ph-0036
print Print

Emend IV (fosaprepitant dimeglumine)

Policy Number: PH-0036

 

Intravenous

 

Last Review Date: 04/01/2020

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

  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 powder for injection: 1 vial per 7 days

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

  • 150 billable units per 7 days
  1. Initial Approval Criteria1,2,3,4,5

Coverage is provided in the following conditions:

  • Patient aged 6 months or older; 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

Highly Emetogenic Chemotherapy (HEC)

Carboplatin

Carmustine

Cisplatin

Cyclophosphamide

Dacarbazine

Doxorubicin

Epirubicin

Ifosfamide

Mechlorethamine

Streptozocin

Moderately Emetogenic Chemotherapy (MEC)

Aldesleukin

Amifostine

Enfortumab vedotin

Azacitidine

Bendamustine

Busulfan

Clofarabine

Cytarabine

Dactinomycin

Daunorubicin

Dinutuximab

Idarubicin

Interferon alfa

Irinotecan

Melphalan

Methotrexate

Oxaliplatin

Temozolomide

Trabectedin

Daunorubicin Liposomal; Cytarabine Liposomal

Fam-trastuzumab deruxtecan

The following regimens can be considered HEC:

FOLFOX

FOLFIRI

FOLFIRINOX;  FOLFOXIRI

AC (any anthracycline + cyclophosphamide)

FDA-approved indication(s)

  1. Renewal Criteria1,2,3

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; 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

Indication

Dose

Prevention of chemotherapy-induced nausea and vomiting

Adult dosing:

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

Pediatric dosing:

Age

Single-Day Chemotherapy Regimen

Multi-Day Chemotherapy Regimen (oral given day 2-3)

12 to 17 years

150 mg IV Day 1

115 mg IV Day 1

2 to < 12 years

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

3 mg/kg (maximum dose 115 mg) Day 1

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 (single dose regimen)

  1. Billing Code/Availability Information

HCPCS code:

J1453 –Injection, fosaprepitant, 1 mg; 1 billable unit = 1 mg

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.; November 2019. Accessed February 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Fosaprepitant. National Comprehensive Cancer Network, 2020.  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 2020.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Antiemesis. Version 1.2020. National Comprehensive Cancer Network, 2020. 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 2020.
  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: http://www.cms.gov/medicare-coverage-database/search/advanced-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

 

 

EMEND® (fosaprepitant) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2020, Magellan Rx Management

White MRx.PNG