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Asset Publisher
Palonosetron: Aloxi®; Palonosetron Ψ
Policy Number: PH-90008
Intravenous
Last Review Date: 07/02/2024
Date of Origin: 10/17/2008
Dates Reviewed: 06/2009, 12/2009, 09/2010, 12/2010, 02/2011, 03/2011, 06/2011, 09/2011, 12/2011, 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, 04/2023, 04/2024, 07/2024
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 will be provided for 6 months and may be renewed, unless otherwise specified.
- PONV: Coverage will be provided for 1 dose and may not be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC unit]:
- Aloxi and Palonosetron Hydrochloride 0.25 mg/5 mL solution for injection in a single-dose vial: 1 vial per 7 day supply
- Aloxi and Palonosetron Hydrochloride 0.075 mg/1.5 mL solution for injection in a single-dose vial: 1 vial
- Max Units (per dose and over time) [HCPCS Unit]:
CINV:
- 10 billable units per 7 days
PONV:
- 3 billable units x 1 dose only
- Initial Approval Criteria
Coverage is provided in the following conditions:
For PEEHIP Members Only |
|
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Adults † 1-4,6
- Patient is receiving highly or moderately emetogenic anticancer chemotherapy (HEC*/MEC***); AND
- Palonosetron is NOT covered for any of the following:
- Breakthrough emesis
- Repeat dosing in multi-day emetogenic chemotherapy regimens
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Pediatric Patients † 1-5,7
- Patient is at least 1 month old and less than 17 years old; AND
- Patient is receiving emetogenic chemotherapy; AND
- Palonosetron is NOT covered for:
- Breakthrough emesis; OR
-
- Repeat dosing in multi-day emetogenic chemotherapy regimens
-
Prevention of Post-Operative Nausea and Vomiting (PONV) in Adults † 1
*Highly emetogenic chemotherapy (HEC):
Highly Emetogenic Chemotherapy (HEC) 4 |
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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 |
|
The following regimens can be considered HEC 3 |
|||
FOLFOX |
FOLFIRI |
FOLFIRINOX; FOLFOXIRI |
AC (any anthracycline + cyclophosphamide) |
***Moderately emetogenic chemotherapy (MEC):
Moderately Emetogenic Chemotherapy (HEC) 4 |
|||
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 |
|
† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-4
Coverage may 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: serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular symptoms, etc.), severe hypersensitivity reactions (including anaphylaxis and anaphylactic shock), etc.
- Dosage/Administration 1,2
Indication |
Dose |
Prevention of chemotherapy-induced nausea and vomiting in adults |
Administer 0.25 mg intravenously, no more frequently than weekly, prior to emetogenic chemotherapy |
Prevention of chemotherapy-induced nausea and vomiting in pediatric patients (1 month to less than 17 years of age) |
Administer 20 mcg/kg (max of 1.5 mg) intravenously, no more frequently than weekly, prior to emetogenic chemotherapy |
Post-operative nausea and vomiting |
Administer 0.075 mg intravenously immediately before the induction of anesthesia |
- Billing Code/Availability Information
HCPCS Code(s):
- J2469 – Injection, palonosetron hcl, 25 mcg: 1 billable unit = 25 mcg (0.025 mg)
- J2468 – Injection, palonosetron hydrochloride (avyxa), not therapeutically equivalent to J2469, 25 micrograms; 1 billable unit = 25 mcg (0.025 mg) Ψ
NDC(s):
- Aloxi§ 0.25 mg/5 mL solution for injection in a single-dose vial: 69639-103-xx
- Aloxi 0.075 mg/1.5 mL solution for injection in a single-dose vial: 69639-103-xx (not commercially available)
- Palonosetron Hydrochloride 0.25 mg/5 mL solution for injection in a single-dose vial: 43598-0530-xx Ψ
- Palonosetron Hydrochloride 0.075 mg/1.5 mL solution for injection in a single-dose vial: 43598-0531-xx Ψ
Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA |
- References
- Aloxi [package insert]. Switzerland; Helsinn Healthcare SA; April 2020. Accessed March 2024.
- Palonosetron Hydrochloride [package insert]. Bachupally, India; Dr. Reddy’s Laboratories Limited; March 2016. Accessed June 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) 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 Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261.
- Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. Journal of Clinical Oncology 2020 38:24, 2782-2797.
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 |
T41.0X5A |
Adverse effect of inhaled anesthetics, initial encounter |
T41.1X5A |
Adverse effect of intravenous anesthetics, initial encounter |
T41.205A |
Adverse effect of unspecified general anesthetics, initial encounter |
T41.295A |
Adverse effect of other general anesthetics, initial encounter |
T41.45XA |
Adverse effect of unspecified anesthetic, initial encounter |
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 |
T88.59XA |
Other complications of anesthesia, initial encounter |
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 |
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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 |
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 |
|