CurrentBlue Cross Blue Shield - IowaPolicy 05.04.71

Spevigo (spesolimab-sbzo) for generalized pustular psoriasis

Defines prior authorization, clinical criteria, dosing limits, and documentation required for Spevigo (spesolimab-sbzo) for treatment of generalized pustular psoriasis (GPP) in members 12 years and older for Wellmark Blue Cross and Blue Shield.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySpevigo (spesolimab-sbzo) for generalized pustular psoriasis

Policy CodePolicy 05.04.71

Change TypeRevised

Effective DateFeb 1, 2023

Next Review DateApr 1, 2026

Key ActionSubmit prior authorization with chart notes documenting pustules, supportive findings (e.g., GPPPGA, biopsy, or genetic test), and TB screening results.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised in April 2026 with a current effective date of April 19, 2026.

≥12minimum age for coverage

40 kgminimum weight for pediatric coverage

1 moauthorization length for GPP flare

12 moauthorization length for non-flare GPP use

Up to 4/yrquantity limit for 450 mg vial

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Coverage Criteria for Spevigo (spesolimab-sbzo)

Generalized pustular psoriasis (GPP) flare

Covered when ALL of the following are met for GPP flare (authorizations up to 1 month):

GPP flare initial criteria: A. Member is presenting with primary, sterile, macroscopically visible pustules (new or worsening) on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques).

Supportive findings (at least one): B. Member has at least one of the following documented: (1) IL36RN, CARD14, AP1S3, MPO or SERPINA gene mutation; (2) skin biopsy confirming presence of Kogoj's spongiform pustules; (3) systemic symptoms or laboratory abnormalities commonly associated with GPP flare (e.g., fever, asthenia, myalgia, elevated C-reactive protein [CRP], leukocytosis, neutrophilia above ULN); (4) GPP flare of moderate-to-severe intensity (e.g., ≥5% body surface area with erythema and pustules; GPPPGA total score ≥3).at least 1 of 4

Generalized pustular psoriasis (GPP) when not experiencing a flare

Covered when ALL of the following are met for GPP when not experiencing a flare (authorizations up to 12 months):

Diagnosis/history: A. Member has a known documented history of GPP (either relapsing: greater than 1 episode; or persistent: greater than 3 months).

Flaring history or refractory course: B. Member meets either: (1) history of at least two moderate-to-severe GPP flares (e.g., ≥5% body surface area with erythema and pustules; GPPPGA total score ≥3); OR (2) history of flaring while on concomitant systemic treatment (e.g., retinoids, methotrexate, cyclosporine).

Current disease status: C. Member currently has clear to almost clear skin.

TB screening and concomitant biologic prohibition: Other: Documented negative tuberculosis (TB) test within 12 months for biologic‑naïve patients (TST or IGRA); if TB screening is positive, further testing to exclude active disease (e.g., chest x‑ray) and treat latent TB prior to initiation. Do not administer if active TB. Member cannot use the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication.

Continuation Therapy

Continuation of therapy:

Continuation for flare: Members requesting continuation must meet all initial authorization criteria for GPP flare.

Continuation for non-flare: For non‑flare use, members must achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms to receive 12‑month reauthorization.

Do not administer Spevigo to members with active tuberculosis infection. Prior to initiation, document a negative tuberculosis (TB) screening test (TST or IGRA) within 12 months for patients who are biologic- or targeted-synthetic-naïve; if screening is positive, perform further testing (for example, chest x-ray) to exclude active disease and treat latent TB before starting therapy. Members may not receive Spevigo concomitantly with any other biologic or targeted synthetic drug for the same indication.

Use of Spevigo (spesolimab-sbzo) is considered not medically necessary for members who do not meet the clinical criteria and documentation requirements specified in this policy.

Procedures and Scoring

Procedures/Billing HCPCSHCPCS

J1747	Injection, spesolimab-sbzo, 1 mg (effective 4/1/2023)
J3490	Unclassified drugs
J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Procedures/Billing HCPCS (alternate grouping)HCPCS

J1747	Injection, spesolimab-sbzo, 1 mg (effective 4/1/2023)
J3490	Unclassified drugs
J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

GPPPGA total score

Required GPPPGA total score>= 3

Scale range0–4 for each domain (Erythema, Pustules, Scaling)

Scoring interpretationScores of 3–4 indicate moderate-to-severe disease (bright red to deep fiery red with high-density pustules)

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for 1 month for GPP flares or up to 12 months for non-flare treatment when all criteria are met.

Prior authorization durations: 1 month (flare) or 12 months (non-flare when criteria met).

Note

Clinical Background and Diagnostic Requirements

For non-flare (maintenance) use the member must have a documented history of relapsing or persistent GPP and meet flare-history or treatment-response requirements. For flare use the member must present with active pustulation and supporting clinical or laboratory evidence.

