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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNorth Carolina Medicaid Spevigo Prior Auth | OpenP…
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    CurrentNorth Carolina MedicaidPolicy N/A

    Systemic Immunomodulators—Spevigo

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    This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Spevigo (spesolimab) used to treat acute generalized pustular psoriasis flares in eligible beneficiaries, including clinical, safety, dosing, and concurrent-therapy requirements.

    Policy Summary
    PayerNorth Carolina Medicaid
    PolicySystemic Immunomodulators—Spevigo
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateAugust 1, 2025
    Next Review DateN/A
    Key ActionObtain prior approval for Spevigo and document all diagnosis, age, flare-severity, safety, infection, vaccine, and concomitant-therapy criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+Minimum age for approval
    30 daysMaximum approval duration
    2 dosesMaximum doses per flare
    GPPGA ≥3Required flare severity
    ≥5%

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    Required affected body surface area
    1Injectable immunomodulators covered at once

    Spevigo Coverage Criteria

    Initial Spevigo therapy

    Spevigo is covered for initial therapy when ALL of the following criteria are met:

    ALL of the following

    • Beneficiary has a diagnosis of generalized pustular psoriasis (GPP).
    • Beneficiary is 18 years of age or older.>= 18 years
      • ALL of the following

        • Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score is moderate or greater.>= 3
        • Fresh pustules are present, defined as new or worsening pustules.
        • GPPGA pustulation subscore is mild or greater.>= 2
        • At least 5% of body surface area has erythema and the presence of pustules.>= 5% body surface area

    The beneficiary must NOT have any of the following conditions: synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome; primary erythrodermic psoriasis vulgaris; primary plaque psoriasis vulgaris without the presence of pustules or with pustules restricted to psoriatic plaques; or drug-triggered acute generalized exanthematous pustulosis (AGEP).

    The beneficiary must NOT have a history of hypersensitivity to any component of Spevigo.

    The beneficiary must have been evaluated and screened for latent tuberculosis (TB) before initiating treatment and must receive ongoing monitoring for TB during treatment.

    The beneficiary must NOT have an active infection, including clinically important localized infections.

    Spevigo must NOT be used concomitantly with a TNFα inhibitor (for example, adalimumab or infliximab), a biologic response modifier (for example, apremilsat or upadacitinib), or a systemic immunosuppressant (for example, a retinoid, cyclosporine, or methotrexate).

    The beneficiary must NOT have received a live virus vaccine within the last 6 weeks and must NOT receive a live virus vaccine during therapy.

    Coding and Clinical Thresholds

    Therapeutic Class Codemixed
    L1AAntipsoriatic Agents, Systemic
    GPPGA Total Score
    Required thresholdGPPGA total score ≥ 3
    Severity classificationModerate
    Clinical applicationRequired for an acute moderate-to-severe generalized pustular psoriasis flare
    GPPGA Pustulation Subscore
    Required thresholdGPPGA pustulation subscore ≥ 2
    Severity classificationMild
    Clinical applicationOne of the required findings for an acute moderate-to-severe generalized pustular psoriasis flare

    Provider Requirements and Approval Risks

    Prior Authorization

    Prior Approval Required

    Prior approval is required for Spevigo under the North Carolina Medicaid outpatient pharmacy criteria. Submit the prior approval request with the clinical and safety documentation supporting all approval criteria.

    • Medication: Spevigo
    • Therapeutic class code: L1A — Antipsoriatic Agents, Systemic
    Documentation Required

    EPSDT Documentation and Prior Approval

    For beneficiaries under 21, EPSDT does not eliminate the prior approval requirement when the requested service, product, or procedure requires prior approval. Documentation must establish that the service is medically necessary to correct or ameliorate the beneficiary’s condition and meets applicable EPSDT criteria; unsafe, ineffective, or experimental/investigational treatment is not required to be covered.

    • Service limitations may be exceeded or may not apply only when provider documentation supports medical necessity under EPSDT.

    Policy Background

    Spevigo (spesolimab) is covered under North Carolina Medicaid outpatient pharmacy prior approval criteria for acute moderate-to-severe flares of generalized pustular psoriasis (GPP), a severe pustular inflammatory psoriasis condition. A qualifying flare requires a GPPGA total score of ≥ 3, fresh or worsening pustules, a GPPGA pustulation subscore of ≥ 2, and erythema with pustules affecting ≥ 5% of body surface area. Coverage also requires age eligibility, tuberculosis screening and monitoring, assessment for infection and hypersensitivity, and compliance with specified concomitant-therapy and live-virus-vaccine restrictions.

