Information updates

Paxlovid® is PBS listed for treatment of COVID-19

Paxlovid® (nirmatrelvir/ritonavir tablets) is listed on the Pharmaceutical Benefits Scheme(PBS) from 1 May 2022, as a treatment for COVID-19. Adults can be prescribed PBS-subsidised Paxlovid® by their doctor or nurse practitioner if they have mild to moderate COVID-19 confirmed by a PCR or medically verified RAT, can start treatment within five days of symptom onset, and:  

  • they are 65 years of age or older, with two other risk factors for severe disease (as increasing age is a risk factor, patients who are 75 years of age of older only need to have one other risk factor); or they identify as Aboriginal or Torres Strait Islander origin, and are 50 years of age or older with two other risk factors for severe disease, or
  • they are moderately to severely immunocompromised.

Paxlovid® is not recommended for use in pregnant or breastfeeding women and in women of childbearing potential who are not using contraception. TGA product information on Paxlovid® is available here.

To prioritise Paxlovid® for patients at highest risk of developing severe COVID-19, prescribers should only prescribe Paxlovid®  in accordance with the PBS eligibility criteria, and are strongly discouraged from providing it via private prescription.

For more information read the PBS factsheet here.

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Allergic diseases and anaphylaxis funding announced in Federal Budget

pdfNAC and NACE statement 6 May 2022 

pdfNAC and NACE Media Release 30 March 2022: 

On behalf of Australians living with allergic diseases, the National Allergy Strategy, a partnership between the Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy & Anaphylaxis Australia (A&AA), and the Centre for Food & Allergy Research (CFAR), we would like to thank the Federal Government for the $26.9 million investment into allergy prevention and management announced as part of the Federal Government’s 2022 budget, that was announced on 29 March 2022.

This funding is in response to the 2019 bipartisan Parliamentary Inquiry into Allergies and Anaphylaxis, and the 24 recommendations in the Walking the allergy tightrope report, which highlighted the critical need for further investment to address this continuing public health challenge.

This investment will provide support to:

  • Enable the National Allergy Strategy to transition into the National Allergy Council (NAC), to develop and implement programs to increase access to care and provide education and support for health professionals, consumers and the community.
  • Fund evidence-based education and support programs that are developed and implemented by the Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy & Anaphylaxis Australia (A&AA), working as a partnership in the National Allergy Council.
  • Expand the Centre for Food & Allergy Research (CFAR) at the Murdoch Children’s Research Institute (MCRI) into the National Allergy Centre of Excellence (NACE), to increase and coordinate research throughout Australia on food allergies, as well as drug, vaccine, insect, and pollen allergies.

Establishing a National Allergy Council (NAC) is a natural progression of the highly valued and successful National Allergy Strategy.  The National Allergy Council will continue to be a partnership between the Australasian Society of Clinical Immunology and Allergy (ASCIA) and Allergy & Anaphylaxis Australia (A&AA), the leading medical and patient support organisations for allergy in Australia.

The Centre for Food & Allergy Research (CFAR) will expand to become the National Allergy Centre of Excellence (NACE). NACE will generate and synthesise the evidence base that underpins the activities of the proposed National Allergy Council (NAC), to ensure that Australia remains at the forefront of evidence-based management of allergic disease.

Working together, these organisations will deliver:

  • A shared care program to significantly cut wait times to see a specialist by at least 50 per cent and improve access to quality allergy care for all Australians, especially in rural and remote areas
  • The digital infrastructure for a National Allergy Registry and Biobank to facilitate precision medicine, allowing individualised allergy healthcare for children and adults. This would include a live anaphylaxis reporting system
  • A world-first National Allergy Clinical Trials Network to provide Australians with accelerated access to safe and effective allergy treatments.
  • Continued public health guidelines and prevention programs such as the successful ‘Nip allergies in the Bub’ program, which includes practical resources for parents and educational resources to support healthcare providers.
  • New clinical and research capabilities to enable Australia to maintain its world-leading status in allergy research and to answer the most important questions in allergy that will guide the way forward.

We greatly appreciate the support that the Australian Government has given for these critical initiatives. The National Allergy Strategy, ASCIA, A&AA and CFAR would like to thank:

  • The Australian Government, and Minister Hunt in particular, for investing in the health and wellbeing of the many Australians living with allergic diseases.
  • The Hon Trent Zimmerman MP (chair) and Dr Mike Freelander MP, (deputy chair) of the bipartisan Parliamentary Inquiry into Allergies and Anaphylaxis committee.
  • Dr Katie Allen MP, member of the of the bipartisan Parliamentary Inquiry into Allergies and Anaphylaxis committee for her tireless work in advocating for those living with allergic disease
  • The other Parliamentary Inquiry into Allergy and Anaphylaxis committee members Mr Tony Zappia MP, Mr Milton Dick MP, Ms Angie Bell MP, Mrs Lucy Wicks MP, Dr Fiona Martin MP and Ms Bridget Archer MP.

