CurrentCareSourcePolicy N/A

Spevigo (spesolimab-sbzo) intravenous for generalized pustular psoriasis flares — Coverage Criteria

Defines prior authorization, coverage criteria, dosing, and prescribing requirements for Spevigo IV for treatment of generalized pustular psoriasis (GPP) flares; applies to providers seeking medical-benefit coverage from the payer.

Policy Summary

PayerCareSource

PolicySpevigo (spesolimab-sbzo) IV for generalized pustular psoriasis flares — Coverage criteria

Policy CodePolicy N/A

Change TypeEligibility and dosing revisions (age lowered to ≥12, weight ≥40 kgclarified IV dosing limits)

Effective DateN/A

Next Review DateApr 9, 2025

Key ActionSubmit prior authorization showing patient meets clinical criteria and dosing limits; prescriptions must be by or with a dermatologist and approvals are for 30 days.

SourceLink

POLICY UPDATE CHANGES

Age requirement changed from ≥18 years to ≥12 years and a weight requirement of ≥40 kg was added.

Clarified criteria for patients currently receiving Spevigo subcutaneous vs those not receiving subcutaneous therapy with separate GPPGA thresholds.

Clarified limits on number and timing of IV doses (approve up to two IV doses; if two prior IV doses given, require ≥12 weeks since last dose).

900 mgsingle IV dose

90 mininfusion duration

up to 2max doses per flare

≥12min age

≥40 kgmin weight

30 daysauthorization period

Coverage Criteria for Spevigo IV

FDA-Approved Indication — Generalized Pustular Psoriasis Flare

Covered when ALL of the following are met:

ALL of the following

Patient is at least 12 years of age.
Patient weighs ≥ 40 kilograms (kg).
Patient is experiencing a flare of moderate-to-severe intensity.
GPP-specific disease activity (one of):
- GPP Physician Global Assessment (GPPGA) total score indicating moderate-to-severe disease (note: GPPGA total score ranges from 0 [clear] to 4 [severe]).

Policy Summary

PayerCareSource

PolicySpevigo (spesolimab-sbzo) IV for generalized pustular psoriasis flares — Coverage criteria

Policy CodePolicy N/A

Change TypeEligibility and dosing revisions (age lowered to ≥12, weight ≥40 kgclarified IV dosing limits)

Effective DateN/A

Next Review DateApr 9, 2025

Key ActionSubmit prior authorization showing patient meets clinical criteria and dosing limits; prescriptions must be by or with a dermatologist and approvals are for 30 days.

SourceLink

On This Page

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Patient has new or worsening pustules and a GPPGA pustulation subscore ≥ 2 and erythema and pustules affecting ≥ 5% body surface area.

Patient has had an increase in GPPGA total score of ≥2 points.

Prior Spevigo IV exposure rules (one of):

Patient is not currently receiving Spevigo subcutaneous injection and has not already received two doses of Spevigo intravenous for treatment of the current flare.
If the patient has previously received two doses of Spevigo intravenous for this flare, at least 12 weeks have elapsed since the last IV dose.

Medication is prescribed by or in consultation with a dermatologist.

Dosing and timing limits (all required when applicable):

Approve 900 mg per dose administered by intravenous (IV) infusion.
If a second IV dose is administered for the same flare, at least 7 days must elapse between doses.
For a new flare, at least 12 weeks must have elapsed since the last dose of Spevigo (if previously treated).

Concomitant use of Spevigo with another biologic prescribed for treatment of generalized pustular psoriasis is not recommended. In clinical studies patients were required to discontinue other biologic therapy prior to receiving Spevigo; concomitant biologic use may increase risk of adverse events and complicate assessment of treatment response.

Spevigo is not recommended for treatment of plaque psoriasis in the absence of generalized pustular psoriasis. Use in plaque psoriasis without GPP has not been studied and is not supported by the FDA-approved indication.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Patients with concomitant plaque psoriasis and generalized pustular psoriasis may be evaluated under the GPP criteria above. Criteria will be updated as new published data become available.

Coding, Age, and Weight Requirements

Covered CPT/HCPCS/NDC codesmixed

NDC or HCPCS not specified

No explicit HCPCS or NDC codes listed in the document

inv-05: Age

Minimum age for approval≥ 12 years

Age change notePolicy age requirement was revised from ≥18 years to ≥12 years (document history).

