ModifiedColorado Rocky Mountain Health PlansPolicy 2025D0119F

Spevigo (spesolimab‑sbzo) for Generalized Pustular Psoriasis

Policy governing medical benefit coverage and authorization criteria for intravenous and subcutaneous Spevigo to treat generalized pustular psoriasis (GPP) flares and prophylactic subcutaneous use, for affected commercial members and prescribers (dermatologists).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySpevigo (spesolimab‑sbzo) for Generalized Pustular Psoriasis

Policy CodePolicy 2025D0119F

Change TypeRevisions to coverage criteria and continuation requirements

Effective DateJuly 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of GPP diagnosis (primary sterile pustules on an erythematous base), required clinical measures, and evidence of clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

Replaced wording for required presence of pustules from 'on non-acral skin' to 'on erythematous base', and clarified pustulation not restricted to acral region or within psoriatic plaques.

Clarified combination therapy exclusion to specify 'for treatment of the same indication'.

Added criterion for continuation of subcutaneous Spevigo therapy requiring reduction in utilization of therapy (e.g., intravenous Spevigo) used for GPP flares.

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

2max doses per flare

21IV auth period (days)

12SC auth (months)

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54%week1 pustulation 0

Coverage Criteria for Spevigo (spesolimab-sbzo)

Intravenous Spevigo for GPP Flares

Covered when ALL of the following are met

IV initial therapy for GPP flare: Diagnosis of generalized pustular psoriasis (GPP); patient has a GPP flare; Spevigo is dosed according to U.S. FDA–labeled dosing for GPP flares; total dose does not exceed two doses per single GPP flare (If the patient was treated for a previous GPP flare, a new/different flare may be treated with up to two doses); authorization will be for no more than 21 days.two doses per flare; authorization ≤ 21 days

Prescribed by a dermatologist is required per related sections.

IV diagnostic confirmation: Diagnosis is based on both: presence of primary, sterile, macroscopically visible pustules on an erythematous base; AND pustulation is not restricted to the acral region or within psoriatic plaques.clinical exam

GPPGA and body-surface-area criteria are used to define moderate-to-severe flares.

Severity criteria for IV use: One of: GPPGA total score ≥ 3; GPPGA pustulation subscore ≥ 2; erythema and pustules cover ≥ 5% body-surface area; new appearance or worsening of pustules.see items

Alternatively, for patients who have already received one initial IV dose for the current flare and require a second dose, persistent symptoms meeting at least one of: GPPGA total score ≥ 2; GPPGA pustulation subscore ≥ 2; fever; asthenia; myalgia; elevated C‑reactive protein; or leukocytosis with peripheral neutrophilia. The second IV dose is given no sooner than one week after the initial dose.

Subcutaneous Spevigo (Prophylaxis / Maintenance)

Covered when ALL of the following are met

Subcutaneous initial therapy (prophylaxis): Diagnosis of generalized pustular psoriasis (GPP) based on both: presence of primary, sterile, macroscopically visible pustules on an erythematous base; and pustulation not restricted to the acral region or within psoriatic plaques; used to prevent GPP flares and patient is not currently experiencing a GPP flare; AND one of: patient has previously been treated with intravenous Spevigo for a GPP flare; OR (patient has not previously received IV Spevigo AND during the prior 12 months the patient had one or more moderate-to-severe GPP flares defined by one of: GPPGA total score ≥ 3; GPPGA pustulation subscore ≥ 2; erythema and pustules covering ≥ 5% BSA; or new/worsening pustules); and prescriber attests the patient would clinically benefit from prophylactic subcutaneous therapy.12-month lookback for flares

For initial subcutaneous use not following IV flare treatment, authorization will be for one loading dose.

Subcutaneous continuation therapy: Documentation of positive clinical response to subcutaneous Spevigo (e.g., preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs/symptoms such as pustules, erythema, pain, itching); AND reduction in utilization of therapy used for acute GPP flares (e.g., decreased need for IV Spevigo); AND patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication; AND prescriber attestation and explanation if patient/caregiver cannot administer maintenance; AND Spevigo dosed per U.S. FDA labeling for treatment of GPP when not experiencing a flare; AND prescribed by a dermatologist; authorization will be for no more than 12 months.

Coverage Criteria (Initial and Continuation)

Covered when ALL of the following are met (per revised policy language and trial definitions):

Initial coverage/indication: Patient has generalized pustular psoriasis (GPP) defined by presence of primary, sterile, macroscopically visible pustules on an erythematous base, not restricted to the acral region or within psoriatic plaques, with clinical severity consistent with a GPP flare (examples include GPPGA total ≥ 3, pustulation subscore ≥ 2, or ≥ 5% BSA with erythema and pustules).

Wording revised in 07/01/2025 update.

