RetiredUnitedHealthcarePolicy CSLA2025D00128C

Veopoz (Pozelimab‑bbfg) (for Louisiana Only) Retired April 1, 2026

UnitedHealthcare Medical Benefit Drug Policy governing coverage and authorization criteria for Veopoz (pozelimab‑bbfg) for treatment of CD55‑deficient protein‑losing enteropathy (PLE/CHAPLE) for Louisiana members.

Policy Summary

PayerUnitedHealthcare

PolicyVeopoz (Pozelimab‑bbfg) (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2025D00128C

Change TypeRetiredrevised combination‑therapy language

Effective DateAugust 1, 2025 - March 31, 2026

Next Review Date

Key ActionObtain prior authorization with submission of medical records confirming diagnosis and biallelic CD55 loss‑of‑function mutation.

SourceLink

POLICY UPDATE CHANGES

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

Coverage criterion wording changed to specify 'another complement protein C5 inhibitor [e.g., Soliris (eculizumab), Ultomiris (ravulizumab)]' rather than listing two products by name only.

Louisianageographic application

J9376HCPCS

D84.1Diagnosis

≤12 moauth duration

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial therapy criteria: Diagnosis of CD55‑deficient protein‑losing enteropathy (PLE) (CHAPLE disease) or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, 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 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 treatment of CHAPLE disease; dosing is in accordance with the FDA‑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 treatment of CHAPLE disease; dosing is in accordance with the FDA‑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 is specifically disallowed. The policy states that the patient must not be receiving Veopoz in combination with another complement protein C5 inhibitor (examples given: Soliris (eculizumab) and Ultomiris (ravulizumab)) for the treatment of CHAPLE disease; concurrent administration with another C5 inhibitor is a basis for denial or noncoverage.

Initial and continuation criteria both reiterate the prohibition on combination use and require that dosing follow the FDA‑approved labeling and that the drug be prescribed by a hematologist or other specialist with CHAPLE expertise. This combination‑therapy prohibition is enforced at both initial authorization and reauthorization.

Medical necessity for Veopoz requires documentation beyond diagnosis: for initial requests, submit medical records (chart notes, laboratory values) confirming a biallelic loss‑of‑function mutation in the CD55 gene and clinical or laboratory findings attributable to CHAPLE disease (for example, hypoalbuminemia, edema, abdominal pain, or diarrhea).

For continuation requests, submit documentation demonstrating a positive clinical response from baseline (examples include normalization of serum albumin, reduction of peripheral or facial edema, or improvement in abdominal symptoms). Both initial and continuation approvals are time‑limited to no more than 12 months per authorization period.

Initial Therapy

Initial authorization criteria

Initial authorization: Diagnosis of CD55‑deficient PLE (CHAPLE disease) or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein‑losing enteropathy; submission of medical records confirming a biallelic loss‑of‑function mutation in the CD55 gene (e.g., genetic test reports); clinical or laboratory evidence attributable to CHAPLE disease (e.g., hypoalbuminemia, edema, abdominal pain, diarrhea); patient is not receiving Veopoz in combination with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab); dosing consistent with United States FDA‑approved labeling; prescribed by a hematologist or other specialist with expertise in CHAPLE disease; initial authorization duration up to 12 months.

Include chart notes, laboratory values, and genetic documentation with the prior authorization request.

Continuation of Therapy

Reauthorization requirements

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); continued absence of combination use with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab); dosing consistent with United States FDA‑approved labeling; prescribed by a hematologist or other specialist with expertise in CHAPLE disease; reauthorization duration up to 12 months.

Submit follow‑up clinical data and relevant labs to support continued benefit.

Coding

HCPCS CodesHCPCS

J9376

Injection, pozelimab-bbfg, 1 mg.

Diagnosis CodesICD-10

D84.1

Defects in the complement system

inv-07: Serum albumin for active disease definition

Serum albumin threshold≤ 3.2 g/dL

Context for active diseaseHypoalbuminemia with serum albumin ≤ 3.2 g/dL plus ≥1 sign/symptom (abdominal pain, diarrhea, peripheral edema, or facial edema) within the prior 6 months

Source study population baselineMean baseline serum albumin 2.2 g/dL (range 1.1–2.9 g/dL) in pivotal study

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Coding

Prior authorization is required. Submit a prior authorization request with supporting medical records and applicable coding details to ensure coverage review. Include documentation of diagnosis, genetic confirmation, baseline labs and signs/symptoms, prescribing specialist, and proposed dosing per FDA labeling.

Prior authorization required for initial and continuation requests
Include HCPCS J9376 (pozelimab-bbfg) on claims as appropriate
Include diagnosis code D84.1 where applicable

Denial Risk

Combination Therapy Prohibition

Veopoz must not be used concomitantly with another complement protein C5 inhibitor. Therapy in combination with agents such as eculizumab (Soliris) or ravulizumab (Ultomiris) for CHAPLE disease is prohibited and will result in denial.

Background

Pozelimab‑bbfg (Veopoz) is a human monoclonal IgG4P antibody that targets complement protein C5 and inhibits terminal complement activation by blocking C5 cleavage and subsequent formation of the membrane attack complex. It is indicated for the treatment of CD55‑deficient protein‑losing enteropathy (PLE), also known as CHAPLE disease, in patients aged one year and older.

As reflected in the coverage criteria, Veopoz’s mechanism of action—anti‑C5 inhibition—underpins both its therapeutic rationale in CHAPLE disease and the policy’s explicit restriction against combining Veopoz with other C5 inhibitors (e.g., eculizumab or ravulizumab).

Definitions

inv-14: CHAPLE disease — CD55-Deficient Protein-Losing Enteropathy (PLE)/CHAPLE

Preferred termCD55‑Deficient Protein‑Losing Enteropathy (PLE), also known as CHAPLE disease

Diagnostic requirementClinical history of PLE with confirmed biallelic CD55 loss‑of‑function mutation

Key clinical featuresHypoalbuminemia and one or more of: abdominal pain, diarrhea, peripheral edema, or facial edema

FDA‑approved populationAdults and pediatric patients 1 year of age and older with CD55‑deficient PLE (CHAPLE)

inv-15: Pozelimab-bbfg — mechanism of action definition

Mechanism summaryHuman monoclonal IgG4P antibody directed against complement protein C5