29 March 2023 - The agenda for the July 2023 PBAC meeting is now available.

For the time being, there are 37 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.

The 37 submissions are for:

• 34 medicines
• 3 gene therapies
• 0 medicinal preparations
• 0 vaccines

As we read it, the agenda is for:

• 13 new medicines
• 0 new vaccines
• 1 new gene therapy
• 2 new biosimilar medicines
• 12 new indications
• 2 new combination products
• 3 restriction changes
• 1 new strength
• 1 new formulation
• 2 reviews

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

• Immunology (9 submissions)
• Oncology (6 submissions)
• Haematology (5 submissions)
  

Eli Lilly is the leading applicant with four submissions. This is the first time Eli Lilly has lead the submission count for a given PBAC meeting. AstraZeneca, Janssen, Juno Pharmaceuticals, Novartis, Pfizer, Sanofi and Sun Pharma all lodged two submissions.

There is one new applicant:

• Alnylam Pharmaceuticals - one submission (patisiran sodium) for certain patients with amyloidosis

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.

• Atogepant (migraine)
• Daprodustat (Jesduvroq)
• Foslevodopa with foscarbidopa (Parkinson's disease)
  
• Lumacaftor with ivacaftor (cystic fibrosis)
• Mirikizumab (ulcerative colitis)
• Olipudase alfa (Niemann-Pick disease)
• Rimegepant sulphate (migraine)
• Sacituzumab govitecan (breast cancer)
• Secukinumab (hidradenitis suppurativa)
• Selpercatinib (non-small-cell lung cancer)
• Tagraxofusp (blastic plasmacytoid dendritic cell neoplasm)

Some insights:

• The PBAC will consider a resubmission from AstraZeneca for acalabrutinib (Calquence) for patients with chronic lymphocytic leukaemia/small cell lymphoma for the fourth time; it was lasted considered by the PBAC in December 2022.
• The PBAC will consider submissions for two new technologies for patients with amyloidosis; patisiran sodium (Onpattro) and tafamidis (Vyndamax); while the former is for patients with polyneuropathy, the latter is for patients with cardiomyopathy.

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