Information updates

In response to an application by CSL Seqirus to the Pharmaceutical Benefits Advisory Committee (PBAC), the Pharmaceutical Benefits Scheme (PBS) listing of Tavneos^® (avacopan) that was recommended by the PBAC in March 2024 has come into effect on 1 October 2024. This listing was supported by a submission from ASCIA.

The Authority PBS listing of Tavneos^® (avacopan) is for anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis.

Treatment Phase: Induction treatment Clinical criteria:

• The condition must be severe granulomatosis with polyangiitis; OR

• The condition must be severe microscopic polyangiitis, AND

• The condition must be active at the time of the first prescription for this drug per treatment cycle, AND

• Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease, AND

• Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug's approved Product Information, AND

• Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction.

A prescriber may apply for more than one induction treatment for their patient avacopan 10 mg capsule,

More information:

https://www.pbs.gov.au/medicine/item/14605Q 

PBS Listings 1 October 20243.31 MB

In response to an application by GSK to the Pharmaceutical Benefits Advisory Committee (PBAC) to remove the oral corticosteroid (OCS) requirement to qualify for biologics in uncontrolled severe asthma, the Pharmaceutical Benefits Scheme (PBS) OCS criteria change that was recommended by the PBAC in March 2024 has come into effect on 1 October 2024. This change was supported by a submission from ASCIA.

The change removes the OCS requirement under defining ‘optimised asthma therapy’ as part of the INITIATION criteria for Nucala^® (mepolizumab). The change aslo applies to other biologics (omalizumab, benralizumab and dupilumab) listed on the PBS for uncontrolled severe asthma.

The updated form is available at https://www.servicesaustralia.gov.au/pb075 

More information:

https://www.pbs.gov.au/medicine/item/14605Q 

PBS Listings 1 October 20243.31 MB

The ASCIA 2024 Conference was held from Tuesday 3rd to Friday 6th September 2024 at the Adelaide Convention Centre. This was a hybrid conference, which enabled virtual or in-person attendance, and on-demand viewing of sessions for all registered delegates for up to six months after the conference.

Congratulations to the Chair, Dr Jovanka King, and her committee on organising a highly successful event with an outstanding program, which attracted a record high number of 712 delegates including:

• 518 in-person (73%)
• 193 virtual (27%)

This was in addition to staff and representatives from 36 sponsor/exhibitor organisations. 

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Shingrix^®  is a varicella zoster virus recombinant vaccine that can provide protection from herpes zoster (shingles) and post-herpetic neuralgia (long-term nerve pain). 

Funding of Shingrix from 1 November 2023 was announced by the hon Mark Butler (Minister for Health and Aged Care) on Sunday 8^th October 2023.  The extended vaccine eligibility for 'high/medium risk' immunocompromised individuals iwill be considered at the November 2023 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), so an announcement about this will be made after the transition from Zostavax to Shingrix on 1 November 2023.

ASCIA made a submission in January 2023  to support the PBS listing of Shingrix.

For details refer page 22 - https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/november-2023-pbac-meeting  

From 1 November 2023 funding of Shingrix will be available for:

1. All Australians over 65 (and over 50 for First Nation Australians), which includes all immunocompromising conditions above those ages.

2. Immunocompromised adults aged 18 years and over with the following medical conditions;  haemopoietic stem cell transplant, solid organ transplant, haematological malignancy and advanced or untreated HIV.

https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/shingles-vaccine-now-free-for-nearly-5-million-australians

ASCIA Oral Immunotherapy (OIT) for Food Allergy Frequently Asked Questions (FAQ) for patients and carers has been updated to include more information about safety concerns. The updated FAQ is available on the ASCIA website https://www.allergy.org.au/patients/allergy-treatments/oral-immunotherapy-for-food-allergy

The additions to Q 6 (highlighted below in bold) have been made in response to concerns about:

• Exercising soon after OIT doses, as this increases the risk of allergic reactions (including anaphylaxis).
• Other factors that increase the risk of allergic reactions (including anaphylaxis).

Q 6: Are there any safety concerns about OIT for food allergy?

