CMS Pub. 100-03, ch. 1, § 110.17

2005)

(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10)

A. General

Oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), and bevacizumab (Avastin™)

are anti-cancer chemotherapeutic agents approved by the Food and Drug Administration (FDA) for the

treatment of colorectal cancer. Anti-cancer chemotherapeutic agents are eligible for coverage when used in

accordance with FDA-approved labeling (see section 1861(t)(2)(B) of the Social Security Act (the Act)),

when the off-label use is supported in one of the authoritative drug compendia listed in section

1861(t)(2)(B)(ii)(I) of the Act, or when the A/B MAC determines an off-label use is medically accepted

based on guidance provided by the Secretary (section 1861(t)(2)(B)(ii)(II).

B. Nationally Covered Indications

Pursuant to this national coverage determination (NCD), the off-label use of clinical items and services,

including the use of the studied drugs oxaliplatin, irinotecan, cetuximab, or bevacizumab, are covered in

specific clinical trials identified by the Centers for Medicare & Medicaid Services (CMS). The clinical trials

identified by CMS for coverage of clinical items and services are sponsored by the National Cancer Institute

(NCI) and study the use of one or more off-label uses of these four drugs in colorectal cancer and in other

cancer types. The list of identified trials is on the CMS Web site at:

http://www.cms.hhs.gov/coverage/download/id90b.pdf.

C. Other

This policy does not alter Medicare coverage for items and services that may be covered or non-covered

according to the existing national coverage policy for Routine Costs in a Clinical Trial (NCD Manual

section 310.1). Routine costs will continue to be covered as well as other items and services provided as a

result of coverage of these specific trials in this policy. The basic requirements for enrollment in a trial

remain unchanged.

The existing requirements for coverage of oxaliplatin, irinotecan, cetuximab, bevacizumab, or other

anticancer chemotherapeutic agents for FDA-approved indications or for indications listed in an approved

compendium are not modified.

A/B MACs shall continue to make reasonable and necessary coverage determinations under section

1861(t)(2)(B)(ii)(II) of the Act based on guidance provided by the Secretary for medically accepted uses of

off-label indications of oxaliplatin, irinotecan, cetuximab, bevacizumab, or other anticancer

chemotherapeutic agents provided outside of the identified clinical trials appearing on the CMS website

noted above.

110.18 - Aprepitant for Chemotherapy-Induced Emesis

A. General

Chemotherapy-induced nausea and vomiting (CINV) can range from mild to severe, with the most severe

cases resulting in dehydration, malnutrition, metabolic imbalances, and potential withdrawal from future

chemotherapy treatments. The incidence and severity of CINV are influenced by the specific

chemotherapeutic agent(s) used; dosage, schedule and route of administration; and drug combinations.

Patient specific risk factors such as gender, age, history of motion sickness, and prior `exposure to

chemotherapeutic agents can also have an effect on CINV incidence and severity. Progress has been made

in reducing CINV, although it can still be hard to control 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. No single antiemetic agent is completely effective in all patients. As noted above,

many factors influence the incidence and severity of CINV, with the specific chemotherapeutic agent as the

primary factor to consider when deciding which antiemetic to administer. Aprepitant (Emend®) is the first

Food and Drug Administration-approved drug of its type. Aprepitant has been proposed to function in

combination with other oral antiemetics for a specified population of Medicare patients receiving highly

emetogenic chemotherapy and/or moderately emetogenic chemotherapy.

CMS is defining highly emetogenic chemotherapy and moderately emetogenic chemotherapy as those

anticancer agents so designated in at least two of three guidelines published by the National Comprehensive

Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of

Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC). The

inclusive examples are: NCCN plus ASCO, NCCN plus ESMO/MASCC, or ASCO plus ESMO/MASCC.

B. Nationally Covered Indications

Effective for services performed between April 4, 2005, and May 28, 2013, the Centers for Medicare &

Medicaid Services makes the following determinations regarding the use of aprepitant in the treatment of

reducing chemotherapy-induced emesis:

The evidence is adequate to conclude that the use of the oral antiemetic three-drug combination of oral

aprepitant (Emend®), an oral 5HT3 antagonist, and oral dexamethasone is reasonable and necessary for a

specified patient population. CMS has defined the patient population for which the use of the oral

antiemetic three-drug combination of oral aprepitant (Emend®), an oral 5HT3 antagonist, and oral

dexamethasone is reasonable and necessary as 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

Effective for services performed on or after May 29, 2013, the oral three-drug regimen of oral aprepitant, an

oral 5HT3 antagonist and oral dexamethasone is reasonable and necessary for beneficiaries receiving, either

singularly or in combination with other drugs the following anticancer chemotherapeutic agents:

• Alemtuzumab

• Azacitidine

• Bendamustine

• Carboplatin

• Carmustine

• Cisplatin

• Clofarabine

• Cyclophosphamide

• Cytarabine

• Dacarbazine

• Daunorubicin

• Doxorubicin

• Epirubicin

• Idarubicin

• Ifosfamide

• Irinotecan

• Lomustine

• Mechlorethamine

• Oxaliplatin

• Streptozocin

The oral three drug regimen must be administered immediately before and within 48 hours after the

administration of these chemotherapeutic agents.

C. Nationally Noncovered Indications

The evidence is adequate to conclude that aprepitant cannot function alone as a full replacement for

intravenously administered antiemetic agents for patients who are receiving highly emetogenic

chemotherapy and/or moderately emetogenic chemotherapy. Medicare does not cover under Part B for oral

antiemetic drugs in antiemetic drug combination regimens that are administered in part, via an oral route and

in part, via an intravenous route. Medicare does not cover under Part B aprepitant when it is used alone for

anticancer chemotherapy related nausea and vomiting.

D. Other

A/B MACs may determine coverage for other all-oral three-drug antiemesis regimens of aprepitant or any

other FDA approved oral NK-1 antagonist in combination with an oral 5HT3 antagonist and oral

dexamethasone with the chemotherapeutic agents listed above, or any other anticancer chemotherapeutic

agents that are FDA approved and are defined as highly or moderately emetogenic.

(Last reviewed May 2013.)