ModifiedColorado Rocky Mountain Health PlansPolicy CSOH2025D0119.D

Spevigo (spesolimab-sbzo) — Coverage Criteria for Generalized Pustular Psoriasis (Ohio)

Defines medical benefit coverage criteria for intravenous and subcutaneous Spevigo for treatment and prevention of generalized pustular psoriasis (GPP) flares for Ohio members and requirements for authorization and prescriber.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySpevigo (spesolimab-sbzo) — Coverage Criteria for GPP (Ohio)

Policy CodePolicy CSOH2025D0119.D

Change TypeCoverage criteria revised — diagnostic language and combination-therapy restriction clarified

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting revised GPP diagnostic criteria and that patient is not receiving Spevigo with another targeted immunomodulator for the same indication.

SourceLink

POLICY UPDATE CHANGES

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

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

Replaced criterion 'The patient is not receiving Spevigo in combination with another targeted immunomodulator' with '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: preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs and symptoms of GPP between flares.

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

2maximum IV doses allowed per single GPP flare

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

≤21 daysmaximum initial IV authorization period

≤12 monthsinitial/continuation SC authorization period

900 mgintravenous single dose used in pivotal trial

10% vs 52%flare rate SC vs placebo (Effisayil‑2)

Coverage criteria for Spevigo (spesolimab-sbzo)

Initial/Rescue IV Therapy

Covered when ALL of the following are met:

IV Initial/Rescue Therapy

Severity threshold: Patient has a moderate to severe GPP flare defined by at least one of: GPPPGA total score ≥ 3; GPPPGA pustulation subscore ≥ 2; erythema and pustules ≥ 5% body-surface area; or new appearance or worsening of pustules.
Second-dose criteria: Alternatively, patient has already received one initial IV dose for the current flare AND documentation supports need for a second dose for persistent symptoms as evidenced by at least one of: GPPPGA total score ≥ 2; GPPPGA pustulation subscore ≥ 2; fever; asthenia; myalgia; elevated C-reactive protein; or leukocytosis with peripheral neutrophilia.
General conditions: Second dose to be administered no sooner than 1 week after the initial dose; patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication; Spevigo is dosed according to FDA labeling for GPP flares; total dose does not exceed two doses per single GPP flare (separate new flares may receive up to two doses); prescribed by a dermatologist; authorization ≤ 21 days.

Operational note: Administration of intravenous Spevigo in excess of two doses per single GPP flare is not medically necessary and may be denied.

Initial SC Therapy (prophylaxis)

Covered when ALL of the following are met:

SC Initial Therapy

Prior IV or flare history: One of the following: patient has previously been treated with intravenous Spevigo for a GPP flare; OR patient has not received IV Spevigo but during the prior 12 months had one or more moderate-to-severe GPP flares defined by at least one: GPPPGA total score ≥ 3; GPPPGA pustulation subscore ≥ 2; erythema and pustules ≥ 5% BSA; or new/worsening pustules.
Attestation and exclusions: Prescriber attests the patient would clinically benefit from prophylactic SC therapy; patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication.
Administration/logistics: SC dosing may be given as a single loading dose for patients not following IV treatment of a flare OR based on prescriber attestation that patient/caregiver cannot be trained or is physically unable to administer maintenance SC doses (explanation required).

SC Continuation Therapy

Covered when ALL of the following are met:

SC Continuation: Documentation of positive clinical response to subcutaneous Spevigo (examples: preventing flares; reducing frequency of flares; prolonging time between flares; controlling signs/symptoms of GPP such as pustules, erythema, pain, itching between flares); reduction in utilization of therapy used for GPP flares (e.g., IV Spevigo); patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication; prescriber attestation that patient/caregiver cannot be trained or is physically unable to administer maintenance SC doses (explanation required); Spevigo dosed per FDA labeling for GPP when not experiencing a flare; prescribed by a dermatologist; authorization ≤ 12 months.

Initial therapy / Coverage rationale

Covered when ALL of the following are met (policy rationale revised 08/01/2025):

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

Reflects IPC and trial-aligned diagnostic language

Indication: Treatment of generalized pustular psoriasis (GPP).

