Saphnelo (anifrolumab) listed on the PBS for patients with severe SLE - 1 July 2024
Saphnelo® (anifrolumab) has been listed on the Pharmaceutical Benefits Scheme (PBS) for patients with severe Systemic Lupus Erythematosus (SLE) with high disease activity despite standard of care from Monday 1 July 2024.
The listing details have been published on the PBS website on 1 July 2024 with the following initial clinical criteria:
- Patient must have a confirmed and documented diagnosis of SLE according to the ACR/ EULAR SLE Classification Criteria 2019, AND
- Patient must have persistent disease activity as supported by a SLEDAI-2K score of at least 10 points, AND
- Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal, AND
- Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal, AND
- Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal, AND
- Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus.
Treatment criteria:
- Must be treated by a specialist physician experienced in the management of this condition.
