on allergen labelling.

Allergy & Anaphylaxis Australia provided comments on CL 2024/24-FL – Information on emerging issues/future work and included the previous feedback to CL 2022/70-FL that was relevant to this submission.

Allergy & Anaphylaxis Australia (A&AA) provided feedback in response to CL 2022/70-FL on 29 November 2022 that we have attached as we believe the issues are still relevant. We have included comments below to some specific points that were raised in the document CX/FL 23/47/13

See PDFs for full submission and referred submission.

Allergy & Anaphylaxis Australia provided comments on the criteria for evaluation and prioritization of the work of Codex Committee for Food Labelling (CCFL).

Allergy & Anaphylaxis Australia provided responded to the questionnaire from the Codex Committee regarding the Labelling of Alcoholic Beverages.

1. Mandatory labelling requirements – A&AA supports the mandatory labelling requirements for ingredients, including common food allergens, on all alcoholic beverages. We do not agree that there should be an exemption for ingredient labelling for low alcohol beverages. See the full submission below.

Please find below the joint submission from Allergy & Anaphylaxis Australia (A&AA) and the National Allergy Council to the Pharmaceutical Benefits Advisory Committee (PBAC) on changes requested by GlaxoSmithKline Australia Pty Ltd to the Pharmaceutical Benefits Scheme listing of mepolizumab (Nucala®) for uncontrolled severe asthma.

Please find below the joint submission from Allergy & Anaphylaxis Australia (A&AA) and the National Allergy Council to the Pharmaceutical Benefits Advisory Committee (PBAC) on changes requested by GlaxoSmithKline Australia Pty Ltd to the Pharmaceutical Benefits Scheme listing of mepolizumab (Nucala®) for uncontrolled severe asthma.

The National Allergy Council and Allergy & Anaphylaxis Australia (A&AA) both support the submission from Sanofi-Aventis to request a Section 100 (Highly Specialised Drugs Program) Authority Required (Written) Pharmaceutical Benefits Scheme (PBS) listing of dupilumab (Dupixent®) for the treatment of uncontrolled severe asthma in patients aged 6 to 11 years.

The National Allergy Council and Allergy & Anaphylaxis Australia support this submission as biologicals with a strong evidence base, such as dupilumab, can greatly improve the management of severe, uncontrolled asthma, understanding that dupilumab does not replace the need for other asthma medication, including oral corticosteroids. It could, however, reduce the use of oral corticosteroids and any reduction, particularly in this young cohort, will be beneficial in the long term. The ability to improve management of severe, uncontrolled asthma will however, improve the health and well-being of patients, particularly those with other allergic conditions and/or comorbidities.

See the full submission below.

Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids – Neocate® Syneo: The National Allergy Council is a partnership between the Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy & Anaphylaxis Australia (A&AA), working in consultation with key stakeholder organisations. This submission supports the approval of Neocate Syneo (new formulation) for the treatment of IgE mediated cow’s milk allergy including those at risk of anaphylaxis, cow’s milk enteropathy, and Eosinophilic Oesophagitis (EoE) in infants and children.

See the full submission below.

Do we need to update more medicine labelling rules in the short term to support medicine safety before we conduct a broader review?

Yes, Allergy & Anaphylaxis Australia (A&AA) believes that an update is required in the short term to the ‘’Declaration of Substances’’, with respect to the food allergens that must be declared. It is vital that information on medicine labels is clear, accurate and comprehensive for people with allergy, their carers, and health professionals to enable them to make informed decisions about the suitability and safety of prescribed and non-prescribed medicines if they have a food allergy.

Allergy & Anaphylaxis Australia (A&AA) does not support the proposed Draft Revision on the General Standard for the Labelling of Pre-Packaged Foods (CXS 1-1985): Provisions relevant to Allergen Labelling for adoption at Step 5.

A&AA has several concerns that we needed to have addressed before we can support the document. See the full submission below.

In Food Labelling (For Adoption at Step 5)

Allergy & Anaphylaxis Australia (A&AA) supports the proposed Draft Guidelines on the Use of Technology to provide Food Information in Food Labelling for adoption at Step 5.

