Subject: Antiemetic NK1 Limit 78-H P01-2025

Policy:

Indications

FDA-approved Indications

Aprepitant capsules

Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Aprepitant capsules, in combination with other antiemetic agents, are indicated in patients 12 years of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Prevention of Postoperative Nausea and Vomiting (PONV)

Aprepitant capsules are indicated in adults for the prevention of postoperative nausea and vomiting.

Limitations of Use

• Aprepitant has not been studied for the treatment of established nausea and vomiting.
• Chronic continuous administration of aprepitant is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

Cinvanti (aprepitant) injectable emulsion

Cinvanti, in combination with other antiemetic agents, is indicated in adults for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single dose regimen.
• delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single dose regimen.
• nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

Limitations of Use

• Cinvanti has not been studied for the treatment of established nausea and vomiting.

Emend (aprepitant) capsules and oral suspension

Emend for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Emend capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Limitations of Use

• Emend has not been studied for the treatment of established nausea and vomiting.
• Chronic continuous administration of Emend is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

Emend (fosaprepitant) for injection

Emend for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Limitations of Use

• Emend has not been studied for the treatment of established nausea and vomiting.

Focinvez (fosaprepitant) injection

Focinvez, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
• delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Limitations of Use

• Focinvez has not been studied for the treatment of established nausea and vomiting.

Varubi (rolapitant) tablets

Varubi is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Initial Limit Quantity

Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength.

The duration of 21 days is used for a 28-day fill period to allow time for refill processing.

These drugs are for short-term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time; there should be no 3 month supplies filled.

Drug	4 Week Limit	12 Week Limit
Cinvanti (aprepitant) 130 mg Injection (Single-Dose 130 mg / 18 mL Vial)	2 vials (36 mL) / 21 days	Does Not Apply
Emend (aprepitant) 80 mg Capsule	4 capsules / 21 days	Does Not Apply
Emend (aprepitant) 125 mg Capsule	2 capsules / 21 days	Does Not Apply
Emend (aprepitant) 125 mg-80 mg Capsules   (Tri-pack contains one 125 mg capsule and two 80 mg capsules)	2 packs (6 capsules) / 21 days	Does Not Apply
Emend (aprepitant) 125 mg for Oral Suspension   (Single-Dose Kit contains 125 mg / 5 mL)	6 kits / 21 days	Does Not Apply
Emend (fosaprepitant) 150 mg for Injection (Single-Dose 150 mg Vial)	6 vials / 21 days	Does Not Apply
Focinvez (fosaprepitant) 150 mg (3 mg / mL) Injection   (Single-Dose 150 mg / 50 mL Vial)	6 vials / 21 days	Does Not Apply
Varubi (rolapitant) 90 mg Tablet   (Single Dose Package contains two 90 mg tablets as one set of twinned blisters)	2 packs (4 tablets) / 21 days	Does Not Apply

These drugs are for short-term acute use.

Drug	Limit
Aprepitant 40 mg Capsule	3 capsules / 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Aprepitant capsules [package insert]. Princeton, NJ: Sandoz Inc.; December 2020.
2. Cinvanti [package insert]. San Diego, CA: Heron Therapeutics, Inc.; March 2024.
3. Emend capsules and oral suspension [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; May 2022.
4. Emend for injection [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.; May 2022.
5. Focinvez [package insert]. North Brunswick, NJ: Spes Pharmaceuticals Inc.; August 2023.
6. Varubi [package insert]. Deerfield, IL: TerSera Therapeutics LLC; August 2020.
7. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed December 11, 2024.
8. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/11/2024).
9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed November 29, 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 06, 2025