Applies toPatients presenting with a generalized pustular psoriasis (GPP) flare meeting all other criteria

inv-06: Weight

Minimum weight for approval≥ 40 kilograms

Threshold contextWeight threshold is required in addition to age for IV Spevigo approval for GPP flare

Applies toPatients meeting all other specified clinical and dosing criteria

Prescriber Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spevigo (certolizumab pegol) for the indications and dosing described in this policy. Approvals are contingent on meeting the clinical criteria and dosing limits specified in the Recommended Authorization Criteria. Requests for doses outside the dosing regimens documented in this policy will be reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist). All approvals are provided for 30 days.

Prior Authorization required for medical benefit coverage
Approvals contingent on meeting clinical criteria and dosing limits
Requests for off-label or higher-than-listed dosing reviewed case-by-case by clinician
Approval duration: 30 days

Note

Guideline Context for Alternative Therapies

Guidelines recommend alternative systemic therapies for generalized pustular psoriasis and place Spevigo within that context. The National Psoriasis Foundation and its Medical Board list first-line options such as acitretin, cyclosporine, methotrexate, and infliximab; second-line options include adalimumab (Humira), etanercept (Enbrel), topical agents, and PUVA. The National Psoriasis Foundation (2024) emphasizes timely access to FDA-approved therapies for generalized pustular psoriasis due to risk of morbidity and mortality; Spevigo is noted as an FDA-approved treatment for GPP flares. Consideration of these guideline-recommended alternatives should occur as part of clinical decision-making when appropriate.

First-line recommended therapies: acitretin, cyclosporine, methotrexate, infliximab
Second-line/replacement options: adalimumab, etanercept, topical corticosteroids/calcipotriene/tacrolimus, PUVA
Spevigo is the first FDA-approved treatment specifically for GPP flares (per NPF 2024)
Timely initiation of approved therapy is important given risks with delayed treatment

Documentation Required

Prescribing and Review Requirements

Spevigo must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., dermatologist). Initial and continuation use require documentation that the patient meets the specific medical necessity criteria (age/weight, GPPGA scoring, extent of BSA involvement, prior dosing history). If prescribing outside the dosing regimens in this policy or requesting additional/alternate dosing, submit a clinical rationale and supporting documentation; these requests will be reviewed individually by a clinician. Approvals are issued for 30 days and can be extended if the patient continues to meet criteria and dosing.

Prescriber requirement: specialist (dermatologist) or consultation with specialist
Documentation required: criteria supporting GPPGA scores, BSA involvement, age/weight, prior Spevigo dosing history
Off-label or additional dosing requests: submit clinical rationale and supporting documentation for case-by-case clinician review
Approval duration: 30 days; extensions allowed if criteria continue to be met

Denial Risk

Denial Triggers

Deny requests when required criteria are not met or when use falls into exclusion scenarios identified in this policy.

Concomitant use with another biologic prescribed for generalized pustular psoriasis is a denial trigger
Use limited to plaque psoriasis without generalized pustular psoriasis is not recommended and should be denied
Requests for indications not listed in the Recommended Authorization Criteria should be denied (unless approved via case-by-case clinician review with supporting evidence)

Background on Spevigo and Indication

Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for treatment of generalized pustular psoriasis (GPP) flares in the approved population. The policy aligns with trial requirements and regulatory labeling emphasizing timely treatment of GPP flares; prior clinical studies required discontinuation of other biologic therapy before receiving Spevigo.

Clinical Definitions and Scales

inv-12: Define GPPGA scoring and pustulation subscore

GPPGA total score range0 (clear) to 4 (severe)

Pustulation subscore roleGPPGA pustulation subscore is used in approval criteria; a pustulation subscore ≥ 2 is required for approval when pustules are new or worsening

Approval pathways using GPPGAApproval may be based on either: (a) new/worsening pustules with pustulation subscore ≥2 plus erythema/pustules affecting ≥5% BSA, or (b) an increase in GPPGA total score of ≥2 points

Subcutaneous-specific requirementPatients currently receiving Spevigo subcutaneous injection must meet subcutaneous-specific GPPGA criteria including an increase in total score ≥2 AND pustulation subscore ≥2