Information updates

ASCIA members who are attending the ASCIA 2024 Conference are invited to attend the ASCIA Annual General Meeting (AGM) on Thursday 5 September 2024, 13.30-14.20, in Hall C, Adelaide Convention Centre, South Australia

Agenda

1. Review of ASCIA 2023 AGM Minutes 
   ASCIA AGM 2023 Minutes502.70 KB
   
2. President's Report - A/Prof Theresa Cole, ASCIA President
3. Financial Report* - Dr Michael O'Sullivan, ASCIA President Elect 
4. Council Elections
5. Closing comments* - A/Prof Theresa Cole, ASCIA President

To access full ASCIA Financial Reports go to the ACNC website

Nomination forms for ASCIA Council positions are available here: 

ASCIA Director 
ASCIA Council Nomination 2024 DIRECTOR65.59 KB

ASCIA Area Representative(ACT, SA) 
ASCIA Council Nomination 2024 AREA REPRESENTATIVE61.08 KB

Chair, ASCIA Immunodeficiency Committee 
ASCIA Council Nomination 2024 COMMITTEE CHAIR57.88 KB 

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The Australasian Society of Clinical Immunology and Allergy (ASCIA) has lodged an application 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 

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

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.

Nestlé Health Science has informed ASCIA that supply of Alfaré^® extensively hydrolysed infant formula (400g) is being discontinued in Australia and will be deleted from the Pharmaceutical Benefits Scheme (PBS) on 1 August 2024. 

There will be a supply only period, which will enable health professionals to dispense the product for existing prescriptions, but no new prescriptions can be written for Alfaré® as of 1 August 2024. 

Nestlé Health Science amino acid formula products for infants (Alfamino^® and Alfamino^® Junior) continue to be available in Australia. For the latest details go to https://www.allergy.org.au/about-ascia/info-updates/update-on-alfamino-r-infant-formula-pbs-listings-1-august-2024 

There is an alternative extensively hydrolysed infant formula product available on the PBS to which parents can transition their infants, and this is included in the ASCIA Guide for Milk Substitutes in Cow’s Milk Allergy, which is on the ASCIA website https://www.allergy.org.au/hp/papers/guide-for-milk-substitutes-cows-milk-allergy

Further information is available here: 

ASCIA Notification Alfare Discontinuation159.48 KB

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

Alfaré^® is not sold in New Zealand, so this update is not applicable to New Zealand.