CurrentMass General Brigham Health PlanPolicy N/A

Veopoz (pozelimab-bbfg) prior authorization

This policy governs prior authorization, coverage criteria, renewal, and quantity limits for Veopoz (pozelimab-bbfg) for Mass General Brigham Health Plan members under pharmacy and medical benefits where applicable.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVeopoz (pozelimab-bbfg) prior authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateFeb 18, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including diagnosis, genetic test confirming CDSS loss-of-function mutation, meningococcal vaccination date, prior eculizumab trial history, and dosing information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearauthorization duration

>=2 yrsminimum age

meningococcal vaccinevaccination requirement

CHAPLE diseaseindicated diagnosis

Coverage Criteria for Veopoz (pozelimab-bbfg)

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Initial Therapy — Authorization may be granted when ALL of the following are met

Authorization may be granted when ALL of the following are met:

Initial therapy criteria

Age: Member is >= 2 years of age>= 2 years
Diagnosis of CDSS-deficient protein-losing enteropathy (PLE) / CHAPLE disease
Vaccination: Member has received a meningococcal vaccine at least two weeks prior to treatment initiation>= 2 weeks before
Genetic testing: Results from genetic testing confirming a CDSS loss-of-function mutation
Prescriber is a specialist in rare genetic or hematologic diseases or specialist consult notes are provided
Prior therapy: Inadequate response, adverse reaction, or contraindication to Soliris (eculizumab)
Dosing: Appropriate dosing provided

Initial coverage — Initial authorization criteria (linked to initial therapy)

Initial authorization criteria:

Initial: Member is >=2 years; diagnosis of CHAPLE disease; meningococcal vaccine given >=2 weeks prior; genetic testing confirming CDSS loss-of-function mutation; prescriber is specialist or consult notes provided; inadequate response/adverse reaction/contraindication to eculizumab; and appropriate dosing provided.

Continuation Therapy — Continuation/reauthorization criteria; medical records must document ALL of the following

Continuation/reauthorization criteria — medical records must document ALL of the following:

Continuation therapy criteria

Clinical status: Improvement or no worsening of clinical symptoms (e.g., abdominal pain, bowel movements, facial and peripheral edema)
Serum albumin response: One of: increase in current serum albumin from baseline OR serum albumin stabilized above lower threshold for normal range (23.5 g/dL)23.5 g/dL lower threshold
Serum IgG response: One of: increase in current serum IgG from baseline OR serum IgG stabilized above age-adjusted lower threshold per tableage-adjusted ranges provided

Reauthorization — Requirements for reauthorization (1 year approvals)

Requirements for reauthorization (approvals granted for 1 year):

Reauthorization evidence: Medical records documenting improvement or no worsening of clinical symptoms plus ONE serum albumin criterion and ONE serum IgG criterion (increase from baseline or stabilization above lower threshold/age-adjusted range)

Initial and reauthorizations granted for 1 year

Products obtained as samples or provided through the manufacturer's patient assistance programs are excluded from case-by-case review for members who are new to the plan and currently receiving the requested medication. In other words, when therapy was supplied to the member via samples or a manufacturer assistance program, that exposure will not trigger a review pathway for continuation under the new-to-plan case‑by‑case process.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Veopoz under the plan. Initial authorization will be granted only when the member meets the clinical criteria listed in the coverage guidelines and required documentation is submitted. Authorization may be reviewed on a case-by-case basis; requests may be denied if the member is not new-to-plan exception and does not meet coverage criteria.

Plan types: Commercial/Exchange; MassHealth UPPL
Benefit: Pharmacy Benefit (Quantity Limit, Step Therapy); Medical Benefit (Specialty Limitations may apply)
Contact (Specialty/Medical & Specialty Medications): Phone 877-519-1908; Fax 855-540-3693
Contact (Non-Specialty Medications / All Plans): Phone 800-711-4555; Fax 844-403-1029

Step Therapy

Step Therapy / Benefit Notes

Step therapy and benefit notes: Veopoz may be subject to step therapy and specialty limitations. Additional agents in this class may be covered through the pharmacy benefit; refer to the MassHealth Drug List for coverage and criteria. Requests should document prior inadequate response, adverse reaction, or contraindication to Soliris (eculizumab) when applicable.

Step therapy: member should have trial and inadequate response or contraindication to indicated prior agents (e.g., Soliris) when required
Specialty limitations: specialty-medication management may apply; prior authorization routed through specialty pharmacy contact above
Pharmacy vs Medical benefit: some agents in this class are managed under pharmacy benefit — check MassHealth Drug List for specifics

Documentation Required

Required Documentation

Required documentation to support the authorization must be submitted. Include diagnosis, genetic testing confirming a CDSS loss-of-function mutation, evidence of meningococcal vaccination, specialist prescriber or consult notes, and dosing information.

Documentation of diagnosis: CDSS-deficient protein-losing enteropathy (PLE) or CHAPLE disease
Genetic testing results confirming CDSS loss-of-function mutation
Proof member received meningococcal vaccine at least two weeks prior to treatment initiation
Prescriber is a specialist in rare genetic or hematologic diseases, or provide specialist consult notes
Clinical rationale: records showing inadequate response, adverse reaction, or contraindication to Soliris (eculizumab) if applicable
Specify proposed dosing and administration schedule

Denial Risk

Authorization Review and Denial Risk

Authorization review and denial risk: requests may be denied if the member does not meet coverage criteria or is not eligible for a new-to-plan exception. Continuation of therapy authorizations require documentation of improvement or no worsening and supporting laboratory data.

Authorization may be reviewed case-by-case for members new to the plan who are currently receiving treatment (excludes samples or manufacturer patient assistance program-supplied product)
Continuation requirements: documentation of improvement or no worsening of clinical symptoms (e.g., abdominal pain, bowel movements, facial/peripheral edema)
Laboratory documentation for continuation: increase in serum albumin from baseline OR serum albumin stabilized above the lower limit of normal (e.g., ≥ 3.5 g/dL) as applicable
Denial risk: lack of required genetic testing, missing vaccination proof, no specialist involvement/consult, or failure to meet step-therapy requirements

Laboratory Reference Ranges and Key Lab Criteria

Age-adjusted serum IgG concentration reference ranges

<1 monthNot specified in table (see policy appendix); laboratory-specific ranges acceptable

1-3 months176-601 mg/dL

4-6 months172-814 mg/dL

7-12 months217-1213 mg/dL

13-24 months424-1051 mg/dL

25-36 months441-1135 mg/dL

3-5 years441-1236 mg/dL

6-8 years633-1280 mg/dL

9-11 years608-1572 mg/dL

12-16 years1066-1218 mg/dL

16-18 years1188-1458 mg/dL

>18 years639-1349 mg/dL

Serum albumin

Serum albumin response optionsIncrease in current serum albumin from baseline OR serum albumin stabilized above lower threshold for normal range

Lower threshold for normal range23.5 g/dL

Documentation requiredMedical records must show one of the serum albumin criteria for continuation/reauthorization

OpenPayer

Veopoz (pozelimab-bbfg) prior authorization

Coverage Criteria for Veopoz (pozelimab-bbfg)

Provider Actions and Documentation Requirements

Laboratory Reference Ranges and Key Lab Criteria

Step Therapy Requirements

Coverage by Site of Care

Key Definitions

Background on Veopoz and Indication