Safety concerns about food OIT include:

• People on food OIT tend to have more allergic reactions overall than people who are avoiding their allergen, due to allergic reactions caused by the OIT itself.
• People on food OIT can still have allergic reactions due to accidental exposure to food allergens.
• Food OIT may make eosinophilic oesophagitis (EoE) worse, or EoE can develop in patients who did not have EoE prior to food OIT.
• Exercise after an OIT dose can increase the risk of allergic reactions (including anaphylaxis). Doses should be given when a person can rest and be observed by a parent/guardian for at least 2 hours.
• Co-factors such as infections, menstruation, poorly controlled asthma, allergic rhinitis and lack of sleep can also increase the risk of allergic reactions (including anaphylaxis) from an OIT dose.

Another addition is "Impact on daily life" to Q 5 as highlighted below in bold.

Q 5: Is OIT a cure for food allergy?

Current food OIT methods are not a cure for food allergy. Any potential benefits of food OIT need to be considered against the following issues to decide if there is likely to be an overall benefit of OIT:

• Possible side effects such as allergic reactions, including severe allergic reactions (anaphylaxis).
• Impact on daily life, time commitment required and cost of OIT.

ASCIA Guidelines for IVIg Replacement Therapy Infusion Rates and Adverse Reactions Guid

Shingrix Vaccine to Prevent Shingles - September 2024 Update

New ASCIA Clinical Care Standard for Inborn Errors of Immunity (IEI)/ Primary Immunodeficiencies (PID) 

New ASCIA Sjögren’s Disease FAQ for patients and carers

New Activity Based Funding for subcutaneous immunoglobulin (SCIg) therapy

New treatment for severe lupus listed on PBS 1 July 2024

New Australian hereditary angioedema (HAE) publication

ASCIA Quicklinks - developed to improve access to ASCIA website information using QR codes

Recent ASCIA website updates that are relevant to anaphylaxis and allergy include:

ASCIA Oral Immunotherapy (OIT) for Food Allergy Frequently Asked Questions (FAQ) for patients and carers - updated to add statements about impact on daily life and factors that can increase the risk of allergic reactions (including anaphylaxis)

New ASCIA Anaphylaxis Refresher Training video – developed to provide training which is accessible and hands-free learning that takes around 16 minutes to watch. Feedback is welcome by mid October 2024 as minor updates will be made at the end of next month.

New ASCIA Management Summary for Allergic Conditions - developed for health professionals to complete, to support continuity of care including transition from paediatric to adult medical care.

ASCIA Anaphylaxis Checklist for Young Adults - updated to make it easier to read and to include a link to Allergy 250K for young adults.

How to position a person having anaphylaxis - updated to include new ASCIA infographic showing how to position a person when adrenaline is given.

ASCIA Quicklinks - developed to improve access to ASCIA website information using QR codes.

ASCIA Anaphylaxis Facts for Parents and Carers – updated to include current information and make it easier to read.

New peanut allergy treatment program for babies in Australia - ten paediatric hospitals across five states have introduced a global first nation-wide peanut oral immunotherapy (OIT) program.

ASCIA application for MBS item for supervised oral food challenges - ASCIA has lodged an application for an MBS item number to improve access to supervised oral food challenges.

ASCIA anaphylaxis e-training reports - for the first time since ASCIA anaphylaxis e-training was introduced in 2010, reports have been developed based on mandatory feedback surveys. 

ASCIA Guidelines - Adrenaline (Epinephrine) Injector Prescription and ASCIA Guidelines - Acute Management of Anaphylaxis - updated to include EpiPen® Jr, EpiPen® and Anapen® 500 devices.

Request for initial adrenaline injector to be provided on PBS Authority prescription by clinical immunology/allergy specialist - updated to make the form easier to find on the ASCIA website.

ASCIA Adverse Reactions to Complementary and Alternative Medicine FAQ - updated to include information about allergic reactions to Andrographis paniculata.

ASCIA Guide for Milk Substitutes in Cow’s Milk Allergy - updated due to Alfaré^® extensively hydrolysed formula being discontinued in Australia and removed from the PBS from 1 August 2024.