Aprepitant (Emend®), a human substance P/neurokinin-1 (NK) receptor antagonist, is the first FDA approved anti-emetic drug of its type. It has been proposed to function in combination with other oral anti-emetics in patients who exhibit both acute and delayed phases of chemotherapy-induced emesis while receiving highly emetogenic chemotherapeutic agents.

Chemotherapy-induced nausea and vomiting (CINV) can range in severity from mild to severe, with the most severe cases resulting in dehydration, malnutrition, metabolic imbalances; potentially requiring withdrawal from future chemotherapy treatments. CINV incidence and severity are influenced by the specific chemotherapeutic agent(s) used, their dosage, schedule and route of administration; and drug combinations. In addition, they can also be affected by patient-specific risk factors such as sex, age, history of motion sickness, and prior exposure to chemotherapeutic agents.

While progress has been made in reducing CINV, symptoms that occur more than a day after chemotherapy, during repeat cycles of chemotherapy, and when chemotherapy is given on more than one day or in very high doses remain hard to control. No single anti-emetic agent is completely effective in all patients.

Coverage for the use of the oral anti-emetic 3-drug combination of aprepitant (Emend®), a 5-HT₃ antagonist, and dexamethasone is considered reasonable and necessary for only those patients who are receiving one or more of the following anti-cancer chemotherapeutic agents:

• Carmustine
• Cisplatin
• Cyclophosphamide
• Dacarbazine
• Mechlorethamine
• Streptozocin
• Doxorubicin
• Epirubicin
• Lomustine

The evidence is adequate to conclude that aprepitant cannot function alone as a full replacement for intravenously administered anti-emetic agents for patients who are receiving highly emetogenic chemotherapy.

See Medicare Advantage Medical Policy Bulletin I-79 for existing coverage on Cancer Chemotherapeutic Agents.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-3, Medicare National Coverage Determinations, Transmittal 40, CR 3831, Section 110.18

CMS Online Manual System Pub. 100-4, Medicare Claims Processing, Transmittal 590, CR 3831

* For dates of service after October 1, 2005