Currentsierra health and lifePolicy 2025D0128D

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

This policy governs medical benefit coverage and authorization criteria for Veopoz (pozelimab‑bbfg) for treatment of CD55‑deficient protein‑losing enteropathy (PLE/CHAPLE) for UnitedHealthcare commercial members; it affects prescribing specialists and providers requesting authorization.

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2025D0128D

Change TypeRevised coverage criteriaclarified references

Effective DateJune 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records confirming a biallelic CD55 loss‑of‑function mutation and clinical evidence of CHAPLE.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria to replace wording about combination therapy with language specifying Veopoz must not be received in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab) for CHAPLE disease.

Updated References/supporting information to reflect the most current information and archived prior policy version 2024D0128C.

1HCPCS code listed (J9376)

10pivotal study patients (NCT04209634)

≤3.2 g/dLserum albumin threshold

12 mo

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Coverage Criteria for Veopoz (pozelimab‑bbfg)

inv-01: Initial Therapy

Covered when ALL of the following are met (Initial Therapy):

Initial Therapy criteria: Diagnosis of CD55-deficient PLE or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein-losing enteropathy (CHAPLE disease).

Genetic 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 attributable to CHAPLE disease (e.g., hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea).

Concurrent therapy restriction: 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 qualifications: Prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease.

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

inv-02: Continuation of Therapy

Continuation of therapy — 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 qualifications: Prescribed by a hematologist or other specialist with expertise in the diagnosis of CHAPLE disease.

The pivotal single-arm study (NCT04209634) expressly prohibited use of other complement inhibitors during treatment with Veopoz; concurrent administration of additional complement inhibitors was not allowed in the trial and therefore concurrent use is not permitted per this coverage policy.

Therapy that does not meet the documented coverage criteria is considered not medically necessary. Examples include absence of documented biallelic CD55 loss‑of‑function mutation, lack of clinical or laboratory signs/symptoms attributable to CHAPLE (for example, hypoalbuminemia, edema, abdominal pain, or diarrhea), dosing that is not in accordance with FDA‑approved labeling, or prescribing by a clinician without the required hematology or CHAPLE expertise. Concurrent use of Veopoz with another complement C5 inhibitor (e.g., eculizumab, ravulizumab) also renders treatment unsupported by this policy.

Initial Authorization Criteria

inv-14: Initial Therapy

Initial authorization conditions:

Confirmed diagnosis of CD55-deficient protein-losing enteropathy (PLE) with biallelic CD55 loss-of-function mutation.

Clinical signs/labs: Clinical signs or laboratory evidence attributable to CHAPLE disease (e.g., hypoalbuminemia, edema, abdominal pain, diarrhea).

Concurrent therapy restriction: Patient is not receiving Veopoz in combination with another complement protein C5 inhibitor for CHAPLE disease.

Dosing per FDA-approved labeling.

Prescriber:

Continuation / Reauthorization Criteria

inv-15: Continuation/Reauthorization

Reauthorization conditions:

Demonstrated benefit: Demonstrated positive clinical response from baseline (e.g., normalization of serum albumin, reduction in edema, reduction in abdominal pain or diarrhea).

Dosing per FDA-approved labeling.

Prescriber: Prescribed by a hematologist or other specialist with expertise in CHAPLE disease.

Reauthorization duration: Reauthorization up to 12 months.

Coding and Diagnosis Codes

Applicable HCPCSHCPCS

J9376

Injection, pozelimab-bbfg, 1 mg

Referenced Diagnosis CodesICD-10

D84.1

Defects in the complement system

inv-07: Serum albumin for active disease

Study definition of active diseaseSerum albumin concentration ≤ 3.2 g/dL (hypoalbuminemia) used to define active CD55‑deficient PLE in the pivotal single‑arm study (NCT04209634)

Context for thresholdActive disease required hypoalbuminemia plus ≥1 sign/symptom (abdominal pain, diarrhea, peripheral edema, or facial edema) within the prior 6 months

Baseline study valuesMean baseline serum albumin was 2.2 g/dL (range 1.1–2.9 g/dL) in the trial population assessed for efficacy

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Veopoz (pozelimab‑bbfg). Requests must include documentation supporting the diagnosis and clinical need. Prior authorization approvals will be time‑limited.

Prior authorization required with supportive documentation
Affected HCPCS: J9376
Relevant diagnosis: D84.1 (Defects in the complement system)

Step Therapy

Concurrent Therapy Restriction

Veopoz must not be used concurrently with other complement C5 inhibitors. Requests for combination therapy with agents such as eculizumab or ravulizumab will be denied.

Concurrent use with Soliris (eculizumab) or Ultomiris (ravulizumab) is prohibited
No step‑therapy sequence with other complement inhibitors

Step Therapy and Concurrent Use Rules

Step	Requirement	Notes
1	Concurrent use with other complement protein C5 inhibitors (e.g., eculizumab, ravulizumab) is prohibited	Policy explicitly disallows receiving Veopoz in combination with another complement C5 inhibitor for CHAPLE disease; applies to both initial and continuation therapy
	No additional step‑therapy sequence with other agents specified	There is no requirement to try or fail another non‑C5 agent prior to Veopoz per this policy

Site of Care and Administration

Note

Follow labeled IV loading then SC maintenance (site‑of‑care per label)

Administer loading and maintenance doses according to the FDA‑approved route and schedule: a single IV loading dose (30 mg/kg over ~1 hour in the pivotal trial) followed by once‑weekly weight‑tiered subcutaneous maintenance injections beginning one week after the loading dose; site‑of‑care and route must follow labeling.

Loading dose administered by intravenous infusion (30 mg/kg in trial) over approximately one hour
Maintenance dosing administered as once‑weekly subcutaneous injections starting one week after the loading dose
Site‑of‑care (infusion center, office, home) and route must follow FDA‑approved labeling

Background and Drug Information

Pozelimab‑bbfg (Veopoz) is a human monoclonal IgG4P antibody directed against the terminal complement protein C5. By binding C5, it blocks cleavage into C5a and C5b and thereby inhibits terminal complement activation and formation of the membrane attack complex.

Key Definitions

inv-13: CHAPLE disease

DefinitionCD55‑deficient protein‑losing enteropathy (CHAPLE disease) is caused by biallelic loss‑of‑function mutations in CD55 leading to complement hyperactivation and protein‑losing enteropathy

Diagnostic requirementDiagnosis in the pivotal study required clinical history of PLE plus confirmed biallelic CD55 loss‑of‑function genotype

Typical clinical featuresCHAPLE presents with hypoalbuminemia, abdominal pain, diarrhea, peripheral or facial edema, and increased thrombotic risk (as described in clinical context)