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Asset Publisher
Fosaprepitant: Emend®; Fosaprepitant Ψ; Focinvez Ψ
Policy Number: VP-0036
(Intravenous)
Last Review Date: 09/05/2023
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
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. |
- Length of Authorization
Coverage is provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- 150 mg single-dose vial: 3 vials per 7 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 450 billable units (450 mg) per 7 days
- 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) †
- Patient is receiving highly and/or moderately emetogenic chemotherapy (see HEC/MEC list below); AND
- Must be used in combination with a 5-HT3 antagonist such as ondansetron, granisetron, palonosetron, etc.; AND
- Must be used in combination with a corticosteroid such as dexamethasone (Note: Only applicable to adult patients)
Highly Emetogenic Chemotherapy (HEC) |
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Carboplatin |
Carmustine |
Cisplatin |
Cyclophosphamide |
Dacarbazine |
Doxorubicin |
Epirubicin |
Fam-trastuzumab deruxtecan-nxki |
Ifosfamide |
Mechlorethamine |
Melphalan ≥140 mg/m2 |
Sacituzumab govitecan-hziy |
Streptozocin |
|
|
|
The following can be considered HEC in certain patients |
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Dactinomycin |
Daunorubicin |
Idarubicin |
Irinotecan |
Methotrexate ≥250mg/m2 |
Oxaliplatin |
Trabectedin |
|
Moderately Emetogenic Chemotherapy (MEC) |
|||
Aldesleukin >12-15 million IU/m2 |
Amifostine >300mg/m2 |
Bendamustine |
Busulfan |
Clofarabine |
Cytarabine >200mg/m2 |
Dinutuximab |
Dual-drug liposomal encapsulation of cytarabine and daunorubicin |
Irinotecan Liposomal |
Lurbinectedin |
Melphalan <140 mg/m2 |
Naxitamab-gqgk |
Romidepsin |
Temozolomide |
|
|
The following regimens can be considered HEC |
|||
FOLFOX |
FOLFIRI |
FOLFIRINOX; FOLFOXIRI |
AC (any anthracycline + cyclophosphamide) |
† FDA-Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-5
Coverage can be renewed based upon the following criteria:
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Disease response; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, severe infusion site reactions, etc.
- Dosage/Administration 1-3
Indication |
Dose |
|||||||||||
Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) |
Adult dosing:
Pediatric dosing:
*Infusion should be completed 30 minutes prior to chemotherapy. |
- 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
- J1434 – Injection, fosaprepitant (focinvez), 1 mg; 1 billable unit = 1 mg (Focinvez Only) Ψ (Effective 04/01/2024)
- J3490 – Unclassified drugs (Focinvez Only) Ψ (Discontinue use on 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
Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA |
- References
- Emend [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; May 2022. Accessed March 2023.
- Fosaprepitant [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; September 2019. Accessed March 2023.
- Focinvez [package insert]. North Brunswick, NJ; Spes Pharm., Inc.; August 2023. Accessed August 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Fosaprepitant. 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. March 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Antiemesis. Version 1.2023. 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 March 2023.
- 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.
- 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
ICD-10 |
ICD-10 Description |
R11.0 |
Nausea |
R11.10 |
Vomiting, unspecified |
R11.11 |
Vomiting without nausea |
R11.12 |
Projectile vomiting |
R11.2 |
Nausea with vomiting, unspecified |
T45.1X5A |
Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter |
T45.1X5D |
Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter |
T45.1X5S |
Adverse effect of antineoplastic and immunosuppressive drugs, sequela |
T45.95XA |
Adverse effect of unspecified primarily systemic and hematological agent, initial encounter |
T45.95XD |
Adverse effect of unspecified primarily systemic and hematological agent, subsequent encounter |
T45.95XS |
Adverse effect of unspecified primarily systemic and hematological agent, sequela |
T50.905A |
Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter |
T50.905D |
Adverse effect of unspecified drugs, medicaments and biological substances, subsequent encounter |
T50.905S |
Adverse effect of unspecified drugs, medicaments and biological substances, sequela |
Z51.11 |
Encounter for antineoplastic chemotherapy |
Z51.12 |
Encounter for antineoplastic immunotherapy |
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 |