Information updates

A new ASCIA Clinical Care Standard for Inborn Errors of Immunity (IEI)/ Primary Immunodeficiencies (PID) has been developed as part of the ASCIA Immunodeficiency Strategy for Australia and New Zealand in consultation with relevant patient/carer support organisations, AusPIPS, IDFA and IDFNZ,

The main purpose of the ASCIA IEI/PID Clinical Care Standard is to assist in benchmarking and advocating for optimal services and treatment, and to guide resource development and updates.

Minor updates have been made to the following documents, which are linked to in the Clinical Care Standard:

ASCIA Treatment Summary for Patients on Immunoglobulin Therapy (previously called the ASCIA Transfer Care Plan)

ASCIA SCIg Treatment Plan

ASCIA SCIg Travel Plan

ASCIA will also be developing a Clinical Care Standard for hereditary angioedema (HAE) in consultation with the patient/carer support organisation HAE Australasia,

Ten paediatric hospitals across five states have partnered with the National Allergy Centre of Excellence (NACE), hosted at Murdoch Children’s Research Institute (MCRI), to be the first globally to introduce a nation-wide peanut oral immunotherapy (OIT) program into mainstream care in Australia. 

Babies diagnosed with peanut allergy will be offered an OIT Program under a world-first model aiming to transform allergy care:

• Under the model, children will follow a carefully planned daily dosing schedule of peanut powder, taken at home, over two years.
• If successful, it is hoped that more hospitals and private allergy clinics will adopt the program, including in regional and remote areas.

The intention of the ADAPT OIT Program is to change the trajectory of Allergy Development via an Accelerated Pathway to Tolerance.  The program aims to change the way the most common food allergy among Australian school aged children is treated from strictly avoiding peanut in diets, to safely building a tolerance to the allergen and hopefully achieving remission.

The free program is only available to children under 12 months, diagnosed with peanut allergy, and who are receiving care by a clinical immunology/allergy specialist (allergist) at one of the participating hospitals listed below. The program capacity at each hospital will depend on demand and resources. Those eligible will follow a carefully planned daily dosing schedule of peanut powder, taken at home, over two years.

Unlike OIT clinical trials, the treatment would be offered as a new standardised model of care. This will be the first peanut allergy treatment program offered in Australian hospitals outside of a clinical trial setting.

The NACE, which is funded by the Federal Government, will lead an evaluation study to analyse the program’s results. If successful, it’s hoped more hospitals and private allergy clinics will then adopt the program, including in regional and remote areas. Like all treatments, OIT may not be suitable for everyone and it does not guarantee remission.

While on the program, children will be prescribed an Australasian Society of Clinical Immunology and Allergy (ASCIA) Action Plan for Anaphylaxis https://www.allergy.org.au/hp/anaphylaxis/ascia-action-plan-for-anaphylaxis and adrenaline injector. Families will receive a comprehensive education pack and have access to an allergist on-call.

Eligible babies will be referred into the program by their allergist from participating hospitals:

• Victoria - The Royal Children’s Hospital
• Western Australia - Perth Children’s Hospital and Fiona Stanley Hospital
• Queensland - Queensland Children’s Hospital
• South Australia - Women’s and Children’s Health Network
• New South Wales - Sydney Children’s Hospital, Randwick; The Children’s Hospital at Westmead;  John Hunter Children’s Hospital, Newcastle; Campbelltown Hospital; Royal Prince Alfred Hospital, Camperdown.

The NACE website includes:

• A media release about the ADAPT OIT Program - https://www.nace.org.au/knowledge-hub/news/2024/babies-offered-peanut-allergy-treatment-program-under-world-first-national-model/
• Information about eligibility, what is OIT and how the program works - https://www.nace.org.au/research/food-allergy/
• FAQ for families - https://www.nace.org.au/knowledge-hub/news/2024/faq-adapt-oit-program/

For more details email This email address is being protected from spambots. You need JavaScript enabled to view it.

Information about oral immunotherapy (OIT) for food allergy is also available on the ASCIA website:

• Patients and Carers - https://www.allergy.org.au/patients/allergy-treatments/oral-immunotherapy-for-food-allergy
• Health Professionals - https://www.allergy.org.au/hp/papers/ascia-oral-immunotherapy-for-food-allergy - updated July 2024

The Australasian Society of Clinical Immunology and Allergy (ASCIA) has lodged an application to the Medical Services Advisory Committee (MSAC) for a Medical Benefits Schedule (MBS) item number for supervised oral food challenges. The content of this application has been developed based on references from recent literature searches, existing ASCIA information and expert consensus. Input was obtained through collaboration with an expert working group comprising clinical immunology/allergy specialists from paediatric and adult services in Australia.  This application has been made as part of the National Allergy Council projects that are assigned to ASCIA. 

