22 November 2023 - The agenda for the March 2024 PBAC meeting is now available.

For the time being, there are 59 agenda items; all appear to be submissions from the pharmaceutical industry. The agenda will no doubt be revised over time with the addition of some medicines rejected or deferred by the PBAC earlier this month. This is the highest number of submissions since the March 2022 meeting (66 submissions).

The 59 submissions are for:

• 52 medicines
• 0 gene therapies
• 4 medicinal preparations
• 3 vaccines

The 59 submissions are comprised on 50 initial submissions and 9 resubmissions.

As we read it, the agenda is for:

• 10 new medicines
• 1 new vaccine
• 0 new gene therapy
• 3 new biosimilar medicines
• 18 new indications
• 2 new combination products
• 9 restriction changes
• 1 new strength
• 14 new formulations
• 1 relativity change
• 0 review
• 0 price review

As usual, the agenda is dominated by technologies for just a few therapeutic areas:

• Immunology (19 submissions)
• Oncology (7 submissions)
• Paediatrics (6 submissions)

AstraZeneca, Pfizer and Novartis are the leading applicants with four submissions. AbbVie, Amgen, Bayer, Nutricia and UCB all lodged three submissions.

We estimate the following submissions have been lodged under the TGA-PBAC parallel processes insofar as they have not yet been approved by the TGA. This may not be 100% correct given the limited level of detail that is currently in the public domain.

• Adalimumab (immune-mediated inflammatory disease)
• Aflibercept (macular oedema)
• Aflibercept (age-related macular degeneration)
• Atezolizumab (multiple cancers)
• Bimekizumab (psoriatic arthritis)
• Bimekizumab (ankylosing spondylitis)
• Bimekizumab (axial spondyloarthritis)
• Brentuximab vedotin (Hodgkin's lymphoma)
• Bulevirtide acetate (hepatitis D)
• Cabozantinib maleate (renal clear cell carcinoma)
• Dabrafenib mesylate (brain cancer)
• Trametinib dimethyl sulphoxide (brain cancer)
• Dapagliflozin propanediol monohydrate with sitagliptin phosphate monohydrate (type 2 diabetes mellitus)
• Elexacaftor with tezacaftor and ivacaftor and ivacaftor (cystic fibrosis)
• Etrasimod arginine (ulcerative colitis)
• Influenza vaccine (quadrivalent) (vaccination)
• Irinotecan hydrochloride trihydrate (liposomal) (pancreatic cancer)
• Larotrectinib sulphate (non-small-cell lung cancer, sarcoma)
• Lebrikizumab (atopic dermatitis)
• Pegcetacoplan (age-related macular degeneration)
• Oestradiol hemifumarate with norethisterone acetate and relugolix (endometriosis)
• Respiratory syncytial virus vaccine (vaccination)
• Sodium zirconium cyclosilicate hydrate (hyperkalaemia)
• Ustekinumab (multiple diseases)

Some insights:

• There are two new applicants: Generic Health and Apellis Pharmaceuticals
• This meeting is remarkable for the high number of submissions for a paediatric patient population (n=6)
• The proposed new indication for adalimumab (Humira) for the treatment of patients with 'immune-mediated inflammatory disease' is unclear as adalimumab has not been approved by any major regulatory agency for this patient population.
• The submission to list an new subcutaneous formulation of atezolizumab for patients with multiple cancers is noteworthy insofar as it is yet to be approved in the US and Europe (positive CHMP opinion earlier this month)
• Dapagliflozin propanediol monohydrate with sitagliptin phosphate monohydrate (Sidapvia) is yet to be approved by the FDA in the US and the European Commission in the European Union
• The agenda states the submission from Seqirus for influenza vaccine (quadrivalent) (Flucelvax Quad) for the
  prevention of influenza in patients aged 6 months and older is a resubmission. We have no record of the PBAC having considered a submission for Flucelvax Quad for use in this patient population.
• The submission to list a new biosimilar of ustekinumab (Wezlana) for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis is also very timely; Wezlana was approved by the US FDA on 31 October 2023.
• Two submissions are associated with a co-dependent technology (bulevirtide acetate and talazoparib tosylate). The MSAC will considered the corresponding applications in April 2024.

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