I also take this opportunity to thank:

  • ASCIA Presidents (current and past), ASCIA members, ASCIA staff, patients, carers and supporters, for their contributions to advocacy for allergic diseases since ASCIA was established over 30 years ago.
  • National Allergy Strategy co-Chairs (Dr Preeti Joshi - ASCIA and Maria Said - A&AA), and Manager (Sandra Vale), for their intense work on advocacy over the past few years.

We are entering very exciting times for allergic diseases and anaphylaxis in Australia.

We look forward to providing more information about the new National Allergy Council during the ASCIA 2022 Conference in September.

Jill Smith

CEO I Australasian Society of Clinical Immunology and Allergy (ASCIA)

This information has been adapted from www.health.gov.au/resources/publications/budget-2022-23-allergic-disease-and-anaphylaxis

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IFNAR1 deficiency and vaccines

The Australian Technical Advisory Group on Immunisation (ATAGI) has prepared a statement on IFNAR1 deficiency, which does not recommend any changes to the National Immunisation Program. ATAGI recommends that all people in Australia, including people of Tongan, Samoan, and Niuean heritage, continue to receive the MMR at 12 months of age and the MMR-V vaccine at 18 months of age, given that illness from wild-type measles and mumps infections is more severe in unvaccinated individuals, including those with undiagnosed IFNAR1 deficiency. People with IFNAR1 deficiency can safely receive the rotavirus vaccine and non-live vaccinations, including the influenza and COVID-19 vaccines. mmunisation against measles is a key objective for the health and wellbeing of all Australians.

pdfAttachment A ATAGI Statement IFNAR1 22 April 2022379.81 KB

The New Zealand Ministry of Health has also developed information which is available at https://www.health.govt.nz/our-work/preventative-health-wellness/immunisation/ifnar1-deficiency-information-healthcare-professionals.

IFNAR1 deficiency is a newly described specific immune deficiency associated with severe adverse events and death following vaccination with some live attenuated virus vaccines, including the MMR vaccine, the yellow fever virus vaccine, and potentially the live varicella vaccine, though disseminated varicella post vaccination has not been seen. MMR and MMRV vaccines are available under the National Immunisation Program for all children at 12 and 18 months of age respectively.

A recent study from New Zealand and Australia described 7 cases of children who were found to have this specific immune deficiency presenting for medical attention with a hyperinflammatory symptom complex of fever, rash, shock, and hepatosplenomegaly, or symptoms of encephalopathy within 1 week of MMR vaccination. The research study can be accessed here: https://rupress.org/jem/article/219/6/e20220028/213170/A-loss-of-function-IFNAR1-allele-in-Polynesia 

Although the role of MMR vaccine is not clear in all cases, 4 out of the 7 children in the study died and 3 had significant ongoing neurodevelopmental morbidity. An earlier report described complications following yellow fever virus vaccination in an adolescent with the condition. No deaths of children have been reported in Australia with IFNAR1 deficiency.

Although extremely rare, affecting less than one in one billion people, IFNAR1 deficiency appears more common in people who have two parents of Tongan, Samoan, or Niuean heritage. It is estimated to affect 1 in every 6,450 people with parents of Samoan heritage. This roughly equates to one child born every two years in Australia.

It is important for health professionals to remain aware of the advice contained in the ATAGI statement when considering administering the MMR and MMRV vaccine for patients.

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A $10 screening test could have helped my ‘bubble’ baby

International Day of Immunology, April 29 | World Primary Immunodeficiency Week, April 22-29: 

Severe Combined Immune Deficiency (SCID) is a life-threatening condition where babies are born without a functional immune system. It gained global recognition in the 1970s due to a young boy called David Vetter, known as a ‘bubble boy’, who lived his short life inside sterile plastic bubbles to avoid infection. Now, a new immunodeficiency strategy for Australia and New Zealand outlines the important work that still needs to be done to address the group of illnesses that SCID belongs to.

Five days before Christmas 2020, at just 18 weeks of age, Isabelle began to turn blue and stopped breathing properly. Fortunately, she was already waiting in the Emergency Room where doctors were able to immediately assist and save her life. Identifying the underlying cause of Severe Combined Immune Deficiency (SCID), a very rare and life-threatening genetic disorder, was also a miracle. Without treatment, SCID babies are not likely to survive past their second birthday due to their inability to fight even simple infections.

“The hospital’s general paediatric doctor noticed Isabelle’s very low white blood cell count. Miraculously, the doctor had recently read a report on SCID, so the doctor happened to know the symptoms and immediately called the immunology specialist. Otherwise, being so rare, it could easily have not been picked up,” says Louise Grant, Isabelle’s Mum. “When everyone else was focusing on Isabelle’s heart and lungs, these doctors fortunately looked at her immune system too.” 

