ModifiedUnitedHealthcarePolicy IEXD0119.05

Spevigo (spesolimab-sbzo) for generalized pustular psoriasis (GPP)

Medical benefit drug policy for use of Spevigo (intravenous and subcutaneous) for treatment and prevention of generalized pustular psoriasis flares in Individual Exchange benefit plans (excludes MA, NV, NY). Applies to prescribers and providers seeking authorization for Spevigo.

Policy Summary

PayerUnitedHealthcare

PolicySpevigo (spesolimab-sbzo) for generalized pustular psoriasis (GPP)

Policy CodePolicy IEXD0119.05

Change TypeCoverage criteria revisedexamples and clarifications added

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization confirming GPP diagnosis that documents primary sterile pustules on an erythematous base and attests patient is not receiving another targeted immunomodulator for the same indication.

SourceLink

POLICY UPDATE CHANGES

Replaced requirement 'Presence of primary, sterile, macroscopically visible pustules on non-acral skin' with 'presence of primary, sterile, macroscopically visible pustules on erythematous base'.

Replaced requirement 'Pustulation is not restricted to the psoriatic plaques' with 'pustulation is not restricted to the acral region or within psoriatic plaques'.

Clarified combination therapy restriction to 'the patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication'.

Added examples of positive clinical responses to subcutaneous Spevigo therapy including preventing flares, reducing frequency of flares, prolonging time between flares, and controlling signs and symptoms of GPP between flares.

Replaced references to 'Stelara (ustekinumab)' with 'ustekinumab'.

2maximum IV doses per single GPP flare allowed

900 mgIV single dose evaluated in pivotal trial

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Coverage Criteria for Spevigo (spesolimab‑sbzo)

IV Spevigo for GPP flares (medically necessary)

Covered when ALL of the following are met:

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

Flare severity or prior treatment: One of the following: patient has a moderate to severe GPP flare defined by GPPPGA total score ≥ 3 OR GPPPGA pustulation subscore ≥ 2 OR erythema and pustules covering ≥ 5% body surface area OR new appearance or worsening of pustules; OR all of the following: patient has already received one initial IV dose of Spevigo for the current GPP flare AND documentation that a second dose is required for persistent symptoms including one of: GPPPGA total score ≥ 2, GPPPGA pustulation subscore ≥ 2, fever, asthenia, myalgia, elevated CRP, or leukocytosis with peripheral neutrophilia (above ULN).

Second IV dose to be administered no sooner than one week after the initial dose.

Concomitant therapy and dosing limits: Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication; Spevigo is dosed per U.S. FDA labeling for GPP flares; total dose does not exceed two doses per single GPP flare; prescribed by a dermatologist.

Authorization for IV use will be for no more than 21 days.

SC Spevigo for prevention of GPP flares / maintenance (medically necessary)

Initial therapy — Covered when ALL of the following are met:

Intent and current status: Intended to prevent GPP flares AND patient is not currently experiencing a GPP flare.

Prior IV or recent flare history: Either patient was previously treated with intravenous Spevigo for a GPP flare OR all of the following: patient has not previously received IV Spevigo for a GPP flare AND during the prior 12 months had one or more moderate to severe GPP flares defined by GPPPGA total score ≥ 3 OR GPPPGA pustulation subscore ≥ 2 OR erythema and pustules ≥ 5% BSA OR new/worsening pustules.

Prescriber must attest that patient would clinically benefit from prophylactic therapy.

Administration and training:

SC Spevigo continuation of therapy

Covered when ALL of the following are met:

Clinical response: Documentation of positive clinical response to subcutaneous Spevigo (examples: preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs and symptoms of GPP such as pustules, erythema, pain, itching between flares).

Concomitant therapy and dosing: Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication; prescriber attestation if patient/caregiver cannot self‑administer (with explanation); Spevigo is dosed per U.S. FDA labeling for non‑flare use; prescribed by a dermatologist; authorization up to 12 months.