MSAC meetings occur 3 times per year, in April, August and December and the due date for this application was 26 July 2024, to be considered at the MSAC meeting in December 2024,  

Although the application has been officially lodged, opportunities still exist for ASCIA to provide MSAC with additional information as it becomes available, or  relevant updates to the information already submitted. We also anticipate that there will be an opportunity for comments to be made in response to a public consultation process,

Supervised oral food challenges are an important way to significantly improve the diagnosis, treatment of management of Australians with food allergy, for the following reasons:

• There is substantial clinical relevance and justification for oral food challenges as outlined in the ASCIA Position Paper - Oral Food Allergen Challenges, which is available open access on the ASCIA website.
• Current access to oral food challenges in public hospital clinics is limited as shown in recent ASCIA workforce surveys, mainly due to long waiting times. This means that management of patients with food allergy needs to be shared by public clinics and private practice. This includes oral food challenges which are an integral part of food allergy diagnosis. Current MBS consultation items are not sufficient to cover oral food challenges.
• Oral food challenges are limited in private practice without an MBS item number, as shown in recent ASCIA workforce surveys, mainly due to costs for patients. With current cost of living issues, it is not feasible for most families to pay significant out of pocket fees for oral food challenges.

Food allergen challenges are standard of care in managing food allergy worldwide. The introduction of an MBS item number for oral food challenges in Australia would greatly assist in reducing wait times, and therefore allow more timely and equitable access to oral food challenges. This would lead to significant cost savings for families and the health system, as well as considerable quality of life benefits.

The Independent Health and Aged Care Pricing Authority has announced Activity Based Funding (ABF) from 1 July 2024 for home delivered subcutaneous immunoglobulin (SCIg) infusion therapy.(2.11) in its Tier 2 Non-Admitted Services Compendium 2024–2025.

This means that SCIg infusion therapy performed by the patient in their own home without the presence of a healthcare provider may now be counted as a non-admitted patient service event, provided there is documentation of the procedures in the patient’s medical record. 

ASCIA acknowledges the advocacy work of patient/carer support organisations AusPIPS and IDFA which have contributed to improved funding of SCIg, including this latest development in ABF.

Example:

A patient self-administers SCIg infusion therapy in their own home 3 times a week, there were no disruptions or changes to this routine for the week and each procedure was documented in the patient’s medical record.

Outcome: one non-admitted patient service event would be counted for each procedure on the day it was delivered and classified to 10.22 Subcutaneous immunoglobulin (SCIg) infusion therapy - home delivered.

Example:

A patient performs SCIg infusion therapy every day in their own home. Within the month, the patient’s hand dexterity worsens requiring assistance to perform the SCIg infusion therapy. A nurse from the clinic makes a home visit the following day to assist the patient with the administration of SCIg infusion therapy and the procedure is documented in the patient’s medical record.

Outcome: The visit by the nurse and the SCIg infusion therapy occur on the same day and would therefore be counted as one non-admitted patient service event and classified to 10.22 Subcutaneous immunoglobulin (SCIg) infusion therapy – home delivered.

More information is available here: 

https://www.ihacpa.gov.au/resources/tier-2-non-admitted-services-2024-25 - this webapge includes links to the following documents:

Tier 2 Non-Admitted Services Compendium 2024–25419.15 KB - 2.11. Counting of home delivered renal dialysis, nutrition procedures, subcutaneous immunoglobulin infusion therapy and home ventilation - Page 23

Tier 2 Non-Admitted Services Definitions Manual 2024–251.59 MB - 10.22 Subcutaneous immunoglobulin (SCIg) infusion therapy - home delivered - Page 41

Arrotex Pharmaceuticals has advised that the sale and distribution of Anapen® Junior 150 and Anapen® 300 adrenaline (epinephrine) injector devices, used for the emergency treatment of anaphylaxis are to cease in Australia:

• Anapen® 300 will be available until end July 2024.
• Anapen® Junior 150 will be available until end September 2024.

Anapen® 500 and Anapen® Trainer devices will remain available and Arrotex is committed to the continued supply of Anapen® 500 as the only 500mcg adrenaline injector device available on the PBS.  

Hard plastic Anapen® cases for Anapen® 500 devices are now available free of charge for patients from their pharmacist. To view the case go to https://anapen.com.au/anapencase/  Arrotex will also have these cases available on their exhibition stand at the ASCIA 2024 Conference in Adelaide.