Due to her inability to fight infection, Isabelle was immediately isolated in a positive pressure room, spent 33 days in paediatric ICU recovering from the severe lung infection she had developed, and was then in and out of hospital for the first year of her life after receiving a Stem Cell Transplant from her dad as the donor. In the absence of routine newborn screening that is available in other countries, Isabelle will now have to live with lifelong secondary consequences of SCID, such as permanent hearing loss and developmental disabilities, due to the delay in diagnosis and treatment.

“I estimate that the cost to the health system of Isabelle’s medical treatment in those first few months alone would easily go into the millions. Her life-long disabilities even more. That does not even touch on the emotional cost to Isabelle and our family” says Louise. “It is incredibly frustrating that Isabelle’s condition is entirely treatable if caught very early and could have been picked up on the newborn screening test which she had done at birth, as part of the Government’s routine newborn screening program. It would cost less than $10 per baby to add SCID to this program.”

“While Isabelle is not in a physical bubble, for the past year our whole family has been living in isolation at home to protect her from infection, rigorously disinfecting everything, until her ‘new’ immune system develops,” explains Louise. “The impact on our lives is all consuming.” 

New national strategy for Primary Immunodeficiencies (PIDs)

The Australasian Society for Clinical Allergy and Immunology (ASCIA) has launched the ASCIA Immunodeficiency Strategy to improve the health and wellbeing of people living with primary immunodeficiencies and minimise the burden on individuals, carers, health services and the community. SCID is the most serious form of primary immunodeficiency disorders, a diverse group of more than 400 potentially serious, chronic illnesses that can lead to frequent or severe infections, swellings and autoimmune problems.

Two key issues outlined in the strategy are the importance of early diagnosis for all primary immunodeficiencies and newborn screening specifically for SCID.

“Due to their rarity, delays in diagnosis of primary immunodeficiencies are common. For infants and very young children with severe PIDs, this leads to severe complications due to recurrent infections and early death, despite being curable if treated in the first few months of life,” says Dr Melanie Wong, Co-Chair of the ASCIA Immunodeficiency Strategy. “That is why we are specifically calling for newborn screening of SCID. While screening is routinely performed in New Zealand, the United States, and in some European countries, it is not yet routinely available in Australia. It is only being trialled in NSW at present.”

“SCID is fatal in the first two years of life without definitive intervention. Early diagnosis is vital to allow curative treatment such as urgent haematopoietic stem cell transplantation (HSCT), also known as bone marrow transplant (BMT),” says Dr Theresa Cole, ASCIA President Elect and ASCIA Immunodeficiency Committee Chair. “Screening is also likely to be more cost-effective for the health system than the cost of prolonged hospital and intensive care unit admissions. It should be a health priority in Australia.” 

While individual PIDs are rare, taken together the overall prevalence is estimated to be 1 in 25,000 people[1]. It is estimated that 70-90% of people are still undiagnosed worldwide[2}. PIDs affect adults as well as children, with the majority occurring in adult life. This can have a serious impact on vital organs and long-term health. Australian (Victorian) data shows that in adults the average delay from symptom onset to diagnosis is 8 years and every year of diagnostic delay costs years in life expectancy[1].

30-year-old Hayley Teasdale has common variable immunodeficiency, which is an umbrella term for a broad spectrum of PIDs. The onset of her symptoms began in her early teens, but she was not diagnosed until she was 24, which has led to chronic health issues. Hayley is now pregnant with her first child and supports improved access to tests to diagnosis for PIDs, including genomic testing.

“I kept getting repeat infections, I was always sick. It started to wear down my body to the point that I kept fainting and could not leave the house or go to university. Living in a small rural town, it went undiagnosed. It was only when I moved to the city that I was referred to an immunologist,” said Hayley. “Like most people, I don’t know if my child will be predisposed to SCID. I would love to be able to get a SCID newborn screening done for peace of mind.”

For older children and adults where curative treatment is not possible, the recent expansion of genomic technologies has the potential to transform care, informing early diagnosis and the delivery of precision medicine. 

“Correct diagnosis will lead to appropriate treatment, including immunoglobulin replacement therapy (IRT), improving quality and length of life. This requires support from expert multi-disciplinary teams comprising of specialist medical, nursing and allied health professionals. With targeted resources, patients with PID can be spared unnecessary interventions, and instead utilise available medical treatments to maximise their opportunities to lead healthy and productive lives,” says Prof Jo Douglass, Co-Chair of the ASCIA Immunodeficiency Strategy.