However, we did have two issues that we feel need to be considered:

1. The definition of consumer.

In the Purpose statement it states, “Provide guidance on the use of technology to provide information to consumers.’’ ‘Consumers’ is defined by General Standard for Labelling of Pre-packaged Foods (CXS 1-1985) as “persons and families purchasing and receiving food in order to meet their personal needs.’’ This definition does not take into account a third party, such as a food service provider, who may also use technology to access food information. The information obtained through technology about a food used in their food production is important in order for them to meet their obligations to consumers, especially around the disclosure of food allergens. A&AA believes guidance on the use of technology to provide information also needs to be provided to others such as food service providers.

See the full submission below.

Offered via E- Commerce (For Adoption at Step 5)

Allergy & Anaphylaxis Australia (A&AA) supports the proposed Draft Guidelines on the Provision of Food Information for Prepackaged foods offered via E-Commerce for adoption at Step 5.

A&AA has one point that we believe needs to be considered.

The definition of ‘consumer’, referred to in the Purpose statement, is defined by General Standard for Labelling of Pre-packaged Foods (CXS 1-1985) as “persons and families purchasing and receiving food in order to meet their personal needs.’’ This definition does not take into account a third party, such as a food service provider, who may also purchase pre-packaged food via e-commerce that is not for personal consumption.

See the full submission below.

Provisions Relevant to Allergen Labelling (For Adoption at Step 5)

Allergy & Anaphylaxis Australia (A&AA) does not support the proposed Draft Revision on the General Standard for the Labelling of Pre-Packaged Foods (CXS 1-1985): Provisions relevant to Allergen Labelling for adoption at Step 5.

A&AA has several concerns that we needed to have addressed before we can support the document. See the full submission below.

A&AA (Allergy & Anaphylaxis Australia) supports the proposal by FSANZ (Food Standards Australia New Zealand) to create a new category of infant formula that has been developed for a specific disease, disorder, or medical condition within Standard 2.9.1. A&AA supports the proposed sale restriction of a SMPPi (Special Medical Purpose Products for Infants). That is, these products must only be sold from or by a medical practitioner or dietitian; a medical practice, pharmacy or responsible institution or a majority seller of that SMPPi, to help manage the risk associated with unsupervised or inappropriate use.

This submission from Allergy & Anaphylaxis Australia (A&AA) to the Pharmaceutical Benefits Advisory Committee concerns the ongoing Pharmaceutical Benefits Scheme listing of Dupilumab (Dupixent®) for the treatment of chronic severe atopic dermatitis in people aged 12 years and over.

Submission from Allergy & Anaphylaxis Australia (A&AA): We welcome the opportunity to lodge our comments in support of the submission for Jorveza® (Budesonide) which is on the March 2023 Pharmaceutical Benefits Advisory Committee (PBAC) meeting agenda. Jorveza® was PBS listed in May 2022 specifically for the treatment of EoE.

Second Consultation Paper – October 2022: The EWG are asked to provide comments on the proposed draft revisions to the GSLPF as discussed in Part 1 of the consultation paper. This includes providing comments on the proposed definitions at Section 2 of Part 1.

Submission from Allergy & Anaphylaxis Australia (A&AA): Change to PBS listing Mepolizumab Injection (Nucala®) to include use for people diagnosed with chronic rhinosinusitis with nasal polyps.

A&AA supports the PBS listing of Mepolizumab so that people with chronic rhinosinusitis with nasal polyps can, together with their treating medical specialist and surgeon, decide on the most appropriate treatment for them.

The listing of this medication would give these people hope for a more normal enjoyable life. 

Submission from Allergy & Anaphylaxis Australia (A&AA): Codex Committee on Food Labelling | Electronic Working Group on Allergen Labelling. 

A&AA provides response on 1st Consultation Paper on the Codex eWG Allergen Labelling online-forum.

Submission from Allergy & Anaphylaxis Australia (A&AA): Codex Contact Point for Australia Secretariat.

A&AA appreciates the opportunity to provide feedback to the Codex Contact Point for Australia Secretariat on food information requirements for pre-packaged foods offered via e-commerce.

