CurrentAetnaPolicy N/A

VEOPOZ (pozelimab-bbfg) Medication Precertification Request — Coverage Criteria

Form and requirements for Aetna precertification of VEOPOZ (pozelimab-bbfg) infusions for members, including initiation and continuation clinical criteria and administration site considerations. Applies to providers requesting coverage/precertification.

Policy Summary

PayerAetna

PolicyVEOPOZ (pozelimab-bbfg) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification request form and required clinical documentation (including genotype confirmation and serum albumin) to Aetna Precertification Notification for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

biallelic CD55genotype

≤3.2 g/dLalbumin threshold

phoneprecert contact

Coverage Criteria

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inv-01: Initial Therapy — Initiation requests are supported when ALL of the following are documented

Initiation requests are supported when ALL of the following are documented

Initiation criteria: 1) Diagnosis of CD55-deficient protein-losing enteropathy (PLE) confirmed by detection of a biallelic CD55 loss-of-function mutation by genotype analysis; 2) Presence of hypoalbuminemia (serum albumin concentration ≤3.2 g/dL) and/or signs or symptoms of CD55 PLE within the past 6 months (abdominal pain, diarrhea, peripheral edema, facial edema); 3) Clinical documentation provided on the precertification form confirming the above findings

From initiation section

inv-02: Continuation Therapy — Continuation requests require documentation of ALL of the following

Continuation requests require documentation of ALL of the following

Continuation criteria: 1) Documentation whether the patient has experienced disease progression or unacceptable toxicity while on the current regimen; 2) Documentation that the patient has demonstrated a positive response to therapy (e.g., normalization of serum albumin and improvement in signs and symptoms); provide clinical details on the precertification form

From continuation section

inv-03: Administration safety criteria — Site-of-care and safety considerations must be addressed

Site-of-care and safety considerations must be addressed

Site and safety: Documentation whether the infusion is in an outpatient hospital setting; whether the patient has had an adverse event with the product not responsive to conventional interventions (e.g., acetaminophen, steroids, diphenhydramine, fluids, other pre-medications or slowing of infusion rate) or a severe adverse event (anaphylaxis, anaphylactoid reaction, myocardial infarction, thromboembolism, seizure); presence of severe venous access issues requiring outpatient hospital interventions; significant behavioral/physical/cognitive impairment without caregiver that impacts infusion safety; or medical instability (respiratory, cardiovascular, renal or other) requiring hospital-level monitoring — with descriptions as requested on the form

From clinical information section

Initial Therapy Requirements

inv-13: Initiation requirements — Initiation requires genotype and clinical evidence

Initiation requires genotype and clinical evidence

Initiation: Confirmed biallelic CD55 loss-of-function mutation by genotype analysis AND hypoalbuminemia (serum albumin ≤3.2 g/dL) and/or recent symptoms of CD55 PLE (abdominal pain, diarrhea, peripheral edema, facial edema within past 6 months)

From initiation section

Continuation Therapy Requirements

inv-14: Continuation requirements — For continuation, provide clinical documentation

For continuation, provide clinical documentation

Continuation: Provide documentation whether the patient has experienced disease progression or unacceptable toxicity while on current regimen, and whether the patient has demonstrated a positive response to therapy (for example, normalization of serum albumin and improvement in signs and symptoms); include details on the precertification form

Continuation questions on form

Billing & Coding

Administration/CPT codesCPT

Administration code(s) (CPT)

Place to list administration CPT codes

inv-05: Serum albumin — ≤3.2 g/dL

Serum albumin thresholdSerum albumin concentration ≤3.2 g/dL

Measurement contextRequired for initiation requests to document hypoalbuminemia

Use in continuationUsed as an objective marker of response (normalization indicates improvement)

Place of Administration

Prior Authorization

Precertification Required

Precertification submission: All infusion/site-of-care requests require precertification. Submit the completed infusion request form and supporting clinical documentation prior to scheduled administration. Include the requested place of administration, dispensing provider/pharmacy details, and administration CPT code(s) when applicable.

Include center/agency name, address, phone, FAX, TIN/PIN and dispensing provider selection (physician office, retail pharmacy, specialty pharmacy, other).
Indicate specific administration CPT code(s) and site of administration (self, office, infusion center, home, outpatient hospital).

Denial Risk

Fraud Warning

Fraud warning: Documentation submitted is subject to verification. Providing false, incomplete, or misleading information may result in claim denial, repayment, or other sanctions. Ensure clinical records and place-of-care information accurately reflect the member’s care and site of administration.

Documentation Required

Required documentation: Clinical documentation must be provided for ALL precertification requests. At a minimum include: diagnosis, relevant prior treatments and responses, history of infusion reactions and management, explanation of why the requested site of care is necessary (if outpatient hospital is selected), and details of venous access, behavioral or medical instability if applicable.

History of prior therapies and responses; documentation of conventional interventions tried for infusion reactions (e.g., acetaminophen, steroids, diphenhydramine, fluids, slowed infusion rate).
If outpatient hospital setting selected, provide rationale (e.g., severe adverse events, need for advanced monitoring or interventions, severe venous access issues, significant behavioral/physical/cognitive impairment without caregiver).
Complete dispensing provider/pharmacy fields: center/agency name, address, phone, FAX, TIN/PIN, and selected dispensing provider type.

