3 April 2024 - The agenda for the July 2024 PBAC meeting is now available.

For the time being, there are only 32 agenda items in version 1; 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.

The 59 submissions are for:

• 30 medicines
• 0 gene therapies
• 1 medicinal preparation
• 1 vaccine

The 32 submissions are comprised on 29 initial submissions and 3 resubmissions.

As we read it, the agenda is for:

• 14 new medicines
• 1 new vaccine
• 0 new gene therapy
• 0 new biosimilar medicine
• 4 new indications
• 1 new combination product
• 2 restriction changes
• 3 new strengths
• 5 new formulations
• 0 relativity change
• 2 reviews
• 0 price review

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

• Oncology (7 submissions)
• Obstetrics/Gynaecology (5 submissions)
• Haematology (4 submissions)
• Immunology (4 submissions)

Bayer, Ipsen, Janssen, Pfizer, Roche and Takeda are the leading applicants with two submissions. There is one new applicant (AA-Med).

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.

• Elranatamab (multiple myeloma)
• Faricimab (macular oedema)
• Fruquintinib (colorectal cancer)
• Iptacopan (paroxysmal nocturnal haemoglobinuria)
• Lecanemab (Alzheimer's disease)
• Linzagolix acetate (uterine fibroids)
• Odevixibat sesquihydrate (cholestasis)
• Zilucoplan (myashenia gravis)

Some insights:

• The high profile submissions are clearly those for lecanemab (Leqembi) for the treatment of patients with early Alzheimer's disease, comprising mild cognitive impairment due to Alzheimer disease, prodromal Alzheimer's disease, or mild Alzheimer's disease dementia, nirsevimab (Beyfortus) for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season; and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season and respiratory syncytial virus vaccine (adjuvanted) (Arexvy) for the prevention of RSV in patients aged 60 years and over.
• There are two submissions seeking a review of an existing Deed of Agreement: nivolumab/ipilumumab for mesothelioma and zanubrutinib for Waldenström's macroglobulinaemia.
• The proposed presentations for fruquintinib are incorrect; expect the publication of version 2 very soon.
• One submission is associated with a co-dependent technology (ivosidenib). The MSAC will considered the corresponding application in August 2024.
• There is no submission for a new biosimilar medicine or a new gene therapy
• There is no sign of a resubmission for nivolumab/ipilimumab and pembrolizumab for multiple indications (initial submission was deferred in December 2023)

Read PBAC agenda