CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines medical-benefit coverage and prior authorization criteria for Veopoz (pozelimab) to treat CD55-deficient protein-losing enteropathy (CHAPLE disease) for eligible members, including initial and reauthorization criteria, dosing/quantity limits, vaccination requirement, and exclusion for other indications.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy

Effective DateApr 1, 2024

Next Review Date

Key ActionPrior authorization is required; submit documentation demonstrating genetic testing confirming biallelic CD55 loss-of-function, baseline hypoalbuminemia, meningococcal vaccination ≥2 weeks prior, specialist prescribing/consultation, and PLE history.

SourceLink

POLICY UPDATE CHANGES

New policy for Veopoz created on 11/06/2023

1Covered Indication (CHAPLE disease)

16 mL/28dQuantity limit

6 moInitial approval duration

12 moReauth duration

Coverage Summary

Defines medical-benefit coverage and prior authorization criteria for Veopoz (pozelimab) to treat CD55-deficient protein-losing enteropathy (CHAPLE disease). Coverage stance: covered_with_criteria. Eligible members must be >= 1 year of age. Prior authorization is required and the medication must be prescribed by or in consultation with a geneticist, hematologist, gastroenterologist, or immunologist. Genetic confirmation requires genotypic analysis showing biallelic loss of function mutations in CD55. Diagnosis confirmation requires history of protein-losing enteropathy and baseline testing must document hypoalbuminemia. Members must receive meningococcal vaccination at least 2 weeks prior to therapy start. Dosing and quantity limits: single 30 mg/kg dose, maintenance 10 mg/kg once weekly (may increase to 12 mg/kg once weekly after >= 3 weekly doses if inadequate response), maximum maintenance dose 800 mg once weekly, and quantity limit 16 mL per 28 days. Initial approval duration is 6 months; reauthorization requires normalization of serum albumin and clinical improvement and grants 12 months if met. Veopoz is excluded (not medically necessary) for indications not listed in this policy and must not be used in combination with eculizumab. Effective date: 2024-04-01; Last review: 2023-11-06.

Thresholds

Age>= 1 year

Meningococcal vaccination timing>= 2 weeks before therapy start

Approval duration - initial6 months

Approval duration - reauthorization12 months

Quantity limit16 mL per 28 days

Maintenance dose escalationIncrease to 12 mg/kg once weekly after >= 3 weekly doses if inadequate response

Maximum maintenance dose800 mg once weekly

Initial Authorization Criteria

Initial Authorization - CHAPLE Disease

Covered when ALL of the following are met:

ALL of the following

Member is at least 1 year of age or older
Medication is prescribed by or in consultation with a geneticist, hematologist, gastroenterologist, or an immunologist
Genetic confirmation
- Genotypic analysis confirming biallelic loss of function mutations to the CD55 gene
Diagnosis confirmation
- Diagnosis of CHAPLE disease confirmed by history of protein-losing enteropathy (PLE)
Member must have meningococcal vaccination at least 2 weeks prior to therapy start date
Member must have a baseline test confirming hypoalbuminemia
Contraindicated combination: Veopoz will not be used in combination with eculizumab

Initial Authorization - Dosing and Duration

ALL of the following

Loading dose: Single 30 mg/kg dose
Maintenance dose: 10 mg/kg once weekly; may be increased to 12 mg/kg once weekly if inadequate response after at least 3 weekly doses
Dose escalation allowed after >= 3 weekly doses if inadequate response
Maximum maintenance dose = 800 mg once weekly
Quantity limit: 16 mL per 28 days
Approval duration: If all requirements are met, approval duration = 6 months

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Veopoz (pozelimab) under the medical benefit in Arkansas PASSE. Submit documentation demonstrating all initial criteria including genetic testing, baseline hypoalbuminemia, meningococcal vaccination timing, prescribing/consultation by an appropriate specialist, and history of protein‑losing enteropathy (PLE).

Genotypic analysis confirming biallelic loss of function mutations in CD55
Baseline test confirming hypoalbuminemia
Documentation of meningococcal vaccination administered at least 2 weeks prior to therapy start
Prescription by or consultation with a geneticist, hematologist, gastroenterologist, or immunologist
Chart notes documenting history of protein‑losing enteropathy (PLE)

Documentation Required

Genetic confirmation documentation

Provide genotypic analysis confirming biallelic loss of function mutations in the CD55 gene.

Documentation Required

Baseline lab documentation

Provide a baseline laboratory test confirming hypoalbuminemia and chart notes documenting a history of protein‑losing enteropathy (PLE).

Documentation Required

Vaccination documentation

Document that meningococcal vaccination was administered at least 2 weeks prior to the therapy start date.

Denial Risk

Concomitant eculizumab

Claims may be denied if Veopoz is used in combination with eculizumab; Veopoz will not be used in combination with eculizumab per policy.

Documentation Required

Reauthorization clinical notes

For reauthorization, provide laboratory evidence showing normalization of serum albumin and chart notes documenting improvement in at least one symptom (daily bowel movement frequency, edema, or abdominal pain).

Billing Rule

Quantity limit enforcement

Adhere to the quantity limit of 16 mL per 28 days and the dosing described in policy. Dosing must follow the single 30 mg/kg dose then maintenance dosing (10 mg/kg once weekly, may be increased to 12 mg/kg once weekly after at least 3 weekly doses if inadequate response; maximum maintenance dose = 800 mg once weekly).

Quantity limit: 16 mL per 28 days
Single 30 mg/kg dose, then maintenance 10 mg/kg once weekly
Increase to 12 mg/kg once weekly after >= 3 weekly doses if inadequate response
Maximum maintenance dose = 800 mg once weekly

Background & Definitions

Veopoz (pozelimab) is a complement inhibitor FDA-approved in August 2023 for treatment of CD55-deficient protein-losing enteropathy (CHAPLE disease) in adult and pediatric patients. CHAPLE is a rare inherited disorder caused by mutation in the CD55 gene leading to complement-mediated protein-losing enteropathy (PLE) that can present with edema, impaired growth, and thrombosis and may be life-threatening.

Term	Definition
CHAPLE disease
Complement Hyperactivation, Angiopathic Thrombosis, and Protein-Losing Enteropathy caused by CD55 deficiency (CD55-deficient protein-losing enteropathy).
PLE
Protein-losing enteropathy

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy

Effective DateApr 1, 2024

Next Review Date

SourceLink

On This Page

OpenPayer

PHARMACY POLICY STATEMENT Arkansas PASSE

Coverage Summary

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Not Medically Necessary / Exclusions

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History