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EMEND ( and )

RATIONALE FOR INCLUSION IN PA PROGRAM

Background Emend is an “”, which works by antagonizing the action of at the neurokinin 1 (NK1) receptor. Emend is used in people to help prevent the nausea and vomiting that happens acutely or which is delayed following the administration of certain anti-cancer medicines (chemotherapy) and it can also be used in the prevention of postoperative nausea and vomiting (1, 2).

Regulatory Status FDA-approved indications: Emend is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: (1, 2)

Emend oral suspension (1) 1. In combination with other antiemetic agents, in patients 6 months of age and older for the: a. Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose b. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)

Emend capsules (1) 1. In combination with other antiemetic agents, in patients 12 years of age and older for the: a. Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin b. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)

2. For the prevention of postoperative nausea and vomiting (PONV)

Emend for injection (2) 1. Indicated for adults, in combination with other antiemetic agents for the:

Emend FEP Clinical Rationale

EMEND (aprepitant and fosaprepitant)

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

Limitations of Use: Emend is not used to treat nausea and vomiting that the patient already has and should not be used continuously for a long time (chronic use) (1-2).

Summary Emend is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy. Emend is also indicated for the prevention of postoperative nausea and vomiting in adults. Emend is not used to treat nausea and vomiting that the patient already has and should not be used continuously for a long time (chronic use) (1, 2).

Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Emend while maintaining optimal therapeutic outcomes.

References 1. Emend Capsules and Emend for Oral Suspension [package insert]. Whitehouse Station, NJ: Merck & CO, Inc.: December 2015. 2. Emend for Injection [package insert]. Whitehouse Station, NJ: Merck & CO, Inc.: February 2016.

Emend FEP Clinical Rationale