ModifiedUnitedHealthcarePolicy CS2025D0119I

Spevigo (spesolimab‑sbzo) — Medical Benefit Drug Policy for Generalized Pustular Psoriasis

Medical benefit drug policy governing use of intravenous and subcutaneous Spevigo for treatment and prevention of generalized pustular psoriasis (GPP) flares; applies to UnitedHealthcare commercial plans with state exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicySpevigo (spesolimab‑sbzo) — Medical Benefit Drug Policy for GPP

Policy CodePolicy CS2025D0119I

Change TypeApplication updated — Arizona exclusion added

Effective Date08/01/2025

Next Review Date

Key ActionObtain prior authorization with clinical documentation meeting specified diagnostic and severity criteria; authorization durations differ by route and indication.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

Archived previous policy version CS2024D00119H.

2maximum intravenous doses per single GPP flare

900 mgintravenous dose used in pivotal trials

12 momax authorization period for subcutaneous use

J1747HCPCS code

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Coverage Criteria for Spevigo (spesolimab‑sbzo)

Intravenous Spevigo for GPP Flares

Covered when ALL of the following are met:

Diagnosis of generalized pustular psoriasis (GPP) based on both of the following: presence of primary, sterile, macroscopically visible pustules on an erythematous base; and pustulation not restricted to the acral region or within psoriatic plaques.

Severity for initial IV dose: Either patient has a moderate-to-severe GPP flare defined by at least one of: GPPGA total score ≥ 3; GPPGA pustulation subscore ≥ 2; erythema and pustules covering ≥ 5% body-surface area; or new appearance/worsening of pustules; OR all of the following: patient has already received one initial IV dose for the current flare and documentation supports need for a second IV dose for persistent symptoms including one of: GPPGA total score ≥ 2; GPPGA pustulation subscore ≥ 2; fever; asthenia; myalgia; elevated C-reactive protein; or leukocytosis with peripheral blood neutrophilia.

Second IV dose must be administered no sooner than one week after the initial dose; total IV doses ≤ 2 per single GPP flare.

Concomitant therapy and dosing: Patient is not receiving Spevigo in combination with another targeted immunomodulator to treat the same condition; Spevigo is dosed according to U.S. FDA–labeled dosing for GPP flares; prescribed by a dermatologist.

Authorization limited to no more than 21 days.

Subcutaneous Spevigo for Prevention of GPP Flares (Initial and Continuation)

Covered when ALL of the following are met:

Diagnosis and intent: Diagnosis of generalized pustular psoriasis (GPP) based on both of the following: presence of primary, sterile, macroscopically visible pustules on an erythematous base; and pustulation not restricted to the acral region or within psoriatic plaques. Intended use is prevention of GPP flares (patient is not currently experiencing a flare).

Prior flare history or prior IV therapy: Either patient has previously been treated with intravenous Spevigo for a GPP flare; OR all of the following: patient has not previously received IV Spevigo and during the prior 12 months had one or more moderate-to-severe GPP flares defined by at least one of: GPPGA total score ≥ 3; GPPGA pustulation subscore ≥ 2; erythema and pustules covering ≥5% BSA; or new appearance/worsening of pustules — and prescriber attests the patient would clinically benefit from prophylactic subcutaneous therapy.

Administration and prescriber requirements: Patient is not receiving Spevigo in combination with another targeted immunomodulator to treat the same condition; Spevigo is dosed per U.S. FDA–labeled dosing for non-flare treatment; prescribed by a dermatologist; prescriber attestation required if patient/caregiver cannot self-administer maintenance dosing.

Unproven and Not Medically Necessary Indications

Explicit not medically necessary indications: Intravenous Spevigo in excess of 2 doses per single GPP flare; atopic dermatitis; Crohn's disease; hidradenitis suppurativa; palmoplantar pustulosis; plaque psoriasis; ulcerative colitis.

