CurrentViva HealthPolicy IC-0161

Zaltrap® (ziv-aflibercept) (Intravenous)

Prior authorization, coverage, renewal, dosing, billing units, and applicable diagnosis codes for intravenous ziv-aflibercept (Zaltrap) for adult patients with colorectal and related cancers. Includes initial and renewal clinical criteria, dosing schedule, HCPCS/NDC codes, limits, and CMS/MAC guidance.

Policy Summary

PayerViva Health

PolicyZaltrap® (ziv-aflibercept) (Intravenous)

Policy CodePolicy IC-0161

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for an initial 6 months and document prior oxaliplatin-containing regimens, irinotecan exposure status, combination with FOLFIRI/irinotecan, and disease response or absence of unacceptable toxicity for renewal.

POLICY UPDATE CHANGES

No material clinical/coverage changes

6 monthsInitial PA duration

6 monthsRenewal interval

500Max billable units per 14 days

4 mg/kg q2wDose frequency

Coverage Summary

Coverage stance: covered with criteria for ziv-aflibercept (Zaltrap) for adult patients with metastatic colorectal and related cancers. The policy provides prior authorization requirements, initial and renewal criteria, dosing and billing guidance as summarized in the scope_summary.

Provider Actions & Operational Rules

Prior Authorization

Prior authorization required

Initial prior authorization provided for 6 months; renewals may be granted every 6 months if renewal criteria met.

Initial PA duration: 6 months; renewals every 6 months

Billing Rule

HCPCS unit billing and dose rounding implications

Report J9400 with 1 billable unit = 1 mg; maximum of 500 billable units allowed every 14 days (operational cap).

Affected codes: J9400
Max units per 14 days: 500

Documentation Required

Document prior therapies and disease status

Document prior oxaliplatin-containing regimens, prior irinotecan exposure status, use in combination with FOLFIRI/irinotecan, and evidence of disease response or progression for renewal.

Prior oxaliplatin-containing regimens (e.g., FOLFOX, CapeOX)
Prior irinotecan exposure status (has or has not received irinotecan)
Whether used in combination with FOLFIRI or irinotecan
Evidence of disease response or progression (stabilization or decrease in tumor size/spread)

Documentation Required

Monitor and document toxicity

Document absence of unacceptable toxicity to support renewal; include proteinuria quantification if applicable.

Quantify proteinuria when applicable (e.g., document g/24 hours)
Unacceptable toxicities (examples): hemorrhage; gastrointestinal perforation; fistula formation; uncontrolled hypertension (e.g., hypertensive crisis, hypertensive encephalopathy); impaired wound healing; arterial thromboembolic events; proteinuria meeting criteria (e.g., nephrotic syndrome, thrombotic microangiopathy, ≥ 2 g/24 hours); neutropenia and neutropenic complications; reversible posterior leukoencephalopathy syndrome (RPLS); severe diarrhea/dehydration

Applicable Codes

HCPCS (J-code) for drug billingHCPCSCovered

J9400

Injection, ziv-aflibercept, 1 mg; 1 billable unit = 1 mg

NDCsNDC

00024-5840-xx	Zaltrap 100 mg/4 mL solution, single-dose vial
00024-5841-xx	Zaltrap 200 mg/8 mL solution, single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

C18.0	Malignant neoplasm of cecum
C18.1	Malignant neoplasm of appendix
C18.2	Malignant neoplasm of ascending colon
C18.3	Malignant neoplasm of hepatic flexure
C18.4	Malignant neoplasm of transverse colon
C18.5	Malignant neoplasm of splenic flexure
C18.6	Malignant neoplasm of descending colon
C18.7	Malignant neoplasm of sigmoid colon
C18.8	Malignant neoplasm of overlapping sites of large intestines
C18.9	Malignant neoplasm of colon, unspecified

1–10 of 19

1/2

Billing definition: For J9400, 1 billable unit = 1 mg of ziv-aflibercept.

Clinical Evidence & References

Primary evidence sources: the Zaltrap package insert (May 2025) and the NCCN Drugs & Biologics Compendium (2025) are cited as the primary sources for the policy.

The FDA label and NCCN compendium are specifically referenced for indication details and for guidance on universal MMR/MSI testing and related testing considerations.

Background

Ziv-aflibercept (Zaltrap) is an intravenous anti-angiogenic biologic indicated for metastatic colorectal cancer to be used in combination with chemotherapy regimens (for example with FOLFIRI after prior oxaliplatin-containing therapy or in specified initial or subsequent treatment settings).

The policy references the FDA label and the NCCN compendium for indication specifics and for testing guidance such as universal MMR/MSI testing in newly diagnosed patients.

Policy metadata

Policy NumberIC-0161

DrugZaltrap (ziv-aflibercept) intravenous

StatusCURRENT

Last Review09/04/2025