CurrentEmblemHealthPolicy MG.MM.PH.398

Veopoz (pozelimab-bbfg) intravenous, subcutaneous injection

Covers medical necessity criteria, dosing, authorization durations, and coding for Veopoz (pozelimab-bbfg) for members with CHAPLE disease; applies to providers seeking preauthorization and ongoing coverage from EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyVeopoz (pozelimab-bbfg) intravenous, subcutaneous injection

Policy CodePolicy MG.MM.PH.398

Change TypeAdded dosing unitsremoved initial meningococcal-history criterion

Effective DateOct 13, 2023

Next Review DateFeb 6, 2025

Key ActionObtain prior authorization: initial approvals are for 3 months and continuation approvals for 12 months per specified criteria.

SourceLink

POLICY UPDATE CHANGES

Added maximum units to dosing information.

Removed the initial criterion 'Patient does not have a history of meningococcal infection'.

≥1 yearminimum patient age for therapy

Initial 3 monthslength of initial authorization

Continuation 12 monthslength of continuation authorization

J9376HCPCS procedure code

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Coverage Criteria for Veopoz (pozelimab-bbfg)

Initial Therapy (Approve for 3 months)

Approve when ALL of the following are met

Initial Therapy criteria

Age: Patient is >= 1 year of age>= 1 year
[documentation required]
Genetic confirmation: Genetic test confirming diagnosis of CHAPLE disease with a biallelic CD55 loss-of-function mutation
[documentation required]
Albumin and active disease: Patient has serum albumin <= 3.2 g/dL AND, per prescriber, active disease with >=1 sign/symptom in the last 6 months (examples: abdominal pain, diarrhea, vomiting, peripheral or facial edema)<= 3.2 g/dL
[documentation required for albumin]; clinical signs per prescribing physician
Vaccinations: Received or in compliance with updated meningococcal, Streptococcus pneumoniae, and Haemophilus influenzae type b (Hib) vaccinations according to current ACIP recommendations
Prescriber expertise: Medication prescribed by a physician with expertise in managing CHAPLE disease

Operational notes: Authorization length: Approve initial therapy for 3 months. Provide required supporting documentation (genetic test results, serum albumin, vaccination status, and evidence of active disease) to complete review.

Continuation Therapy (Approve for 12 months)

Approve when ALL of the following are met for patients currently receiving Veopoz

Continuation criteria

Age: Patient is >= 1 year of age>= 1 year
Genetic confirmation: Genetic test confirming diagnosis of CHAPLE disease with a biallelic CD55 loss-of-function mutation
[documentation required]
Prescriber expertise: Medication prescribed by a physician with expertise in managing CHAPLE disease
Response to therapy:

This policy covers Veopoz (pozelimab-bbfg) for treatment of CD55-deficient protein‑losing enteropathy (CHAPLE disease) when the specific medical necessity criteria are met. Authorization is required prior to initiation of therapy; per policy the initial approval period is 3 months and the continuation approval period is 12 months. Operational dosing and billing limits have been specified in the policy (see coding and dosing sections) and were updated in the most recent revision.

The document does not include any additional explicit statements declaring Veopoz or its uses to be "not medically necessary." Changes recorded in the revision history note deletions and operational clarifications to criteria (for example, removal of a prior meningococcal‑history criterion and addition of maximum billing units), but no formal "not medically necessary" language is present.

Coding, Dosing, and Billing Details

Applicable Procedure CodesHCPCSCovered

J9376

Injection, pozelimab-bbfg, 1 mg

Applicable NDCsNDCCovered

61755-0014-XX

Veopoz 200mg/mL- 2mL

Applicable ICD-10 DiagnosesICD-10

K90.49	Malabsorption due to intolerance, not elsewhere classified.
D84.1	Defects in the complement system

Maintenance maximum dose

Maintenance dosingUp to 12 mg/kg subcutaneously once weekly (maximum 800 mg)

RouteSubcutaneous (SC)

FrequencyOnce weekly for maintenance

Weight-based dosingDose calculated by mg/kg up to the 800 mg cap

Billing units — loading and maintenance

Loading dose billing units3200 billable units on day 1

Maintenance billing units

Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals for new starts are limited to 3 months; continuation (patients currently receiving therapy) approvals are up to 12 months (1 year).

Prior authorization required prior to initiation of therapy
Initial approval duration: 3 months
Continuation/renewal approval duration: 12 months (1 year)

Denial Risk

Missing Documentation May Prevent Approval

The treating provider must submit documentation supporting the diagnosis and necessity of therapy. Missing or incomplete documentation may result in denial or delay of the request.

Clinical evidence that the member meets stated criteria must be submitted

Background and Clinical Context

CHAPLE disease (CD55‑deficient protein‑losing enteropathy) is a rare, complement‑mediated disorder caused by biallelic loss‑of‑function mutations in CD55 leading to uncontrolled terminal complement activation. The resulting pathology includes protein‑losing enteropathy with manifestations such as abdominal pain, diarrhea, vomiting, peripheral or facial edema, and malabsorption. Veopoz (pozelimab‑bbfg) is a human monoclonal antibody that targets C5, blocking its cleavage and preventing membrane‑attack complex formation, and is indicated for patients age 1 year and older with this diagnosis.

Definitions and Drug Description

Veopoz (pozelimab-bbfg) — definition & mechanism

Drug class and targetHuman IgG4P monoclonal antibody directed against complement protein C5

Mechanism of actionInhibits terminal complement activation by blocking cleavage of C5 into C5a and C5b, preventing membrane‑attack complex formation (C5b‑C9)

Indication (brief)Indicated for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE disease) in patients ≥1 year of age

Documentation Required

Required Supporting Clinical Documentation

Specific clinical documentation must be provided with the request to support approval decisions.

Genetic testing report confirming biallelic CD55 loss-of-function mutation (documentation required)
Serum albumin level documentation (e.g., lab report) demonstrating ≤ 3.2 g/dL for initial therapy or documentation of improvement/maintenance for continuation requests
Documentation of clinical signs or symptoms within the last 6 months for initial therapy (examples: abdominal pain, diarrhea, vomiting, peripheral or facial edema)
For continuation (current Veopoz recipients): documentation of prior response to therapy (examples: increased or maintained serum albumin, reduced albumin transfusions, clinical improvement, reduced hospitalizations, improved growth percentiles, reduced corticosteroid use)
Vaccination records showing compliance with current ACIP recommendations for meningococcal, Streptococcus pneumoniae, and Haemophilus influenzae type b vaccinations
Provider attestation that medication is prescribed by a physician with expertise in managing CHAPLE disease