following a full submission:
avacopan (Tavneos®) is accepted for use within NHSScotland.
Indication under review: In combination with a rituximab or cyclophosphamide regimen, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
In a phase III study, avacopan demonstrated non-inferiority to prednisone for remission at week 26, and was superior to prednisone for sustained remission at week 52 in patients with GPA or MPA.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Download detailed advice777KB (PDF)
Medicine details
- Medicine name:
- avacopan (Tavneos)
- SMC ID:
- SMC2578
- Indication:
In combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
- Pharmaceutical company
- Vifor Fresenius Medical Care Renal Pharma UK Ltd
- BNF chapter
- Immunological products and vaccines
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 13 November 2023
The MHRA has informed the marketing authorisation holder of its decision to suspend the use, supply, and sale of Avacopan Vifor to new patients from 1 September 2026. The MHRA intends to revoke the UK marketing authorisation on 1 March 2027.
For the full press release please see: MHRA concludes review of Avacopan Vifor following reassessment of benefit-risk balance - GOV.UK
This advice will be removed from the SMC website from 1 March 2027.