CurrentCignaPolicy IP0649

Inflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy

Prior authorization requirements and medical necessity criteria for coverage of Spevigo subcutaneous injection for generalized pustular psoriasis in Cigna-administered health plans, including initial and continuation criteria, exclusions, and prescribing provider requirements.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0649

Change TypeAdministrative updatesappendix revised

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and document history of ≥2 moderate-to-severe GPP flares, prior treatment trials or intolerance, and baseline/follow-up GPPGA scores; initial approvals must involve a dermatologist.

SourceLink

POLICY UPDATE CHANGES

New policy created and titled 'Inflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy' with initial effective date 09/15/2024 and subsequent effective dates updated.

Appendix updated to include only biologics FDA approved for the treatment of plaque psoriasis.

1Covered Indication (GPP)

2Minimum prior flares required

4 monthsRequired prior treatment trial duration

6 months

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Continuation therapy established duration

Coverage Summary

Covered with criteria: Spevigo (spesolimab-sbzo) subcutaneous prior authorization for generalized pustular psoriasis (GPP) per policy IP0649 — coverage limited to patients ≥ 12 years and weighing ≥ 40 kg, with required documentation of disease history, prior treatment trials or intolerance, GPPGA assessment, and dermatology prescribing/consultation. Continuation and reauthorization rules and exclusions apply as specified in the policy.

Eligibility thresholds (quick facts)

Age>= 12 years

Weight>= 40 kg

Prior flaresHistory of at least two generalized pustular psoriasis flares of moderate-to-severe intensity

Prior treatment duration4-month trial of at least one treatment (e.g., methotrexate, acitretin, cyclosporine, or biologics) or documented intolerance

Established therapy duration>= 6 months (required for continuation approval)

Initial Therapy Criteria

FDA-Approved Indication: Generalized Pustular Psoriasis

A) Initial Therapy

Age and weight
- Age: Patient is ≥ 12 years of age>= 12 years
- Weight: Patient weighs ≥ 40 kilograms (kg)>= 40 kg
Disease history and severity

Continuation Therapy Criteria

FDA-Approved Indication: Generalized Pustular Psoriasis - Continuing Therapy

B) Patient is Currently Receiving Spevigo Subcutaneous

Established on therapy: Patient has been established on therapy for at least 6 months>= 6 months
Beneficial clinical response: Patient has experienced a beneficial clinical response, defined as improvement from baseline in at least one of the following: reduction of generalized pustular psoriasis flares or an improvement in GPPGA scoreImprovement in flares or GPPGA

Other Coverage Rules / General

Policy-level statements and constraints

Timing relative to IV formulation: Spevigo subcutaneous may be initiated or reinitiated 4 weeks after treatment with Spevigo intravenous for a generalized pustular psoriasis flare4 weeks after IV
Dosage and site of care: Dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity and previous response
Samples do not satisfy criteria: Receipt of sample product does not satisfy any criteria requirements for coverage

Not Medically Necessary / Exclusions

Spevigo subcutaneous for any other use is considered not medically necessary, including but not limited to:

Concomitant use with other biologic or DMARD: Concomitant use with another biologic or disease-modifying antirheumatic drug (DMARD) prescribed for treatment of generalized pustular psoriasis
Use for plaque psoriasis (Spevigo has not been studied in patients with plaque psoriasis without generalized pustular psoriasis)

Applicable Codes / Drugs Referenced

Relevant drugs/brands referencedmixed

Spevigo

spesolimab-sbzo subcutaneous injection - Boehringer Ingelheim (brand name referenced rather than billing code)

Appendix: Other biologics referenced (for context only)mixed

Adalimumab SC Products	Humira and biosimilars
Certolizumab pegol SC	Cimzia
Etanercept SC Products	Enbrel and biosimilars
Infliximab IV Products	Remicade and biosimilars
Golimumab SC	Simponi
Ustekinumab SC Products	Stelara SC and biosimilars
Brodalumab SC	Siliq
Bimekizumab SC	Bimzelx
Secukinumab SC	Cosentyx
Ixekizumab SC	Taltz

1–10 of 13

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Clinical Evidence & References

References:

• FDA Prescribing Information: Spevigo intravenous infusion and subcutaneous injection, March 2026.