Revised Coverage Highlights (partial)

Revised coverage criteria highlights (partial):

Diagnostic criteria: Presence of primary, sterile, macroscopically visible pustules on erythematous base; pustulation is not restricted to the acral region or within psoriatic plaques.

Replaces prior phrasing requiring non‑acral skin and non‑restriction to psoriatic plaques.

Combination therapy restriction: Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication.

Clarifies previous broader prohibition on combination therapy.

Clinical response examples: Examples of positive clinical responses to subcutaneous Spevigo include preventing flares, reducing frequency of flares, prolonging time between flares, and controlling signs and symptoms of GPP (e.g., pustules, erythema, pain, itching) between flares.

Listed as examples of expected/desired responses for continuation or assessment of benefit.

Spevigo (spesolimab-sbzo) is considered not medically necessary or unproven for several non‑GPP indications and situations. Specifically, use is not supported for atopic dermatitis, Crohn’s disease, hidradenitis suppurativa, palmoplantar pustulosis, plaque psoriasis, or ulcerative colitis. Additionally, administration of intravenous Spevigo in excess of 2 doses per single GPP flare is listed as not medically necessary.

Phase 2 trial (Effisayil‑1) design and prior exclusion criteria are relevant when assessing phenotypes appropriate for Spevigo. The trial excluded patients with plaque psoriasis without pustules and those with pustules that were restricted to psoriatic plaques. This underscores that plaque psoriasis lacking generalized pustulation is not the phenotype indicated for GPP‑directed spesolimab therapy.

The policy limits intravenous dosing per individual GPP flare: IV administration of Spevigo beyond 2 doses per single GPP flare is explicitly considered not medically necessary. The policy also excludes use of Spevigo for the specified non‑GPP indications listed (see exclusions), and such uses may prompt denial of authorization.

Information about U.S. Food and Drug Administration labeling is provided for reference only. While Spevigo is FDA‑approved for treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients age 12 years and older who weigh at least 40 kg, the policy states that FDA approval alone is not a basis for coverage and that member‑specific plan terms govern final coverage decisions.

Applicable Coding

Applicable HCPCS CodesHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg.

Applicable ICD-10 CodesICD-10

L40.1

Generalized pustular psoriasis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spevigo. Approvals are limited to the specified indications, dosing limits, and durations described in the coverage criteria. Prescriptions must follow FDA labeled dosing for the relevant route of administration and will be authorized only for the durations noted (e.g., IV use: authorization for no more than 21 days; subcutaneous use: initial or continuation authorizations as specified).

Prior authorization required for Spevigo (intravenous and subcutaneous) for treatment of generalized pustular psoriasis (GPP).
Authorizations limited to FDA labeled dosing and the durations specified in policy: IV use — up to 21 days; subcutaneous use — loading dose or up to 12 months per criteria.
Total IV doses do not exceed two doses per single GPP flare.

Prior Authorization

Spevigo Prior Authorization — Diagnostic and Concomitant Therapy Requirements

For Spevigo requests, confirm the diagnosis and treatment context meet the revised GPP phenotype criteria and that Spevigo is not being used concurrently with another targeted immunomodulator for the same indication.

Background on Generalized Pustular Psoriasis (GPP)

Generalized pustular psoriasis (GPP) is a rare, severe, episodic neutrophilic skin disease characterized by macroscopically visible sterile pustules on an erythematous base. Flares can be associated with systemic inflammation and organ involvement and are clinically distinct from plaque psoriasis; GPP flares may be life‑threatening and typically require prompt targeted therapy such as spesolimab in appropriate patients.

Spesolimab is a humanized monoclonal antibody that antagonizes the interleukin‑36 receptor (IL‑36R), a pathway implicated in GPP pathogenesis. Clinical assessments used to define flare severity include tools such as the Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA), which evaluates pustulation, erythema, and scaling to guide treatment decisions.

Key Definitions and Assessment Tools

GPP diagnostic criterion — primary pustulation

Diagnostic requirementPresence of primary, sterile, macroscopically visible pustules on an erythematous base (not restricted to acral regions or within psoriatic plaques).

