Saphnelo (anifrolumab) listed on the PBS for patients with severe SLE - 1 July 2024
Saphnelo® (anifrolumab) has been listed on the PBS for patients with severe SLE with high disease activity despite standard of care from Monday 1st July 2024. The listing details have been published on the PBS website on 1 July 2024 with the below initial treatment criteria.
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.