CurrentViva HealthPolicy IC-P0674

Spevigo (spesolimab) (Intravenous) — Coverage Criteria

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Defines Viva Health prior authorization, dosing, and medical necessity criteria for intravenous Spevigo (spesolimab) for members, including initial authorization, dosing limits, and renewal restrictions.

Policy Summary

PayerViva Health

PolicySpevigo (spesolimab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-P0674

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization; initial approval valid 30 days and may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysinitial prior authorization validity

No renewalsrenewal availability

900 mgloading dose per infusion

300 mgmaintenance dose every 28 days

J1747

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CurrentViva HealthPolicy IC-P0674

Spevigo (spesolimab) (Intravenous) — Coverage Criteria

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Policy Summary

PayerViva Health

PolicySpevigo (spesolimab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-P0674

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization; initial approval valid 30 days and may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysinitial prior authorization validity

No renewalsrenewal availability

900 mgloading dose per infusion

300 mgmaintenance dose every 28 days

J1747

HCPCS billing code (1 mg units)

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Age/Indication: Member has an FDA labeled indication and either is within FDA-labeled age for the indication or there is support for use in the member's age

TB screening: Member does not have active or latent tuberculosis OR if latent TB is present, member has begun or completed therapy for latent TB prior to initiating therapy

Prescriber is a specialist in the area of the member's diagnosis or has consulted with a specialist

Contraindications: Member does not have any FDA labeled contraindications to the requested agent

Indication-specific: Either member has GPP and is currently experiencing a flare, has not received 2 or more Spevigo IV infusions for the current flare, and weighs >=40 kg; OR member has another FDA labeled indication for the agent

Combination therapy: Either agent will NOT be used in combination with another immunomodulatory agent; OR if used in combination, prescribing information does not limit such use AND supporting evidence for combination therapy is provided

Submit clinical trials/guidelines when combination is planned

A member who has received 2 or more Spevigo IV infusions for the current GPP flare does not meet the initial approval criteria and is excluded from coverage under the initial therapy requirements. The policy requires that, for GPP flares, the member has not received 2 or more Spevigo intravenous infusions for the current flare as a condition of initial authorization.

Prior authorization for Spevigo is time-limited. Initial authorization is valid for 1 month (30 days) and prior authorization validity may not be renewed; renewal or continuation beyond the initial authorization is not provided under this policy.

Initial Spevigo for GPP Flare

Initial Spevigo for GPP flare — Initial dosing and eligibility for GPP flare

Initial dosing and eligibility for GPP flare

Diagnosis and flare: Member has diagnosis of generalized pustular psoriasis (GPP) and is currently experiencing a flare

Prior infusions: Member has not received 2 or more Spevigo IV infusions for the current flare

Requests for more than two infusions for the current flare are outside initial criteria and risk denial

Weight: Member weighs >= 40 kg>= 40 kg

Dosing:

Continuation Therapy

Continuation Therapy — Renewal/Continuation

Renewal/Continuation

Continuation not allowed: Prior authorization validity may not be renewed; continuation beyond initial authorization is not provided

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J1747

Injection, spesolimab-sbzo, 1 mg; 1 billable unit = 1 mg

NDCNDC

00597-0035xx

Spevigo 450 mg/7.5 mL (60 mg/mL) two-pack single-dose vial for intravenous use

Covered Diagnosis CodesICD-10Covered

L40.1

Generalized pustular psoriasis

Weight

Weight requirement>= 40 kg

Where statedMember weighs greater than or equal to 40 kg as part of GPP flare initial criteria

Related criteriaMember has not received 2 or more Spevigo IV infusions for the current flare (paired with weight requirement)

Spevigo (spesolimab) dosing — regimen summary

Loading dose (per infusion)900 units (900 mg) on days 1 and 8

Maintenance dose300 units (300 mg) every 28 days

Provider Actions & Documentation

Prior Authorization

Prior authorization required; initial 30-day validity

Prior authorization is required for Spevigo (spesolimab) IV. Initial authorization is valid for 1 month (30 days) and may not be renewed.

