CurrentHealth NetPolicy CP PHAR.325

Ziv-Aflibercept (Zaltrap) coverage

Defines medical necessity and prior authorization criteria for ziv-aflibercept (Zaltrap) for members across Commercial, HIM, and Medicaid lines of business when used for colorectal cancer and other indications per formulary/off-label policies.

Policy Summary

PayerHealth Net

PolicyZiv-Aflibercept (Zaltrap) coverage

Policy CodePolicy CP PHAR.325

Change TypeNo material changes

Effective Date03.01.17

Next Review Date

Key ActionProvider must submit clinical documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including diagnosis, prior therapies, prescribing clinician specialty, and regimen details.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Standard maximum dose per policy

6 monthsInitial approval duration (all lines of business)

12 monthsContinued therapy approval duration (Medicaid/HIM)

J9400HCPCS code for ziv-aflibercept 1 mg

Medical Necessity Criteria for Ziv-Aflibercept (Zaltrap)

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Initial approval — Metastatic colorectal cancer (CRC)

Zaltrap is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of advanced, unresectable, or metastatic colorectal cancer (CRC)
Prescribed by or in consultation with an oncologist
Previous treatment (one of):
- Previous treatment with an oxaliplatin-containing regimen (e.g., FOLFOX, CapeOX)
- Previous treatment with a capecitabine-containing regimen (off-label)
- Previous treatment with a 5-fluorouracil and leucovorin-containing regimen (off-label)
Prescribed in combination with irinotecan or FOLFIRI
Dose does not exceed 4 mg/kg every 2 weeks4 mg/kg every 2 weeks
If higher dose requested, must be supported by practice guidelines or peer-reviewed literature and prescriber must submit supporting evidence
Provider must submit documentation (office notes, labs, clinical information) supporting that member meets all approval criteria

Initial approval — Other diagnoses/indications

For other diagnoses the following applies (must meet 1 or 2):

ANY of the following

If drug is on the formulary (commercial, marketplace) or PDL (Medicaid): follow the no coverage criteria policy for the relevant line of business (see related policies CP.CPA.190; HIM.PA.33; CP.PMN.255)
If drug is NOT on the formulary/PDL: follow the non-formulary policy for the relevant line of business (see related policies CP.CPA.190; HIM.PA.103; CP.PMN.16)
If requested use is not specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' and initial CRC criterion does not apply: refer to the off-label use policy for the relevant line of business (see related policies CP.CPA.09; HIMPA.154; CP.PMN.53)

Continued therapy — General

Continued therapy is allowed when ALL of the following are met:

ALL of the following

Member is currently receiving the medication via the Centene benefit, or documentation shows member has received Zaltrap for a covered indication for at least 30 daysMember has received Zaltrap for at least 30 days
Member is responding positively to therapy (for CRC: response or clinical benefit documented)
New dose does not exceed 4 mg/kg every 2 weeks4 mg/kg every 2 weeks
If dose increase is requested it must be supported by practice guidelines or peer-reviewed literature and prescriber must submit supporting evidence

Not authorized / Exclusions

Coverage is not authorized for:

ALL of the following

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policy

Prior Authorization, Documentation, and Billing Rules

Prior Authorization

Documentation for prior authorization

Provider must submit clinical documentation (such as office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including the diagnosis, prior therapies, that the prescribing clinician is an oncologist (or consulted with one), and regimen details (e.g., combination with irinotecan or FOLFIRI).

Include office notes and relevant lab results
Document prior oxaliplatin-containing regimen (e.g., FOLFOX, CapeOX) or other prior 5-FU/capecitabine regimens as applicable
Confirm prescribing clinician specialty or documentation of oncology consultation
Provide regimen details showing combination with irinotecan or FOLFIRI

Documentation Required

Support dose increases

If the requested dose exceeds the policy maximum of 4 mg/kg every 2 weeks, the prescriber must submit supporting evidence from practice guidelines or peer-reviewed literature to justify the higher (off-label) dose.

Specify the requested new dose and clinical rationale
Attach guideline excerpts or peer-reviewed publications supporting the higher dose

Prior Authorization

Formulary/off-label routing

For uses outside the listed colorectal cancer criteria, route prior authorization requests according to the member's line of business: follow the applicable formulary/no-coverage, non-formulary, or off-label use policy referenced in related policies.

If drug is on the formulary/PDL, follow the no coverage criteria policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255)
If drug is not on the formulary/PDL, follow the non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.103, CP.PMN.16)
If use is not listed and CRC criteria do not apply, follow the off-label use policy for the relevant line of business (see CP CPA.09, HIMPA.154, CP.PMN.53)

Clinical and Policy Background

Ziv‑aflibercept (Zaltrap) is a vascular endothelial growth factor (VEGF) inhibitor used in oncology to target tumor angiogenesis and impede tumor blood supply, consistent with its pharmacologic class description. The agent is supplied as single‑use vials for injection and is coded under HCPCS as J9400 (injection, ziv‑aflibercept, 1 mg).

Zaltrap is FDA‑approved in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (CRC) that is resistant to or has progressed following an oxaliplatin‑containing regimen. The policy requires that the prescribed regimen be FDA‑approved or recommended by NCCN, reflecting alignment with both the FDA approval language and NCCN guidance for CRC management.

Per the clinical policy, initial and continued coverage for Zaltrap is limited to patients with advanced, unresectable, or metastatic CRC when prescribed by or in consultation with an oncologist and used in combination with irinotecan or FOLFIRI. The policy also mirrors the product dosing guidance by setting a maximum dose of 4 mg/kg every 2 weeks, and requires documentation of prior oxaliplatin exposure (e.g., FOLFOX or CapeOX) before initial approval.

Policy Summary

PayerHealth Net

PolicyZiv-Aflibercept (Zaltrap) coverage

Policy CodePolicy CP PHAR.325

Change TypeNo material changes

Effective Date03.01.17

Next Review Date

SourceLink

On This Page

OpenPayer

Ziv-Aflibercept (Zaltrap) coverage

Medical Necessity Criteria for Ziv-Aflibercept (Zaltrap)

Relevant Billing Codes

Prior Authorization, Documentation, and Billing Rules

Clinical and Policy Background

Defined Terms

Quick Policy Metrics

Ziv-Aflibercept (Zaltrap) coverage

Medical Necessity Criteria for Ziv-Aflibercept (Zaltrap)

Relevant Billing Codes

Prior Authorization, Documentation, and Billing Rules

Clinical and Policy Background

Defined Terms

Policies to Read With This Policy

Quick Policy Metrics