CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Veopoz (pozelimab-bbfg) coverage

Clinical coverage and authorization requirements for Veopoz (pozelimab-bbfg) for Medicaid, Commercial, and Medicare members, including indications, dosing, vaccination requirements, and renewal criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVeopoz (pozelimab-bbfg) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit genetic testing results confirming biallelic CD55 loss-of-function mutation with supporting chart documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization length

J9376HCPCS code

>=1 yrmin patient age

3200 mgloading dose

800 mgmax weekly maintenance

Coverage Criteria for Veopoz (pozelimab-bbfg)

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Initial Therapy

Covered when ALL of the following are met:

Age: Patient is at least 1 year of age>= 1 year

Prescriber: Medication must be prescribed by or in consultation with a hematologist, gastroenterologist, or a specialist familiar with the treatment of rare genetic hematologic diseases

Diagnostic confirmation: Confirmed clinical diagnosis of CD55-deficient protein-losing enteropathy (CHAPLE) evidenced by biallelic CD55 loss-of-function mutation detected by genotype analysis; genetic testing results must be submittedbiallelic CD55 loss-of-function mutation

Active disease defined as hypoalbuminemia (serum albumin ≤3.2 g/dL) with one or more signs or symptoms attributed to CD55-deficient PLE within the last six months (e.g., abdominal pain, diarrhea, peripheral or facial edema); chart notes or medical record documentation supporting signs/symptoms must be submittedserum albumin <= 3.2 g/dL

Vaccination and infection precautions: Patient must receive meningococcal vaccines (serogroups A, C, W, Y and B) at least 2 weeks prior to initiation (if urgent, vaccinate as soon as possible and provide 2 weeks of antibacterial prophylaxis); pneumococcal and Hib vaccinations per guidelines; no unresolved Neisseria meningitidis infection

If urgent therapy in unvaccinated patient, give vaccine immediately and provide 2 weeks antibacterial prophylaxis

Concomitant therapy restrictions: Will not be used in combination with other complement therapies (e.g., sutimlimab, ravulizumab, avacopan, eculizumab, pegcetacoplan); avoid concomitant IVIG if possible—if unavoidable monitor closely

Renewal Criteria

Renewal covered when ALL of the following are met:

Continued criteria: Patient continues to meet the universal and indication-specific criteria identified for initial approval

Toxicity: Absence of unacceptable toxicity from the drug (examples include serious meningococcal infections, other serious bacterial infections, serious hypersensitivity reactions)

Clinical response: Patient exhibits disease response compared to pretreatment baseline in ALL of: normalization or improvement in serum proteins (e.g., albumin or IgG); stabilization or improvement in signs and symptoms; and reduction in albumin transfusion, exogenous immunoglobulin, and/or hospitalizations as applicable (documentation required)

Documentation required

Investigational Use / Not Covered

Not covered when:

Investigational use: Use at a dose or for a condition other than recognized medically accepted indications, or uses not supported by standard compendia or peer-reviewed literature, is considered investigational and is not covered

Therapies used at doses or for conditions that are not recognized as medically accepted indications in standard reference compendia or the peer‑reviewed medical literature are considered investigational. Standard compendia include AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed published literature. Neighborhood does not provide coverage for drugs when used for investigational purposes.

Use of a drug for an unapproved indication or at a dosage not supported by recognized compendia or peer‑reviewed literature is treated as not medically necessary and will not be covered. Providers should ensure that requested uses and dosing are consistent with accepted references and published evidence before submitting authorization requests.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Prescriptions must be written by or in consultation with a hematologist, gastroenterologist, or a specialist experienced in rare genetic hematologic diseases. Coverage is authorized for six (6) months; renewals require documentation of continued benefit and absence of unacceptable toxicity.

Prescriber requirement: hematologist, gastroenterologist, or specialist familiar with rare genetic hematologic diseases
Authorization length: 6 months; may be renewed with documentation of continued benefit and safety

Step Therapy

Step Therapy Exemption for Recent Users

Medicare members who received the medication within the past 365 days are exempt from Step Therapy requirements.

Step therapy exemption window: prior receipt within 365 days

Documentation Required

Required Documentation for Initial Requests

Provide genetic testing results and medical record documentation with initial requests. For CHAPLE disease, submit genotype analysis showing biallelic CD55 loss-of-function mutation and chart notes documenting active disease signs/symptoms within the last 6 months.

Required genetic testing: biallelic CD55 loss-of-function mutation (submit results)
Clinical documentation: evidence of active disease — hypoalbuminemia (≤3.2 g/dL) plus ≥1 sign/symptom (abdominal pain, diarrhea, peripheral edema, facial edema) within prior 6 months (submit chart/medical record)

Documentation Required

Documentation Required for Renewal Requests

Renewal requests must include documentation that the patient continues to meet universal and indication-specific criteria, evidence of treatment response (improvement/stabilization in serum proteins and signs/symptoms), reduction in albumin transfusion/exogenous immunoglobulin and/or hospitalizations, and absence of unacceptable toxicity (e.g., serious meningococcal infection, other serious bacterial infections, serious hypersensitivity).

Renewal documentation: continued meeting of criteria from Section IV
Treatment response: normalization/improvement in serum proteins (e.g., albumin), stabilization/improvement in signs/symptoms, reduced transfusion/IG/hospitalizations
Safety: no unacceptable toxicity (serious meningococcal infections, serious bacterial infections, severe hypersensitivity)

Denial Risk

Documentation and Diagnostic Confirmation Required — Denial Risk

Denial risk if genetic confirmation of CD55 deficiency or documentation of active disease is absent. Failure to submit required genetic test results or chart/medical record evidence of signs/symptoms and hypoalbuminemia may result in request denial.

Missing genetic test results (biallelic CD55 mutation) increases denial risk
Absent documentation of hypoalbuminemia (≤3.2 g/dL) and recent signs/symptoms within 6 months increases denial risk

OpenPayer

Veopoz (pozelimab-bbfg) coverage

Coverage Criteria for Veopoz (pozelimab-bbfg)

Coding and Billing

Provider Actions and Documentation Requirements

Background

Definitions