Regulatory review – March 2021 PBAC meeting

3 minute read

We review recommendations by PBAC to the PBS that are relevant to the rheumatology community.

We go through public announcements of 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.

Decisions – March 2021 meeting

Ciclosporin (Ikervis – Seqiris): streamlined authority listing for treatment of dry eye disease with keratitis – recommended.

It’s nice to have options in this space without having to rely on compounding pharmacies. Any option for Sjogren’s is a good option, no matter how few data there are.

Filgotinib (Jyseleca – Gilead): add listing for treatment of severe RA – submission withdrawn.

Well… that could have gone better.

Melatonin (Slenyto – Aspen): phone authority listing for insomnia treatment in patients aged 2 to 18 with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome (SMS) – not recommended.

This may not have got through, but soon enough we could be heading towards melatonin being cheaply available in pharmacies as in the US. Come 1 June 2021, melatonin will become Schedule 3, and you too will be able to go and get some without a prescription before you get on your overseas flight.

Nintedanib (Ofev – Boehringer Ingelheim): written authority listing for treatment of progressive fibrosing interstitial lung disease (PF-ILD) – not recommended.

Well, it’s all a little helpless as far as fibrosing ILD is concerned, but anti-fibrotics give the sense that at least something is being done. Nevertheless, nintedanib has copped it for supposedly causing a lot of diarrhoea and variable benefit. It’s understandable (and predictable) that this price is going to need to be negotiated down to something workable.

Teduparatide (Terrosa – Gedeon Richter): streamlined listing of teriparatide biosimilar for severe established osteoporosis – recommended.

Biosimilar teriparatide is here. The move to a streamline biosimilar makes life very slightly easier compared with the authority required for the originator Forteo (Eli Lilly). More importantly, competition may drive down the price, and could even allow for broader use in the future – something which would actually open up options in osteoporosis.

Upadacitinib (Rinvoq – AbbVie): written authority new listings for treatment of ankylosing spondylitis (AS) and severe psoriatic arthritis (PsA) – both recommended.

No surprises here, but it is well and truly on for upadacitinib in Australia. A single daily-dose tablet for all types of inflammatory arthritis? Clearly, for AbbVie, it was worth Humir-ing the wait…

Ustekinumab (Stelara – Janssen-Cilag): written authority listing for paediatric severe chronic plaque psoriasis (CPP) – recommended.

Ustekinumab is now available for kids with psoriasis, providing an alternative to etanercept.

See all the March 2021 PBAC outcomes.

Agenda for consideration – July 2021

Adalimumab (Abrilada – Pfizer): for treating numerous conditions including juvenile idiopathic arthritis, severe active RA, AS, severe CPP under same conditions as originator biologic. General Schedule and Section 100 (Highly Specialised Drug Program) listing.

Etanercept (Enbrel – Pfizer): change to listing – new delivery method.

Hypromellose (Revive Tears – Petrus): change to listing – listing of new brand under same conditions as originator.

Secukinumab (Cosentyx – Novartis): change to listing for AS – increased quantity per prescription, reduction in repeats.

See the full July 2021 agenda here.

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