Step Therapy

PA applied due to drug cost (NQTL)

Prior authorization is applied because the plan considered drug cost as a Non‑Quantitative Treatment Limitation (NQTL).

Documentation Required

Submit diagnosis, weight, prior infusions, prescriber specialty, and TB documentation

Site of Care Requirements

Note

Infusion must be given in a healthcare setting

Intravenous infusion of Spevigo must be administered by a healthcare professional in a healthcare setting.

Administer single 900 mg IV infusion over 90 minutes; if needed, a second 900 mg IV dose may be given one week later

Quantity Limits

Spevigo (spesolimab) dosing summary

Loading regimenLoad: 900 units (900 mg) on days 1 and 8

Maintenance regimenMaintenance: 300 units (300 mg) every 28 days

Dose form/unitsHCPCS billing in billable units where 1 unit = 1 mg

Step Therapy / Prior Authorization Rationale

NQTL factor	Considered for prior authorization?
Cost of drug	covered
Indication	covered
Safety and efficacy	not_covered
Potential for misuse/abuse	not_covered

Background

Generalized pustular psoriasis (GPP) is a severe, potentially acute inflammatory pustular eruption. Spevigo (spesolimab) is indicated for treatment of GPP flares and is administered intravenously by a healthcare professional in a healthcare setting. The policy follows FDA-labeled indications and references prescribing information and consensus guidance for use in members with active GPP flares.

Definitions

Generalized pustular psoriasis (GPP)

ICD-10 codeL40.1

DescriptionGeneralized pustular psoriasis (GPP)

UseCovered diagnosis code for GPP indication in this policy

Policy Summary

PayerViva Health

PolicySpevigo (spesolimab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-P0674

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization; initial approval valid 30 days and may not be renewed.

SourceLink

On This Page

Administer single 900 mg IV infusion over 90 minutes; if flare persists, an additional 900 mg IV dose may be administered one week after the initial dose; maintenance dosing 300 mg every 28 days as noted in dosing limits

Infusion must be administered by a healthcare professional in a healthcare setting

Administration route

Intravenous infusion by a healthcare professional in a healthcare setting

Include documentation of the diagnosis of generalized pustular psoriasis (GPP) with current flare status, the member’s weight (≥40 kg), evidence of number of prior Spevigo infusions for the current flare, and prescriber specialty or consultation; also include documentation of TB status or latent TB therapy when applicable.

Diagnosis: GPP and current flare
Member weight ≥ 40 kg
Number of prior Spevigo IV infusions for the current flare
Prescriber is a specialist or documentation of specialist consultation
Documentation of TB status or latent TB treatment

Documentation Required

Provide prescribing info and clinical evidence for combination immunomodulatory therapy

If the requested agent will be used in combination with another immunomodulatory therapy, submit the prescribing information showing combination use is not limited and supporting clinical evidence (clinical trials, phase III studies, or guidelines) that combination therapy is appropriate.

Prescribing information must not limit concomitant immunomodulatory use
Submit supporting clinical trials, phase III studies, or guidelines when combination is planned

Denial Risk

Document TB status and prescriber specialty to avoid denial

Provide evidence that the member does not have active or latent tuberculosis, or documentation that latent TB treatment has been begun or completed; also provide evidence the prescriber is a specialist or consulted a specialist to avoid denial.

Proof member does NOT have active or latent TB OR documentation latent TB therapy has been started/completed prior to initiation
Documentation that prescriber is a specialist or consulted a specialist

Denial Risk

Requests >2 IV infusions for current flare risk denial

Requests for more than two Spevigo IV infusions for the current GPP flare exceed the initial approval criteria and may be denied.

Initial criteria allow fewer than 2 infusions for the current flare; more than two infusions are outside initial approval