CurrentUnitedHealthcarePolicy CSIND00128.04

Veopoz (Pozelimab-Bbfg) — Medical Benefit Drug Policy (Indiana)

Medical Benefit Drug Policy governing coverage of Veopoz for treatment of CD55-deficient protein-losing enteropathy (CHAPLE) for UnitedHealthcare Community Plan members in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyVeopoz (Pozelimab-Bbfg) — Medical Benefit Drug Policy (Indiana)

Policy CodePolicy CSIND00128.04

Change TypeRevised clinical criterion (clarified concomitant C5 inhibitor language)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation confirming biallelic CD55 loss-of-function mutation and clinical evidence of CHAPLE disease.

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'.

1 yearminimum patient age indicated in FDA approval

12 monthsmaximum initial authorization period

J9376HCPCS code

D84.1diagnosis code

Policy Summary

PayerUnitedHealthcare

PolicyVeopoz (Pozelimab-Bbfg) — Medical Benefit Drug Policy (Indiana)

Policy CodePolicy CSIND00128.04

Change TypeRevised clinical criterion (clarified concomitant C5 inhibitor language)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation confirming biallelic CD55 loss-of-function mutation and clinical evidence of CHAPLE disease.

SourceLink

On This Page

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patients in pivotal study

Coverage Criteria for Veopoz (pozelimab-bbfg)

Initial Therapy

Veopoz is medically necessary when ALL of the following are met:

Diagnosis of CD55-deficient protein-losing enteropathy (PLE) (i.e., CHAPLE disease) or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein-losing enteropathy

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

Clinical signs: Laboratory results, signs, and/or symptoms attributed to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea)

Active disease definition in clinical study: serum albumin ≤ 3.2 g/dL plus symptoms within 6 months

No concomitant C5 inhibitor: 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

Prescriber: Prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease

Authorization duration: Initial authorization will be for no more than 12 months

Continuation of Therapy

Continuation/reauthorization is covered when ALL of the following are met:

Clinical response: 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)

Dosing is in accordance with the United States Food and Drug Administration approved labeling

Prescriber: Prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease

Use of Veopoz in combination with another complement protein C5 inhibitor for the treatment of CD55-deficient protein‑losing enteropathy (CHAPLE) disease is prohibited. The policy explicitly states that the patient must not be receiving Veopoz concomitantly with another C5 inhibitor (e.g., Soliris [eculizumab], Ultomiris [ravulizumab]) and such combination use would trigger denial of coverage.

Coding

HCPCS CodesHCPCSCovered

J9376

Injection, pozelimab-bbfg, 1 mg

Diagnosis CodesICD-10

D84.1

Defects in the complement system

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Veopoz (pozelimab‑bbfg) for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE disease). Requests must include diagnostic confirmation, supporting clinical documentation, and dosing consistent with FDA labeling. Initial and reauthorizations will be for up to 12 months.

Prior authorization required for both initiation and continuation
Dosing must follow United States FDA‑approved labeling
Initial authorization: up to 12 months; Reauthorization: up to 12 months

Step Therapy

No step therapy is specified for Veopoz in the treatment of CD55‑deficient PLE.

Background

Pozelimab‑bbfg (Veopoz) is a human monoclonal immunoglobulin G4P (IgG4P) antibody directed against the terminal complement protein C5. By binding C5, pozelimab‑bbfg inhibits cleavage of C5 into C5a and C5b and prevents formation of the membrane attack complex, thereby blocking terminal complement activation. It is indicated for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE disease) and was evaluated in a single‑arm clinical study demonstrating rapid normalization of serum albumin and clinical improvement in pediatric and adult patients.

Definitions

pozelimab-bbfg (Veopoz) mechanism of action

Mechanism of actionHuman monoclonal IgG4P antibody directed against complement protein C5 that blocks cleavage of C5 into C5a and C5b, preventing formation of the membrane-attack complex (C5b-C9)

Targeted step in complement cascadeInhibits terminal complement activation by blocking C5 cleavage

Functional consequencePrevents generation of the anaphylatoxin C5a and C5b-mediated membrane-attack complex, reducing complement-mediated cell lysis

Active CD55-deficient PLE (CHAPLE) — definition

Definition of active diseaseActive CD55-deficient protein-losing enteropathy (PLE) is hypoalbuminemia with serum albumin ≤ 3.2 g/dL plus ≥1 sign or symptom within the prior 6 months

Signs and symptoms considered

Authorization duration:

Reauthorization will be for no more than 12 months

Documentation Required

Required Documentation for Initiation

For initiation, submit medical records confirming the diagnosis and genetic testing, plus supporting labs and clinical signs/symptoms.

Documentation of diagnosis: CD55‑deficient PLE (CHAPLE disease) or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein‑losing enteropathy
Medical records confirming a biallelic loss‑of‑function mutation in the CD55 gene (genetic test report or geneticist/clinician documentation)
Relevant laboratory results and clinical findings attributable to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea)
Prescriber specialty: hematologist or other specialist with expertise in CHAPLE disease
Statement that Veopoz will not be used in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab)

Documentation Required

Required Documentation for Continuation

For continuation, provide clinical documentation demonstrating a positive response compared with baseline and continued adherence to dosing and monotherapy requirements.

Documentation demonstrating a positive clinical response from baseline (examples: normalization or improvement in serum albumin, reduction in peripheral or facial edema, decreased frequency or severity of abdominal pain or diarrhea)
Ongoing documentation that the patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., Soliris/eculizumab, Ultomiris/ravulizumab)
Confirmation that dosing remains consistent with United States FDA‑approved labeling
Prescriber remains a hematologist or other specialist with expertise in CHAPLE disease
Reauthorization will be for no more than 12 months

Denial Risk

Combination Therapy Prohibition

Veopoz must not be administered in combination with another complement protein C5 inhibitor for the treatment of CHAPLE disease.

Combination therapy with other C5 inhibitors (e.g., eculizumab, ravulizumab) is prohibited

Abdominal pain, diarrhea, peripheral edema, or facial edema (one or more within last 6 months)

Diagnostic confirmationDiagnosis based on clinical history of PLE with confirmed biallelic CD55 loss-of-function mutation

Baseline severity in pivotal studyMean baseline serum albumin was 2.2 g/dL (range 1.1–2.9 g/dL) in study participants