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

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Section: Prescription Drugs Effective Date: April 1, 2017 Subject: Emend Page: 1 of 6 Last Review Date: March 17, 2017 Emend Description Emend (aprepitant), Emend injection (fosaprepitant) Background Emend is an antiemetic, which works by antagonizing the action of substance P 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 highdose cisplatin b. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) Emend capsules (1)

2 Subject: Emend Page: 2 of 6 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 highdose 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: a. Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including highdose 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). Related policies Akynzeo, Varubi Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Emend oral suspension may be considered medically necessary for patients 6 months of age or older who have nausea and vomiting associated with initial and repeat courses of cancer Emend capsules may be considered medically necessary for patients 12 years of age or older who have nausea and vomiting associated with initial and repeat courses of cancer

3 Subject: Emend Page: 3 of 6 Emend capsules may be considered medically necessary for patients 18 years of age or older for the prevention of postoperative nausea and vomiting. Emend for injection may be considered medically necessary for patients 18 years of age or older who have nausea and vomiting associated with initial and repeat courses of cancer Emend oral suspension is considered investigational in patients below 6 months of age and for all indications other than nausea and vomiting associated with initial and repeat courses of cancer Emend capsules is considered investigational in patients below 12 years of age and for all indications other than nausea and vomiting associated with initial and repeat courses of cancer Emend capsules is considered investigational in patients below 18 years of age who do not meet criteria for prevention of postoperative nausea and vomiting. Emend for injection is considered investigational in patients below 18 years of age and for all other indications other than nausea and vomiting associated with initial and repeat courses of cancer Prior-Approval Requirements Prior authorization is not required if prescribed by an oncologist Emend oral suspension Diagnosis Patient must have the following: Emend capsules 1. Prevention of acute or delayed nausea and vomiting a. Undergoing chemotherapy for cancer b. Used in combination with other antiemetic c. 6 months of age or older

4 Subject: Emend Page: 4 of 6 Diagnoses Patient must have ONE of the following: Emend for Injection Diagnosis 1. Prevention of acute or delayed nausea and vomiting a. Undergoing chemotherapy for cancer b. Used in combination with other antiemetic c. 12 years of age or older 2. Postoperative nausea and vomiting (PONV) a. 18 years of age or older Patient must have the following: 1. Prevention of acute or delayed nausea and vomiting a. Undergoing chemotherapy for cancer b. Used in combination with other antiemetic c. 18 years of age or older Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance Quantity Emend 40mg 1 capsules per 90 days 80 mg 12 capsules per 90 days 125mg 6 capsules per 90 days Bi-pack (contains two 80mg caps) 6 packs per 90 days Tri-pack (contains one 125mg and two 80mg) 6 packs per 90 days 150mg Injection 6 vials per 90 days Emend suspension 125mg 6 kits per 90 days **Quantities are based 2 chemotherapy treatments per month

5 Subject: Emend Page: 5 of 6 Prior - Approval Limits Quantity Postoperative nausea and vomiting Emend 40mg Acute or Delayed nausea and vomiting Emend 80 mg 125mg Bi-pack (contains two 80mg caps) Tri-pack (contains one 125mg and two 80mg) 150mg Injection Emend suspension 125mg 5 capsules per 90 days 48 capsules per 90 days OR 12 capsules per 90 days OR 24 packs per 90 days OR 12 packs per 90 days OR 12 vials per 90 days OR 18 kits per 90 days Duration 12 months Prior Approval Renewal Limits Quantity Postoperative nausea and vomiting Emend 40mg Acute or Delayed nausea and vomiting Emend 80 mg 125mg Bi-pack (contains two 80mg caps) Tri-pack (contains one 125mg and two 80mg) 150mg Injection Emend suspension 125mg 5 capsules per 90 days 48 capsules per 90 days OR 12 capsules per 90 days OR 24 packs per 90 days OR 12 packs per 90 days OR 12 vials per 90 days OR 18 kits per 90 days Duration 12 months Rationale Summary Emend is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer Emend is also indicated for the prevention of postoperative nausea and vomiting in adults. Emend is not used to treat nausea

6 Subject: Emend Page: 6 of 6 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 Emend for Injection [package insert]. Whitehouse Station, NJ: Merck & CO, Inc.: February 2016 Policy History Date February 2015 June 2015 September 2015 January 2016 March 2016 June 2016 September 2016 March 2017 Keywords Action New addition to PA Annual editorial review and reference update Annual review Update to qty limits Addition of Emend suspension and the ages for the different forms Annual editorial review Changed Emend suspension quantity limits from 12 to 18 per SME Policy number change from Annual editorial review Addition of Emend injection Annual editorial review and reference update. Annual editorial review This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 17, 2017 and is effective on April 1, Deborah M. Smith, MD, MPH