Allergy & Anaphylaxis Australia lodged a further submission with Food Standards Australia New Zealand (FSANZ) with regard to P1028 – Infant formula.

A&AA supports the creation of a new category Special Medical Purpose Products for infants (SMPPi) within Standard 2.9.1, and supports the proposed labelling requirements for inner packages, preferably with the addition of
ingredient listing. 

A&AA remains concerned that formula claiming lactose free or low lactose could be mistakenly fed to an infant with a milk allergy. 

A&AA remains concerned that that partially hydrolysed infant formulas may be recommended by health practitioners for the mitigation or prevention of allergy.

A&AA strongly advocates for Standard 2.9.1 to indicate that infants around the age of 6 months and not before 4 months should be offered foods in addition to the infant formula product.

Submission from Allergy & Anaphylaxis Australia (A&AA):Dupixent for severe eczema. 

A&AA asks that you consider the changed lives of people with severe eczema who are now taking Dupixent in the July 2022 PBAC meeting.

People are utilising the medication because there has been a huge need for a treatment that works without the need for immunosuppressive medication.

People are sharing their stories and those who were disengaged are now re engaging with health professionals that can review their health condition and offer those with severe eczema this new treatment.

Submission from Allergy & Anaphylaxis Australia (A&AA): Review of the WA Food Act. 

A&AA has no issue with the efficacy of the current provisions in the WA Food Act, noting that they appear in line with the Model Food Provisions.

A&AA strongly urges the addition of provisions in the WA Food Act to address food allergy management throughout the food chain, but with emphasis on food service, food safety supervisors with competency-based training including allergen management.

Allergy & Anaphylaxis Australia (A&AA): Food allergen content exemptions cannot be considered because there is a huge food safety risk to consumers with food allergy. This will impact greatly on the health and wellbeing of people with food allergy and potentially add more of a challenge to an existing crisis such as Covid-19/natural disasters. Ideally, we need to have a plan to get appropriate food to people with potentially life threatening dietary needs during a crisis, such as a natural disaster or pandemic, and not consider food allergen labelling exemptions. 

Allergy & Anaphylaxis Australia lodged a submission with Food Standards Australia New Zealand Food Standards Australia New Zealand (FSANZ) concerning Proposal P1053: Food safety management tools for the food service and closely related retail sectors.

Allergy & Anaphylaxis Australia lodged a submission with Codex Australia concerning the proposed Guidelines on the Use of Technology to Provide Food Information.

Allergy & Anaphylaxis Australia lodged a submission with Pharmaceutical Benefits Advisory Committee (PBAC) supporting the Pharmaceutical Benefits Scheme (PBS) listing of Dupilumab (Dupixent®) for the treatment of severe atopic dermatitis (commonly known as eczema) in children aged 6 to 11 years.

Allergy & Anaphylaxis Australia lodged a submission with Food Standards Australia New Zealand (FSANZ) with regard to P1028 – Infant formula.

With respect to the management of food allergy, A&AA has had access to the draft submissions of both the NAS and ASCIA and supports and endorses their submissions.

Allergy & Anaphylaxis Australia (A&AA) lodged a submission to the Review of National Medicines Policy. 

Included were submisions on:

Terms of Reference 1: Evaluate the current NMP objectives and determine whether these should be modified or additional objectives included. This includes consideration of the proposed Principles to be included within the NMP.

Terms of Reference 2: Consider the definition of medicines and whether the NMP needs to be expanded to include health technologies.

Terms of Reference 3. Assess the NMP’s utility in the context of rapidly evolving treatment options, population changes, interconnected relationships, and system-wide capacities.

Terms of Reference 4: Consider the centricity of the consumer within the NMP and whether it captures the diversity of consumers’ needs and expectations.

Terms of Reference 5: Identify options to improve the NMP’s governance; communications, implementation (including enablers) and evaluation.

Terms of Reference 6: Review the NMP partners and provide options for building greater accountability including addressing conflicts of interest.

Allergy & Anaphylaxis Australia lodged comments in support of the application for Pharmaceutical Benefits Scheme (PBS) listing of JORVEZA® for both induction of remission and maintenance of remission in adult patients with Eosinophilic Oesophagitis (EoE).

