Subject: Antiemetic NK1 Limit Policy 78-H 01-2024
| ANTIEMETIC AGENTS – NK1 RECEPTOR ANTAGONISTS |
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aprepitant
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CINVANTI
(aprepitant)
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EMEND
(aprepitant)
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EMEND INJECTION
(fosaprepitant)
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FOCINVEZ
(fosaprepitant injection)
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VARUBI
(rolapitant)
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Policy:
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.
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INITIAL LIMIT QUANTITY
Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength
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Drug
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4 Week Limit*
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12 Week Limit*
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Cinvanti (aprepitant) 130 mg Injection (Single-Dose 130 mg / 18 mL Vial)
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2 vials (36 mL) / 21 days
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Does Not Apply**
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Emend (aprepitant) 80 mg Capsule
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4 capsules / 21 days
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Does Not Apply**
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Emend (aprepitant) 125 mg Capsule
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2 capsules / 21 days
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Does Not Apply**
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Emend (aprepitant) 125 mg-80 mg Capsules
(Tri-pack contains one 125 mg capsule and two 80 mg capsules)
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2 packs (6 capsules) / 21 days
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Does Not Apply**
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Emend (aprepitant) 125 mg for Oral Suspension (Single-Dose Kit contains 125 mg / 5 mL)
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6 kits / 21 days
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Does Not Apply**
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Emend (fosaprepitant) 150 mg for Injection (Single-Dose 150 mg Vial)
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6 vials / 21 days
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Does Not Apply**
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Focinvez (fosaprepitant) 150 mg (3 mg / mL) Injection (Single-Dose 150 mg / 50 mL Vial)
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6 vials / 21 days
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Does Not Apply**
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Varubi (rolapitant) 90 mg Tablet
(Single Dose Package contains two 90 mg tablets as one set of twinned blisters)
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2 packs (4 tablets) / 21 days
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Does Not Apply**
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* 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 mail limit will be the same as the retail limit. The intent is for prescriptions of the requested drug to be filled one month at a time, even if filled at mail order; there should be no 3-month supplies filled.
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Drug
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Limit***
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Aprepitant 40 mg Capsule
*** These drugs are for short-term acute use.
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3 capsules / 6 months
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Place of Service:
Outpatient
The above policy is based on the following references:
- Aprepitant capsules [package insert]. Princeton, NJ: Sandoz Inc.; December 2020.
- Cinvanti [package insert]. San Diego, CA: Heron Therapeutics, Inc.; September 2023.
- Emend capsules and oral suspension [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; May 2022.
- Emend for injection [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.; May 2022.
- Focinvez [package insert]. North Brunswick, NJ: Spes Pharmaceuticals Inc.; August 2023.
- Varubi [package insert]. Deerfield, IL: TerSera Therapeutics LLC; August 2020.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. Chttps://online.lexi.com..com. Accessed December 12,
- Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/12/2023).
- National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed November 30, 2023.
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 16, 2024
