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Asset Publisher
Aloxi® (palonosetron) (Intravenous)
Policy Number: VP-008
Last Review Date: 03/31/2023
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
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, unless otherwise specified.
- PONV: Coverage will be provided for 1 dose and may not be renewed.
II. Dosing Limits
- Quantity Limit (max daily dose) [NDC unit]:
- Aloxi 0.25 mg/5 mL solution for injection: 1 vial per 7 day supply
- Aloxi 0.075 mg/1.5 mL solution for injection: 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
III. 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 emetogenic chemotherapy (HEC)*; OR
- Patient is receiving moderately emetogenic chemotherapy (MEC); AND
- Palonosetron is NOT covered for:
- Breakthrough emesis; OR
- Repeat dosing in multi-day emetogenic chemotherapy regimens
Prevention of Chemotherapy induced Nausea and vomiting (CINV) in Pediatric Patients † 1-4,6
- 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) |
|||
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 |
|||
Dactinomycin |
Daunorubicin |
Idarubicin |
Irinotecan |
Methotrexate ≥250mg/m2 |
Oxaliplatin |
Trabectedin |
|
The following regimens can be considered HEC |
|||
FOLFOX |
FOLFIRI |
FOLFIRINOX; FOLFOXIRI |
AC (any anthracycline + cyclophosphamide) |
** Failure is defined as:
- Two or more documented episodes of vomiting attributed to the current chemotherapy regimen
† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug
IV. Renewal Criteria 1-3
Coverage may be renewed based upon the following criteria:
-
- Patient continues to meet 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: serotonin syndrome, severe QT prolongation, severe hypersensitivity reactions (including anaphylaxis and anaphylactic shock), etc.
V. Dosage/Administration 1
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 pediatrics |
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 |
VI. Billing Code/Availability Information
HCPCS Code:
- J2469 – Injection, palonosetron HCl, 25 mcg: 1 billable unit = 25 mcg (0.025 mg)
NDC:
- Aloxi 0.25 mg/5 mL solution for injection; single-dose vial: 69639-103-xx*
- Aloxi 0.075 mg/1.5 mL solution for injection; single-dose vial: 69639-103-xx (not commercially available)
*Generics available from multiple manufacturers
VII. References
- Aloxi [package insert]. Switzerland; Helsinn Healthcare SA; April 2020. Accessed March 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) palonosetron. 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.
- 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 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)
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 Article (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://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 |