Allergy & Anaphylaxis Australia to made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) on change ot Pharmaceutical Benefits Scheme listing of Mepolizumab Injection (Nucala®) to include use for people diagnosed with chronic rhinosinusitis with nasal polyps.

Allergy & Anaphylaxis Australia to made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) on Pharmaceutical Benefits Scheme listing of ABROCITINIB Tablet 100 mg Tablet 200 mg Cibinqo® for severe atopic dermatitis.

Allergy & Anaphylaxis Australia to made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) on Pharmaceutical Benefits Scheme listing of Upadacitinib (Rinvoq®) for the treatment of chronic severe atopic dermatitis (AD).

Allergy & Anaphylaxis Australia made a submission to to Pharmaceutical Benefits Advisory Committee (PBAC) on Pharmaceutical Benefits Scheme (PBAC) listing of Baricitinib (Olumiant®) for the treatment of chronic severe atopic dermatitis (AD).

Allergy & Anaphylaxis Australia (A&AA) made a submission with regard to Request for comments / information on allergen labelling: revision of the General Standard for the Labelling of Pre-packaged Foods (CXS 1 1985) (For further information please see CL 2021/9/OCS-FL).

Allergy & Anaphylaxis Australia (A&AA) made a submission to Pharmaceutical Benefits Advisory Committee (PBAC).

Eosinophilic Oesophagitis (EoE) currently affects about 1 in 1000 Australians¹ (both children and adults). It is a debilitating disease that has no cure. The symptoms of EoE are varied and include difficulty swallowing and food sticking in the oesophagus, and can result in permanent scarring and narrowing of the oesophagus. Although more is known about the disease now thanks to increasing research, there is still much to be understood. People with EoE often have a poor quality of life so any treatment that improves their wellbeing is welcomed.

Currently, the goal of treatment is to improve symptoms by eliminating or reducing the number of eosinophils in the oesophagus. To date, medications used for other allergic conditions such as allergic asthma have been used to treat EoE.  Asthma steroid medications’ such as Flixotide (Fluticasone propionate) and Pulmicort (Budesonide) have been sprayed into the mouth and/or swallowed to try to get the steroid medication to the oesophagus, and steroid liquid has been mixed into a slurry and swallowed.

Despite being beneficial for EoE, none of these asthma medications (inhalers and nebules/respules) have been indicated for EoE by the Pharmaceutical Benefits Advisory Committee (PBAC). People with EoE who are already marginalised by their condition, have to pay full cost of inhaled steroids that their treating specialist prescribes for EoE if they do not also have asthma. It is important that people with rarer disease states that greatly impact on health and wellbeing have access to a range of medications (proven to improve the rare disease state such as EoE) to treat their medical condition.

Jorveza® is a new medication that contains Budesonide (the same medication in Pulmicort) in tablet form that dissolves in the mouth and can be swallowed, therefore coating the target area which is the oesophagus.

A&AA strongly supports PBS listing of Jorveza® as it is the only medication specifically formulated to target the oesophagus. The steroid aerosols and slurries currently used to treat EoE have improved the condition, so a disintegrating tablet specifically for EoE should help compliance and management. Having EoE often means people have difficulty eating so having a medication that is easy to take, targeted and affordable can improve eating challenges for people with EoE who often have many restrictions.

We implore the government to make other medications such as Budesonide respules and Neocate Spoon (sometimes used to mix Budesonide respule into a slurry to be swallowed) to be made available to consumers with EoE via the Pharmaceutical Benefits Scheme (PBS) as some people may not be able to have Jorveza® because of excipients used in the tablet formulation. It is important people with allergic disease and their treating doctors have a choice of treatments that best suit the disease state and the person taking it.

Reference

1. ASCIA www.allergy.org.au/patients/food-other-adverse-reactions/eosinophilic-oesophagitis

Allergy & Anaphylaxis Australia (A&AA) made a submission to Food Standards Australia New Zealand re: Application A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme).

