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Emend® (fosaprepitant dimeglumine)

Policy Number: PH-0036

 

Intravenous

 

Last Review Date: 06/06/2022

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

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

 

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.

  1. Length of Authorization

Coverage is provided for six months and may be renewed.

  1. Dosing Limits

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

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

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

  • 450 billable units (450 mg) per 7 days
  1. Initial Approval Criteria 1-5

Coverage is provided in the following conditions:

  • Patient is at least 6 months of age; AND

Universal Criteria

  • 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)

Carboplatin

Carmustine

Cisplatin

Cyclophosphamide

Dacarbazine

Doxorubicin

Epirubicin

Ifosfamide

Mechlorethamine

Streptozocin

Melphalan

Sacituzumab govitecan

The following can be considered HEC in certain patients

Dactinomycin

Daunorubicin

Irinotecan

Oxaliplatin

Methotrexate ≥250mg/m2

Trabectedin

Idarubicin

Moderately Emetogenic Chemotherapy (MEC)

Aldesleukin >12-15 million IU/m2

Amifostine >300mg/m2

Amivantamab-vmjw

Azacitidine

Bendamustine

Busulfan

Clofarabine

Cytarabine >200mg/m2

Daunorubicin Liposomal; Cytarabine Liposomal

Dinutuximab

Fam-trastuzumab deruxtecan

Irinotecan Liposomal

Lurbinectedin

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

  1. Renewal Criteria 1-3

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 the following: severe hypersensitivity reactions, severe infusion site reactions, etc.
  1. Dosage/Administration 1

Indication

Dose

Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

Adult dosing:

  • Administer 150 mg intravenously (IV) over 20 to 30 minutes Day 1

Pediatric dosing:

Age

Single-Day Chemotherapy Regimen

Single or Multi-Day Chemotherapy Regimens (oral formulations may be given as an alternative on Days 2-3)

12 to 17 years

150 mg IV Day 1

115 mg IV Day 1, then 80 mg IV/PO Days 2-3

2 to < 12 years

4 mg/kg (maximum dose 150 mg) IV Day 1

3 mg/kg (maximum dose 115 mg) Day 1, then 2 mg/kg (maximum dose 80 mg) IV/PO Days 2-3

6 months to <2 years

(patient ≥ 6 kg)

5 mg/kg (maximum dose 150 mg) IV Day 1

*Infusion should be completed 30 minutes prior to chemotherapy.

  1. Billing Code/Availability Information

HCPCS Code:

  • J1453 – Injection, fosaprepitant, 1 mg; 1 billable unit = 1 mg
  • J1456 – Injection, fosaprepitant (teva), not therapeutically equivalent to J1453, 1 mg; 1 billable unit = 1 mg (Effective 01/01/2023)

NDC:

  • Emend* 150 mg powder for injection, single-dose vial: 00006-3061-xx

*Available generically from multiple manufacturers

  1. References
  1. Emend [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; May 2022. Accessed May 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Fosaprepitant. National Comprehensive Cancer Network, 2022.  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. February 2022.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Antiemesis. Version 1.2022. National Comprehensive Cancer Network, 2022. 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 February 2022.
  4. 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.
  5. 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.

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

T45.1X5S

Adverse effect of antineoplastic and immunosuppressive drugs, sequela

T45.95XA

Adverse effect of unspecified primarily systemic and hematological agent, initial encounter

T50.905A

Adverse effect of unspecified drugs, medicaments and biological substances, 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 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

 

 

 

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