Veopoz (pozelimab‑bbfg) — Medical Benefit Coverage Criteria for CD55‑deficient PLE (CHAPLE)
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This policy governs medical benefit coverage and prior authorization criteria for Veopoz (pozelimab‑bbfg) for members on UnitedHealthcare Commercial and Individual Exchange plans for treatment of CD55‑deficient protein‑losing enteropathy (PLE/CHAPLE). It applies to providers seeking coverage under those plans.
No material clinical or coverage changes in this revision.
Coverage criteria and usage restrictions
Initial Therapy — Veopoz
Veopoz is medically necessary when ALL of the following are met for initial therapy:
Continuation Therapy — Veopoz
Continuation of therapy is covered when ALL of the following are met:
Use of other complement protein C5 inhibitors is specifically prohibited during treatment for CHAPLE disease. The policy requires that the patient not be receiving Veopoz in combination with another complement C5 inhibitor (for example, eculizumab or ravulizumab) as a condition of both initial and continuation authorization.
This prohibition appears in the initial authorization criteria and in the continuation criteria and is a trigger for denial if documentation shows concomitant therapy with another C5 inhibitor.
This policy does not authorize broad off‑label or investigational use of Veopoz. Coverage decisions for off‑label or experimental indications depend on the member’s specific benefit plan and any applicable state mandates; the member’s Certificate of Coverage and plan language must be consulted to determine whether such uses may be covered.
Veopoz is FDA‑approved for treatment of CD55‑deficient protein‑losing enteropathy (PLE) (CHAPLE disease) in patients aged 1 year and older, but FDA approval alone does not guarantee coverage—coverage is determined by the plan and policy criteria described here.
Billing and diagnosis codes
| J9376 | Injection, pozelimab-bbfg, 1 mg |
| D84.1 | Defects in the complement system |
Prior authorization, documentation, and denial triggers
Obtain prior authorization with genetic and clinical confirmation
Prior authorization is required and must document: diagnosis of CD55‑deficient PLE (CHAPLE) or CD55 deficiency with complement hyperactivation/angiopathic thrombosis/protein‑losing enteropathy; submission of medical records confirming a biallelic loss‑of‑function mutation in CD55; laboratory results, signs, or symptoms attributable to CHAPLE (for example hypoalbuminemia, peripheral or facial edema, abdominal pain, diarrhea); that the patient is not receiving Veopoz in combination with another complement C5 inhibitor; dosing per FDA‑approved labeling; prescribed by a hematologist or other specialist with CHAPLE expertise; and initial authorization limited to no more than 12 months.
- Diagnosis of CD55‑deficient PLE or CD55 deficiency with complement hyperactivation, angiopathic thrombosis, protein‑losing enteropathy
- Medical records confirming a biallelic loss‑of‑function mutation in CD55
- Laboratory results, signs, or symptoms attributable to CHAPLE (e.g., hypoalbuminemia, edema, abdominal pain, diarrhea)
- Confirmation patient is not receiving Veopoz with another complement C5 inhibitor (e.g., eculizumab, ravulizumab)
- Dosing consistent with FDA labeling
- Prescribed by a hematologist or specialist with CHAPLE expertise
- Initial authorization limited to up to 12 months
No step therapy; concomitant C5 inhibitors prohibited
No step‑therapy requirements are specified in this policy. Do not co‑administer Veopoz with other complement C5 inhibitors — concomitant use with agents such as eculizumab or ravulizumab for CHAPLE is prohibited.
- Policy lists no required prior failure of alternative therapies (no step therapy)
- Concomitant use with C5 inhibitors (e.g., eculizumab, Ultomiris/ravulizumab) is explicitly excluded
Provide medical records confirming genetic diagnosis and baseline/follow‑up labs
Submit complete medical records to support the authorization request, including chart notes and laboratory values that confirm a biallelic CD55 loss‑of‑function mutation and provide baseline and follow‑up data documenting CHAPLE signs/symptoms and treatment response; include documentation of the specialist prescriber (hematologist or other CHAPLE expert).
- Genetic test results confirming biallelic CD55 loss‑of‑function mutation
- Baseline laboratory values (e.g., serum albumin) and relevant follow‑up labs
- Clinical notes documenting CHAPLE signs/symptoms (edema, abdominal pain, diarrhea, etc.) and response to therapy
- Prescriber specialty and evidence of CHAPLE expertise
Denial triggers: missing genetics, concomitant C5 inhibitor, or noncompliance with dosing/prescriber/authorization rules
Coverage may be denied if requested documentation does not confirm a biallelic loss‑of‑function mutation in CD55, if the patient is receiving Veopoz together with another complement C5 inhibitor (e.g., eculizumab, ravulizumab), or if dosing, prescriber specialty, or authorization duration requirements are not met.
- Absence of genetic confirmation of biallelic CD55 mutation
- Concomitant administration of Veopoz with another C5 inhibitor
- Non‑compliant dosing relative to FDA labeling, inappropriate prescriber specialty, or authorization requests exceeding the 12‑month initial limit
Initial authorization criteria
Initial Therapy — Authorization Criteria & Limitations
Initial authorization criteria and limitations for Veopoz:
Criteria for continued coverage
Continuation Therapy — Requirements
Continuation requires documented clinical benefit and the same restrictions as initial therapy:
Step therapy and prerequisites
| Step | Requirement |
|---|---|
| {"text":"1","status":""}|{"text":"No step-therapy requirement specified; initiation requires genetic confirmation of a biallelic loss-of-function CD55 mutation and documentation of diagnosis of CD55‑deficient PLE (CHAPLE) with laboratory results, signs/symptoms attributable to CHAPLE, dosing per FDA labeling, and prescribed by a hematologist or other specialist with CHAPLE expertise; initial authorization limited to up to 12 months.","status":""} | |
| {"text":"Concomitant Therapy","status":""}|{"text":"Concomitant use of Veopoz with another complement protein C5 inhibitor (e.g., eculizumab, ravulizumab/Ultomiris) for treatment of CHAPLE is not allowed.","status":"not_covered"} |
Administration site considerations
No site‑of‑care limits here — consult Site of Care policy and plan
This policy does not impose site‑of‑care specific limits for infusion centers; consult the related Provider Administered Drugs - Site of Care policy and the member’s benefit plan for any site‑of‑care rules that may apply.
- No site‑of‑care specific limits stated in this policy (chunk 6).
- Refer to Provider Administered Drugs - Site of Care policy and member specific benefit plan for applicable rules (chunk 15).
Definitions used in this policy
Clinical background
CD55‑deficient protein‑losing enteropathy (CHAPLE) is caused by biallelic loss‑of‑function mutations in the CD55 gene, which result in uncontrolled complement activation. Complement hyperactivation leads to formation of the membrane attack complex and contributes to intestinal protein loss, hypoalbuminemia, edema, and an increased risk of angiopathic thrombosis.
Pozelimab‑bbfg (Veopoz) is a targeted anti‑C5 monoclonal antibody that inhibits cleavage of C5, preventing downstream complement activity; the clinical criteria in this policy require genetic confirmation of CD55 deficiency and clinical findings attributable to CHAPLE (for example, hypoalbuminemia and edema) to establish medical necessity.
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