ModifiedAnthemPolicy CC-0221

Medical Drug Clinical Criteria

Clinical criteria for medical-benefit coverage, prior authorization, quantity limits, and coding for Spevigo (spesolimab-sbzo) intravenous vials and subcutaneous prefilled syringes for treatment of generalized pustular psoriasis (GPP).

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria

Policy CodePolicy CC-0221

Change TypeAdded quantity limits and subcutaneous clinical criteria; updated age criteria

Effective DateApr 1, 2023

Next Review Date

Key ActionPrior authorization required with clinical documentation demonstrating applicable initiation or continuation criteria (GPP diagnosis, GPPGA scores, BSA, prior response if applicable, TB testing).

POLICY UPDATE CHANGES

Added quantity limit for new 300 mg syringe.

Added clinical criteria and quantity limit for new subcutaneous formulation and updated age criteria for vial formulation per label (05/17/2024).

Added HCPCS J1747 and ICD-10 L40.1 effective 4/1/2023; removed miscellaneous HCPCS (J3490, J3590, C9399).

2Formulations covered (IV vials, SC syringes)

1Covered indication (GPP)

2Approval durations (IV:1wk; SC:1yr)

J1747Primary HCPCS code

Coverage Summary

Coverage stance: covered_with_criteria. Formulations covered: IV vials for acute flares and SC prefilled syringes for maintenance. Covered indication: Generalized pustular psoriasis (GPP). Approval durations: 1 week per IV infusion and 1 year for SC. Primary HCPCS code: J1747. Scope: Clinical criteria for medical-benefit coverage, prior authorization, quantity limits, and coding for Spevigo (spesolimab-sbzo) intravenous vials and subcutaneous prefilled syringes for treatment of generalized pustular psoriasis (GPP).

Initial Therapy Criteria — IV vials (900 mg)

Additional IV Dose Criteria (second 900 mg dose one week later)

Exclusions / Not Approved — IV vials

Initiation Criteria — SC prefilled syringes (maintenance)

Continuation Therapy Criteria — SC prefilled syringes

Exclusions / Not Approved — SC prefilled syringes

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with clinical criteria

Prior authorization (clinical review) is required. Approval is granted only when submitted documentation demonstrates all applicable initiation or continuation criteria for GPP treatment, including diagnosis, disease severity, prior response if applicable, and tuberculosis screening.

Affected code: J1747
Documentation must demonstrate: diagnosis of GPP, applicable GPPGA scores and subscores, percent BSA with erythema and pustules, prior response to prior spesolimab treatment if applicable, and TB testing (TST or CDC-recommended equivalent) prior to initiation

Documentation Required

Document GPPGA and BSA

Providers must document the GPPGA components and body surface area to support medical necessity for initiation or continuation of therapy.

Applicable Codes

Drug HCPCSHCPCSCovered

J1747

Injection, spesolimab-sbzo, 1 mg [Spevigo]

Diagnosis Codes (informational)ICD-10

L40.1

Generalized pustular psoriasis

Clinical Evidence Summary

54%GPPGA pustulation subscore 0 at Week 1 (single 900 mg IV): 54% vs 6% placebo

6%Placebo rate for pustulation subscore 0 at Week 1: 6%

10%At least one GPP flare over 48 weeks with SC spesolimab (600 mg LD then 300 mg q4w): 10% vs 52% placebo

Evidence summary: IV (single 900 mg) produced rapid pustule clearance in Effisayil 1 (Bachelez 2021), with 54% achieving a GPPGA pustulation subscore of 0 at week 1 versus 6% for placebo. SC maintenance dosing (600 mg loading then 300 mg every 4 weeks) reduced flare frequency in Effisayil 2 (Morita 2023), with 10% versus 52% experiencing at least one flare over 48 weeks.

Background

Background: Spevigo (spesolimab-sbzo) is an IL-36 receptor antagonist approved for generalized pustular psoriasis (GPP). The intravenous formulation is used for treatment of acute GPP flares (single 900 mg IV infusion studied in Effisayil 1), and the subcutaneous formulation is used as maintenance to reduce flare frequency (studied in Effisayil 2 with 600 mg loading then 300 mg q4 weeks). Pivotal trials referenced are Effisayil 1 (Bachelez 2021) and Effisayil 2 (Morita 2023).

Definitions: GPPGA — Generalized Pustular Psoriasis Physician Global Assessment is a composite of erythema, pustules, and scaling subscores (0–4). Acute GPP flare (intravenous criteria) — GPPGA total score of >= 3, pustulation subscore of >= 2, presence of fresh pustules, and >= 5% BSA with erythema and pustules.

Revision History

2025-11-14materialLatest

Annual Review: Added quantity limit for new 300 mg prefilled syringe. Coding reviewed — no changes.

2024-05-17material

Select Review: Added clinical criteria and quantity limit for new subcutaneous formulation (prefilled syringes); updated age criteria for vial (intravenous) formulation per label. Coding reviewed — no changes.

2022-11-18non-material

Annual Review: Coding changes effective 04/01/2023 — Added HCPCS J1747 and ICD-10-CM L40.1; removed miscellaneous HCPCS codes J3490, J3590, and C9399.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria

Policy CodePolicy CC-0221

Change TypeAdded quantity limits and subcutaneous clinical criteria; updated age criteria

Effective DateApr 1, 2023

Next Review Date

On This Page

GPPGA total (composite) score
GPPGA pustulation subscore
Presence of fresh/new or worsening pustules
Percent BSA with erythema and pustules

Denial Risk

Denial if TB screening not performed when initiating

Claims or requests to initiate spesolimab may be denied if a tuberculin skin test (TST) or a CDC-recommended equivalent to evaluate for latent tuberculosis was not performed prior to initiation of therapy.

Billing Rule

Approval duration for IV infusions

Approval duration for intravenous infusions is one week per infusion. A second IV infusion for the same GPP flare may only be approved no sooner than one week after the initial infusion.

Affected code: J1747
Approval duration: 1 week per infusion
Second infusion for same flare allowed no sooner than 1 week after initial infusion

Billing Rule

Subcutaneous approval duration and dosing intervals

Initial and continuation approval duration for subcutaneous prefilled syringes is one year. Dosing limits and timing relative to IV treatment must be observed; initiation of subcutaneous therapy after an IV infusion is allowed no earlier than four weeks after the most recent infusion.

Initial and continuation approval duration: 1 year
If switching from IV to SC, initiate SC no earlier than 4 weeks after most recent IV infusion
SC quantity limits: 150 mg syringes — 2 per 28 days (with override possibilities for initiation); 300 mg syringe — 1 per 28 days