Anifrolumab SC (Saphnelo SC)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Saphnelo subcutaneous (SC) be reimbursed by public drug plans in addition to standard therapy for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) subcommittee determined that Saphnelo SC demonstrates acceptable clinical value versus placebo or Saphnelo IV in patients with SLE. This determination was enough for the CDEC subcommittee to recommend that Saphnelo SC be reimbursed. Given that Saphnelo is expected to be an alternative to placebo or Saphnelo IV, acceptable clinical value refers to at least comparable value versus placebo or Saphnelo IV.
• Evidence from 1 phase III, randomized controlled trial (TULIP-SC) comparing Saphnelo SC with placebo (standard of care) in 367 patients with SLE demonstrated there were clinical benefits observed with Saphnelo, including an increased British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, which is a composite global measure of SLE disease activity. According to the clinical experts consulted for this review, the reporting of harms was as they expected and broadly consistent with the safety profile for Saphnelo IV. The SC and IV formulations were compared in bioequivalence studies that were reviewed by Health Canada; the SC formulation received its Notice of Compliance (NOC) on March 5, 2026.
• The availability of a SC formulation may address an unmet need to improve the ease of administration for patients by alleviating treatment burden associated with the IV formulation. This may include travel time to an infusion centre and resources required by the health care system to support IV infusion. However, there is a lack of direct clinical evidence to inform how Saphnelo SC compares with Saphnelo IV, and the efficacy of Saphnelo SC relative to all relevant comparators available in practice is uncertain.
• Saphnelo SC should only be reimbursed for patients with active, autoantibody-positive SLE in line with the Health Canada indication.
• Saphnelo SC should only be reimbursed similar to each public drug plan’s current initiation, renewal, discontinuation, and prescribing criteria for Saphnelo IV for the treatment of adult patients with active, autoantibody-positive SLE and if the total drug acquisition cost of Saphnelo SC does not exceed the total drug acquisition cost for Saphnelo IV.