• National Psoriasis Foundation consensus statement, 2024 — advocates timely access to FDA-approved therapy for generalized pustular psoriasis.

Note: The policy uses the Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) to assess severity and response.

Trial / endpoint highlights

Initial approval duration6 months (when initial criteria met)

Continuation approval duration1 year (when established on therapy >=6 months with clinical benefit)

Clinical response definitionImprovement from baseline in at least one: reduction of GPP flares or improvement in GPPGA score

Background

Background: Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for generalized pustular psoriasis in adults and pediatric patients ≥ 12 years and weighing ≥ 40 kg. The subcutaneous formulation is intended for non-flare maintenance use, whereas the intravenous formulation is used to treat generalized pustular psoriasis flares. Per the policy, Spevigo subcutaneous may be initiated or reinitiated 4 weeks after treatment with Spevigo intravenous. Initial use requires prescription by or consultation with a dermatologist and other policy-specified documentation and criteria.

Revision History

2024-07-25created

New policy created (Review Date 07/25/2024) titled 'Inflammatory Conditions - Spevigo Subcutaneous' with initial effective date 09/15/2024; administrative creation, no material changes to clinical criteria.

2024-09-12administrative_update

Policy title updated to 'Inflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy' (no criteria changes).

2024-11-01effective_date_update

Definitions

GPPGAGeneralized Pustular Psoriasis Physician Global Assessment; used to assess disease severity and response (policy requires score of 0 or 1 in initial criteria)

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0649

Change TypeAdministrative updatesappendix revised

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Patient has history of at least two generalized pustular psoriasis flares of moderate-to-severe intensity in the past

History of ≥ 2 flares

GPPGA score: Patient has a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 0 or 1GPPGA = 0 or 1

Prior treatment trial or intolerance

a) Prior treatment trial and flaring
- 4-month trial: Patient has had a 4-month trial of at least one treatment for generalized pustular psoriasis4 months
  Examples include methotrexate, acitretin, cyclosporine, or biologics
- Flaring on or with dose change: Patient has had a history of flaring while on treatment or with dose reduction or discontinuation of treatment
b) Intolerance to treatment: Patient has tried at least one treatment for generalized pustular psoriasis but was unable to tolerate a 4-month trialUnable to tolerate 4-month trial

Specialist involvement: The medication is prescribed by or in consultation with a dermatologist

Initial approval requires specialist prescription or consultation

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Spevigo subcutaneous. Initial approvals require the medication to be prescribed by or in consultation with a dermatologist. All approvals are provided for the durations specified in the policy.

Documentation Required

Documentation of prior treatments and flares

Providers must document a history of at least two generalized pustular psoriasis flares of moderate-to-severe intensity, prior treatment trials including duration (e.g., a 4-month trial of treatments such as methotrexate, acitretin, cyclosporine, or biologics) or inability to tolerate a 4-month trial, and evidence of flaring while on therapy or with dose reduction/discontinuation when applicable. Document baseline and follow-up Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) scores to demonstrate response.

Billing Rule

Sample products do not meet criteria

Receipt of a sample product does not satisfy any criteria requirements for coverage and cannot be used to meet prior authorization criteria.

Documentation Required

Timing relative to IV formulation

Spevigo subcutaneous may be initiated or reinitiated 4 weeks after treatment with Spevigo intravenous for a generalized pustular psoriasis flare. Document prior IV use and the timing relative to initiation or reinitiation of the subcutaneous formulation.

Policy effective date updated to 11/01/2024; administrative update with no changes to clinical criteria.

2025-04-24review

Policy reviewed (04/24/2025); no criteria changes (administrative).

2025-05-15effective_date_update

Policy effective date updated to 05/15/2025; administrative update with no changes to clinical criteria.

2026-04-30review

Policy reviewed (04/30/2026); no criteria changes. Appendix updated to include only biologics FDA approved for treatment of plaque psoriasis (administrative clarification).

2026-06-01effective_date_updateLatest

Policy effective date updated to 06/01/2026; administrative update with no material changes to clinical criteria. Policy remains titled 'Inflammatory Conditions - Spevigo Subcutaneous Prior Authorization Policy' and maintains prior authorization clinical requirements for Spevigo subcutaneous.