The decision to discontinue Anapen® Junior 150 and Anapen® 300 is due to lack of demand for a second brand of adrenaline autoinjector for the 150mcg and 300mcg strengths. This decision is voluntary and not related to any quality, safety or efficacy issues regarding the products. Patients with prescriptions for either product can be substituted at pharmacy level with appropriate training (Anapen® Junior 150 and Anapen® 300 are ‘a’ flagged to EpiPen Junior and EpiPen). More information is available at www.anapen.com.au  

The following ASCIA anaphylaxis guidelines and authority form have been updated due to a change in supply of Anapen^® adrenaline injector devices in Australia:

• ASCIA Guidelines - Adrenaline (Epinephrine) Injector Prescription and ASCIA Guidelines - Acute Management of Anaphylaxis – have both been updated to only include EpiPen® Jr (150 microgram), EpiPen® (300 microgram) and Anapen® 500 (500 microgram) devices.
• Request for initial adrenaline injector to be provided on PBS Authority prescription by clinical immunology/allergy specialist - this form has been updated to include Anapen^® 500, as well as EpiPen® and EpiPen® Jr, and to make the form easier to find on the ASCIA website.

A study on hereditary angioedema (HAE) prevalence and satisfaction with prophylaxis in South Australia has been published in the World Allergy Organization Journal (2024) 17:100918 http://doi.org/10.1016/j.waojou.2024.100918 by Alexander Troelnikov, Karen Milburn, Pravin Hissaria, Thanh Thao (Adriana) Le, and William Smith. 

This study was funded by an AIFA (Allergy and Immunology Foundation of Australasia) Primary Immunodeficiency Research Grant that was awarded in 2020.

Results from the published study include:

• Identification of 35 people with HAE in South Australia, yielding a population prevalence of 1 in 52,400, in line with average established international prevalence.
• HAE was identified in 4 patients of Indigenous Australian heritage.
• Seventeen of 31 adult patients completed an additional multi-questionnaire survey, revealing overall satisfactory disease control.
• Most common prophylactic therapies were danazol, lanadelumab, and subcutaneous C1 inhibitor.
• Many patients (mostly male) with milder disease had responded well to low-dose danazol with good tolerance and have continued to use it, whereas patients with higher disease burden are now using newer therapies, and overall satisfaction with current prophylaxis is high.

To support AIFA allergy and immunology research grants go to https://www.allergyimmunology.org.au/donate

Research projects funded by AIFA grants are listed at https://www.allergyimmunology.org.au/projects/projects#latest

The Therapeutic Goods Administration (TGA) is seeking public comment on proposed reforms to Part 5 of the Therapeutic Goods Regulations 1990. The proposed reforms are aimed at strengthening and modernising the legislative framework for the examination, testing and analysis of therapeutic goods.

The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing conducted by the TGA assesses compliance with quality and performance standards for the therapeutic goods. This testing provides the TGA, as the regulator, with scientific data to inform and support regulatory decisions and actions, ensuring the safety of therapeutic goods for Australian consumers.

The proposed reforms will impact the procedures for examination, testing and analysis of goods that we conduct within the regulatory framework.

The TGA is seeking consideration of proposed reforms to Part 5 to ensure this improvement activity strikes the right balance of safety for consumers and patients without imposing unnecessary regulatory burden on industry. The TGA understands that changes to legislation can impact how businesses make decisions. Your engagement is critical to ensuring that these reforms are fit for purpose.

The complete consultation, including your opportunity to provide feedback, can be found at https://consultations.tga.gov.au/medical-devices-and-product-quality-division/reforming-australias-therapeutic-goods-testing-reg

The consultation closes on 18 August 2024.

Nestlé Health Science has informed ASCIA that only the updated recipe of Alfamino® amino acid formula for infants will be available on the Pharmaceutical Benefits Scheme (PBS) from 1 August 2024. Since 1 September 2023, both the newer and older recipe Alfamino® products have been available on the PBS. 

The new recipe Alfamino® will also be listed on Pharmac as of 1 August 2024. Both formulations will be listed on Pharmac for a few months to assist with availability while supply changes from Alfamino® to Alfamino® with the inclusion of HMOs. This will also allow time for infants to transition to the new formulation.

The recipe of Alfamino® was updated in 2023 with the addition of two Human Milk Oligosaccharides (HMOs) 2’-FL and LNnT, which are structurally identical to those HMOs found in breastmilk.  From 1 August 2024, the older formulation of Alfamino® infant formula will be deleted, which means that prescribers should only use the item codes (listed below) for the updated Alfamino® product.

PBS item codes for Alfamino®400g with HMOs

The updated Alfamino® recipe (with HMOs) introduced in 2023 will continue to be available on the PBS, using the item codes below:

• 13615N - Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides with 2-fucosyllactose and lacto-N-neotetraose powder for oral liquid, Alfamino 400 g
• 13627F - Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides with 2-fucosyllactose and lacto-N-neotetraose powder for oral liquid, Alfamino 400 g

The older formulation of Alfamino® infant formula will be deleted from the PBS on 1 August 2024. There will be a supply only period, which will enable dispensing the product for existing prescriptions but no new prescriptions can be written for the below item numbers as of 1 August 2024.

Further information is available here: 

ASCIA Notification Alfamino and PBS update254.23 KB

Health professionals can also contact Nestlé Health Science for further information.