ModifiedUnitedHealthcarePolicy MMG2O9.B

Spevigo (spesolimab-sbzo) IV and Subcutaneous Formulations (for UHCWest Only)

UnitedHealthcare medical benefit drug policy for Spevigo (spesolimab-sbzo) IV and subcutaneous formulations (UHCWest only) defining medical necessity criteria for treatment of GPP flares (IV) and maintenance/prophylaxis (SC), continuation criteria, excluded indications, applicable billing codes, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicySpevigo (spesolimab-sbzo) IV and Subcutaneous Formulations (for UHCWest Only)

Policy CodePolicy MMG2O9.B

Change TypeRevised coverage criteria and continuation requirements

Effective DateJul 1, 2025

Next Review Date

Key ActionAuthorize per limits: IV Spevigo up to 21 days per flare and SC Spevigo up to 12 months; document pustules on erythematous base, severity scores, and reduction in IV use for SC continuation.

POLICY UPDATE CHANGES

Coverage criteria updated: replaced 'on non-acral skin' with 'on erythematous base' for presence of pustules and refined language about pustulation not restricted to acral region or within plaques.

Also clarified combination-therapy exclusion to specify 'for treatment of the same indication', added continuation requirement for SC therapy (reduction in IV therapy use) and examples of positive clinical responses, replaced branded drug reference formatting, and updated supporting sections.

Archived previous policy version MMG2O9.A

1Covered Indication (GPP)

7Unproven / Not Covered Indications Listed

Authorization Durations (IV vs SC)

Coverage Summary

Coverage stance: covered_with_criteria for Spevigo (spesolimab-sbzo) intravenous (IV) formulation for treatment of generalized pustular psoriasis (GPP) flares and subcutaneous (SC) formulation for prophylaxis/maintenance (non-flare) per the policy. Scope summary: UnitedHealthcare medical benefit drug policy for Spevigo (spesolimab-sbzo) IV and subcutaneous formulations (UHCWest only) defining medical necessity criteria for treatment of GPP flares (IV) and maintenance/prophylaxis (SC), continuation criteria, excluded indications, applicable billing codes, and authorization durations. Effective date: 2025-07-01. Last review: 2025-07-01.

Quick Facts & Thresholds

Policy numberMMG2O9.B

PayerUnitedHealthcare (UHCWest)

Minimum age / weight (FDA)>= 12 years and >= 40 kg

IV authorization durationAuthorization for no more than 21 days per flare (up to 2 IV doses per single flare)

SC authorization durationAuthorization for no more than 12 months (initial and continuation approvals)

Coverage stancecovered_with_criteria

Initial / Rescue Therapy — IV Spevigo (GPP Flares)

Spevigo IV — Medically Necessary for GPP Flares (initial/rescue)

Spevigo for intravenous use is medically necessary for treatment of GPP flares when ALL criteria below are met:

ALL of the following

Diagnostic criteria
- Presence of primary, sterile, macroscopically visible pustules on erythematous base
- Pustulation is not restricted to the acral region or within psoriatic plaques
ONE of the following severity criteria
- Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score > 3 (moderate)> 3

Initial Therapy — SC Spevigo (Non‑flare / Prophylaxis)

Spevigo SC — Medically Necessary for GPP (non-flare / prophylaxis / maintenance)

Spevigo for subcutaneous use is medically necessary for the treatment of GPP when ALL criteria below are met:

ALL of the following

Prior IV treatment status
- Diagnostic criteria
  - Presence of primary, sterile, macroscopically visible pustules on erythematous base
  - Pustulation is not restricted to the acral region or within psoriatic plaques
- If patient has not previously been treated with IV Spevigo

Continuation Therapy — SC Spevigo

Continuation of Therapy — Subcutaneous Spevigo

For continuation of subcutaneous therapy, ALL of the following must be met:

ALL of the following

Reduction in the utilization of therapy (e.g., intravenous Spevigo) used for GPP flares
Documentation of positive clinical response to subcutaneous Spevigo therapy (examples: preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs and symptoms of GPP such as pustules, erythema, pain, itching between flares)
Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication (examples listed)
Prescribed by a dermatologist

Not Medically Necessary / Unproven Indications

Spevigo (spesolimab-sbzo) is unproven and not medically necessary for the following conditions and situations:

