Last Review Date: 04/01/2020

Date of Origin: 11/21/2017

Dates Reviewed: 11/2017, 02/2018, 05/2018, 04/2019, 04/2020

1. Length of Authorization

Coverage is provided for six months and may be renewed.

2. Dosing Limits

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

• Cinvanti 130 mg vial injection: 1 vial per 7 days

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

• 130 billable units per 7 days

3. Initial Approval Criteria^1,2,3,4,5

Coverage is provided in the following conditions:

• Patient is age of 18 years 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

† FDA-approved indication(s)

4. Renewal Criteria ^1,2,3

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,  etc.

5. Dosage/Administration

6. 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

7. References

1. Cinvanti [package insert]. San Diego, CA; Heron Therapeutics; October 2019. Accessed February 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Aprepitant. 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

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): N/A