27 July 2022 - The agenda for the November 2022 PBAC meeting is now available.

For the time being, there are 40 agenda items (37 industry submissions). The agenda will no doubt be revised over time with the addition of some medicines rejected earlier this month.

The 37 submissions are for:

• 32 medicines
• 3 medicinal preparations
• 1 gene therapy
• 1 vaccine

As we read it, the agenda is for:

• 12 new medicines
• 1 new vaccine
• 1 new biosimilar medicine
• 12 new indications
• 2 new combination products
• 3 restriction changes
• 6 new formulations

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

• Immunology (8 submissions)
• Oncology (8 submissions)
• Haematology (5 submissions) - 4 of the 5 are for cancer

AstraZeneca and BMS have both lodged three submissions. There are no new applicants.

We estimate the following 10 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.

• Avatrombopag maleate
• Deucravitinib
• Fremanezumab (new indication)
• Lenacapravir sodium
• Mavacamten
• Mobocertinib succinate
• Pembrolizumab (cervical cancer)
• Pneumococcal polysaccharide conjugate vaccine (20 valent, adsorbed)
  
• Polatuzumab vedotin
• Upadacitinib monohydrate (axial spondyloarthritis)

Some insights

• Deucravitinib and lenacapravir sodium have not yet been registered by the FDA or the EMA/EC.
• Mavacamten is presented as 2.5 mg, 5 mg, 10 mg & 15 mg capsules. Keep an eye out for version 2 of the agenda any day now.
• Selumetinib sulphate (Koselugo) will be the first medicine to be considered by the PBAC for patients with neurofibroma.

Read agenda for November 2022 PBAC meeting