Spevigo is FDA‑approved for GPP in patients ≥12 years and ≥40 kg (informational)

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

Combination therapy exclusion narrowed to same‑indication use

The policy lists several uses for which Spevigo (spesolimab‑sbzo) is considered unproven and not medically necessary. These include administration of intravenous Spevigo in excess of 2 doses per single GPP flare, and off‑label indications such as atopic dermatitis, Crohn's disease, hidradenitis suppurativa, palmoplantar pustulosis, plaque psoriasis, and ulcerative colitis.

Plaque psoriasis that lacks pustules or in which pustules are confined to psoriatic plaques was an exclusion criterion in the Effisayil‑1 phase 2 trial of spesolimab. For coverage determinations, use for plaque psoriasis without pustules or with pustules restricted to psoriatic plaques may therefore be considered non‑applicable to generalized pustular psoriasis (GPP) indications and excluded from coverage.

The policy specifies a limit on intravenous administrations for a single GPP flare: administration of IV Spevigo in excess of 2 doses per single GPP flare is considered not medically necessary and may be denied.

FDA approval of Spevigo is provided for informational context only. FDA approval alone is not sufficient to establish coverage; the policy requires supporting clinical documentation that the patient meets the policy’s diagnostic and clinical criteria for GPP.

Applicable codes and measurement thresholds

Applicable HCPCS CodesHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg

Applicable Diagnosis CodesICD-10

L40.1

Generalized pustular psoriasis

GPPPGA and disease extent thresholds — eligibility and rescue dosing

GPPPGA total score (initial eligibility)GPPPGA total score ≥ 3 (moderate) defines a moderate-to-severe flare for IV rescue dosing

GPPPGA pustulation subscore (initial eligibility)GPPPGA pustulation subscore ≥ 2 qualifies as a severity criterion for IV rescue dosing

Erythema + pustules (initial eligibility)Erythema and pustules covering ≥ 5% body surface area meets disease-extent threshold for IV rescue dosing

Second-dose / rescue thresholdsAfter an initial IV dose, a second IV dose may be given if persistent symptoms meet any: GPPPGA total score ≥ 2; GPPPGA pustulation subscore ≥ 2; fever; asthenia; myalgia; elevated CRP; or leukocytosis with neutrophilia

Pivotal trial single IV doseThe pivotal trial used a single intravenous dose of 900 mg spesolimab-sbzo; rescue/second IV doses in the trial were 900 mg

Prescriber and authorization requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spevigo (spesolimab). Authorization durations: IV administration for a GPP flare is authorized for no more than 21 days; subcutaneous authorization varies by indication — one loading dose if not following IV treatment, or up to 12 months when used following IV treatment or for continuation therapy as specified in criteria. Documentation must demonstrate dosing per U.S. FDA–labeled dosing for GPP and that total IV doses do not exceed two doses per single GPP flare.

Prior authorization required
IV authorization: ≤ 21 days
SC authorization: loading dose (single) if not following IV; initial/continuation authorizations up to 12 months as applicable
Total IV doses ≤ 2 per single GPP flare

Denial Risk

Use for Plaque Psoriasis Excluded

Background on generalized pustular psoriasis and therapy

Generalized pustular psoriasis (GPP) is a distinct, rare neutrophilic skin disease characterized by recurrent acute flares with primary, sterile, macroscopically visible pustules on an erythematous base. Flares can be systemic and severe, may include fever, elevated C‑reactive protein, or neutrophilia, and are clinically and pathophysiologically distinct from plaque psoriasis. Spevigo targets the IL‑36 receptor signaling pathway implicated in GPP pathogenesis and was studied for IV treatment of flares and subcutaneous prevention of flares.

Key definitions and assessment tools

Generalized pustular psoriasis (GPP) diagnostic criterion

Core diagnostic findingPresence of primary, sterile, macroscopically visible pustules on an erythematous base

Anatomic restrictionPustulation must not be restricted to the acral region or confined within psoriatic plaques

Relation to systemic inflammationMay occur with or without systemic inflammation (e.g., fever, elevated CRP, neutrophilia)

GPPGA — Generalized Pustular Psoriasis Physician Global Assessment

DefinitionGeneralized Pustular Psoriasis Physician Global Assessment (GPPGA) is a physician global scale whose total score is the average of subscores for pustulation, erythema, and scaling

Scoring rangeGPPGA total score ranges 0 (clear) to 4 (severe); subscores for pustulation, erythema, and scaling use the same range

