ModifiedAmeriHealth Caritas VIP CarePolicy MA08.155b

Spesolimab-sbzo (Spevigo) intravenous treatment for generalized pustular psoriasis flares

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This policy governs Medicare Advantage medical-benefit coverage and medical necessity for intravenous spesolimab-sbzo (Spevigo) in members with generalized pustular psoriasis flares, subject to benefit limitations and the criteria in this policy.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicySpesolimab-sbzo (Spevigo) intravenous treatment for generalized pustular psoriasis flares

Policy CodePolicy MA08.155b

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionEnsure the medical record documents medical necessity and make supporting records available upon request.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were added for intravenous spesolimab-sbzo in pediatric individuals aged 12 years and older who weigh at least 40 kg.

12+Minimum age

900 mg IVInitial dose

5%Minimum BSA

GPPPGA 3–4Flare severity

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.155b

Spesolimab-sbzo (Spevigo) intravenous treatment for generalized pustular psoriasis flares

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicySpesolimab-sbzo (Spevigo) intravenous treatment for generalized pustular psoriasis flares

Policy CodePolicy MA08.155b

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionEnsure the medical record documents medical necessity and make supporting records available upon request.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were added for intravenous spesolimab-sbzo in pediatric individuals aged 12 years and older who weigh at least 40 kg.

12+Minimum age

900 mg IVInitial dose

5%Minimum BSA

GPPPGA 3–4Flare severity

Medical Necessity and Covered Uses

Other Uses

All other uses of Spesolimab-sbzo (Spevigo) are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

The requested use is an accepted off-label use under the applicable policy on off-label coverage for prescription drugs and biologics.

Coverage is excluded when the individual has any of the following: synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome; primary erythrodermic psoriasis vulgaris; primary plaque psoriasis vulgaris without pustules or with pustules restricted to psoriatic plaques; drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP); an immediate life-threatening GPP flare or a flare requiring intensive care treatment, such as cardiovascular/cytokine-driven shock, pulmonary distress syndrome, or renal failure; or severe, progressive, or uncontrolled hepatic disease, defined as more than 3-fold the upper limit of normal (ULN) elevation in AST, ALT, or alkaline phosphatase, or more than 2-fold ULN elevation in total bilirubin.

If flare symptoms persist, an additional intravenous 900 mg dose may be administered one week after the initial dose.

Coding and Clinical Thresholds

HCPCS Level II CodeHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg

ICD-10 Diagnosis CodeICD-10Covered

L40.1

Generalized pustular psoriasis

CPT Procedure CodesCPT

N/A	CPT Procedure Code Number(s)

ICD-10 Procedure CodesICD-10

N/A	ICD-10 Procedure Code Number(s)

ICD-10 Diagnosis CodesICD-10

L40.1

Generalized pustular psoriasis

HCPCS Level II CodesHCPCS

No codes listed

Revenue CodesRevenue

N/A	Revenue Code Number(s)

Body Surface Area Involvement

Minimum BSA involvementAt least 5% of body surface area

Required skin findingErythema covering the involved body surface area

PustulesPustules must be newly appearing or worsening

GPPPGA Total Score

Qualifying scoreGPPPGA total score of 3 to 4

Moderate diseaseScore of 3

Severe diseaseScore of 4

Hepatic Laboratory Exclusion

AST or ALTGreater than 3-fold the upper limit of normal (ULN)

Alkaline phosphataseGreater than 3-fold ULN

Total bilirubinGreater than 2-fold ULN

Documentation and Noncovered Use Requirements

Documentation Required

Medical Necessity Records

The individual's medical record must reflect the medical necessity for the care provided. Supporting documentation may include, but is not limited to, records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

Denial Risk

Noncovered Uses

All other uses of Spesolimab-sbzo (Spevigo) are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the applicable medical policy for off-label coverage of prescription drugs and biologics.

Denial Risk

Insufficient Documentation

Generalized Pustular Psoriasis Overview

Generalized pustular psoriasis is a rare, lifelong skin disease characterized by sudden flares of painful, pus-filled blisters over large areas of the body. These flares may be life-threatening if untreated.

Clinical Definitions

Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA)

Assessment rangeTotal score ranges from 0 (clear) to 4 (severe)

Moderate diseaseA total score of 3 indicates moderate disease

Severe diseaseA total score of 4 indicates severe disease

BSA Involvement

DefinitionBody surface area covered with erythema together with new or worsening pustules

Minimum requiredAt least 5% BSA

Qualifying flareThe flare must include erythema and pustules

Initial Treatment of GPP Flare

Covered as a single-dose intravenous infusion for a qualifying generalized pustular psoriasis flare when all criteria are met.

Initial intravenous therapy: The individual is at least 12 years old, has generalized pustular psoriasis with a current moderate-to-severe flare involving at least 5% of body surface area with erythema and new or worsening pustules, is prescribed by or in consultation with a dermatologist, and has none of the listed exclusionary conditions.age >= 12 years; BSA >= 5%; GPPPGA total score 3-4

The dose is 900 mg intravenously as a one-time initial dose.

Persistent Flare Additional Dose

If flare symptoms persist after the initial dose, an additional intravenous dose may be administered one week later.

Additional dose for persistent flare: An additional 900 mg intravenous dose may be administered when generalized pustular psoriasis flare symptoms persist after the initial dose.900 mg IV one week after initial dose

This is an additional dose for the persistent flare, not routine maintenance therapy.

Dose and Supply Limits

Spesolimab-sbzo (Spevigo)

Initial doseOne-time 900 mg intravenous dose

Package supply2 x 450 mg/7.5 mL vials

Additional doseIf flare symptoms persist, one additional intravenous 900 mg dose may be administered one week after the initial dose

Administration Setting

Billing Rule

Use the appropriate infusion setting

When administration can occur in multiple settings, reimbursement may be limited to services furnished in the most appropriate and cost-effective setting consistent with the member's medical needs and condition.

The determination considers the member's current medical condition, required monitoring, and any additional services that may coincide with delivery of the service.