CurrentAvMedPolicy N/A

Spevigo (spesolimab‑sbzo) — Pharmacy Prior Authorization for Generalized Pustular Psoriasis (GPP) — Coverage Criteria

Defines prior authorization and step-edit requirements for Spevigo (subcutaneous) when used for maintenance treatment of generalized pustular psoriasis (GPP) for AvMed members; applies to prescribers and specialty pharmacy processing.

Policy Summary

PayerAvMed

PolicySpevigo (spesolimab‑sbzo) — Pharmacy Prior Authorization for GPP maintenance

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and provide chart notes, labs, and documentation to support all checked clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial approval

12 moReauthorization

2 mL/28dQuantity limit

≥12 yrs / ≥40 kgMin eligibility

Coverage Criteria for Spevigo (spesolimab-sbzo)

Initial Therapy Criteria

Policy Summary

PayerAvMed

PolicySpevigo (spesolimab‑sbzo) — Pharmacy Prior Authorization for GPP maintenance

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and provide chart notes, labs, and documentation to support all checked clinical criteria.

SourceLink

On This Page

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Age/Weight and Prescriber: Member is ≥ 12 years of age and weighs ≥ 40 kg; medication is prescribed by or in consultation with a dermatologist, rheumatologist, or other specialist in the treatment of psoriasis.

Prior Spevigo use or initiation regimen: Member must meet ONE of: received Spevigo for active flare within the past 4 weeks and provider requests a maintenance dose of 300 mg starting 4 weeks after last IV dose; OR no prior Spevigo and initiating maintenance without active flare with loading 600 mg at week 0 then 300 mg at week 4 then every 4 weeks; OR previously received maintenance Spevigo under current/previous plan and requesting continuation (note: use of samples does NOT meet criteria); OR documented history of GPP and not currently in flare meeting additional subcriteria.

Verified by chart notes and/or pharmacy & medical paid claims

Documented GPP history subcriteria: If relying on documented history of GPP (not currently in flare), member must have either relapsing (≥1 episode) or persistent (≥3 months) disease; have a GPPPGA total score of 0 or 1; and have had at least TWO prior GPP flares of moderate-to-severe intensity with fresh pustulation in the past (BSA ≥5% with erythema and presence of pustules; GPPPGA total ≥3).

Verified by chart notes

Prior treatment attempts: Member has had a 4-month trial of at least one systemic GPP treatment (e.g., methotrexate, acitretin, cyclosporine, or biologics) with flaring while on treatment, dose reduction, or discontinuation; OR unable to tolerate a 4-month trial.4 months

Examples provided in policy

Safety and monitoring requirements: Member has received age-appropriate vaccinations prior to initiating treatment; has been evaluated and screened for latent tuberculosis prior to initiating and will have ongoing TB monitoring; does not have an active infection; will not receive live vaccines during therapy; and is not on concurrent treatment with an IL-inhibitor, TNF-inhibitor, other biologic response modifier, or specified non-biologic agents (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib).

Specific excluded concomitant agents and excluded diagnoses listed in policy

Spevigo (spesolimab‑sbzo) will NOT be permitted for the treatment of plaque psoriasis without generalized pustular psoriasis (GPP). Excluded conditions that preclude coverage include: SAPHO syndrome (synovitis‑acne‑pustulosis‑hyperostosis‑osteitis), 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).

Initial Authorization Requirements

Initial authorization

Initial authorization requirements

Age/Prescriber: Member is ≥ 12 years of age and ≥ 40 kg; prescribed by or in consultation with a dermatologist, rheumatologist, or other psoriasis specialist.

Eligibility pathways: Member meets one of the following pathways: prior IV Spevigo for active flare with request for 300 mg subcutaneous maintenance starting 4 weeks after last IV dose; OR initiating maintenance without active flare using 600 mg subcutaneous loading at week 0 then 300 mg at week 4 then every 4 weeks; OR continuation of previously authorized maintenance Spevigo (use of samples to initiate does NOT meet criteria); OR documented history of GPP and not currently in flare meeting specified subcriteria.

Verified by chart notes and/or pharmacy & medical paid claims

Prior therapies and vaccinations: Member has had a 4-month trial of at least one systemic GPP treatment (e.g., methotrexate, acitretin, cyclosporine, or biologics) with flaring while on treatment, dose reduction, or discontinuation, OR was unable to tolerate a 4-month trial; and has received age-appropriate vaccinations prior to initiating treatment.4 months

Maintenance and Reauthorization

Maintenance dosing

Continuation/maintenance dosing and reauthorization

Maintenance after IV flare: Subcutaneous maintenance: 300 mg starting 4 weeks after last IV dose, then every 4 weeks thereafter.

Supported dosing in policy

Maintenance initiation without active flare: Subcutaneous initiation: 600 mg loading dose at week 0, followed by 300 mg at week 4, then every 4 weeks thereafter.