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ASCIA Immunodeficiency Strategy launch

The ASCIA Immunodeficiency Strategy has been launched on Friday 29 April 2022, 9-9.45am AEST, during World Primary Immunodeficiency (PID) Week 22-29 April 2022 and on the International Day of Immunology, 29 April 2022.

A media release is now available here pdfASCIA IMMUNODEFICIENCY STRATEGY MEDIA RELEASE 2022-04-29226.29 KB or you can view it online at https://www.allergy.org.au/about-ascia/info-updates/ascia-immunodeficiency-strategy-launch-29-april-2022

Another media release that is specifically about HAE and how it relates to the ASCIA Immunodeficiency Strategy will be issued on 16 May 2022 to coincide with World HAE Day.

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Changes to IVIg supply

From 4 April 2022 the National Blood Authority (NBA) has advised that some patients will transition to another intravenous immunoglobulin (IVIg) product, who have the following conditions:

  • Pemphigus vulgaris
  • Pyoderma Gangrenosum
  • Bullous pemphigoid
  • Scleromyxedema
  • Immune thrombocytopenic purpura (ITP) adults only
  • Multifocal motor neuropathy (MMN)
  • Myasthenia gravis (MG)

Clinicians treating patients with the conditions listed above are aware of the change.

The NBA consulted with clinical experts through the National Immunoglobulin Governance Advisory Committee (NIGAC) to minimise the impact on the smallest number of patients possible.

Changing to another product can be stressful for the patient, clinician and hospital. Patients or carers should discuss any concerns with their treating clinician. Additionally, the NPS MedicineWise ViP Ig pamphlet Switching Immunoglobulin Products – What Should I know? What Can I Do? may be useful. More information is also available at www.blood.gov.au

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New and updated ASCIA anaphylaxis resources

A new ASCIA Fast Facts about adrenaline injectors is now available on the ASCIA website, following review by the ASCIA Anaphylaxis committee, as well as a new one page ‘How to give adrenaline injectors’ guide:

In response to recent feedback, questions 11 and 12 in the ASCIA Action Plans FAQ have been reworded slightly to make the information clearer, with the main updates highlighted in blue below.

Q 11: Who should have a green ASCIA Action Plan?

  • The green ASCIA Action Plan for Allergic Reactions has been developed for children or adults with a confirmed allergy to foods or insects, who have not been prescribed an adrenaline injector, as they are considered to be at low risk of anaphylaxis.
  • The dark green ASCIA Action Plan for drug (medication) allergy has been developed for children or adults with a confirmed allergy to drugs (medications). Adrenaline injectors are not usually prescribed for people with a drug allergy.
  • Allergies to foods, insects or drugs have the potential to result in anaphylaxis, and the green ASCIA Action Plans provide guidance on how to manage anaphylaxis if it occurs. 
Q 12: Should a person with allergic rhinitis (hay fever) have an ASCIA Action Plan for Allergic Reactions completed by their doctor or nurse practitioner?

No. ASCIA Action Plans are not required for people with allergy to environmental inhalant allergens such as grass pollen, dust mite, or mould, resulting in allergic rhinitis (hay fever). Whilst allergic rhinitis can cause uncomfortable symptoms, they are not potentially life-threatening allergic reactions and hence an ASCIA Action Plan is not required. However, if the allergic rhinitis affects an individual's asthma, their Asthma Action Plan should be followed. People with allergic rhinitis can be given an ASCIA Treatment Plan for Allergic Rhinitis for personal/home use.

The ASCIA Treatment Plan for Allergic Rhinitis is completed by a doctor, nurse practitioner or pharmacist, and is meant for the person or the parent, not for schools. Most schools do not play a role in the treatment and management of allergic rhinitis. However, when medication administration is required at school, parents should liaise with the school.

We hope that this new and updated information is useful.

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New ASCIA antibiotic allergy challenge resources

ASCIA is intending to apply for a Medicare Benefits Schedule (MBS) item number for antibiotic allergy challenges in 2022. In preparation for this application, a new ASCIA FAQ for patients and carers, as well as a new Consent Form, have been developed, following review by the ASCIA Drug Allergy committee. These resources are now available open access on the ASCIA website:

ASCIA Antibiotic Allergy Challenge FAQ New March 2022

ASCIA Consent Form - Antibiotic Allergy Challenges New March 2022

The new resources complement the ASCIA antibiotic allergy information for health professionals, which is also available on the ASCIA website www.allergy.org.au/hp/papers#p2 

We note that in the Federal Budget announcement on Tuesday 29 March 2022, it was stated that the Australian Government’s investment would include support to improve access to allergy diagnostics and to gather evidence to support MBS items for food and drug challenge testing. Our aim is for the new resources listed above to assist in this process.

To read more about the Federal Budget announcement go to www.allergy.org.au/about-ascia/info-updates/allergic-diseases-and-anaphylaxis-funding-announced-in-federal-budget

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