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Zaltrap® (ziv-aflibercept) (Intravenous)

Policy Number: VP-0161

Last Review Date: 03/02/2023

Date of Origin: 02/07/2013

Dates Reviewed: 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 2/2018, 5/2018, 09/2018, 12/2018, 03/2019, 06/2019, 9/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2022, 03/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Zaltrap 100 mg/4 mL injection: 2 vials per 28 days
  • Zaltrap 200 mg/8 mL injection: 4 vials per 28 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 500 billable units every 14 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Patient does not have recent history of severe hemorrhage; AND
  • Ziv-aflibercept will be not administered for at least 4 weeks following major surgery; AND
  • Patient does not have a surgical wound that has not fully healed; AND

Colorectal Cancer (CRC) † 1,2,6

  • Patient has metastatic disease that is resistant to or has progressed following an oxaliplatin-containing regimen (e.g., FOLFOX, CapeOX) ; AND
  • Used in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan); OR
  • Used as primary treatment for patients with unresectable metastases and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months; AND
  • Used in combination with irinotecan or FOLFIRI; OR
  • Used as subsequent therapy for progression of advanced or metastatic disease in patients not previously treated with irinotecan-based therapy; AND
  • Used in combination with irinotecan or FOLFIRI

Appendiceal Adenocarcinoma ‡ 2

  • Used as subsequent therapy for progression of advanced or metastatic disease in patients not previously treated with irinotecan-based therapy; AND
  • Used in combination with irinotecan or FOLFIRI

FDA-labeled indication(s);Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria 1,2

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the universal and indication-specific criteria as identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size or spread of tumor; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hemorrhage, gastrointestinal perforation, fistula formation, uncontrolled hypertension, hypertensive crisis, hypertensive encephalopathy, wound healing complications, arterial thromboembolic events, proteinuria (≥2 g/24 hours), nephrotic syndrome, thrombotic microangiopathy (TMA), neutropenic complications, reversible posterior leukoencephalopathy syndrome (RPLS), severe diarrhea/dehydration, etc.

V. Dosage/Administration 1,2

Indication

Dose

All indications

Administer 4 mg/kg of actual body weight as an intravenous (IV) infusion every two weeks, until disease progression or unacceptable toxicity.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9400 – Injection, ziv-aflibercept, 1 mg; 1 billable unit = 1 mg

NDC(s):

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

VII. References

  1. Zaltrap [package insert]. Bridgewater, NJ; Sanofi-Aventis U.S. LLC; December 2020. Accessed February 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) ziv-aflibercept. National Comprehensive Cancer Network, 2023.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.
  3. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
  4. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
  5. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
  6. Tabernero J, Paccard C, Chiron M, et al. Placental growth factor and the angiogenic environment based on analysis of baseline plasma biomarkers from the VELOUR trial.  Journal of Clinical Oncology35, no. 4_suppl(February 01, 2017)592-592. DOI: 10.1200/JCO.2017.35.4_suppl.592
  7. Sanofi. A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen. Available from: https://clinicaltrials.gov/ct2/show/NCT00561470?term=NCT00561470&draw=2&rank=1. ClinicalTrials.gov Identifier: NCT00561470. Accessed January 2020.
  8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 3.2022. National Comprehensive Cancer Network, 2023.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

C19

Malignant neoplasm of rectosigmoid junction

C20

Malignant neoplasm of rectum

C21.8

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C78.00

Secondary malignant neoplasm of unspecified lung

C78.01

Secondary malignant neoplasm of right lung

C78.02

Secondary malignant neoplasm of left lung

C78.6

Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

Z85.038

Personal history of other malignant neoplasm of large intestine

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):  N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC