PBS listings for nr-axSpA biologic and adalimumab biosimilars

Psoriatic arthritis

By Michael Woodhead

21 Aug 2018

A wide range of new PBS listings for arthritis drugs have been given the green light, including golimumab for non-radiographic axial spondyloarthritis (nr-axSpA) and two new biosimilars for adalimumab.

Other positive recommendations for PBS listing from the Pharmaceutical Benefits Advisory Committee include ixekizumab for severe psoriatic arthritis and new forms of adalimumab, tocilizumab and subcutaneous methotrexate.

In a widely anticipated move, the PBAC recommended golimumab (Simponi) for an Authority Required (written) listing for patients with nr-axSpa.

In a previous unsuccessful application for listing the PBAC said it saw a clinical need for an effective treatment, particularly in patients at greatest risk of progression to Ankylosing Spondylitis (AS).

In other positive decisions from the July meeting the PBAC  recommended listings for:

  • Two adalimumab biosimilars, Amgevita (Amgen) and Hadlima (MSD), which the PBAC said should be treated as equivalent to the originator Humira for PBS-listed indications. The PBAC also recommended that prescribing of the biosimilars be encouraged via “uptake driver” incentives” including lower-level restrictions on continuing prescriptions.
  • Two new forms of adalimumab (Humira) 20mg and 80mg pre-filled pens.
  • Ixekizumab (Taltz) as an Authority Required PBS listing for the treatment of severe psoriatic arthritis as an alternative to PBS-listed bDMARDs
  • Five new forms of methotrexate (Methoblastin) pre-filled syringes (7.5, 10, 15, 20, 25mg) as an Authority Required (Streamlined) listing that may be substituted at the point of dispensing to the equivalent currently listed subcutaneous  methotrexate, Trexject.
  • A new form of subcutaneous tocilizumab (Actemra 162 mg in 0.9 mL) auto-injector for the treatment of severe active rheumatoid arthritis (RA) in adult patients.

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