CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Spevigo (spesolimab) — coverage criteria for generalized pustular psoriasis (GPP)

Medical and pharmacy coverage guidance for Spevigo (spesolimab) intravenous and subcutaneous formulations for treatment and prevention of generalized pustular psoriasis (GPP) in eligible patients; affects Medicaid, Commercial, and MMP members per scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySpevigo (spesolimab) — coverage criteria for generalized pustular psoriasis (GPP)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2023

Next Review Date

Key ActionSubmit prior authorization specifying indication (GPP flare vs maintenance); flare requests are limited to two IV doses (900 mg each).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1800Max IV dose per flare (mg total)

600→300SC regimen

≥12 / ≥40kgMin age/weight

J1747HCPCS code

1Covered dx codes

Related Billing Codes

HCPCS-J1747-SPESOLIMAB-INJECTION-1MG

HCPCS Level II J1747: Injection, spesolimab-sbzo, 1 mg

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Coverage Criteria for Spevigo (spesolimab)

Initial Approval Criteria

Covered when ALL of the following are met:

Age and vaccination: Patient is ≥12 years of age and weighs ≥40 kg; and has received all age-appropriate vaccinations prior to initiating treatment

Specialist prescriber: Prescribed by, or in consultation with, a specialist in dermatology

Universal safety and concomitant therapy criteria: Patient evaluated and screened for latent tuberculosis prior to initiating treatment and will receive ongoing TB monitoring; no active infection; will not receive live vaccines during therapy; not on concomitant systemic immunosuppressants, specified topical agents, TNF-inhibitors, other biologic response modifiers, or specified non-biologic agents

Applies to patients receiving IV Spevigo for GPP per Universal Criteria

Indication: Acute GPP flare: Patient is experiencing an acute moderate-to-severe GPP flare with documented history of GPP (relapsing or persistent) and primary sterile, macroscopically visible pustules on non-acral skin (not restricted to psoriatic plaques); AND at least one supporting finding (IL36RN/CARD14/AP1S3 mutation OR skin biopsy confirming Kogoj's spongiform pustules OR systemic symptoms or labs consistent with GPP flare e.g., fever, elevated CRP, leukocytosis/neutrophilia OR at least 5% BSA with erythema and pustules); AND GPPPGA total score ≥3 AND GPPPGA pustulation subscore ≥2

If met, total IV dose must not exceed two 900 mg doses per single GPP flare

Indication: Maintenance (not currently flaring): Patient is not currently experiencing a flare, has documented history of GPP (relapsing or persistent), objective baseline disease assessment (e.g., GPPPGA, DLQI, PSS) with GPPPGA total score 0–1, AND either history of ≥2 moderate-to-severe GPP flares in the past year OR history of flaring while on concomitant systemic therapy

Subcutaneous regimen (loading and maintenance) applies for maintenance

Renewal Criteria

Renewal allowed when ALL of the following are met:

Ongoing eligibility: Patient continues to meet universal and indication-specific criteria as described in Initial Approval Criteria

Tolerability: Absence of unacceptable toxicity from the drug (e.g., serious infections, anaphylaxis, DRESS, or other hypersensitivity reactions)

For treatment of a single GPP flare (IV), coverage may not be renewed beyond the authorized doses

Evidence of response for maintenance: For patients treated when not experiencing a flare (maintenance), documentation of clinical response compared to baseline such as decreased number or frequency of GPP flares, stabilization or improvement in GPPPGA total score, and/or improvement in DLQI or Psoriasis Symptom Scale (PSS)

General coverage stance

Covered when consistent with FDA labeling and plan clinical criteria; individual review required.

Summary: Use for members with generalized pustular psoriasis (ICD-10 L40.1) when prescriber documentation demonstrates an indication consistent with FDA-approved labeling or supporting clinical literature; requests will be reviewed individually and the plan will consider cost-effective alternatives and applicable Medicare NCDs/LCDs for INTEGRITY members.

Detailed item-level criteria are contained in the Initial Approval and Renewal sections.

Coverage excludes use of Spevigo for patients with the following conditions when assessing treatment for a GPP flare: 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). These exclusions apply specifically to requests for treatment of an acute GPP flare and are part of the universal criteria assessed prior to approval.

For Medicare (INTEGRITY) members, National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence where applicable. The plan’s clinical criteria apply only in the absence of an applicable NCD or LCD. Providers should consult the CMS coverage database for any relevant NCD/LCD/LCA guidance when requesting coverage for outpatient Part B drugs.