Source consensusCriterion aligned with ERASPEN and International Psoriasis Council (IPC) consensus definitions for GPP diagnosis.

Clinical notePustules are the primary lesion differentiating GPP from plaque psoriasis and may occur with or without systemic inflammation.

GPPPGA — Physician Global Assessment scoring

DefinitionGPPPGA total score is the average of subscores for pustulation, erythema, and scaling (range 0–4).

Pustulation subscoreGPPGA pustulation subscore ranges 0 (no visible pustules) to 4 (severe pustulation) and is used independently to define flare severity.

Revision History and Policy Changes

2025-07-01coverage_criteria_revisionLatest

Revised coverage criteria: replaced diagnostic language to require 'presence of primary, sterile, macroscopically visible pustules on erythematous base' and clarified that pustulation is not restricted to the acral region or within psoriatic plaques.

2025-07-01coverage_criteria_revision

Clarified combination therapy restriction to state the patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication.

2025-07-01

Policy Summary

PayerUnitedHealthcare

PolicySpevigo (spesolimab-sbzo) for generalized pustular psoriasis (GPP)

Policy CodePolicy IEXD0119.05

Change TypeCoverage criteria revisedexamples and clarifications added

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request to establish that the coverage criteria are met.

Documentation of diagnosis of generalized pustular psoriasis (GPP) that includes: presence of primary, sterile, macroscopically visible pustules on an erythematous base; and confirmation that pustulation is not restricted to the acral region or confined within psoriatic plaques.
Clinical evidence of a moderate to severe GPP flare (e.g., GPPPGA total score ≥ 3, GPPPGA pustulation subscore ≥ 2, erythema and pustules covering ≥ 5% BSA, or new/worsening pustules) OR documentation that the patient has already received one IV dose for the current flare and requires a second dose with evidence of persistent symptoms (e.g., GPPPGA scores, fever, asthenia, myalgia, elevated CRP, leukocytosis with neutrophilia).
If requesting subcutaneous Spevigo for prophylaxis: documentation of prior IV Spevigo for flare OR, if no prior IV Spevigo, documentation of one or more moderate to severe flares in the prior 12 months and prescriber attestation that prophylactic therapy is clinically indicated.
Prescriber attestation that the patient is not receiving another targeted immunomodulator for the same indication and, where applicable, attestation that the patient or caregiver cannot self-administer maintenance subcutaneous therapy with an explanation.
Prescribed by a dermatologist.

Denial Risk

Documentation Specifics — Pustule Description

Be sure documentation explicitly states the presence of primary, sterile, macroscopically visible pustules on an erythematous base; absence of this specific detail may place the request at high risk for denial.

Explicit statement that pustules are primary, sterile, macroscopically visible, and located on an erythematous base.
Explicit confirmation that pustulation is not restricted to the acral region or confined within psoriatic plaques.
Failure to document these revised specific diagnostic criteria is a common basis for denial.

Step Therapy

Step Therapy / Sequencing

Step therapy sequencing is not prescribed in this excerpt; focus prior authorization review on meeting diagnostic criteria, prior IV exposure where required, dosing limits, and absence of contraindicated concomitant targeted immunomodulators.

No explicit step therapy sequence mandated in this policy excerpt.
For subcutaneous prophylactic use, prior IV Spevigo exposure or documented history of flares in the prior 12 months is required as detailed under coverage criteria.
If step therapy requirements are needed, they are not specified here and denials should not be based on unspecified step sequencing.

Generalized pustular psoriasis (GPP) — definition

Concise definitionGeneralized pustular psoriasis (GPP) is a rare neutrophilic skin disease characterized by macroscopically visible sterile pustules on an erythematous base that are not restricted to the acral region or within psoriatic plaques.

Distinct entityGPP is clinically and pathophysiologically distinct from plaque psoriasis; pustules, not plaques, are the primary lesion.

Systemic involvementFlares may include systemic inflammation and extra‑cutaneous organ manifestations (e.g., fever, elevated CRP, neutrophilia, possible liver or kidney involvement).