Lupus, PsA, spondyloarthritis and ANCA-associated vasculitis patients are among the potential beneficiaries of the March 2024 PBAC recommendations.
The March 2024 PBAC outcomes were released on Friday, with good news for rheumatologists and their patients.
It was a case of third time lucky for AstraZeneca’s Saphnelo, with anifrolumab for lupus patients getting the nod.
The PBAC acknowledged that for some patients with severe refractory systemic lupus erythematosus and high disease activity, anifrolumab offered significant benefits over standard of care alone, and noted that its concerns raised with the previous resubmission – largely relating to evidence of efficacy – had been sufficiently addressed.
Also successful was CSL Vifor’s Tavneos (avacopan), which was resubmitted for the treatment of severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) when taken in combination with rituximab or cyclophosphamide.
Avacopan was approved by the TGA in January last year, and the PBAC recognised its value in reducing glucocorticoid use and the potential improvements in renal outcomes. Thanks to “changes to the economic model” since its last submission in July 2023, with a cost-effectiveness ratio “high but acceptable given the clinical need”, it’s now recommended for PBS listing.
Bimekizumab (Bimzelx, UCB Australia), which was PBS listed last year for plaque psoriasis, was recommended for PBS listing for psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
The dual IL-17A/17F targeting agent demonstrated sustained benefit for psoriatic arthritis and axial spondyloarthritis patients in the BE OPTIMAL and BE MOBILE studies published last year.
Meanwhile, a new form and strength of tofacitinib for treating rheumatoid arthritis and psoriatic arthritis was recommended. Xeljanz XR (Pfizer) is an 11mg modified release tablet to be taken once daily and is equivalent to tofacitinib 5mg taken twice daily.
The latest biosimilar to be recommended for PBS listing is Amgen Australia’s Wezlana, which was approved by the TGA in January this year. It’s the first ustekinumab biosimilar to hit the Australian market and was recommended for psoriatic arthritis, chronic plaque psoriasis, Crohn’s disease and ulcerative colitis.
New forms of the reference ustekinumab biologic Stelara (Janssen) were also approved.
The only rheumatology-related PBAC submission not recommended was adalimumab for immune-mediated inflammatory disease in children, which has been deferred pending further consultation with relevant clinical groups.
PBAC’s main issue was that IMID covered a broad range of indications, with varying levels of available evidence for the use of adalimumab. Adalimumab is not TGA-registered for all of them, and already PBS-listed for some. As such, PBAC “did not accept the request for a broad indication for IMIDs”.
PBAC March 2024 outcomes
Among the PBAC outcomes, the following are relevant to rheumatologists. Note that recommendation does not mean immediate PBS listing.
Adalimumab (Humira, AbbVie): request streamlined authority listing for treatment of immune-mediated inflammatory disease in children. Deferred.
Anifrolumab (Saphnelo, AstraZeneca): request Section 100 (Highly Specialised Drugs Program) written authority listing for severe systemic lupus erythematosus – resubmission. Recommended.
Avacopan (Tavneos, Sequirus): request a streamlined authority listing for treatment of severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) – resubmission. Recommended.
Bimekizumab (Bimzelx, UCB): Request written authority listings for psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. Recommended.
Tofacitinib (Xeljanz, Pfizer): Request new dose and form of tablet (11mg extended release) under the same conditions as existing listings for 5mg dose for severe rheumatoid arthritis and psoriatic arthritis. Recommended.
Ustekinumab (Stelara, Janssen): Request written authority listing for new forms of delivery. Recommended.
Ustekinumab (Wezlana, Amgen): Request general schedule and Section 100 (Highly Specialised Drugs Program) streamlined authority listings under the same conditions as its reference biologic. Recommended.
See the full list of outcomes from the March 2024 PBAC meeting for more.
