Information updates

PBAC Meeting March 2023  

ASCIA has lodged four submissions on 20 January 2023 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 2023 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  The submissions can be accessed at www.allergy.org.au/ascia-reports#s1

AMINO ACID SYNTHETIC FORMULA SUPPLEMENTED WITH LONG CHAIN POLYUNSATURATED (LCP) FATTY ACIDS (EleCare® LCP) - Abbott Australasia Pty Ltd 
Oral powder 400g
Clinical indications: Cow's milk anaphylaxis, severe cow's milk protein enteropathy with failure to thrive, combined intolerance to cow's milk protein, soy protein and protein hydrolysate formulae, cow's milk anaphylaxis, proven combined immunoglobulin E (IgE) mediated allergy to cow's milk protein and soy protein, severe intestinal malabsorption including short bowel syndrome.
Proposed change to PBS listing: To request that EleCare LCP with new source of docosahexaenoic acid (DHA) continue to be listed on the PBS under the current conditions.
 
ANIFROLUMAB (Saphnelo®) - AstraZeneca Pty Ltd
Solution concentrate for I.V. infusion 300 mg in 2 mL vial
Clinical indication: Systemic lupus erythematosus (SLE)
Proposed new PBS listing: Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required (written) listing for the treatment of severe SLE with a high degree of disease activity despite standard therapy.
 
BUDESONIDE (Jorveza®) - Dr Falk Pharma Australia Pty Ltd
Tablet 500 micrograms and tablet 1 mg (orally disintegrating)
Clinical indication: Eosinophilic oesophagitis (EoE)
Proposed change to PBS listing: To request PBAC advice regarding the number of biopsies to confirm eligibility for initial treatment; removal of the histological assessment to determine eligibility for continuing treatment; and an expansion to the treatment criteria to include physicians or surgeons experienced in the diagnosis and management of EoE.
 
VARICELLA ZOSTER VIRUS RECOMBINANT VACCINE (Shingrix®) - GlaxoSmithKline Australia Pty Ltd
Injection [1 vial] & adjuvant substance diluent [0.5 mL vial]
Clinical indication: Prevention of herpes zoster and post-herpetic neuralgia
New PBS listing:  Resubmission to request a National Immunisation Program listing for the prevention of herpes zoster and post-herpetic neuralgia in:
  • Adults 65 years of age with ongoing catch-up for adults over 65 years of age.
  • Aboriginal and Torres Strait Islander adults 50 years of age with ongoing catch-up for adults over 50 years of age. 

Providing input

Feedback is due by 25 January 2023 at https://ohta-consultations.health.gov.au/ohta/pbac-march-2023

The PBAC considers these public consultation inputs when considering the clinical and economic evidence presented by the applicant (sponsor). Consultation input for items to be considered by the PBAC in March 2023 can be submitted via the online survey on the Office of Health Technology Assessment Consultation Hub. Questions in the survey focus on issues such as:

  • Unmet needs or challenges around current treatment
  • Health or quality of life outcomes that are considered important
  • Expected benefits of the medicine
  • Side effects - what is manageable and what is not
  • Costs associated with current treatment

 

This news item was issued on 9 January 2023, and updated on 20 January 2023 by Jill Smith, CEO of the Australasian Society of Clinical Immunology and Allergy (ASCIA). ASCIA is the peak professional body for clinical immunology and allergy in Australia and New Zealand. 

 

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