Policy revision history

2025-08-01policy_revisionLatest

Revised coverage criteria: diagnostic wording changed to 'presence of primary, sterile, macroscopically visible pustules on erythematous base'; anatomical restriction clarified to 'pustulation is not restricted to the acral region or within psoriatic plaques'; combination-therapy exclusion narrowed to 'for treatment of the same indication'; examples of measurable positive clinical responses to subcutaneous therapy were added (preventing flares, reducing frequency, prolonging time between flares, controlling signs and symptoms between flares); terminology standardized (replaced 'Stelara (ustekinumab)' with 'ustekinumab').

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySpevigo (spesolimab-sbzo) — Coverage Criteria for GPP (Ohio)

Policy CodePolicy CSOH2025D0119.D

Change TypeCoverage criteria revised — diagnostic language and combination-therapy restriction clarified

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting revised GPP diagnostic criteria and that patient is not receiving Spevigo with another targeted immunomodulator for the same indication.

SourceLink

On This Page

Dosing and prescriber: Spevigo dosed according to FDA labeling for GPP when not experiencing a flare; prescribed by a dermatologist; authorization = one loading dose if not following IV treatment, or initial authorization up to 12 months when following IV treatment.

Operational note: Prior authorization is required; initial SC authorizations follow the stated limits and prescriber attestation requirements must be submitted.

Spevigo is indicated for generalized pustular psoriasis (GPP) only. Use of Spevigo for plaque psoriasis without pustules, or plaque psoriasis with pustules restricted to psoriatic plaques, is excluded per trial entry criteria and is considered unproven/not medically necessary.

Plaque psoriasis without pustules — not covered
Plaque psoriasis with pustules restricted to psoriatic plaques — not covered

Documentation Required

Prescribing Information and Clinical Trial Documentation

Prescriber and evidence expectations: therapy must be prescribed by a dermatologist. Prescribers should document diagnosis using revised GPP diagnostic language (presence of primary, sterile, macroscopically visible pustules on an erythematous base, with pustulation not restricted to the acral region or within psoriatic plaques). Include supporting prescribing information and clinical trial references (for example, FDA prescribing information and Effisayil™‑1 trial publications) to substantiate the diagnosis and indication.

Must be prescribed by a dermatologist
Document presence of primary sterile visible pustules on erythematous base
Document pustulation not restricted to acral region or within psoriatic plaques
Provide prescribing information and relevant clinical trial references (e.g., Effisayil™‑1)

Step Therapy

Step Therapy / Prescriber Requirements

Step-therapy and prescriber requirements: no explicit medication step-therapy trials are required by this policy. However, prescriber must be a dermatologist and dosing must follow FDA-labeled dosing for the GPP indication. Combination use with another targeted immunomodulator for the same indication is not permitted.

No specific step-therapy trials required
Prescriber must be a dermatologist
Dosing must follow FDA-labeled dosing for GPP
Do not combine Spevigo with another targeted immunomodulator for the same indication

Note

Policy Revisions: Diagnostic and Response Documentation

Policy language was revised to clarify diagnostic criteria and to add examples of acceptable documentation of clinical response supporting continuation therapy. Examples of clinical response 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.

Revised diagnostic wording: 'primary, sterile, macroscopically visible pustules on erythematous base'
Clarified pustulation exclusion: 'not restricted to the acral region or within psoriatic plaques'
Added examples of clinical response to support ongoing therapy: preventing flares; reducing frequency of flares; prolonging time between flares; controlling signs/symptoms between flares

Use in policyGPPGA total score and pustulation subscore are used to define moderate-to-severe flares (total ≥3 or pustulation subscore ≥2) and to determine rescue/second-dose eligibility (total ≥2 or pustulation subscore ≥2)

Generalized pustular psoriasis (GPP) — concise definition

Concise definitionA rare neutrophilic skin disease characterized by macroscopically visible sterile pustules on an erythematous base that are not restricted to the acral region or confined within psoriatic plaques

Distinct from plaque psoriasisGPP is clinically and pathophysiologically distinct from plaque psoriasis and is defined by pustules as the primary lesion rather than scaly plaques

Clinical courseMay be relapsing or persistent and can be associated with systemic symptoms and severe extra‑cutaneous organ involvement