Agenda for July 2022 PBAC meeting

PBAC

1 April 2022 - 30 March 2022 - The agenda for the July 2022 PBAC meeting is now available.

For the time being, the PBAC is on track to consider 36 submissions at its next major meeting in July. it is likely that the agenda will be revised over time with the addition of some medicines rejected earlier this month.

The agenda is comprised solely of PBS medicines; there are no submissions for PBS medicinal preparations, NIP vaccines or LSDP medicines.

As we read it, the agenda is for:

  • 9 new medicines
  • 1 new biosimilar medicine
  • 14 new indications
  • 2 new combination products
  • 4 restriction changes
  • 1 new strength
  • 4 new formulations
  • 1 review

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

  • Immunology (10 submissions)
  • Oncology (9 submissions)
  • Haematology (3 submissions) - all are for one disease; acute myeloid leukaemia

AstraZeneca and Janssen have both lodged four submissions. There is one new applicant; Jazz Pharmaceuticals.

We estimate the following 12 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.

  • Anifrolumab
  • Asciminib hydrochloride
  • Azacitidine
  • Cemiplimab
  • Cytosine arabinoside with daunorubicin (nanoparticle, liposomal)
  • Nivolumab (bladder cancer)
  • Nivolumab (oesophageal cancer)
  • Nivolumab with relatlimab - this is clearly one submission to watch. We think it is 'nivolumab with relatlimab' rather than 'relatlimab with nivolumab.'
  • Ruxolitinib phosphate
  • Tezepelumab
  • Upadacitinib monohydrate
  • Vosoritide

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Michael Wonder

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Michael Wonder