When Spevigo is authorized for treatment of a single acute GPP flare using the IV regimen, coverage is limited to the authorized dosing for that flare and may not be renewed. The IV flare regimen is administered as two 900 mg doses (day 1 and day 8) and no additional doses for the same flare will be approved beyond the authorized doses.

Medicare Part B outpatient drug policies are governed by CMS rules and any applicable NCDs/LCDs. Where Medicare guidance applies, the plan defers to CMS policy for benefit determination and claims processing. This policy’s non‑Medicare coverage rules do not replace Medicare Part B requirements.

Billing and Diagnosis Codes

HCPCS Code (IV formulation ONLY)HCPCSCovered

J1747

injection, spesolimab-sbzo, 1mg

NDCsNDC

0597-0620-xx	Spevigo 150 mg/mL two-pack single-dose pre-filled syringe for subcutaneous use
00597-0035-xx	Spevigo 450 mg/7.5 mL (60 mg/mL) two-pack single-dose vial (SDV)

Covered ICD-10 Diagnosis CodesICD-10Covered

L40.1

Generalized pustular psoriasis

Max IV treatment per flare

Maximum IV doses per GPP flareTwo IV doses of 900 mg each (total 1,800 mg) given on day 1 and day 8

Per-dose billing units (HCPCS)900 billable units (900 mg) correspond to 2 vials on each administration day

Quantity limit (IV vials)Spevigo 450 mg/7.5 mL single-dose vial: up to 4 vials one time only for IV use (per dosing instructions)

Prescriber and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required and Medical Appropriateness Review

Prior authorization is required for Spevigo (spesolimab). Requests will be reviewed for medical appropriateness against the plan criteria and FDA labeling. Neighborhood will give individual consideration to each request using information submitted by the prescriber and other information available to the plan. Requests that do not demonstrate use consistent with FDA labeling or the plan's clinical criteria may be denied.

Prior authorization required and reviewed for medical appropriateness
Individual consideration based on prescriber-submitted information and plan documentation
Requests inconsistent with FDA labeling or plan criteria may be denied

Prior Authorization

Prior Authorization and Authorization Length

Authorization length depends on the indication: for treatment of an acute GPP flare, coverage is for up to two IV doses (900 mg each) and treatment for a flare may not be renewed; for treatment when not experiencing a flare (prevention/maintenance), authorization is provided for 6 months and may be renewed. Members previously treated with Spevigo within the past 365 days are exempt from step therapy requirements.

Background and Clinical Context

Generalized pustular psoriasis (GPP; ICD‑10 L40.1) is a rare, severe dermatologic disorder characterized by widespread sterile pustules often accompanied by systemic symptoms. Spevigo (spesolimab) is an interleukin‑36 receptor antagonist approved for the treatment of GPP in patients aged ≥12 years and weighing ≥40 kg. Clinical evidence supporting Spevigo demonstrates rapid pustulation clearance following IV dosing for acute flares and a subcutaneous regimen used for prevention/maintenance in patients with recurrent disease. When used for flare management, the IV formulation is billed with HCPCS J1747 (1 mg/unit) and the authorized IV flare regimen is limited to two 900 mg doses (1800 mg total) per flare.

Key Definitions

GPPPGA

Scale name and purposeGeneralized Pustular Psoriasis Physician Global Assessment (GPPPGA): disease activity score used to assess pustulation and overall GPP severity

Score rangeTotal GPPPGA score ranges from 0 (clear) to 4 (severe)

Pustulation subscore useA pustulation subscore is used to define presence and severity of pustules; trials used pustulation subscore of 0 (no pustules) and ≥2 to define flare endpoints

L40.1

ICD-10 codeL40.1 — Generalized pustular psoriasis

Use in policyListed in Appendix 1 as the covered diagnosis code for GPP

Policy Revision History

2023-04-01policy_effectiveLatest

Policy went into effect with clinical coverage criteria for Spevigo (spesolimab) including IV flare treatment (two 900 mg doses per flare) and SC maintenance regimens; prior authorization and documentation requirements established.

2023-04-01policy_review

Policy was reviewed on 2023-04-01 (last review date) with renewal and authorization length specified: flare treatment limited to two IV doses and may not be renewed; non-flare treatment authorization periods and renewal criteria defined.