    Clinical and Program Definitions

    Acute Moderate-to-Severe GPP Flare
    GPPGA total scoreAt least 3 (moderate)
    PustulesFresh pustules that are new or worsening
    Pustulation subscoreAt least 2 (mild)
    Affected body surface areaAt least 5% with erythema and pustules
    GPPGA
    Full termGeneralized Pustular Psoriasis Physician Global Assessment
    AbbreviationGPPGA

    Initial Therapy Eligibility

    Approval Duration and Dose Limits

    Spevigo Approval Duration
    DrugSpevigo
    Maximum approval durationUp to 30 days
    Approval unitCourse
    Spevigo Dosing Limit
    Maximum doses2 doses per GPP flare
    Additional doseAn additional 900 mg dose may be administered 1 week after the initial dose
    Condition for additional doseGPP symptoms persist after the initial dose
    Policy Summary
    PayerNorth Carolina Medicaid
    PolicySystemic Immunomodulators—Spevigo
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateAugust 1, 2025
    Next Review DateN/A
    Key ActionObtain prior approval for Spevigo and document all diagnosis, age, flare-severity, safety, infection, vaccine, and concomitant-therapy criteria.
    SourceLink
    On This Page
    Spevigo Coverage CriteriaCoding and Clinical ThresholdsProvider Requirements and Approval RisksPolicy BackgroundClinical and Program DefinitionsInitial Therapy EligibilityApproval Duration and Dose Limits
    Body Surface Area
    Required affected areaAt least 5% of body surface area
    Required skin findingsErythema and the presence of pustules
    Clinical applicationOne of the required findings for an acute moderate-to-severe generalized pustular psoriasis flare
  1. Use the NCTracks Provider Claims and Billing Assistance Guide and EPSDT provider resources for additional prior approval requirements.
  2. Documentation Required

    Clinical Eligibility Documentation

    Document the diagnosis, acute flare findings, exclusions, and safety screening needed to demonstrate clinical eligibility for Spevigo approval.

    • Generalized pustular psoriasis (GPP) diagnosis; beneficiary is 18 years of age or older.
    • Acute GPP flare of moderate to severe intensity: GPPGA total score ≥ 3; fresh pustules that are new or worsening; GPPGA pustulation subscore ≥ 2; and ≥ 5% body surface area with erythema and pustules.
    • Document absence of SAPHO syndrome, primary erythrodermic psoriasis vulgaris, primary plaque psoriasis vulgaris without pustules or with pustules restricted to psoriatic plaques, and drug-triggered acute generalized exanthematous pustulosis (AGEP).
    • Document no history of hypersensitivity to any product component and no active infection, including clinically important localized infection.
    • Document latent tuberculosis evaluation and screening before treatment, with ongoing monitoring for TB during treatment.
    • Document that the beneficiary has not received a live virus vaccine within the previous 6 weeks and will not receive one during therapy.
    • Document that concomitant TNFα inhibitors, biologic response modifiers, and systemic immunosuppressants will not be used.
    Denial Risk

    Failure to Meet Clinical or Safety Criteria

    Requests may be denied when the beneficiary does not meet the clinical eligibility requirements or when a safety exclusion is present. Ensure the submitted record supports every required criterion before requesting approval.

    • Diagnosis is not generalized pustular psoriasis, or the beneficiary is younger than 18.
    • The documented flare does not meet all required GPPGA, pustulation, and body-surface-area thresholds.
    • An excluded psoriasis/AGEP condition, hypersensitivity history, active infection, or inadequate TB screening/monitoring is present.
    • Concomitant prohibited immunomodulator therapy or prohibited live-virus vaccination is planned or has occurred.
    Denial Risk

    Dose and Concurrent-Therapy Limits

    Approval is limited by duration, dosing, and concurrent injectable immunomodulator restrictions. Requests exceeding these limits require supporting documentation and remain subject to the applicable criteria.

    • Approve for up to 30 days.
    • If GPP symptoms persist after the initial dose, an additional 900 mg dose may be administered 1 week after the initial dose; maximum of 2 doses per GPP flare.
    • Only one injectable immunomodulator may be covered at a time.
    Assessment typePhysician Global Assessment total score
    EPSDT
    Full termEarly and Periodic Screening, Diagnostic, and Treatment
    Applies toMedicaid beneficiaries under 21 years of age
    Coverage standardMedically necessary services, products, or procedures to correct or ameliorate a defect, illness, or condition identified through a screening examination
    Prior approvalPrior approval remains required when the service, product, or procedure requires it