Currentblue cross blue shield - tennesseePolicy ID_CHS_2026

Spesolimab-sbzo (Spevigo)

Policy defines prior authorization criteria, documentation requirements, prescribing specialty, and coverage durations for spesolimab (Spevigo) for treatment of generalized pustular psoriasis (GPP) in patients aged 12 years and older weighing at least 40 kg. It excludes non-FDA-approved indications as investigational.

Policy Summary

Payerblue cross blue shield - tennessee

PolicySpesolimab-sbzo (Spevigo)

Policy CodePolicy ID_CHS_2026

Change Typeclarified

Effective DateJul 31, 202654d

Next Review Date

Key ActionSubmit prior authorization with required documentation (genetic test results, labs, biopsy, GPPPGA, chart notes, prior medication history for initial requests, and documentation of positive clinical response for continuation).

SourceLink

POLICY UPDATE CHANGES

Policy effective and implementation date listed as 7/31/26; do not implement until that date.

1FDA-approved indication covered

0Non–FDA indications covered

12m / 1mAuthorization durations (maintenance / flare)

Coverage Summary

This policy defines prior authorization criteria, documentation requirements, prescribing specialty, and coverage durations for spesolimab (Spevigo) for the treatment of generalized pustular psoriasis (GPP) in patients aged >= 12 years and weighing at least >= 40 kg. Coverage is limited to the FDA‑approved indication for GPP; all other uses are considered investigational. Authorization durations specified in the policy are 1 month for treatment of a GPP flare (short-course) and 12 months for maintenance treatment when not experiencing a flare. The coverage stance for spesolimab in this policy is covered_with_criteria. Key supporting sources include the Spevigo package insert (October 2025) and primary clinical trials such as the Trial of spesolimab for GPP (N Engl J Med. 2021;385(26):2431-2440).

Initial Therapy Criteria

FDA-Approved Indication

Covered when ALL of the following are met:

ALL of the following

Indication: Treatment of generalized pustular psoriasis (GPP).
Age: Member is 12 years of age or older.>= 12 years
Weight: Member weighs at least 40 kg.>= 40 kg

Authorization for GPP Flare (short-course: 1 month)

Authorization of 1 month may be granted when ALL of the following are met:

ALL of the following

Age: Member is 12 years of age or older.>= 12 years
Documented findings
- Clinical presentation: Member is presenting with primary, sterile, macroscopically visible pustules (new or worsening) on an erythematous base (excluding cases where pustulation is restricted to psoriatic plaques).
- Genetic variant: Presence of IL36RN, CARD14, AP1S3, MPO, or SERPINA gene variant.
- Biopsy: Skin biopsy confirming presence of Kogoj's spongiform pustules.

Authorization for GPP When Not Experiencing a Flare (maintenance: 12 months)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Age: Member is 12 years of age or older.>= 12 years
History
- Relapsing or persistent: Member has a known documented history of GPP (either relapsing [greater than 1 episode] or persistent [greater than 3 months]).
- Recurrent flares: Member has had a history of at least two moderate-to-severe GPP flares (e.g., at least 5% body surface area is covered with erythema and the presence of pustules; GPPPGA total score >= 3).

Continuation Therapy Criteria

Continuation Criteria

Continuation requests must meet all applicable requirements:

ALL of the following

Flare continuation: For GPP flare: All members 12 years and older requesting continuation must meet all requirements in the coverage criteria (i.e., initial flare criteria).
Maintenance continuation: For GPP when not experiencing a flare: Members must achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.
Documentation for continuation: Chart notes or medical record documentation supporting positive clinical response must be provided for continuation requests.

Unproven / Exclusions & Therapy Restrictions

Concomitant Therapy and TB Screening Requirements

ALL of the following

Concomitant therapy restriction: Member cannot use spesolimab concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Claims may be denied if used concurrently.
TB screening recency: Member must have a documented negative TB test (TST or IGRA) within 12 months of initiating therapy if biologic/targeted-synthetic naïve.within 12 months
TB positive follow-up: If TB screening is positive, further testing (e.g., chest x-ray) is required to exclude active disease; do not administer medication to members with active TB infection; latent TB must be treated before initiation.
Operational: exclude active TB and treat latent TB prior to initiation.

The policy only covers FDA‑approved indications. Uses of spesolimab outside of the FDA‑approved indication for GPP are considered investigational and not medically necessary.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Submit a prior authorization request including the required clinical documentation to support the indication and requested duration of therapy.

Genetic test results
Laboratory results
Biopsy results
GPPPGA (Generalized Pustular Psoriasis Physician Global Assessment) score / severity assessment
Chart notes documenting clinical presentation of pustules and affected areas
Prior medication history and response to therapy for initial requests
Documentation of positive clinical response (chart notes) for continuation requests

Documentation Required

Prescriber specialty

This medication must be prescribed by or in consultation with a dermatologist.

Documentation Required

TB screening documentation

Provide a documented negative TB test (TST or IGRA) within 12 months for patients naïve to biologic or targeted‑synthetic therapies; if screening is positive, obtain further testing (e.g., chest x‑ray) to exclude active TB, and document latent TB treatment prior to initiation — do not administer the medication to patients with active TB.

Billing Rule

Concomitant biologic restriction

Do not administer spesolimab concomitantly with any other biologic or targeted synthetic drug for the same indication; claims may be denied if used concurrently.

Clinical Evidence and References

Key references supporting the policy include the pivotal clinical trial: Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440, and the product labeling: Spevigo [package insert], October 2025. The policy references the package insert and key clinical trials, consensus statements, and related literature as noted in the background and reference list.

Background

Spesolimab (Spevigo) is FDA‑approved for treatment of generalized pustular psoriasis (GPP) in patients aged 12 years and older and weighing at least 40 kg. This policy covers only the FDA‑approved indication for GPP; other uses are investigational. References supporting these statements include the Spevigo package insert (October 2025) and key clinical trials and consensus statements.

Definitions: Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA): a disease severity assessment tool; a GPPPGA total score >= 3 is used in this policy to indicate moderate‑to‑severe disease in examples and authorization criteria.

Policy Summary

Payerblue cross blue shield - tennessee

PolicySpesolimab-sbzo (Spevigo)

Policy CodePolicy ID_CHS_2026

Change Typeclarified

Effective DateJul 31, 202654d

Next Review Date

SourceLink

On This Page

OpenPayer

Spesolimab-sbzo (Spevigo)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions & Therapy Restrictions

Provider Actions & Requirements

Applicable Codes

Clinical Evidence and References

Background

Revision History