ALL of the following

Administration of intravenous Spevigo in excess of 2 doses per single GPP flare
Atopic dermatitis
Crohn's disease
Hidradenitis suppurativa
Plaque psoriasis

Applicable Codes

HCPCS / Procedure Code for SpevigoHCPCS

J1747

Injection, spesolimab-sbzo, 1 mg

Diagnosis Codes referencedICD-10

L40.1

Generalized pustular psoriasis

Provider Actions & Billing Rules

Prior Authorization

Authorization required and duration limits

Authorization is required. IV authorization: no more than 21 days per flare and total IV doses must not exceed two doses per single GPP flare. SC authorization: authorization will be for no more than 12 months for initial and continuation approvals when criteria are met.

Authorization required for IV and SC per policy
IV: authorization for no more than 21 days per flare; total IV doses ≤ 2 per flare
SC: authorization for no more than 12 months

Documentation Required

Diagnostic and severity documentation

Document presence of primary sterile pustules on an erythematous base and that pustulation is not restricted to acral regions or within plaques. Provide GPPPGA scores, BSA, and systemic indicators (fever, CRP, leukocytosis) as applicable to establish diagnosis and severity.

Clinical Evidence

10%Spevigo (recommended SC regimen): % with a GPP flare up to week 48

52%Placebo: % with a GPP flare up to week 48

Background evidence: Clinical trials support IV use of Spevigo for treatment of GPP flares (Study Effisayil-1) and SC use to reduce flare recurrence (Study Effisayil-2). The FDA indication includes adults and pediatric patients 12 years of age and older and weighing at least 40 kg.

Background & Definitions

Spevigo is a humanized antagonistic monoclonal IgG1 that blocks activation of the interleukin-36 receptor (IL-36R), a pathway involved in the pathogenesis of generalized pustular psoriasis (GPP). It is indicated for treatment of GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. GPP is a rare, potentially life‑threatening neutrophilic skin disease with episodic flares characterized by primary, sterile, macroscopically visible pustules on an erythematous base and may be associated with systemic inflammation and extra-cutaneous organ involvement.

Definitions & Thresholds

GPPPGA total score — definitionAverage of subscores for pustulation, erythema, and scaling (scale 0-4)

GPPPGA total score (moderate flare threshold)> 3

GPPPGA total score (rescue/end of week 1 threshold)>= 2

GPPPGA pustulation subscore threshold>= 2

Body surface area (BSA) threshold

Revision History

2025-07-01material_changeLatest

Coverage criteria updated: replaced 'on non-acral skin' with 'on erythematous base' for presence of pustules; clarified 'pustulation is not restricted to the acral region or within psoriatic plaques'; specified combination-therapy exclusion to apply 'for treatment of the same indication'; added continuation requirement for subcutaneous therapy requiring reduction in utilization of IV rescue therapy and examples of positive clinical responses; replaced branded drug reference formatting and updated supporting sections.

archived_policy

Archived previous policy version MMG2O9.A

Policy Summary

PayerUnitedHealthcare

PolicySpevigo (spesolimab-sbzo) IV and Subcutaneous Formulations (for UHCWest Only)

Policy CodePolicy MMG2O9.B

Change TypeRevised coverage criteria and continuation requirements

Effective DateJul 1, 2025

Next Review Date

On This Page

Moderate to severe flare based on one of the following

Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation subscore >= 2 (mild)>= 2
Erythema and pustules cover > 5% of body-surface area> 5%
New appearance or worsening of pustules

Criteria for second (rescue) IV dose during same flare

Documentation that the patient requires a second dose of Spevigo to treat persistent GPP flare symptoms
One of the following persistent symptom indicators
- GPPPGA total score > 2> 2
- Fever
- GPPPGA pustulation subscore >= 2>= 2
- Asthenia
- Elevated C-reactive protein
- Myalgia
- Leukocytosis with peripheral blood neutrophilia (above the upper limit of normal)
Second dose is to be administered no sooner than one week after the initial dose

Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication (examples listed)

Total dose of Spevigo does not exceed two doses per single GPP flare (a new/different GPP flare may be treated with up to two doses)

Spevigo is dosed according to U.S. FDA labeled dosing for GPP flares

Prescribed by a dermatologist

Authorization will be for no more than 21 days

Prior Authorization

Authorization required and duration limits

Authorization required for IV Spevigo with limits: authorization will be for no more than 21 days per GPP flare. IV use must follow FDA‑labeled dosing for flares and total IV doses must not exceed two doses per single flare. Authorization is required; include documentation and prescriber requirements per policy.

