23 November 2022 - The agenda for the March 2023 PBAC meeting is now available.

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

For the time being, there are 54 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 54 submissions are for:

• 44 medicines
• 1 gene therapy
• 7 medicinal preparations
• 2 vaccines

As we read it, the agenda is for:

• 8 new medicines
• 1 new vaccine
• 0 new biosimilar medicine
• 21 new indications
• 3 new combination products
• 7 restriction changes
• 1 new strength
• 12 new formulations
• 1 review

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

• Oncology (13 submissions)
• Immunology (8 submissions)
• Nutrition (7 submissions)

AstraZeneca is the leading applicant with five submissions. Bayer, Cortex Health, Juniper Pharmaceuticals, Merck/MSD & Vitaflo all lodged three submissions.

There are two new applicants:

• Juniper Pharmaceuticals - three submissions. While Juniper is the current sponsor of some PBS listed medicines, it has never lodged a PBAC submission.
• Synvepi - one submission (tebentafusp). While the submission was clearly prepared and lodged and prepared by Synvepi, the sponsor of tebentafusp is Immunocore.

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.

• Difelikefalin acetate
  
• Durvalumab (biliary tract cancer)
• Enzalutamide
• Niraparib tosylate monohydrate
  
• Nivolumab (non-small-cell lung cancer)
• Olaparib (breast cancer)
• Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed)
  
• Tofacitinib citrate (ankylosing spondylitis, juvenile idiopathic arthritis)
  
• Upadacitinib monohydrate (Crohn's disease)
  
• Zanubrutinib (chronic lymphocytic leukaemia, non-Hodgkin's lymphoma)

Some insights:

• The PBAC will consider a resubmission from Amgen for apremilast (Otezla) for patients with psoriatic arthritis for the third time; it was lasted considered by the PBAC in 2015.
• Novartis has made a second attempt to secure a PBS listing for inclisiran sodium (Leqvio) for patients with hypercholesterolaemia; the initial submission was withdrawn.
• The PBAC will consider submissions for two new medicines for patients with malignant melanoma; nivolumab with relatlimab (Opdualag) and tebentafusp (Kimmtrak). 
• UCB has made another attempt to secure a favourable recommendation for bimekizumab (Bimzelx) for patients with psoriasis. Bimekizumab was recommended by the PBAC in March this year on the basis of a cost minimisation against the lowest cost biological disease-modifying anti-rheumatic drug (bDMARD).  The recommendation has not been implemented.

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