Anifrolumab decision headlines PBAC outcomes

2 minute read

Mixed news for patients and prescribers in PsA, psoriasis and more.

The outcomes of the March 2023 PBAC meeting, released on Friday, report mixed results for rheumatology prescribers and patients.

Anifrolumab (Saphnelo, AstraZeneca) was knocked back again for severe SLE, having previously applied in July last year.

In considering the evidence for the claims of superior efficacy over standard of care, PBAC determined that while there was clinical improvement for some patients, “the magnitude of benefit was modest and uncertain”.

This, acknowledged the PBAC, was in part a reflection of the “complex and variable nature of the condition and the challenges associated with assessing outcomes in SLE”.

There were also concerns that the utilisation estimates remained high.

Also getting the knockback was apremilast (Otezla, Amgen) for severe psoriatic arthritis. While acknowledging that there were patients for whom currently available treatments weren’t suitable and who could potentially benefit, “the proposed restriction criteria did not adequately identify the appropriate cohort of patients”.

There was better news for psoriasis patients, with bimekizumab (Bimzelx, UCB) and deucravacitinib (Sotyktu, BMS) recommended for chronic plaque psoriasis. However, a request to allow eligible patients in clinical trials to transition to PBS-subsidised tildrakizumab (Ilumya, Sun Pharma) for chronic plaque psoriasis was not recommended.

JAK inhibitors also got the nod, with tofacitinib (Xeljanz, Pfizer) recommended for ankylosing spondylitis and juvenile idiopathic arthritis, and upadacitinib (Rinvoq, AbbVie) recommended for non-radiographic axial spondylitis.

For osteoporosis patients, romosozumab (Evenity, Amgen) was recommended for the treatment of severe established osteoporosis in the first-line setting, providing a significant improvement over alendronate. However, Theramex’s request to expand the age eligibility for risedronic acid (Actonel) to patients under 70 was not recommended.

Also of note for rheumatologists is the recommendation for Shingrix to be included on the National Immunisation Program for people 18 and over with immunocompromise.

The full list of March 2023 PBAC outcomes is available on the PBAC website.

July 2023 agenda

Items of interest for rheumatologists in the upcoming July PBAC meeting include:

  • Adalimumab biosimilar (Ardalicip, Cilpa) under the same conditions as the reference biologic.
  • Avacopan (Tavneos, Vifor) for severe active granulomatosis with polyangiitis and severe active microscopic polyangiitis.

See the full agenda here.

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