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Cinvanti™ (aprepitant)

Policy Number: VP-0336

Intravenous

 

Last Review Date: 10/03/2023

Date of Origin: 11/21/2017

Dates Reviewed: 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 04/2023, 10/2023

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.

  1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Cinvanti 130 mg single-dose vial: 1 vial per 7 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 130 billable units per 7 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

For PEEHIP Members Only

Emend (fosaprepitant dimeglumine) is the preferred product and Cinvanti (aprepitant) is the non-preferred product.

  • Patients must have tried and had an inadequate response, intolerance or contraindication to Emend (fosaprepitant dimeglumine) while receiving current chemotherapy regimen prior to consideration of Cinvanti (aprepitant); AND
  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Patient is not taking pimozide concurrently; AND
  • Patient must have failed or experienced intolerable side effects to a fosaprepitant product (e.g., Emend, Fosaprepitant, Focinvez, etc.) prior to consideration of Cinvanti; AND

Prevention of Chemotherapy induced Nausea and vomiting (CINV) † 1-5

  • 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

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

Moderately Emetogenic Chemotherapy (MEC)

Aldesleukin >12-15 million IU/m2

Amifostine >300mg/m2

Bendamustine

Busulfan

Clofarabine

Cytarabine >200mg/m2

Dinutuximab

Dual-drug liposomal encapsulation of cytarabine and daunorubicin

Irinotecan Liposomal

Lurbinectedin

Melphalan <140 mg/m2

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

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: severe hypersensitivity reactions, etc.
  1. Dosage/Administration 1

Indication

Dose

Prevention of chemotherapy-induced nausea and vomiting

Administer as either a 30 minute infusion or 2 minute injection

HEC (Single Dose Regimen)

  • 130 mg intravenously (IV) on Day 1 approximately 30 minutes prior to chemotherapy

MEC (3-Day Regimen with oral aprepitant)

  • 100 mg IV on Day 1 approximately 30 minutes prior to chemotherapy followed by oral aprepitant (80mg) on Days 2 and 3.

MEC (Single-dose Regimen)

  • 130 mg IV on Day 1 approximately 30 minutes prior to chemotherapy
  1. Billing Code/Availability Information

HCPCS Code:

  • J0185 - Injection, aprepitant, 1 mg; 1 billable unit =  1 mg

NDC:

  • Cinvanti 130 mg/18 mL injectable emulsion single-dose vial: 47426-0201-xx
  1. References
  1. Cinvanti [package insert]. San Diego, CA; Heron Therapeutics; March 2022. Accessed March 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Aprepitant. 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. March 2023.
  3. 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.
  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 Guideline Update. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. Doi: 10.1200/JCO.20.01296.

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)

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

 

 

 

 

CINVANTI™ (aprepitant) Prior Auth Criteria
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