CurrentCignaPolicy N/A

Inflammatory Conditions - Spevigo (spesolimab‑sbzo) Subcutaneous Prior Authorization Policy

Prior authorization guidance for coverage of Spevigo subcutaneous injection for treatment of generalized pustular psoriasis in patients meeting specified clinical criteria; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySpevigo (spesolimab-sbzo) subcutaneous prior authorization — generalized pustular psoriasis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 9, 2025

Next Review DateApr 9, 2025

Key ActionSubmit prior authorization with documentation of age ≥12 years, weight ≥40 kg, flare history and GPPGA, prior treatment trials or intolerance, and dermatology prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum approved patient age for coverage

≥40 kgminimum approved patient weight for coverage

6 moinitial approval duration

1 yrrenewal approval duration

Dermatologist involvementprescriber requirement

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Coverage Criteria for Spevigo (spesolimab-sbzo)

FDA-Approved Indication - Generalized Pustular Psoriasis

Spevigo is covered as medically necessary for generalized pustular psoriasis when the patient meets ONE of the following (A or B):

Approval paths: Choose A (Initial Therapy) OR B (Currently Receiving Spevigo)

A. Initial Therapy (approve 6 months)

Age: Patient is ≥ 12 years of age
Weight: Patient weighs ≥ 40 kg
Flare history: Patient has history of at least two generalized pustular psoriasis flares of moderate-to-severe intensity in the past
GPPGA: Patient has a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 0 or 1
Prior treatment or intolerance: Either (a) patient had a 4-month trial of at least one treatment for generalized pustular psoriasis and history of flaring while on treatment or with dose reduction/discontinuation OR (b) patient tried at least one treatment but was unable to tolerate a 4-month trial
Examples of treatments include methotrexate, acitretin, cyclosporine, or biologics
Prescriber: Medication is prescribed by or in consultation with a dermatologist

B. Currently Receiving Spevigo (approve 1 year)

Established therapy: Patient has been established on therapy for at least 6 months
A patient who has received <6 months of therapy or who is restarting therapy should be considered under Initial Therapy
Clinical response: Patient has experienced a beneficial clinical response, defined as improvement from baseline in at least one of: reduction of generalized pustular psoriasis flares or improvement in GPPGA score

Concomitant use of Spevigo with another biologic agent or a disease-modifying antirheumatic drug (DMARD) prescribed for generalized pustular psoriasis is considered not medically necessary. The policy reflects that the pivotal trial for Spevigo required discontinuation of other therapies for generalized pustular psoriasis prior to initiating Spevigo, and case reports of other biologics in this condition do not establish concurrent use as appropriate.

Spevigo is considered not medically necessary for any use other than generalized pustular psoriasis. This includes, but is not limited to, concomitant use with another biologic or DMARD for generalized pustular psoriasis and use for plaque psoriasis in the absence of generalized pustular psoriasis, since Spevigo has not been studied for plaque psoriasis alone.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals: 6 months for new starts; 1 year for patients currently receiving therapy who meet continuation criteria.

Applies to Spevigo (spesolimab‑sbzo) subcutaneous injection
Initial prescriber must be a physician specialist or in consultation with one (dermatologist)

Step Therapy

Prior Treatment Requirement

Initial therapy requires documentation of a trial of at least one treatment for generalized pustular psoriasis for a minimum of 4 months, or documentation of intolerance to such a 4‑month trial. Examples of treatments include methotrexate, acitretin, cyclosporine, or biologics.

At least a 4‑month trial of one therapy OR inability to tolerate a 4‑month trial must be documented
If trial was completed, document history of flaring while on therapy or with dose reduction/discontinuation when applicable

Definitions and Assessment Tools

Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) — policy definition and use

DefinitionGeneralized Pustular Psoriasis Physician Global Assessment (GPPGA) is a clinician-rated assessment used to define disease activity in this policy.

Scoring referenced in criteriaA GPPGA total score of 0 or 1 is required for Initial Therapy approval (criterion A.iv).

Role in renewal decisionsImprovement in GPPGA score from baseline is one of the acceptable measures of beneficial clinical response for renewal (criterion B.ii).

Use timingGPPGA is assessed at baseline (prior to initiating therapy) and used to document response during ongoing therapy.

Documentation expectationPrescriber documentation should include the GPPGA total score to support that the patient meets the required threshold for approval.

Background — Drug and Indication

Spevigo is an interleukin-36 receptor antagonist indicated for treatment of generalized pustular psoriasis flares in adults and pediatric patients aged ≥ 12 years who meet weight criteria. The subcutaneous formulation is used for control of flares and includes dosing guidance in the product labeling.