Authorization for no more than 21 days per flare; IV authorization limits.

Billing Rule

Dose limit per flare (IV)

Billing limitation: do not bill for more than two IV doses of Spevigo for a single GPP flare (total dose per single flare must not exceed two doses).

Do not bill for more than two IV doses of Spevigo per single GPP flare.

Denial Risk

Combination therapy exclusion

Claims may be denied if Spevigo is administered in combination with another targeted immunomodulator for treatment of the same indication. Examples of other targeted immunomodulators are listed in the policy.

Not in combination with another targeted immunomodulator for same indication.

During the previous 12 months prior to initiating SC Spevigo the patient has had one or more moderate to severe GPP flares based on one of the following

Severity criteria (one required)

GPPPGA total score > 3 (moderate)> 3
GPPPGA pustulation subscore >= 2 (mild)>= 2
New appearance or worsening of pustules
Erythema and pustules cover >= 5% of body-surface area>= 5%

Prescriber attests that the patient has experienced flares of a severity and/or frequency such that the patient would clinically benefit from prophylactic therapy with subcutaneous Spevigo

Patient is not currently experiencing a GPP flare

Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication (examples listed)

Spevigo is dosed according to U.S. FDA labeled dosing for treatment of GPP when not experiencing a flare

Prescribed by a dermatologist

Authorization will be for no more than 12 months

Prior Authorization

Authorization required and duration limits

Authorization required for SC Spevigo for non‑flare use: authorization will be for no more than 12 months for initial approval. SC dosing must follow FDA‑labeled dosing and be prescribed by a dermatologist.

SC authorization for no more than 12 months for initial approval.

Denial Risk

Combination therapy exclusion

Claims may be denied if Spevigo is administered concurrently with another targeted immunomodulator for treatment of the same indication; examples of such agents are listed in the policy.

Not in combination with another targeted immunomodulator for same indication.

Documentation Required

Diagnostic and severity documentation

Document diagnostic criteria and disease severity for GPP: presence of primary, sterile pustules on an erythematous base and that pustulation is not restricted to the acral region or within plaques. Provide GPPPGA scores, BSA involvement, and relevant systemic signs/labs as applicable.

Presence of primary sterile pustules on erythematous base
GPPPGA scores
Body surface area (BSA) involvement
Fever
Elevated C‑reactive protein (CRP)
Leukocytosis

Spevigo is dosed according to U.S. FDA labeled dosing for treatment of GPP when not experiencing a flare

Authorization will be for no more than 12 months

Documentation Required

Continuation response evidence

For continuation of SC therapy, document reduction in utilization of IV rescue therapy and provide evidence of positive clinical response to SC Spevigo. Examples of positive clinical response include preventing flares, reducing flare frequency, prolonging time between flares, and controlling signs/symptoms of GPP.

Reduction in IV rescue use
Examples of positive clinical response: preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs/symptoms

Denial Risk

Combination therapy exclusion

Claims may be denied if Spevigo is given in combination with another targeted immunomodulator for treatment of the same indication; the policy lists example agents that would constitute combination therapy.

Not in combination with another targeted immunomodulator for same indication.

Palmoplantar pustulosis

Denial Risk

Combination therapy exclusion

Claims may be denied when Spevigo is used in combination with another targeted immunomodulator for treatment of the same indication. The policy provides examples of such agents.

Billing Rule

Dose limit per flare (IV)

Billing rule: do not bill for more than two IV doses of Spevigo per single GPP flare; administration in excess of two IV doses per flare is considered unproven/not medically necessary.

> 5% or >= 5% (context-dependent: >5% used in IV flare criteria; >=5% used in SC/maintenance criteria)

Diagnostic pustulation requirementPresence of primary, sterile, macroscopically visible pustules on erythematous base; pustulation not restricted to acral region or within psoriatic plaques