CurrentUnitedHealthcarePolicy IEXD0128.04

Veopoz (pozelimab-bbfg) for CD55-deficient protein‑losing enteropathy (CHAPLE disease)

Defines medical necessity criteria, authorization requirements, and coding for Veopoz for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE) for applicable UnitedHealthcare Individual Exchange plans.

Policy Summary

PayerUnitedHealthcare

PolicyVeopoz (pozelimab-bbfg) for CD55-deficient protein‑losing enteropathy (CHAPLE disease)

Policy CodePolicy IEXD0128.04

Change TypeRevised clinical criterion languagereference updates

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization with submission of medical records confirming diagnosis, biallelic CD55 loss-of-function mutation, and relevant clinical data.

SourceLink

POLICY UPDATE CHANGES

Replaced criterion requiring 'the patient is not receiving Veopoz in combination with Soliris (eculizumab) or Ultomiris (ravulizumab)' with 'the patient is not receiving Veopoz in combination with another complement protein C5 inhibitor [e.g., Soliris (eculizumab), Ultomiris (ravulizumab)] for the treatment of CD55-deficient protein-losing enteropathy (CHAPLE) disease'.

Updated References section to reflect the most current information and archived previous policy version IEXD0128.03.

1 yearmaximum initial authorization period

1 yearmaximum reauthorization period

J9376listed HCPCS code

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Coverage Criteria for Veopoz (pozelimab-bbfg)

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy criteria: Diagnosis of CD55-deficient PLE or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein-losing enteropathy (CHAPLE disease); submission of medical records (e.g., chart notes, laboratory values) confirming a biallelic loss-of-function mutation in the CD55 gene; laboratory results, signs, and/or symptoms attributed to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea); patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., Soliris/eculizumab, Ultomiris/ravulizumab) for the treatment of CHAPLE disease; dosing is in accordance with the United States Food and Drug Administration approved labeling; prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease; initial authorization will be for no more than 12 months.

Continuation of Therapy

Covered when ALL of the following are met:

Continuation criteria: Documentation demonstrating a positive clinical response from baseline (e.g., normalization of serum albumin, reduction of peripheral or facial edema, reduction in abdominal pain or diarrhea); patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., Soliris/eculizumab, Ultomiris/ravulizumab) for the treatment of CHAPLE disease; dosing is in accordance with the United States Food and Drug Administration approved labeling; prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease; reauthorization will be for no more than 12 months.

Use of Veopoz in combination with another complement protein C5 inhibitor for the treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE) is not permitted under this policy. Clinical documentation submitted for initial or continuation authorization must confirm the patient is not receiving Veopoz concurrently with another C5 inhibitor (for example, eculizumab or ravulizumab).

FDA approval information is provided for context only. The U.S. Food and Drug Administration has approved Veopoz (pozelimab‑bbfg) for treatment of adult and pediatric patients 1 year of age and older with CD55‑deficient protein‑losing enteropathy (PLE, CHAPLE disease). FDA approval alone is not a basis for coverage; coverage determinations are made according to the member’s specific benefit plan and applicable laws.

Coding and Diagnostic Criteria

HCPCS CodesHCPCS

J9376

Injection, pozelimab-bbfg, 1 mg

Diagnosis CodesICD-10

D84.1

Defects in the complement system

inv-07: Serum albumin — key clinical threshold for active disease (e.g., ≤ 3.2 g/dL).

Serum albumin threshold≤ 3.2 g/dL

Context of thresholdDefines hypoalbuminemia used to identify active CD55‑deficient PLE in the pivotal study and policy criteria

Use for baseline assessmentUsed to confirm active disease prior to initiating Veopoz treatment (serum albumin concentration ≤ 3.2 g/dL)

Efficacy benchmarkMean baseline serum albumin in study cohort was 2.2 g/dL (range 1.1–2.9 g/dL)

Response targetNormalization defined in study as reaching ≥ 3.5 g/dL (median time to ≥ 3.5 g/dL was 15.5 days)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Veopoz (pozelimab-bbfg) for CHAPLE disease. Initial authorizations will be approved for up to 12 months; reauthorizations (continuation of therapy) will also be approved for up to 12 months.

Prior authorization required before initiation of therapy
Maximum initial authorization duration: 12 months
Maximum reauthorization (continuation) duration: 12 months

Documentation Required

Concomitant Therapy Restriction

Veopoz must not be used concomitantly with another complement protein C5 inhibitor for treatment of CHAPLE disease. Concurrent therapy with agents such as eculizumab (Soliris) or ravulizumab (Ultomiris) for the same indication is prohibited and may result in denial.

Definitions

inv-14: Active CD55-deficient PLE — definition including hypoalbuminemia threshold and required signs/symptoms within timeframe.

DefinitionActive CD55‑deficient protein‑losing enteropathy (PLE) is hypoalbuminemia with serum albumin concentration ≤ 3.2 g/dL plus one or more signs/symptoms within the prior six months

Required signs/symptoms (examples)Abdominal pain, diarrhea, peripheral edema, or facial edema occurring within the last six months

Diagnostic confirmationDiagnosis in the pivotal study required clinical history of PLE and a confirmed biallelic CD55 loss‑of‑function mutation

Clinical application timeframeSigns or symptoms must have occurred within the past six months to meet the definition of active disease

Implication for authorizationHypoalbuminemia (≤ 3.2 g/dL) plus qualifying signs/symptoms support medical necessity for Veopoz per policy criteria

Background

Pozelimab‑bbfg (Veopoz) is a human monoclonal antibody that targets complement component C5 and inhibits terminal complement activation by preventing C5 cleavage and subsequent membrane attack complex formation. It was evaluated in a single‑arm study in children and adolescents with genetically confirmed biallelic CD55 loss‑of‑function mutations and clinical features of CHAPLE disease, and is intended to treat CD55‑deficient protein‑losing enteropathy by blocking complement‑mediated injury.

Revision History

2025-06-01Revised coverage criteriaLatest

Replaced the specific prohibition on concomitant use with Soliris (eculizumab) or Ultomiris (ravulizumab) by broader wording prohibiting Veopoz in combination with another complement protein C5 inhibitor (e.g., Soliris, Ultomiris) for treatment of CD55‑deficient PLE (CHAPLE) disease.

2025-06-01Supporting information update

Updated the References section to reflect the most current information and archived previous policy version IEXD0128.03.