Age/weight: Patient is 12 years of age or older and weighs at least 40 kg (per trial enrollment and FDA information).

From clinical trial and FDA informational sections.

Therapy exclusivity: Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication.

Clarified in 07/01/2025 update.

Spevigo (spesolimab-sbzo) is considered unproven and not medically necessary when administered in excess of 2 intravenous doses per single GPP flare. The product is also listed as unproven and not medically necessary for the following conditions and situations: atopic dermatitis, Crohn’s disease, hidradenitis suppurativa, palmoplantar pustulosis, plaque psoriasis, and ulcerative colitis.

Patients presenting with plaque psoriasis without pustules, or with pustules that are restricted to psoriatic plaques, were excluded from a phase 2 trial evaluating spesolimab for GPP flares and therefore such presentations are not aligned with the GPP indication reflected in this policy. The revised coverage language clarifies that pustulation must be clearly consistent with GPP rather than limited to plaque-confined findings.

Examples of unproven or not medically necessary uses include administering IV Spevigo beyond two doses per single GPP flare and use for non-GPP dermatologic or inflammatory conditions listed above (e.g., atopic dermatitis, Crohn’s disease, ulcerative colitis). The policy revision further clarifies that combination use with another targeted immunomodulator for the same indication is not permitted under the coverage criteria.

The policy requires that pustulation meet the revised descriptive criterion of being primary, sterile, macroscopically visible pustules on an erythematous base, and explicitly states that pustulation must not be restricted to the acral region or confined within psoriatic plaques. This clarifies that eligible pustulation for GPP is generalized rather than limited to acral sites or plaque-limited pustules.

Coding — Diagnosis and Procedure Codes

Applicable HCPCS CodesHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg.

Applicable Diagnosis CodesICD-10

L40.1

Generalized pustular psoriasis

GPPGA thresholds used in trials — flare, rescue, recurrent flare

Flare (trial definition)GPPGA total score ≥3; new or worsening pustules; GPPGA pustulation subscore ≥2; ≥5% body surface area with erythema and presence of pustules.

Rescue (week 1 threshold)Eligible for open‑label rescue dose on day 8 if GPPGA total score ≥2 at end of week 1 and GPPGA pustulation subscore ≥2 with clinician assessment of persistent severity.

Recurrent flare (post‑response)After achieving GPPGA total 0 or 1, reoccurrence defined as an increase of ≥2 points in both GPPGA total score and pustulation subscore, permitting single‑dose rescue.

Provider Actions — Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required and Limits

Prior authorization is required for both intravenous (IV) and subcutaneous (SC) Spevigo. Authorization limits: IV Spevigo for a single GPP flare is limited to no more than two 900 mg IV doses per flare and will be authorized for no more than 21 days; SC Spevigo initial authorization following IV treatment is for no more than 12 months and continuation authorizations are for no more than 12 months when continuation criteria are met.

IV Spevigo: maximum 2 doses per single GPP flare; authorization ≤ 21 days
SC Spevigo: initial authorization ≤ 12 months when following IV treatment; continuation authorizations ≤ 12 months

Prior Authorization

Prior Authorization — Required Clinical Confirmation

Prior authorization requests must confirm the covered indication and meet the applicable coverage criteria for the route of administration. For GPP: confirm diagnosis, patient age/weight meets labeling (≥ 12 years and ≥ 40 kg), route (IV vs SC), prescriber specialty (dermatologist for GPP indications), and that Spevigo will not be used in combination with another targeted immunomodulator for the same indication.

Background on Generalized Pustular Psoriasis and Spevigo

Generalized pustular psoriasis (GPP) is a severe, episodic inflammatory skin disease characterized by repeated acute flares with sterile pustules on erythematous skin and potential systemic features (for example, fever, elevated inflammatory markers, or neutrophilia). Spevigo (spesolimab-sbzo) is an anti–IL-36R monoclonal antibody directed at a pathway implicated in GPP pathogenesis and has demonstrated rapid reduction of pustulation in clinical trials; the updated policy criteria align coverage with trial-defined GPP features and FDA-labeled use.

Definitions and Scales

Definition of Generalized Pustular Psoriasis (GPP)

DefinitionGeneralized pustular psoriasis (GPP) is a severe, episodic neutrophilic skin disease characterized by primary sterile pustules on an erythematous base, often with systemic inflammation (fever, elevated CRP, neutrophilia) and potential organ involvement.

Distinct from plaque psoriasisGPP differs from plaque psoriasis in presentation (pustules on erythematous base vs. scaly plaques), pathophysiology, histopathology, genetics, and clinical course.

Diagnostic consensus criteriaConsensus definitions (ERASPEN/IPC/NPF) require macroscopically visible sterile pustules on erythematous base not restricted to acral regions or within psoriatic plaques; may be relapsing or persistent.