Summary:

A&AA is not opposed to the application, but has issues and concerns which do not appear to have been fully addressed. The labelling obligation seem to be stated ambiguously and should be expressed more emphatically. The issues surrounding allergenicity, processing and digestion may need investigation in greater depth, and accordingly A&AA urges the referral of matters of allergenicity to the FSANZ Food Allergy and Intolerance Scientific Advisory Group of experts in allergic disease as a matter of routine. 

Allergy & Anaphylaxis Australia (A&AA) made a submission to Food Standards Australia New Zealand re: Application A1193 – Irradiation as a phytosanitary measure for all fresh fruit and vegetables.

Summary:

A&AA strongly encourages Food Standards Australia New Zealand (FSANZ) to seek advice on issues surrounding irradiation of fruit and vegetables, allergenicity and impact on nutritional content for people with food allergy through the FSANZ Food Allergy and Intolerance Scientific Advisory Group of experts in allergic disease as a matter of routine. Considering that fruit and vegetable allergy is on the increase world-wide, the need to have expert advice on the effect of irradiation on fruit and vegetables in terms of allergenicity is not unwarranted.

Allergy & Anaphylaxis Australia (A&AA) welcomes the opportunity to comment on the terms of reference of the House of Representatives parliamentary inquiry into approval processes for new drugs and novel medical technologies in Australia.

We thank the Australian government for considering the needs of Australians living with allergic disease in the context of the need for improved approval processes for new drugs and novel medical technologies.

Allergy & Anaphylaxis Australia (A&AA) made a submission to Pharmaceutical Benefits Advisory Committee (PBAC)

Allergy & Anaphylaxis Australia (A&AA) made a submission to Pharmaceutical Benefits Advisory Committee (PBAC)

Allergy & Anaphylaxis Australia (A&AA) made a submission to Food Standards Australia New Zealand (FSANZ)

Allergy & Anaphylaxis Australia (A&AA) made a submission to Food Standards Australia New Zealand (FSANZ)

Allergy & Anaphylaxis Australia (A&AA) made a submission to Pharmaceutical Benefits Advisory Committee (PBAC)

Submission from Allergy & Anaphylaxis Australia

In August this year, Minister for Health the Hon Greg Hunt MP announced that a Parliamentary Inquiry into allergies and anaphylaxis would be undertaken by the Standing Committee on Health.

Allergy & Anaphylaxis Australia’s Parliamentary Inquiry Submission has now been lodged and published.

You can read our submission by downloading the PDF below, or go to the parliamentary inquiry website page Allergies and Anaphylaxis Submissions [then to submission number 184]

Further to our submission, Allergy & Anaphylaxis Australia attended the public hearing in Sydney Tuesday the 19th of November.

There was also a public hearing in Melbourne Monday the 18th of November.

You can view the programs here: Allergies and Anaphylaxis Public Hearings

View the Walking the allergy tightrope response here.

Allergy & Anaphylaxis Australia (A&AA) is deeply concerned that the Illness Reduction Strategy 2018 – 2021+ will seemingly not address allergic reactions on the basis that “allergens were not a defined hazard”. It also appears that there is little or no impetus through either Food Regulation Standing Committee (FRSC) or Food Standards Australia New Zealand (FSANZ) to address this issue through effective alternate strategies.

It is fortunate that some States and Territories do have strategies in place and will continue to enact unilateral and non-uniform legislation to address this undefined but recognised hazard particularly in the food service area. Nonetheless this action usurps the role of FRSC and FSANZ.

A&AA proposes a number of measures to move forward promptly on this real and increasing hazard. To illustrate the extent of the problem there has been 1353 anaphylaxis presentations to Victorian emergency departments since November 2018 (as at 3/6/19). Personal correspondence from the Victorian Anaphylaxis Notifications scheme reveals that twenty three percent of anaphylaxis presentations to Victorian emergency departments were due to food from food service establishments (fifteen percent of these were referred to local council).

See the full submission below.

Submission to the Therapeutic Goods Administration (TGA) from Allergy & Anaphylaxis Australia on the management and communication of medicine shortages.

In March 2018, Food Standards Australia New Zealand (FSANZ) called for submissions on proposal (P1044) for Plain English Allergen Labelling (PEAL).