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.​

This news item was issued on 2 July 2024 by Jill Smith, CEO of ASCIA, the peak professional body for clinical immunology and allergy in Australia and New Zealand.