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    Saphnelo™

    Drug - Saphnelo™ (anifrolumab-fnia) [AstraZeneca Pharmaceuticals LP]

    April 2022

    Therapeutic Area - Immunomodulators, Lupus

    Initial approval criteria

    • Patient is at least 18 years of age AND
    • Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy AND

    Universal Criteria  

    • Patient must not have a clinically significant active infection AND
    • Patient will not receive a live or live-attenuated vaccine concurrently with treatment AND
    • Will not be used in combination with other biologic therapies, including B-cell targeted therapies (e.g., belimumab), cyclophosphamide or voclosporin AND
    • Will be used in combination with standard therapy (e.g., anti-malarials, corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressives) AND
    • Patient does not have any of the following exclusion criteria:
      • Severe active central nervous system lupus 
      • Severe active lupus nephritis AND

    Systemic Lupus Erythematosus (SLE) 

    • Patient has a confirmed diagnosis of SLE with at least 4 diagnostic features (find list of diagnostic SLE criteria in the next section*) one of which must include a positive autoantibody test (e.g., anti-nuclear antibody [ANA] greater than laboratory reference range and/or antidouble-stranded DNA [anti-dsDNA] greater than 2 fold the laboratory reference range if tested by ELISA) AND
    • Patient has failed to respond adequately to at least one (1) standard therapy such as anti-malarials, corticosteroids, or immunosuppressives AND
    • Patient has moderate to severe disease as evidenced by ALL of the following:
      • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) score of ≥ 6 
      • British Isles Lupus Assessment Group-2004 (BILAG) B organ domain score of ≥ 2 
      • Physician’s Global Assessment [PGA] score of ≥ 1

    *Systemic Lupus Erythematosus Diagnostic Criteria

    Patient must have at least 4 out of 11 diagnostic SLE features:

    • Malar rash 
    • Discoid rash 
    • Photosensitivity 
    • Oral ulcers 
    • Nonerosive arthritis (involving 2 or more peripheral joints) 
    • Pleuritis/pericarditis 
      • Pleuritis - history of pleuritic pain or rubbing heard by a physician or evidence of pleural effusion
      • Pericarditis - documented by electrocardiogram or rubbing heard by a physician or evidence of pericardial effusion
    • Renal disorder 
      • Persistent proteinuria > 0.5 grams/day or > 3+ on urine dipstick
      • Cellular casts (red cell, hemoglobin, granular, tubular, or mixed)
    • Seizures/psychosis 
    • Hematologic disorder 
      • Hemolytic anemia with reticulocytosis
      • Leukopenia < 4,000/mm3 on ≥ 2 occasions
      • Lymphopenia < 1,500/mm3 on ≥ 2 occasions
      • Thrombocytopenia < 100,000/mm3 in the absence of offending drugs
    • Immunologic disorder 
      • Presence of anti-Sm or antiphospholipid antibodies
      • Presence of anti-double-stranded DNA [anti-dsDNA] greater than 2 fold the laboratory reference range if tested by ELISA
    • Positive anti-nuclear antibody [ANA] greater than laboratory reference range

    Renewal criteria

    • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in the initial approval criteria AND
    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: serious infections, malignancy, severe hypersensitivity reactions/anaphylaxis, etc. AND
    • Adequate documentation of disease stability and/or improvement as indicated by one or more of the following when compared to pre-treatment baseline:
      • No worsening in the SLEDAI-2K score where worsening is defined as >0 point increase OR
      • Reduction of baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥2 new BILAG-2004 B OR
      • No worsening (<0.30 –point increase) in Physician’s Global Assessment (PGA) score OR
      • Seroconverted (negative)

    Quantity limits

    • 300mg every 4 weeks

    Billing for Saphnelo

    • Saphnelo must be billed as a medical claim

    Background

    Saphnelo is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. The efficacy of Saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of Saphnelo is not recommended in these situations. 

    Questions?

    MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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