Supported dosing in policy

Authorization durations and quantity limit: Initial authorization is limited to 6 months; reauthorization limited to 12 months with documentation of positive clinical response. Quantity limit: 2 mL per 28 days.

Documentation required for reauthorization

Step	Requirement
1	Member must have trialed at least one systemic GPP therapy for 4 months (e.g., methotrexate, acitretin, cyclosporine, or biologics) with history of flaring while on treatment, dose reduction, or discontinuation; OR be unable to tolerate a 4-month trial.

Prescriber & Submission Requirements

Documentation Required

Submission requirements

The prescribing physician must sign and clearly print their name (preprinted stamps not valid). Complete member and prescriber fields (including NPI, office contact, phone and fax) and fax the completed form to 1-305-671-0200. Incomplete, incorrect, or illegible information can delay processing or result in denial. Use of samples to initiate therapy does NOT meet preauthorization criteria.

Prescriber signature and printed name required (no preprinted stamps).
Include Member AvMed #, DOB, diagnosis, ICD code (if applicable), weight and date obtained (if applicable).
Include prescriber NPI, office contact, phone and fax.
Fax to 1-305-671-0200.

Prior Authorization

Authorization durations

Initial authorizations are limited to 6 months. Reauthorization/continuation approvals are limited to 12 months and require documentation of a positive clinical response and ongoing medical necessity.

Initial Authorization: up to 6 months.
Reauthorization/Continuation: up to 12 months — must document improvement from baseline (e.g., reduced flares or improved GPPGA).

Step Therapy

Prior treatment requirement

Member must have trialed at least one systemic treatment for generalized pustular psoriasis for approximately 4 months (examples: methotrexate, acitretin, cyclosporine, or biologic agents) unless there is documented intolerance or contraindication.

Document a 4-month trial of at least one systemic GPP treatment OR documented intolerance to such a trial.
Previous therapies will be verified via pharmacy paid claims or chart notes.

Documentation Required

Required supporting documentation

Provide supporting documentation for every checked clinical criterion. Acceptable documentation includes chart notes, laboratory results, diagnostic reports, and pharmacy & medical paid claims. Failure to provide supporting documentation may result in denial.

Chart notes verifying diagnosis, disease history, flares, GPPGA scores, and prior treatments.
Lab results (e.g., TB screening) and diagnostic reports as applicable.
Pharmacy & medical paid claims to verify prior therapies and sample use note: use of samples to initiate therapy does NOT meet criteria.

Denial Risk

Non-covered indications and prohibited concomitant biologics

Spevigo is NOT permitted for treatment of plaque psoriasis without generalized pustular psoriasis. The Health Plan considers use of more than one concomitant biologic immunomodulator (e.g., Dupixent, Entyvio, Humira, Rinvoq, Stelara) for the same or different indications to be experimental and investigational; such combinations are not permitted.

Non-covered indication: plaque psoriasis without generalized pustular psoriasis (Spevigo not studied or permitted).
Prohibited concomitant biologics: concurrent use of multiple biologic immunomodulators (IL-inhibitors, TNF-inhibitors, other biologic response modifiers) is not allowed.
Member must not be on concurrent IL-inhibitor, TNF-inhibitor, or other listed agents (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib).

Definitions and Assessment Tools

GPPGA (Generalized Pustular Psoriasis Physician Global Assessment)

DefinitionGeneralized Pustular Psoriasis Physician Global Assessment (GPPGA) score used to assess disease severity and response, documented as part of criteria (GPPPGA total score referenced)

Usage in policyRequired for documented-history pathway: GPPPGA total score of 0 or 1 when not currently in flare; GPPPGA total ≥3 used to define prior moderate-to-severe flares

DocumentationGPPGA scores must be verified by chart notes as part of authorization criteria

GPP (Generalized Pustular Psoriasis) — Definition

Core definitionDiagnosis defined by presence of primary, sterile, macroscopically visible pustules on non-acral skin not restricted to psoriatic plaques

Disease courseMay be relapsing (≥1 episode) or persistent (≥3 months) as referenced for documented-history pathway

Exclusions distinctionPolicy excludes SAPHO, primary erythrodermic psoriasis vulgaris, primary plaque psoriasis without pustules or with pustules restricted to plaques, and drug‑triggered AGEP

Background

Generalized pustular psoriasis (GPP) is a distinct pustular disorder characterized by primary, sterile pustules on non‑acral skin that can be relapsing or persistent and often requires specialized management beyond standard plaque psoriasis therapies. Because GPP can present with systemic symptoms and recurrent flares, patients may require targeted biologic therapy for maintenance after control of active flares; prior screening for latent tuberculosis and avoidance of live vaccines during therapy are required, and active infections must be excluded before initiating treatment.

OpenPayer