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Last Review Date: 04/04/2024

Date of Origin: 12/01/2011

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 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, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 06/2022, 04/2023, 09/2023, 04/2024

1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• 150 mg single-dose vial: 3 vials per 7 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 450 billable units (450 mg) per 7 days

3. Initial Approval Criteria ^1-3

Coverage is provided in the following conditions:

• Patient is at least 6 months of age; AND

Universal Criteria ^1-7

• Patient is not taking pimozide concurrently; AND

Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) † ‡ ^1-5

• Patient is receiving highly and/or moderately emetogenic anticancer chemotherapy (HEC*/MEC**); AND

• Used in combination with a 5-HT₃ antagonist (e.g., ondansetron, granisetron, palonosetron, etc.); AND
• Used in combination with a corticosteroid such as dexamethasone(Note: Only applicable to adult patients); AND
• Used with or without olanzapine (applies to HEC only); OR

• Patient experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine or NK-1 receptor antagonist-containing regimen); AND

• Used in combination with olanzapine, 5HT3 antagonist and dexamethasone as a component of a 4-drug regimen if not previously given

*Highly emetogenic chemotherapy (HEC):

**Moderately emetogenic chemotherapy (MEC):

† FDA-Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-5

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Beneficial response as evidenced by reduction in nausea and vomiting; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions (including anaphylaxis), severe infusion site reactions, etc.

5. Dosage/Administration ^1-3

6. Billing Code/Availability Information

HCPCS Code:

• J1453 – Injection, fosaprepitant, 1 mg; 1 billable unit = 1 mg (Emend Only)
• J1456 – Injection, fosaprepitant (teva), not therapeutically equivalent to J1453, 1 mg; 1 billable unit = 1 mg Ψ
• J3490 – Unclassified drugs (Focinvez Only) Ψ(Discontinue use on 04/01/2024)
• J1434 – Injection, fosaprepitant (focinvez), 1 mg; 1 billable unit = 1 mg (Focinvez Only) Ψ (Effective 04/01/2024)

NDC:

• Emend* 150 mg powder for injection, single-dose vial: 00006-3061-xx
• Fosaprepitant 150 mg powder for injection, single-dose vial: 00591-4385-xx Ψ
• Focinvez 150 mg/50 mL (3 mg/mL) ready-to-use injection solution in a single-dose vial: 82243-1001-xx Ψ

7. References

1. Emend [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; May 2022. Accessed March 2024.
2. Fosaprepitant [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; October 2023. Accessed March 2024.
3. Focinvez [package insert]. North Brunswick, NJ; Spes Pharm., Inc.; August 2023. Accessed March 2024.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Fosaprepitant. National Comprehensive Cancer Network, 2024.  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. March 2024.
5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Antiemesis. Version 1.2024. National Comprehensive Cancer Network, 2024. 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 March 2024.
6. Roila F, Molassiotis A, Herrstedt J, et al. MASCC and ESMO Consensus Guidelines for the Prevention of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting: ESMO Clinical Practice Guidelines. Ann Oncol (2016) 27 (suppl 5): v119-v133.
7. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: American Society of Clinical Oncology Guideline Update. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. doi: 10.1200/JCO.20.01296.

Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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

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