CurrentCareSourcePolicy N/A

Veopoz (pozelimab) coverage for CD55-deficient protein-losing enteropathy (CHAPLE disease)

Defines prior authorization and medical necessity criteria for Veopoz (pozelimab) for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE disease) in patients age ≥ 1 year; affects providers prescribing Veopoz and outlines diagnostic, vaccination, dosing, and reauthorization requirements.

Policy Summary

PayerCareSource

PolicyVeopoz (pozelimab) coverage for CD55-deficient protein-losing enteropathy (CHAPLE disease)

Policy CodePolicy N/A

Change TypeSelected revision (10/09/2024)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation (including genetic test confirming biallelic CD55 loss‑of‑function mutation, relevant labs, and vaccination records) to support approval for Veopoz per the stated criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

For initial therapy, the requirement that the patient does not have a history of meningococcal infection was removed.

≥1Minimum patient age for coverage

30→10–12 mg/kgDosing (loading then maintenance)

800 mgMaximum weekly maintenance dose

Prior authAuthorization requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA‑Approved Indication — Initial therapy

Approve for patients meeting ALL of the following (A OR B structure in original; here represented as the initial therapy pathway):

ALL of the following

Patient is ≥ 1 year of age
Diagnostic confirmation and disease activity
- Genetic test confirming diagnosis of CHAPLE disease with a biallelic CD55 (CDSS) loss-of-function mutation
  Documentation required
- Serum albumin level < 3.2 g/dL< 3.2 g/dL
  Documentation required
- Patient has active disease with one or more signs or symptoms within the last 6 months
  Examples: abdominal pain, diarrhea, vomiting, peripheral or facial edema; documentation required
Vaccination requirements
- Patient has received or is in compliance with updated meningococcal vaccinations per current ACIP recommendations
  Complete or update at least 2 weeks before first dose unless risks of delaying therapy outweigh meningococcal infection risk
- Patient has received or is in compliance with updated vaccinations for Streptococcus pneumoniae and Haemophilus influenzae type b per current ACIP guidelines
Medication is prescribed by or in consultation with a physician who specializes in managing CHAPLE disease

FDA‑Approved Indication — Ongoing therapy / Reauthorization (patients currently receiving Veopoz)

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 1 year of age
Genetic test confirming diagnosis of CHAPLE disease with a biallelic CD55 loss-of-function mutation
Documentation required for initial approval; subsequent reviews do not require resubmission of genetic test documentation
Medication is prescribed by or in consultation with a physician who specializes in managing CHAPLE disease
Patient had experienced a response to therapy
Documentation required; examples include increased or maintained serum albumin, reduced need for albumin transfusions, improved clinical symptoms (reduced abdominal pain, reduced bowel frequency, reduced facial/peripheral edema), improved protein or immunoglobulin levels, reduced corticosteroid use

Dosing Criteria

Dosing that will be authorized if criteria met:

ALL of the following

Single 30 mg/kg loading dose by intravenous infusion on Day 1
Maintenance: 10 mg/kg subcutaneous injection once weekly
If inadequate clinical response after at least three weekly doses (starting from Week 4), maintenance dose may be increased to 12 mg/kg once weekly
Maximum maintenance dosage: 800 mg once weekly800 mg weekly
Doses exceeding 400 mg require two injections

Not recommended for approval

Coverage is not recommended in the following situations:

ANY of the following

Concomitant use with other complement inhibitors (prohibited in pivotal study)
Use for circumstances not listed in the Recommended Authorization Criteria

Prior Authorization, Documentation, and Prescribing Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Veopoz; approval is recommended only for patients who meet the policy’s specified criteria and dosing. Requests for doses outside the established dosing documented in this policy will be considered on a case‑by‑case basis by a clinician (e.g., Medical Director or Pharmacist).

Documentation Required

Documentation required

Documentation is required for initial approval and may include chart notes, laboratory data, and genetic test results confirming a biallelic CD55 (CDSS) loss‑of‑function mutation. For reauthorization, genetic test documentation that has been previously provided and reviewed is not required to be resubmitted.

Chart notes documenting signs/symptoms and clinical course
Laboratory data (e.g., serum albumin)
Genetic test confirming biallelic CD55 (CDSS) loss‑of‑function mutation (initial approval only; not required again for reauthorization if previously reviewed)

Documentation Required

Vaccination documentation and timing

Document the patient’s meningococcal vaccination status and receipt/compliance with vaccinations for Streptococcus pneumoniae and Haemophilus influenzae type b per current ACIP guidance. Complete or update meningococcal vaccination at least 2 weeks before the first dose of Veopoz unless the risks of delaying therapy outweigh the risk of meningococcal infection.

Record meningococcal vaccination dates and whether vaccinations are up to date per ACIP
Record pneumococcal and Hib vaccination status per ACIP recommendations
If delaying treatment to vaccinate, document clinical rationale if risks of delay outweigh meningococcal infection risk

Note

Specialist prescriber requirement

Veopoz must be prescribed by or in consultation with a physician who specializes in managing CHAPLE disease (a clinician with expertise in the condition).

Denial Risk

Concomitant complement inhibitor use denied

Coverage is not recommended for concomitant use of Veopoz with other complement inhibitors; the pivotal study prohibited use of other complement inhibitors.

Clinical Background

Veopoz (pozelimab) is a complement inhibitor approved for treatment of CD55‑deficient protein‑losing enteropathy (CHAPLE disease) in patients aged ≥ 1 year. CHAPLE disease (Complement Hyperactivation, Angiopathic thrombosis, and Protein‑Losing Enteropathy) is an ultra‑rare inherited immune disorder caused by biallelic loss‑of‑function mutations in CD55complement overactivation, which can cause the complement system to attack the patient's own tissues. [[1],[2]]

The condition primarily affects children, including infants, and is associated with significant morbidity and increased risk of mortality. Typical clinical features include protein‑losing enteropathy manifested by gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea, poor appetite, weight loss, and impaired growth, as well as peripheral or facial edema. Patients with CHAPLE disease are also at risk for severe thrombotic vascular occlusions, which can be life‑threatening. Fewer than 100 patients have been diagnosed worldwide. [[2]]

Policy revisions note that the initial‑therapy requirement excluding patients with a history of meningococcal infection was removed in the selected revision dated 10/09/2024. Management of patients receiving Veopoz requires specialist involvement and adherence to recommended vaccination and monitoring procedures described in the policy. [[11],[7],[8]]

OpenPayer

Veopoz (pozelimab) coverage for CD55-deficient protein-losing enteropathy (CHAPLE disease)

Medical Necessity Criteria for Veopoz (pozelimab)

Relevant Billing and Diagnosis Codes

Prior Authorization, Documentation, and Prescribing Requirements

Clinical Background

Defined Terms

Policy Changes