Regulatory review – March 2022 PBAC recommendations

3 minute read


We go through public announcements from recommendations by PBAC to the PBS for funding listing that might be of interest to the rheumatology community.


We go through public announcements from recommendations by PBAC to the PBS for funding listing that might be of interest to the rheumatology community.

While perhaps overshadowed by the news about recommended changes in authority approvals for specialised drugs for RA, AS and JIA, there were more recommendations relevant to rheumatologists to come out of the March 2022 PBAC meeting.

Note, recommendation does not mean immediate listing.

Decisions – March 2022 meeting

Apremilast (Otezia – Amgen):

  • request to allow dermatology registrars to initiate treatment in consultation with dermatologist – recommended.
  • request to allow GPs to prescribe maintenance treatment – not recommended.

For a medication more expensive than leflunomide ever was, it’s predictable that the reins will be held by specialists and specialists alone.

Bimekizumab (Bimzelx – UCB): request written authority listing for adults with moderate to severe plaque psoriasis – recommended.

Another agent on, with the promise (yet to be completely proven) of an advance on what we have now – having been TGA-approved in March, bimekizumab is now recommended for PBS listing.

Infliximab (Remsima – Celltrion): request authority listing for new forms of infliximab (pre-filled pen and pre-filled syringe) for the treatment of AS, PsA, psoriasis and Crohn’s disease – recommended.

Options never hurt – and to get portable infliximab for all diseases makes perfect sense.

Risankizumab (Skyrizi – AbbVie):

  • request to allow eligible psoriasis clinical trial patients to transition to PBS-subsidised Risankizumab – recommended.
  • new listing for psoriatic arthritis – recommended.

Another IL-23A targeting agent to the market means that AbbVie now has a suite of MOA in psoriatic arthritis.

Secukinumab (Cosentyx – Novartis): request listings of new forms of secukinumab under same conditions as current listing – recommended.

The 300mg dose, which appears to bring added benefit over the 150mg without too much of a safety cost, is now officially open for all indications.

Review of PBS Authority Required (Written) listings – Tranche 6

PBAC considered the Authority Required (Written) restriction level for PBS-listed medicines for the treatment of rheumatology, dermatological and vasculitis conditions, with major implications for rheumatology prescribers and patients.

Various biologics and JAK inhibitors – RA and AS patients – getting any targeted agent (except for upadacitinib) will be streamlined for subsequent continuing scripts for all biologics, including originator TNF inhibitors Humira, Enbrel and Remicade, as well as JAK inhibitors tofacitinib and baricitinib. Adalimumab, etanercept and infliximab biosimilars now initial via phone or online, continuing streamlined.

Adalimumab, etanercept and tocilizumab – JIA – was written; now initial via phone or online, continuing streamlined.

Tocilizumab – systemic JIA – was written; now initial via phone or online, continuing streamlined.

Golimumab – nr-axSpA – change to authority requirements not recommended.

Etanercept – psoriasis (juvenile) – was written; now initial via phone or online, continuing streamlined.

Various biologics – adult psoriasis – change to authority requirements not recommended.

See the full March 2022 outcomes here.

PBAC July 2022 agenda

Adalimumab (Yuflyma – Celltrion): request listing of biosimilar under same conditions as the reference biologic.

Anifrolumab (Saphnelo – AstraZeneca): request written authority for SLE in patients with high degree of disease activity.

Polyethylene glycol 400 with propylene glycol (Optix – Petrus): request a restricted benefit listing of a new brand under the same conditions as the currently listed brand for patients with dry eye syndrome, including Sjogren’s syndrome.

Ustekinumab (Stelara – Janssen): request written authority listing for new form of ustekinumab for severe chronic plaque psoriasis and Crohn’s disease.

See the full July 2022 agenda here.

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