GPPGA — Generalized Pustular Psoriasis Physician Global Assessment and subscores

GPPGA (physician global assessment)A clinician‑rated scale composed of subscores for pustulation, erythema, and scaling; used to define flare severity and response (each subscore range 0–4).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySpevigo (spesolimab‑sbzo) for Generalized Pustular Psoriasis

Policy CodePolicy 2025D0119F

Change TypeRevisions to coverage criteria and continuation requirements

Effective DateJuly 1, 2025

Next Review Date

SourceLink

On This Page

clinical response evidence

Prescriber must submit explanation if patient/caregiver cannot self-administer.

Continuation criteria for subcutaneous therapy: For continuation of subcutaneous Spevigo, there must be reduction in utilization of acute IV Spevigo used for GPP flares and evidence of clinical benefit such as preventing flares, reducing frequency of flares, prolonging time between flares, or controlling signs/symptoms between flares.

Added in 07/01/2025 update; examples of positive clinical response include preventing flares, reducing frequency, prolonging interval between flares, and controlling pustules/erythema/pain/itching.

Confirm indication: generalized pustular psoriasis (GPP) flare vs prevention/prophylaxis
Confirm patient meets FDA age/weight labeling: ≥ 12 years and ≥ 40 kg
Prescriber: dermatology
No concurrent targeted immunomodulator for same indication

Denial Risk

Denial Risks — Coverage Criteria Nonconformance

Failure to meet the coverage criteria will result in denial of the request. Examples of nonconformance include absence of the required diagnostic features (e.g., no primary sterile pustules on an erythematous base), exceeding the dosing limit for IV Spevigo (> 2 doses per flare), or use of Spevigo in combination with another targeted immunomodulator to treat the same indication.

Denial if required primary diagnostic features are not documented (macroscopically visible sterile pustules on erythematous base not present)
Denial for IV administration exceeding 2 doses per single GPP flare
Denial if used in combination with another targeted immunomodulator for the same indication

Documentation Required

Required Clinical Documentation — Diagnostic Features

Required clinical documentation with the prior authorization submission must include a clear diagnosis and description of the diagnostic features of GPP. Specifically document presence of primary, sterile, macroscopically visible pustules on an erythematous base and that pustulation is not restricted to the acral region or confined within psoriatic plaques.

Document diagnosis: Generalized Pustular Psoriasis (GPP)
Document presence of primary, sterile, macroscopically visible pustules on an erythematous base
Document that pustulation is not restricted to acral regions or only within psoriatic plaques
If applicable, note patient age and weight to confirm FDA labeling criteria

Documentation Required

Required Clinical Documentation — Severity, Response, and Continuation

For requests involving assessment of severity, initial eligibility, or continuation of SC therapy, submit objective disease activity measures and evidence of benefit. Include GPP-specific measures such as GPPGA total score and pustulation subscore, body surface area (BSA) affected (erythema and pustules % BSA), and clinical notes describing recent flares and treatment response. For continuation of SC Spevigo provide documentation of positive clinical response (for example: preventing flares, reducing flare frequency, prolonging time between flares, controlling signs/symptoms such as pustules, erythema, pain, itching) and evidence of reduced utilization of IV Spevigo or other acute flare therapies.

Provide GPPGA total score and pustulation subscore when available (e.g., GPPGA total ≥ 3 or pustulation subscore ≥ 2 supports moderate disease)
Report percent BSA with erythema and pustules (e.g., ≥ 5% BSA)
For SC continuation: document positive clinical response and reduction in IV therapy utilization
Include dates and descriptions of prior IV Spevigo administrations if applicable

Pustulation subscoreRange 0 (no visible pustules) to 4 (severe pustulation); used as a key component for rescue and response thresholds in trials.

Scoring range and useGPPGA total and subscores range 0–4; utilized to determine eligibility for rescue dosing and to define moderate‑to‑severe flares.

GPP flare definition (trial-derived criteria)

Primary flare definition (trial)GPPGA total ≥3 plus new or worsening pustules and pustulation subscore ≥2 with ≥5% BSA involvement of erythema and pustules.

Week‑1 rescue thresholdPersistent symptoms eligible for open‑label dose on day 8 if GPPGA total ≥2 and pustulation subscore ≥2 at end of week 1 with clinician assessment of severity.

Recurrent flare after responseIncrease of ≥2 points in both GPPGA total and pustulation subscore after GPPGA total has reached 0 or 1 constitutes reoccurrence permitting rescue treatment.

GPPGA total score — calculation and range

CompositionGPPGA total score = average of the three subscores: pustulation, erythema, and scaling.

Score rangeEach subscore and the resulting total range from 0 (clear) to 4 (severe).

InterpretationTotal score reflects overall disease severity and is used with pustulation subscore to define flares, rescue, and response endpoints in trials.