RetiredUnitedHealthcarePolicy CSLA2025D00128C

Veopoz (Pozelimab-Bbfg) (for Louisiana Only)

Defines UnitedHealthcare Community Plan medical benefit drug policy for Veopoz in the treatment of CD55-deficient protein-losing enteropathy (PLE) for Louisiana members, including initial and continuation authorization criteria and coding references.

Policy Summary

PayerUnitedHealthcare

PolicyVeopoz (Pozelimab-Bbfg) (for Louisiana Only)

Policy CodePolicy CSLA2025D00128C

Change TypeRetirementcoverage language clarified

Effective DateAug 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records confirming biallelic CD55 loss-of-function mutation and clinical/laboratory evidence of CHAPLE disease; initial auth ≤12 months.

SourceLink

POLICY UPDATE CHANGES

Policy retired and Louisiana plan membership disenrolled on Apr. 1, 2026.

Coverage criteria language clarified to state patient must not receive Veopoz in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab) for treatment of CHAPLE disease.

Louisiana-onlygeographic applicability

CD55-deficient PLEcovered diagnosis

J9376listed drug code

≤12 moauthorization duration

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Coverage Criteria for Veopoz (pozelimab-bbfg)

Initial Therapy — covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy for Veopoz: Diagnosis of CD55-deficient protein-losing enteropathy (PLE) (CHAPLE disease) or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy; 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 attributable 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 for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continuation/Reauthorization: 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.

The pivotal single-arm study (NCT04209634) evaluated Veopoz in patients with active CD55-deficient protein-losing enteropathy (PLE) confirmed by biallelic CD55 loss-of-function mutations; patients had hypoalbuminemia and related symptoms. In that trial, use of other complement inhibitors was prohibited, and the policy similarly requires that a patient not receive Veopoz in combination with another complement protein C5 inhibitor (for example, eculizumab or ravulizumab) for treatment of CHAPLE disease.

Study-treated patients received a single 30 mg/kg intravenous loading dose followed by a once-weekly weight-tiered subcutaneous maintenance schedule; meningococcal vaccination and antibacterial prophylaxis for meningococcal infection were given per study protocol. The policy aligns with the study context and labeling by restricting concurrent complement C5 inhibitor use and by referencing the study-derived dosing and safety measures.

Therapy with Veopoz is considered not medically necessary when the coverage criteria are not met. Examples include absence of a confirmed diagnosis of CD55-deficient PLE with documentation of a biallelic loss-of-function CD55 mutation, lack of clinical signs or laboratory evidence attributable to CHAPLE disease (such as hypoalbuminemia, edema, abdominal pain, or diarrhea), dosing that is not in accordance with FDA-approved labeling, or when the patient is receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab).

Additional reasons for denial include prescriptions by clinicians without appropriate specialty expertise or failure to provide required medical records demonstrating baseline and follow-up clinical and laboratory data supporting medical necessity; reauthorizations without documentation of a positive clinical response from baseline may also be considered not medically necessary.

Initial Authorization Requirements

Initial Therapy — initial authorization requirements

Initial authorization requirements

Initial Authorization: Confirmed diagnosis of CD55-deficient PLE (CHAPLE disease) or CD55 deficiency with complement hyperactivation and protein-losing enteropathy; Submission of medical records confirming a biallelic loss-of-function mutation in CD55; Presence of laboratory, sign(s), or symptom(s) attributable to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea); Patient must not be receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., Soliris/eculizumab, Ultomiris/ravulizumab); Dosing consistent with FDA-approved labeling; Prescribed by a hematologist or other specialist with CHAPLE expertise; Initial authorization limited to no more than 12 months.

Reauthorization / Continuation Criteria

Reauthorization — criteria for reauthorization / continuation

Criteria for reauthorization

Reauthorization: Documentation of a positive clinical response from baseline (for example, normalization or improvement of serum albumin, reduction in peripheral or facial edema, reduction in abdominal pain or diarrhea); Continued non-use of other complement protein C5 inhibitors for treatment of CHAPLE disease (e.g., Soliris/eculizumab, Ultomiris/ravulizumab); Dosing in accordance with FDA-approved labeling; Prescribed by a hematologist or other specialist with expertise in CHAPLE disease; Reauthorization limited to no more than 12 months.

Billing and Diagnosis Codes

HCPCSHCPCS

J9376

Injection, pozelimab-bbfg, 1 mg

Diagnosis Codes (ICD-10)ICD-10

D84.1

Defects in the complement system

Active disease albumin threshold

Active disease albumin thresholdSerum albumin ≤ 3.2 g/dL

Supporting clinical contextDefined in study as hypoalbuminemia with serum albumin concentration of ≤ 3.2 g/dL plus ≥1 sign/symptom within last 6 months (abdominal pain, diarrhea, peripheral or facial edema)

Baseline values observed in pivotal studyMean baseline serum albumin 2.2 g/dL (range 1.1–2.9 g/dL)

Clinical outcome tied to thresholdMedian time to reach ≥3.5 g/dL was 15.5 days (all 10 patients normalized by Week 12)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are limited to no more than 12 months when all criteria are met.

Initial authorization duration: ≤ 12 months
Reauthorization duration: ≤ 12 months

Note

Step Therapy

No step therapy is specified for this medication. This is informational for the provider and does not impose a step requirement prior to prescribing Veopoz.

Documentation Required

Documentation Submission Requirements

Documentation must be submitted to support medical necessity requests. Include medical records, chart notes, and relevant laboratory values at baseline and for follow-up/continuation requests.

Site of Care and Administration

Billing Rule

Dosing route & schedule — IV loading then weekly SC maintenance

Administer per label: single IV loading dose (~30 mg/kg over ~1 hour) then once-weekly weight-tiered subcutaneous maintenance starting one week after the loading dose; site of care may be infusion center, clinic, or home per labeling.

Loading dose: single IV infusion (~30 mg/kg over approximately 1 hour).
Maintenance: once-weekly subcutaneous injections per weight-tiered schedule beginning one week after the load.
Ensure meningococcal vaccination and appropriate prophylactic antibacterials per trial/label guidance prior to treatment.

Definitions

CD55-deficient PLE (CHAPLE disease)

Disease name and shorthandCD55-deficient protein-losing enteropathy (PLE) — CHAPLE disease

Genetic causeBiallelic loss-of-function mutations in CD55

PathophysiologyCD55 deficiency leads to complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy

Clinical presentationHypoalbuminemia with symptoms such as abdominal pain, diarrhea, peripheral or facial edema

Therapeutic targetComplement protein C5 (pozelimab‑bbfg blocks C5 cleavage to prevent membrane-attack complex formation)

Background

Pozelimab‑bbfg (Veopoz) is a human monoclonal immunoglobulin G4P (IgG4P) antibody directed against the terminal complement protein C5. By binding C5 and preventing its cleavage, pozelimab inhibits formation of the membrane attack complex and reduces downstream complement‑mediated injury.

CD55‑deficient PLE (CHAPLE disease) is a genetic disorder caused by biallelic loss‑of‑function mutations in CD55 that leads to complement hyperactivation, angiopathic thrombosis, and protein‑losing enteropathy. In the pivotal study, active disease was defined as hypoalbuminemia with a serum albumin concentration of ≤ 3.2 g/dL plus one or more relevant signs or symptoms (abdominal pain, diarrhea, peripheral or facial edema).

Step Therapy

Step	Requirement
1	No step therapy specified.