Pharmacy Prior Authorization Criteria

Spevigo (spesolimab-sbzo)

Indications for Prior Authorization

Spevigo (spesolimab-sbzo)

• For diagnosis of Generalized Pustular Psoriasis (GPP)
  Indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.

Criteria

Spevigo IV

Prior Authorization

Length of Approval: 14 Days [A]

• 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 of 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) [B]
• GPPPGA pustulation sub score of at least 2 (mild)
AND
• Both of the following:
• Patient is 12 years of age or older
• Patient weighs at least 40kg
AND
• Prescribed by or in consultation with a dermatologist
AND
• Patient has not already received two infusions of Spevigo for a single flare

Spevigo SC

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of generalized pustular psoriasis (GPP) as defined by both of the following [2]:
• Primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques)
• Disease is relapsing (>1 episode) or persistent (>3 months)
AND
• Subcutaneous formulation will not be used to treat GPP flare
AND
• Both of the following:
• Patient is 12 years of age or older
• Patient weighs at least 40kg
AND
• Prescribed by or in consultation with a dermatologist

Spevigo SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduction in number of flares)

P & T Revisions

2024-05-22, 2024-05-01, 2023-10-30, 2022-12-02, 2022-12-02, 2022-11-03

References

1. Spevigo Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. March 2024.
2. Navarini AA, Burden AD, Capon F, Mrowietz U, Puig L, Köks S, Kingo K, Smith C, Barker JN1.2. Navarini AA, Burden AD, Capon F, et al; ERASPEN Network. European consensus statement on phenotypes of pustular psoriasis. J Eur Acad Dermatol Venereol. 2017 Nov;31(11):1792-1799. doi: 10.1111/jdv.14386. Epub 2017 Aug 29.

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End Notes

1. Spevigo is administered as a single intravenous infusion. If GPP flare symptoms persist, an additional intravenous dose may be administered one week after the initial dose [1].
2. The total Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) score ranges from 0 (clear) to 4 (severe) [1].

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Revision History

• 2024-05-22: Attached EHB formulary.
• 2024-05-01: Updated IV formulation criteria due to expanded indication and added criteria for new SC formulation.
• 2023-10-30: Annual review - no criteria changes
• 2022-12-02: New program
• 2022-12-02: New program
• 2022-11-03: New program

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