CurrentUnitedHealthcarePolicy CS2025D00128E

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

UnitedHealthcare medical benefit drug policy governing coverage criteria for Veopoz for treatment of CD55-deficient protein-losing enteropathy (CHAPLE disease); applies to specified state exceptions and to providers submitting authorizations.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS2025D00128E

Change TypeTemplate updatestate applicability language revised

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, biallelic CD55 loss-of-function mutation, clinical signs/symptoms, and dosing per FDA label.

SourceLink

POLICY UPDATE CHANGES

Template updated and prior policy version CS2025D00128D archived; language regarding state applicability (Mississippi removed; Louisiana and Ohio referenced) was updated and a link to state-specific policy versions was added.

1FDA-approved indication

J9376HCPCS code listed

10Patients in pivotal study

≤3.2 g/dLHypoalbuminemia threshold

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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).

Genotype Confirmation: Submission of medical records (e.g., chart notes, laboratory values) confirming a biallelic loss-of-function mutation in the CD55 gene.

Clinical Evidence: Laboratory results, signs, and/or symptoms attributed to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea).Serum albumin ≤ 3.2 g/dL may define active disease per trial

No Concomitant C5 Inhibitor: Patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab) for the treatment of CHAPLE disease.

Dosing and Prescriber: Dosing is in accordance with FDA-approved labeling and 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

Clinical Response for Continuation: 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).

No Concomitant C5 Inhibitor for Continuation: Patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab) for the treatment of CHAPLE disease.

Dosing and Prescriber for Continuation: Dosing is in accordance with FDA-approved labeling and prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease.

Reauthorization will be for no more than 12 months.

The pivotal single‑arm study prohibited the use of other complement inhibitors; accordingly, this policy requires that Veopoz not be used in combination with another complement protein C5 inhibitor (for example, eculizumab or ravulizumab) when treating CD55‑deficient protein‑losing enteropathy (CHAPLE disease).

Coverage is contingent on documentation confirming a biallelic loss‑of‑function mutation in the CD55 gene and clinical evidence consistent with CHAPLE disease. Clinical supporting information should include laboratory results and signs/symptoms attributed to CHAPLE (for example, hypoalbuminemia, peripheral or facial edema, abdominal pain, or diarrhea). Therapy is not supported without these genotype and clinical findings.

Regimen	Dosing (per FDA labeling / trial)	Route & Schedule	Indication	Coverage
Single 30 mg/kg loading dose, then weight-tiered maintenance
30 mg/kg loading dose once (IV); maintenance once weekly at weight-tiered doses (per FDA labeling and as used in the pivotal trial)
Loading dose: intravenous infusion over ~1 hour; Maintenance: subcutaneous injection once weekly starting 1 week after the loading dose
Treatment of CD55-deficient protein‑losing enteropathy (CHAPLE disease) in patients with confirmed biallelic CD55 loss-of-function mutation and active disease (hypoalbuminemia)
covered

Coding and Diagnostic Codes

Applicable HCPCS CodesHCPCS

J9376

Injection, pozelimab-bbfg, 1 mg

Diagnosis CodesICD-10

D84.1

Defects in the complement system

Serum albumin threshold for active disease

Serum albumin threshold≤ 3.2 g/dL

Clinical contextDefines hypoalbuminemia consistent with active CD55‑deficient PLE used for trial enrollment

Use for coverage decisionsApplied as the laboratory threshold for ‘active disease’ in initial therapy and effectiveness assessment

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation including diagnosis of CD55-deficient protein‑losing enteropathy (CHAPLE), confirmation of a biallelic CD55 loss‑of‑function mutation, clinical signs/symptoms and laboratory data attributed to CHAPLE (for example hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea), prescribing specialist (hematologist or other specialist with CHAPLE expertise), and dosing consistent with FDA‑approved labeling. Initial authorizations and reauthorizations will be granted for no more than 12 months.

Initial authorization: up to 12 months
Reauthorization: up to 12 months
Required documentation: medical records, chart notes, laboratory values confirming biallelic CD55 mutation and baseline/follow‑up clinical data
Prescriber: hematologist or other specialist with expertise in CHAPLE disease
Dosing: per FDA‑approved labeling

Documentation Required

Combination Therapy Restriction

Veopoz must not be used concomitantly with another complement C5 inhibitor for the treatment of CHAPLE disease. Examples of prohibited concurrent therapies include eculizumab (Soliris) and ravulizumab (Ultomiris).

Prohibited combination: Veopoz plus another complement C5 inhibitor (e.g., Soliris, Ultomiris)

Denial Risk

Triggers for Denial

The request may be denied if submitted records do not confirm a biallelic CD55 loss‑of‑function mutation or if the patient is receiving Veopoz concurrently with a prohibited complement C5 inhibitor. Lack of required clinical documentation demonstrating CHAPLE‑related signs/symptoms or failure to show a positive clinical response for continuation requests may also result in denial.

Denial triggers: no documentation of biallelic CD55 mutation
Denial triggers: concurrent use of Veopoz with another complement C5 inhibitor (e.g., Soliris, Ultomiris)
Denial triggers: insufficient clinical or laboratory documentation supporting diagnosis or response

Genetic and Biomarker Requirements

CD55 (biallelic loss-of-function mutation) — confirmation required

RequirementDocumentation confirming a biallelic loss-of-function mutation in the CD55 gene is required for coverage

Evidence sourceGenotype confirmation was required for enrollment in the pivotal single-arm study (NCT04209634)

Denial implicationTherapy is not supported without documentation of a biallelic CD55 loss-of-function mutation

Definitions and Trial Eligibility Thresholds

Active CD55‑deficient protein‑losing enteropathy (PLE) — trial definition

Definition (trial)Active CD55‑deficient PLE: serum albumin ≤ 3.2 g/dL plus one or more signs or symptoms within the last 6 months (abdominal pain, diarrhea, peripheral or facial edema)

Signs/symptoms windowSigns or symptoms considered if present within the last six months

Role in enrollment and assessmentUsed to identify patients with ‘active disease’ for study inclusion and to support medical necessity in the policy

Background

Pozelimab‑bbfg (Veopoz) is a human monoclonal immunoglobulin G4P (IgG4P) antibody that specifically targets the terminal complement protein C5. By binding C5, the agent inhibits terminal complement activation and formation of the membrane attack complex, which is the mechanistic rationale for treating CD55‑deficient protein‑losing enteropathy (CHAPLE disease).