Saphnelo

Anifrolumab

• Brand(s): Saphnelo
• Dosage Form/Strength: 150 mg/mL (300 mg vial) Injection
• Effective Date: December 19, 2023

Initiation criteria:

For the treatment of adult patients with active, moderate to severe systemic lupus erythematosus (SLE) meeting all the following criteria;

1. Patient is at least 18 years of age;
   AND
2. Documented autoantibody positive SLE;
   AND
3. Moderate-to-severe SLE as defined by SLE Disease Activity Index 2000 (SLEDAI-2K) score of 6 or higher (Note 1);
   AND
4. Inadequate disease control in spite of treatment with an oral corticosteroid (OCS) dose of at least 10 mg daily of prednisone (or another equivalent corticosteroid) in addition to standard of care therapy for SLE (i.e., one or any combination of OCS, antimalarials, and/or immunosuppressants) (Note 2);
   AND
5. Request is provided by a prescriber with expertise in the diagnosis and management of SLE.

Exclusion Criteria:

• Anifrolumab will not be reimbursed when used in combination with other biologic treatments for SLE.
• Anifrolumab will not be reimbursed in patients with severe or unstable neuropsychiatric SLE.
• Anifrolumab will not be reimbursed in patients with severe active SLE nephritis.

Initial renewal criteria:

Renewal of funding for anifrolumab will be provided upon meeting the following criteria:

1. The dose of OCS is decreased to atleast 7.5 mg daily day of prednisone (or equivalent)
   OR
   The OCS dose remains higher than 7.5 mg daily of prednisone (or equivalent) but has decreased by at least 50% from the baseline OCS dose;
   AND
2. There is a reduction in disease activity as demonstrated by a reduction of the SLEDAI-2K score to 5 or less OR by BILAG-2004 improvement in organ systems and no new worsening.

Subsequent renewal criteria:

Subsequent renewal of funding will be provided for those who are able to maintain their initial response that was demonstrated after 12 months of therapy with anifrolumab.

Notes:

1. For this funding criteria, the SLEDAI-2K should be used as the validated measure to assess disease activity at baseline, however, the British Isles Lupus Assessment Group (BILAG)-2004 index can be considered on a case-by-case basis where the SLEDAI-2K was not available. The same index/scale should be used at baseline and all subsequent renewals.
2. Note that if BILAG-2004 is the index used to evaluate response at baseline compared to after 12 months of treatment, the interpretation of improvement may be as described below: Improvement in involved BILAG organs (A [severe] and B [moderate]) at baseline (e.g., reduction of all baseline BILAG-2004 A to B, C, or D and baseline BILAG-2004 B to C or D, and no BILAG) with no worsening (where worsening is defined as 1 or more new BILAG-2004 A items or 2 or more new BILAG-2004 B items)
3. Standard of care for SLE is defined as using an antimalarial drug (e.g., hydroxychloroquine) (discontinuation upon developing toxicity), at least one immunosuppressive drug (e.g., cyclophosphamide, azathioprine, methotrexate, cyclosporine, and mycophenolate), and OCS (e.g. prednisone), with or without (non-steroidal anti-inflammatory drugs) NSAIDs.
4. Pediatric patients with SLE meeting the anifrolumab criteria may be considered on a case-by-case basis.

Approved dose: Up to 300 mg IV every 4 weeks

Approval duration for initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests