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Information updates

PBAC Meeting March 2024 - ASCIA Submissions

ASCIA has lodged five submissions on 24 January 2024 in support of applications for new or updated Pharmaceutical Benefits Scheme (PBS) listings of products (listed below) that are relevant to allergy and immunology. These applications are on the agenda of the  March 2024 Pharmaceutical Benefits Advisory Committee (PBAC) meeting. 

The submissions can be accessed at https://www.allergy.org.au/ascia-submissions

AMINO ACID FORMULA SUPPLEMENTED WITH PREBIOTICS, PROBIOTICS AND LONG CHAIN POLYUNSATURATED FATTY ACIDS
Neocate® Syneo - Oral powder 400 g 
NUTRICIA AUSTRALIA PTY LIMITED
Clinical indications:
Cows' milk protein enteropathy
Severe cows' milk protein enteropathy with failure to thrive
Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Cows' milk anaphylaxis
Severe intestinal malabsorption including short bowel syndrome
Eosinophilic oesophagitis To request Neocate® Syneo with new formulation continue to be listed on the PBS under the existing conditions.
Purpose of submission: To request Neocate® Syneo with new formulation continue to be listed on the PBS under the existing conditions
 
ANIFROLUMAB
Saphnelo® - Solution concentrate for I.V. infusion 300 mg in 2 mL vial
ASTRAZENECA PTY LTD
Clinical indication: Systemic lupus erythematosus (SLE)
Purpose of submission: Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required (Written) PBS listing for the treatment of severe SLE with a high level of disease activity despite standard therapy.
 
AVACOPAN
Tavneos® Capsule 10 mg
SEQIRUS (AUSTRALIA) PTY LTD
Clinical Indication: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) Resubmission to request a General Schedule Authority Required (STREAMLINED) listing for treatment of severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) in combination with rituximab or cyclophosphamide.
Purpose of submission: New PBS listing
 
DUPILUMAB
Dupixent® - Injection 200 mg in 1.14 mL pre-filled syringe, Injection 300 mg in 2 mL pre-filled syringe
SANOFI-AVENTIS AUSTRALIA PTY LTD
Clinical indication: Asthma
Purpose of submission: To request a Section 100 (Highly Specialised Drugs Program) Authority Required (Written) PBS listing for the treatment of uncontrolled severe asthma in patients aged 6 to 11 years.
 
MEPOLIZUMAB
Nucala® - Powder for injection 100 mg, Injection 100 mg in 1 mL single dose pre-filled pen
GLAXOSMITHKLINE AUSTRALIA PTY LTD
Clinical indication: Uncontrolled severe asthma
Purpose of submission: To request a change to the restriction level of the existing PBS listings for initial treatment from Authority Required (Written) to Authority Required (Telephone/Online), and for continuing treatment from Authority Required (Written) to Authority Required (STREAMLINED) for the treatment of uncontrolled severe asthma.
The submission also requested a change to the current requirement for treating with oral corticosteroids as part of optimised asthma therapy for the initial treatment of uncontrolled severe asthma.
 
 
 

How to provide input

Feedback is due by 31 January 2024 for the March 2024 PBAC meeting agenda: 

https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/march-2024-pbac-meeting

The PBAC welcomes input from patients, carers, health professionals, consumer groups or organisations and members of the public on medicines submitted for PBAC consideration. The PBAC considers these public consultation inputs when considering the clinical and economic evidence presented by the applicant.

  • Input can be submitted via the online survey.  A copy of the questions asked in the survey and additional guidance can be downloaded below under ‘Related’ to assist your preparation.
  • There is the option to upload a file with your submission. The preferred file types are PDF or Microsoft Word, however other file types will be accepted, provided they are no larger than 25mb. If your file is too large, or you wish to upload more than one file, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.
  • You can save and come back at any time to your response before the consultation close date.
  • Once you have submitted, a copy of your submission will be emailed to the contact email address provided.
 
 

This news item was issued on 7 December 2023 and updated on 25 January 2024 by Jill Smith, CEO of ASCIA, the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand.