SPEVIGO (spesolimab-sbzo)

SPEVIGO (spesolimab-sbzo)

Medical-Administration – intravenous

Diagnosis considered for coverage:

• Generalized Pustular Psoriasis (GPP): Indicated for the treatment of generalized pustular psoriasis flares in adults.

Coverage Criteria:

For diagnosis of generalized pustular psoriasis (GPP):

• Dose does not exceed 900 mg per dose by intravenous infusion over 90 minutes; AND
• Patient is 18 years of age and older; AND
• Prescribed by or in consultation with a dermatologist; AND
• Diagnosis of generalized pustular psoriasis (GPP); AND
• Patient has a moderate to severe GPP flare based on one of the following:
  •  Presence of fresh pustules (new appearance or worsening pustules)
  • At least 5% of body surface area (BSA) covered with erythema and the presence of pustules
  • A Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score of at least 3 (moderate)
  • GPPPGA pustulation sub-score of at least 2 (mild); AND
• Patient has not already received more than two infusions of Spevigo for a single flare

Coverage Duration: 

• 14 days

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosage and Administration
  • Administer as a single 900 mg dose by intravenous infusion over 90 minutes
  • If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose
• Testing and Procedures Prior to Treatment Initiation 
  • Evaluate patients for tuberculosis (TB) infection
    • Spevigo initiation is not recommended in patients with an active TB infection. Consider initiating treatment of latent TB prior to initiation of Spevigo
  • Generalized Pustular Psoriasis Physician Global Assessment (GPPPPGA) is based on the Patient Global Assessment, modified by dermatology experts to measure specific GPP treatment outcomes (for more information, please refer to https://pro.boehringer-ingelheim.com/products/spevigo/study#GPPGA)

Policy Updates:

• 3/1/2023 – New policy approved by P&T

References:

1. Spevigo Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. September 2022.
2. Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11(3):e043666. doi:10.1136/bmjopen-2020-043666
3. Burden AD, Choon SE, Gottlieb AB, Navarini AA, Warren RB. Clinical disease measures in generalized pustular psoriasis. Am J Clin Dermatol. 2022;23(suppl 1):39-50. doi:10.1007/s40257-021-00653