Regulatory Review – December 2020 PBAC recommendations

3 minute read

We go through recommendations by PBAC to the PBS for funding that are relevant to the rheumatology community.

In this new regular column, we’ll go through public announcements from recommendations by PBAC to the PBS for funding listing that might be of interest to the rheumatology community, keeping you alert to what’s on the horizon.

(Note, recommendation does not mean immediate listing.) 


Infliximab (Remisma SC – Celltrion): new listing for all infliximab conditions – recommended

COVID has highlighted how it’s nice to have non-infusion options. Subcutaneous infliximab is here and coming soon to the PBS (note, this is also TGA approved) with the innovation driven by a biosimilar manufacturer. This is great for people who want to change from intravenous to subcutaneous, and options are always good, but do we need a fifth subcutaneous TNF inhibitor though?

Secukinumab (Cosentyx – Novartis): change in listing to add nr-axSpA – recommended

Another option in this disease, and a different mechanism of action; good news by any measure, but surely use is still only going to be a fraction of that in AS?

Tofacitinib (Xeljanz–Pfizer): change in listing to add IBD – recommended

IBD gets to join the oral agent party, also with the 10mg bd dosing approved. If we were watching the 5mg bd dose for safety, this will keep things interesting…

Adalimumab (Hadilma – MSD): requested streamline for continuing; phone/online for initial application – not recommended
Etanercept (Brenzys – MSD): requested phone/online authority for initial 1, initial 2, and first continuing – not recommended

Well, you don’t ask, you don’t get, right? That doesn’t mean that they have to give … goes to show that both originator and biosimilar manufacturers will do their best to get any advantage they can.

Cannabidiol (Epidyolex – Emerge Health): new listing for Lennox-Gastaut syndrome, Dravet syndrome – recommended

CBD has been approved for two rare epilepsy syndromes, but it goes to show that PBS approvals are going to remain tightly correlated with the evidence, and the evidence for rheumatology indications, if it ever comes, is still well in the distance.

Agenda for consideration – March 2021

  • filgotinib (100mg and 200mg) for RA (new indication)
  • melatonin (1mg and 5mg) for insomnia in autism/Smith-Magenis syndrome (new indication)
  • nintedanib (100mg and 150mg) for progressive fibrosing interstitial lung disease (new indication)
  • teriparatide (2.4mL) for osteoporosis (same indication, Streamline listing)
  • upadacitinib (15mg) for AS, PsA (new indications)
  • ustekinumab (45mg) for plaque psoriasis for children (new indication)

The full agenda for the March 2021 PBAC meeting is available on the PBS website. Comments from health professionals, patients, carers, members of the public and members of consumer interest groups are welcomed.

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