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Asset Publisher
Akynzeo® (fosnetupitant/palonosetron) (Intravenous)
Policy Number: VP-0363
Intravenous
Last Review Date: 04/04/2024
Date of Origin: 05/01/2018
Dates Reviewed: 05/2018, 06/2018, 02/2019, 02/2020, 10/2020, 04/2021, 4/2022, 04/2023, 04/2024
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]:
- Akynzeo 235 mg/0.25 mg (fosnetupitant/palonosetron) single-dose vial: 1 vial per 7 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 1 billable unit per 7 days
- Initial Approval Criteria 1
For PEEHIP Members Only |
Akynzeo is a non-covered product. |
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Prevention of chemotherapy-induced nausea and vomiting (CINV) † ‡ 1-5
- Patient meets one of the following criteria:
- Used in combination with dexamethasone; AND
- Patient is receiving highly emetogenic anticancer chemotherapy (HEC)*; OR
- Patient is receiving moderately emetogenic anticancer chemotherapy (MEC) **; OR
- Patient has 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 and dexamethasone as a component of a 4-drug regimen if not previously given; AND
- Patient has experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine or NK-1 receptor antagonist-containing regimen); AND
- Akynzeo is NOT covered for any of the following:
- Breakthrough emesis
- Repeat dosing in multi-day emetogenic chemotherapy regimens
- CINV related to an anthracycline plus cyclophosphamide chemotherapy regimen
*Highly emetogenic chemotherapy (HEC):
Highly Emetogenic Chemotherapy (HEC) 3
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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 3 |
|||
Dactinomycin |
Daunorubicin |
Idarubicin |
Irinotecan |
Methotrexate ≥250mg/m2 |
Oxaliplatin |
Trabectedin |
|
The following regimens can be considered HEC 3 |
|||
FOLFOX |
FOLFIRI |
FOLFIRINOX; FOLFOXIRI |
AC (any anthracycline + cyclophosphamide) |
**Moderately emetogenic chemotherapy (MEC):
Moderately Emetogenic Chemotherapy (HEC) 3 |
|||
Aldesleukin >12–15 million IU/m2 |
Amifostine >300 mg/m2 |
Bendamustine |
Busulfan |
Clofarabine |
Cytarabine >200 mg/m2 |
Dinutuximab |
Dual-drug liposomal encapsulation of cytarabine and daunorubicin |
Irinotecan (liposomal) |
Lurbinectedin |
Melphalan <140 mg/m2 |
Mirvetuximab soravtansine-gynx |
Naxitamab-gqgk |
Romidepsin |
Temozolomide |
|
¥ Patient risk factors for anticancer agent-induced nausea/vomiting 3 |
|||
|
† FDA-Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-3
Coverage can be renewed based upon the following criteria:
- Patient continues to meet the 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/or vomiting; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions (including anaphylaxis), serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular symptoms, seizures, etc.)
- Dosage/Administration 1-3
Indication |
Dose |
Prevention of chemotherapy-induced nausea and vomiting (CINV) |
Administer the contents of 1 vial, intravenously, on Day 1 of each chemotherapy cycle approximately 30 minutes prior to the start of chemotherapy |
- Billing Code/Availability Information
HCPCS Code:
- J1454 - Injection, fosnetupitant 235 mg and palonosetron 0.25 mg; 1 billable unit = fosnetupitant 235 mg and palonosetron 0.25 mg
NDC(s):
- Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron); single-dose vial for injection (lyophilized powder): 69639-0102-xx
- Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron per 20 mL); single-dose vial for injection (solution; to-be-diluted): 69639-0105-xx
- Akynzeo (235 mg fosnetupitant/0.25 mg palonosetron per 20 mL); single-dose vial for injection (solution; ready-to-use): 69639-0106-xx
- References
- Akynzeo [package insert]. Helsinn Therapeutics (U.S.), Inc., Iselin, NJ, under license of Helsinn Healthcare SA, Switzerland. February 2023. Accessed March 2024.
- Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) fosnetupitant/palonosetron. 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.
- 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.
- 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.
- Karthaus M, Szabo P, Voisin D, et al. Phase III study of palonosetron (PALO) given as 30-min IV infusion (IV inf) versus 30-sec IV bolus (IV bol) for prevention of chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy (HEC). Journal of Clinical Oncology 35(31_suppl):227-227; November 2017. DOI: 10.1200/JCO.2017.35.31_suppl.227.
- Schwartzberg L, Roeland E, Andric Z, et al. Phase III safety study of intravenous NEPA: a novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann Oncol. 2018 Jul 1;29(7):1535-1540. Doi: 10.1093/annonc/mdy169.
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)
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
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 Government Benefit Administrators |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
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 |