ModifiedmhnPolicy CP.PHAR.606

SPEVIGO (PDF)

Clinical policy defining medical necessity criteria, dosing, reauthorization, exclusions, and coding guidance for Spevigo (spesolimab-sbzo) across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

Payermhn

PolicySPEVIGO (PDF)

Policy CodePolicy CP.PHAR.606

Change TypeMODIFIED

Effective DateMar 1, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added criteria for newly approved pediatric extension for patients 12 years of age and older weighing at least 40 kg and added newly approved subcutaneous formulation.

Added HCPCS code J1747 for spesolimab-sbzo.

Extended initial approval duration from 6 to 12 months for HIM/Medicaid and added ICHRA line of business.

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 2026-01-01).

Removed expired HCPCS codes C9399 and J3590 for Spevigo.

Added new dosage form (300 mg/2 mL single-dose prefilled syringe) to product availability and criteria.

1FDA-approved indication(s)

12Min age (years)

40 kgMin pediatric weight

J1747

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Coverage Summary

This policy covers Spevigo (spesolimab-sbzo) for the FDA‑approved indication of generalized pustular psoriasis (GPP) under a "covered with criteria" stance. Coverage applies across Commercial, HIM/ICHRA, and Medicaid lines of business as reflected in the scope_summary and Line of Business fields. The policy follows the FDA‑approved minimum age and weight requirements of ≥ 12 years and ≥ 40 kg. It distinguishes intravenous (IV) use for treatment of acute moderate‑to‑severe GPP flares and subcutaneous (SC) regimens for prevention/maintenance (including combined IV initial treatment with subsequent SC maintenance), with approval durations and operational details specified by line of business.

Key thresholds

Minimum approved age12 years

Minimum pediatric weight≥ 40 kg

Required prior systemic therapy trial duration≥ 3 consecutive months

Active HCPCS codeJ1747

IV use indicationFor acute moderate-to-severe GPP flares (IV: 900 mg one time; optional second 900 mg at 1 week)

SC use indicationPrevention/maintenance dosing (SC: 600 mg once then 300 mg every 4 weeks)

Initial Therapy Criteria - Generalized Pustular Psoriasis

Initial Therapy Criteria - Other Diagnoses / Indications

Re-authorization / Continued Therapy Criteria - Generalized Pustular Psoriasis

Provider Actions & Documentation Requirements

Prior Authorization

Documentation submission required

Provider must submit documentation supporting that the member has met all approval criteria. Acceptable documentation includes office chart notes, laboratory results, or other clinical information.

Prior Authorization

Prescriber specialty requirement

Spevigo must be prescribed by or in consultation with a dermatologist. When prescribed in consultation, include documentation of the dermatologist consultation with the request.

Prior Authorization

Step therapy / prior systemic therapy requirement

Member must have failed a ≥ 3 consecutive month trial of methotrexate, cyclosporine, or acitretin at up to maximally tolerated/contraindicated doses prior to initial approval. State-specific exemptions apply (e.g., Illinois HIM: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395).

Applicable Codes

HCPCS - Drug code for spesolimab-sbzoHCPCSCovered

J1747

Injection, spesolimab-sbzo, 1 mg

Expired/Removed HCPCS codes referencedHCPCS

C9399	Unclassified drugs or biologicals (expired - removed for Spevigo)
J3590	Unclassified biologics (expired - removed for Spevigo)

Clinical Evidence

Key evidence cited in the policy includes the randomized trial: Bachelez H et al., Trial of spesolimab for generalized pustular psoriasis. N Engl J Med 2021;385:2431-40, and the Spevigo Prescribing Information (Boehringer Ingelheim; October 2025). These sources are referenced as the primary clinical evidence supporting spesolimab's efficacy for GPP flare resolution and for maintenance prevention regimens as summarized in the brief and policy.

Product Background

Spevigo (spesolimab-sbzo) is an interleukin‑36 receptor antagonist indicated for treatment of generalized pustular psoriasis in patients aged ≥ 12 years and weighing ≥ 40 kg. The policy defines IV administration (900 mg once, with an optional second 900 mg dose one week later if flare symptoms persist) for treatment of acute moderate‑to‑severe GPP flares, and SC regimens for prevention/maintenance (initial 600 mg once then maintenance 300 mg every 4 weeks; or initiation of SC 4 weeks after IV as specified). Product availability includes IV single‑dose vials (450 mg/7.5 mL) and single‑dose prefilled syringes including the new 300 mg/2 mL format. Contraindications and safety exclusions include severe hypersensitivity/DRESS, and the policy specifies that Spevigo is not to be prescribed concurrently with biological disease‑modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) due to additive immunosuppression and infection risk.

Policy metadata

Policy numberCP.PHAR.606

SubjectSpevigo (spesolimab-sbzo) for generalized pustular psoriasis

Effective date2023-03-01

Last review date2026-05-26

Definitions

Definitions: GPP (Generalized pustular psoriasis) — a rare, severe form of psoriasis characterized by widespread sterile pustules and systemic symptoms; GPPPGA — Generalized Pustular Psoriasis Physician Global Assessment, the mean of erythema, pustules, and scaling/crusting scored 0–4 used to classify GPP intensity; bDMARD — biological disease‑modifying antirheumatic drug.

Revision History

04.17.23added (material)

Added HCPCS code J1747 for spesolimab-sbzo.

1Q2024removed (non-material)

Removed expired HCPCS codes C9399 and J3590 for Spevigo (non-material).

04.04.24RT4 update (material)

Added criteria for newly approved pediatric extension for patients 12 years of age and older weighing at least 40 kg and added newly approved subcutaneous formulation.