GPP flare criteria include new or worsening primary sterile pustules on non-acral skin and at least one of: relevant gene mutation (IL36RN, CARD14, AP1S3, MPO, SERPINA), biopsy showing Kogoj's spongiform pustules, systemic symptoms or lab abnormalities (e.g., fever, elevated CRP, leukocytosis/neutrophilia), or moderate-to-severe flare (≥5% BSA with pustules or GPPPGA ≥3).
Non-flare (maintenance) criteria: documented history of GPP (relapsing: >1 episode or persistent: >3 months) AND either ≥2 moderate-to-severe flares historically (≥5% BSA with pustules or GPPPGA ≥3) OR history of flaring while on concomitant systemic treatment (e.g., retinoids, methotrexate, cyclosporine). Member must currently have clear to almost clear skin.

Background on Generalized Pustular Psoriasis and Spevigo

Generalized pustular psoriasis (GPP) is an inflammatory pustular disorder that can present with sterile, macroscopically visible pustules and may be accompanied by systemic symptoms or laboratory abnormalities. Spevigo (spesolimab-sbzo) is indicated for treatment of GPP; the policy requires objective documentation of disease (for example visible pustules, genetic mutations, skin biopsy, systemic signs, or a GPPPGA score meeting the policy threshold) to support authorization and safe use, including TB screening and avoidance of concomitant biologic or targeted synthetic therapy.

Definitions and Scoring Instruments

GPPPGA — Generalized Pustular Psoriasis Physician Global Assessment

Domains scoredErythema, Pustules, Scaling (each rated 0–4)

0 - descriptionNormal or post-inflammatory hyperpigmentation; no visible pustules; scaling = 0 (clear)

1 - descriptionFaint, diffuse pink or slight red erythema; low-density occasional small discrete pustules (noncoalescent); scaling = 1 (almost clear)

2 - descriptionLight red erythema; moderate density grouped discrete small pustules (noncoalescent); scaling = 2 (mild)

3 - descriptionBright red erythema; high density pustules with some coalescence; scaling = 3 (moderate)

4 - descriptionDeep fiery red erythema; very high-density pustules with pustular lakes; scaling = 4 (severe)

Policy Revision History

2026-04policy_revisionLatest

Policy reviewed and revised in April 2026; current effective date April 19, 2026.

2023-02-01policy_effective

Original policy effective date established (February 1, 2023).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySpevigo (spesolimab-sbzo) for generalized pustular psoriasis

Policy CodePolicy 05.04.71

Change TypeRevised

Effective DateFeb 1, 2023

Next Review DateApr 1, 2026

Key ActionSubmit prior authorization with chart notes documenting pustules, supportive findings (e.g., GPPPGA, biopsy, or genetic test), and TB screening results.

SourceLink

On This Page

Documentation Required

Required Documentation

Submit chart notes or medical records and supporting diagnostic data to initiate prior authorization review. Documentation should demonstrate diagnosis, disease history, prior treatments and response, and any applicable test results.

For GPP flare: chart notes documenting pustules and affected areas; genetic test results (if performed), laboratory results, biopsy results, and GPPPGA score or other severity assessments if available.
For GPP when not experiencing a flare — initial requests: chart notes documenting history of GPP including history of flares; chart notes/records/claims supporting prior medications tried and response. Continuation requests: chart notes documenting positive clinical response.
Include any applicable imaging, labs, or pathology reports as relevant to the diagnosis and treatment response.

Documentation Required

TB Screening and Concomitant Therapy

Document a negative tuberculosis (TB) screening within 12 months for members naïve to biologic or targeted synthetic agents; if TB screening is positive, perform further testing to exclude active disease and do not start therapy until appropriate management is done.

Acceptable TB screening: TST or IGRA within 12 months prior to initiating therapy for biologic- or targeted-synthetic–naïve members.
If TB test positive: obtain chest x-ray or other testing to rule out active TB. Do not administer requested medication for active TB. If latent TB is identified, begin TB treatment prior to initiating the requested medication.
Requested medication must not be used concomitantly with any other biologic or targeted synthetic drug for the same indication.

Denial Risk

Denial Triggers and Missing Information

Requests lacking required diagnostic or documentation elements, or for members who do not meet the clinical criteria, will be denied.

Denial triggers include: absence of chart notes documenting GPP diagnosis or active pustulation (for flares); missing documentation of prior flares or prior therapy and response for non-flare requests; lack of required genetic, biopsy, or laboratory evidence when applicable; missing TB screening within 12 months for biologic/targeted-synthetic–naïve members; request to use concomitantly with another biologic/targeted synthetic for same indication.
Spevigo (spesolimab-sbzo) will be considered not medically necessary for members who do not meet the above criteria.