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    Spevigo®

    Drug - Spevigo® (spesolimab-sbzo) [Boehringer Ingelheim Pharmaceuticals, Inc.]

    March 2025

    Therapeutic Area - Cytokine and CAM Antagonists

    Approval criteria

    • Patient is at least 18 years of age; AND 
    • Diagnosis of generalized pustular psoriasis (GPP); AND 
    • Patient does NOT have any of the following conditions: synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome, primary erythrodermic psoriasis vulgaris, primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques, or drug-triggered acute generalized exanthematous pustulosis (AGEP); AND 
    • Patient is experiencing an acute GPP flare of moderate to severe intensity defined by all of the following: Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of ≥ 3 (moderate), presence of fresh pustules (new or worsening), a GPPGA pustulation sub score of ≥ 2 (mild), and ≥ 5% of body surface area with erythema and the presence of pustules; AND 
    • Patient must NOT have history of hypersensitivity to any component of the product; AND 
    • Patient has been evaluated and screened for the presence of latent tuberculosis (TB) prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND 
    • Patient does NOT have an active infection, including clinically important, localized infections; AND 
    • Patient will NOT use concomitantly with any of the following: TNF-α inhibitor (e.g., adalimumab, infliximab), biologic response modifier (e.g., apremilsat, upadacitinib), systemic immunosuppressant (e.g., retinoid, cyclosporine, methotrexate), or topical agent (e.g., corticosteroid, calcipotriene, tacrolimus); AND 
    • Patient has NOT received a live virus vaccine in the last 6 weeks and will NOT receive a live virus vaccine during therapy; AND
    • Documentation of a follow-up plan following the initial Spevigo dose (i.e., safety and effectiveness monitoring plan including the evaluation of need for second Spevigo dose).

    Quantity limits

    • 30 mL (4 vials) once; 900 mg/15 mL, maximum of 2 doses per flare

    Billing for Spevigo

    Spevigo must be billed as a medical claim.

    Questions

    Provider Call Center (844) 575-7887

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