Documentation Required

Infusion Reaction Management Documentation

Infusion reaction management documentation: For any history of infusion-related adverse events, provide detailed documentation of the event(s), interventions performed, patient response, and whether events resolved with conventional measures. If severe reactions occurred (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, seizures), include emergency management records and rationale for site selection. If reactions did not respond to standard interventions, note that in the submission.

Describe interventions attempted (medications, infusion rate modification, fluids) and the outcome.
Provide ER/hospital records if severe adverse events occurred or if advanced management was required.
If continuing therapy despite prior reaction, document mitigation plan and monitoring available at the chosen site of care.

Provider Actions & Submission Requirements

Prior Authorization

Use the Aetna precertification form and contacts

Submit the precertification request using the VEOPOZ Medication Precertification Request form and contact Aetna Precertification Notification by phone or fax as listed on the form for review and processing.

Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277

Step Therapy

Record attempted conventional interventions for infusion reactions

Document whether the patient experienced infusion adverse events and whether conventional interventions were attempted (e.g., acetaminophen, steroids, diphenhydramine, fluids, other pre‑medications, or slowing the infusion rate); record if events did not respond and describe the reaction.

Indicate if adverse event occurred and if it was unresponsive to conventional interventions.
If severe adverse event occurred (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures), document details.

Documentation Required

Submit all required clinical and administrative documentation

Provide completed, legible patient, insurance, prescriber, administration, product, diagnosis (ICD), and required clinical information on the form, including diagnosis confirmation, genotype results for CD55 deficiency when applicable, serum albumin value, signs/symptoms, and prior treatment/adverse events.

Complete Sections A–G with patient, prescriber, product, and diagnosis (ICD) information.
Include genotype confirmation for biallelic CD55 loss‑of‑function mutation for initiation requests.
Record serum albumin value and recent signs/symptoms of CD55 PLE, and details of prior treatments or adverse events.

Denial Risk

Fraudulent information may lead to penalties

Acknowledgement states that knowingly filing a request with materially false or concealed information is a fraudulent insurance act that may subject the filer to criminal and civil penalties and that the plan may request additional information to evaluate requests.

Do not submit materially false or concealed information; such acts may result in criminal and civil penalties.
Be prepared to provide additional information if requested by the plan.

Definitions

inv-11: CD55 PLE — CD55-deficient protein-losing enteropathy (PLE) — a diagnosis queried on the form; initiation asks for genotype confirmation by detection...

Defined conditionCD55-deficient protein-losing enteropathy (PLE)

Genotype confirmation required for initiationDiagnosis must be confirmed by detection of biallelic CD55 loss-of-function mutation via genotype analysis

Form queryForm asks whether patient has a diagnosis of CD55-deficient PLE

Clinical evidenceInitiation also requires recent signs/symptoms and lab evidence (hypoalbuminemia) as documented on the form

inv-12: Hypoalbuminemia threshold — Hypoalbuminemia defined on form as serum albumin concentration of ≤3.2 g/dL.

Hypoalbuminemia definitionSerum albumin concentration of ≤3.2 g/dL

Role for initiationPresence of hypoalbuminemia is required (or signs/symptoms) for initiation requests

Documentation locationForm includes a checkbox asking whether the patient has hypoalbuminemia (≤3.2 g/dL)

Background

VEOPOZ (pozelimab-bbfg) is indicated for patients with CD55-deficient protein‑losing enteropathy (PLE), and this precertification form captures the clinical and administrative information Aetna requires to evaluate initiation and continuation of therapy. The form specifically requests confirmation that the diagnosis was established by biallelic CD55 loss‑of‑function mutation detected by genotype analysis for initiation requests, and asks for recent clinical evidence (signs/symptoms and laboratory data) to support medical necessity.

For initiation, the form asks whether the patient has hypoalbuminemia (serum albumin ≤3.2 g/dL) and which CD55 PLE signs or symptoms (abdominal pain, diarrhea, peripheral edema, facial edema) occurred within the past 6 months; for continuation, the form requires documentation that the patient has demonstrated a positive response to therapy (for example, normalization of serum albumin and clinical improvement) and that there is no disease progression or unacceptable toxicity while on the current regimen.

The form also captures site‑of‑care and safety considerations relevant to administration (outpatient hospital setting, infusion center, home infusion, physician office, or self‑administration) and asks whether the patient has a history of severe infusion adverse events not responsive to conventional interventions, severe venous access issues, significant behavioral/physical/cognitive impairment without caregiver support, or medical instability that would require higher‑level monitoring.

Step Therapy / Prior Interventions

Requirement	Documentation / Notes
Evidence that conventional interventions for infusion adverse events were tried	Checkbox on form asks whether patient experienced an adverse event that has not responded to conventional interventions (examples listed: acetaminophen, steroids, diphenhydramine, fluids, other pre‑medications, or slowing of infusion rate)
Description of which interventions were attempted	Provider must document which conventional interventions were used and the patient's response (form includes space for clinical information)
Documentation that adverse event was not responsive to interventions or was severe	Form asks if adverse event did not respond to conventional interventions or was a severe adverse event (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures)
If outpatient hospital setting required, reason must be indicated	Form asks whether infusion request is in an outpatient hospital setting and whether severe venous access issues or medical instability require hospital‑level monitoring or interventions

Policy Summary

PayerAetna

PolicyVEOPOZ (pozelimab-bbfg) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification request form and required clinical documentation (including genotype confirmation and serum albumin) to Aetna Precertification Notification for review.

SourceLink

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