Spevigo (spesolimab‑sbzo) is considered unproven and not medically necessary for the following indications and situations: administration of intravenous Spevigo in excess of 2 doses per single GPP flare, atopic dermatitis, Crohn's disease, hidradenitis suppurativa, palmoplantar pustulosis, plaque psoriasis, and ulcerative colitis.

This Medical Benefit Drug Policy does not apply to the state of Arizona. For members in Arizona, refer to the state's Medicaid clinical policy for guidance on coverage and authorization requirements.

Requests for intravenous Spevigo that would result in administration of more than 2 doses per single GPP flare are considered unproven and not medically necessary and may be denied.

Coding

Applicable HCPCS CodesHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg

Applicable Diagnosis CodesICD-10

L40.1

Generalized pustular psoriasis

GPPGA thresholds used in policy/trials

Moderate-to-severe flare definitionGPP flare of moderate-to-severe intensity defined as GPPGA total score ≥ 3, new or worsening pustules, GPPGA pustulation subscore ≥ 2, and ≥5% BSA with erythema and pustules.

Pustulation subscore thresholdGPPGA pustulation subscore ≥ 2 indicates clinically meaningful pustulation (pustulation subscore range 0–4).

Rescue treatment (trial definition)After initial treatment and achieving GPPGA total 0–1, reoccurrence of flare defined as increase of ≥2 points in both GPPGA total and pustulation subscore triggered single IV 900 mg rescue dose in trial protocol.

Intravenous trial dose and timingPivotal trials used a single IV dose of 900 mg spesolimab; a second IV dose of 900 mg could be given no sooner than 1 week after the initial dose for persistent symptoms (GPPGA total ≥2 or pustulation subscore ≥2).

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization and authorization durations

Prior authorization is required for Spevigo (spesolimab‑sbzo). Authorization will be issued consistent with the clinical criteria in this policy and the member's benefit plan; federal, state, or contractual requirements may supersede. Authorization durations: for intravenous use, authorization will be for no more than 21 days; for subcutaneous use as a single loading dose (when not following IV treatment) authorization will be for one loading dose; for subcutaneous use following IV treatment, initial authorization will be for up to 12 months; continuation authorizations for subcutaneous maintenance will be for no more than 12 months.

Prior authorization required with clinical documentation
IV Spevigo: authorization up to 21 days
Subcutaneous Spevigo (loading dose, not after IV): authorization for one loading dose
Subcutaneous Spevigo following IV: initial authorization up to 12 months; continuation up to 12 months

Note

Prior authorization guidance

Coverage determinations are governed by the member's UnitedHealthcare benefit plan terms and any applicable federal, state, or contractual requirements. In the event of a conflict between this policy and those requirements, the federal, state, or contractual requirements govern. UnitedHealthcare may use external tools (e.g., InterQual) to assist in administration. This policy is informational and does not constitute medical advice.

Background

Generalized pustular psoriasis (GPP) is a severe, episodic inflammatory skin disease characterized by the repeated occurrence of acute flares and by the presence of primary sterile pustules on an erythematous base. Flares may be accompanied by systemic findings such as fever, elevated inflammatory markers, and neutrophilia, and can involve significant morbidity.

Definitions

GPP (diagnostic essential)

Essential diagnostic featurePresence of primary, sterile, macroscopically visible pustules on an erythematous base not restricted to acral regions or confined within psoriatic plaques (per ERASPEN consensus).

Distribution notePustulation on non-acral skin is a key criterion; cases where pustulation is restricted to psoriatic plaques are excluded from the GPP diagnosis definition.

Associated findingsGPP may occur with or without systemic inflammation and may be relapsing (>1 episode) or persistent (>3 months).

GPPGA scores

GPPGA total score calculationGPPGA total score is the average of the subscores for pustulation, erythema, and scaling.

Pustulation subscore rangePustulation subscore is scored from 0 (no visible pustules) to 4 (severe pustulation).