Page 67 - Medicare Benefit Policy Manual

Effective August 12, 2015 – Lexi-Drugs

The listed compendia employ various rating and recommendation systems that may not be
readily cross-walked from compendium to compendium. In general, a use is identified by a
compendium as medically accepted if the:

1. indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in
DrugDex; or,

2. narrative text in AHFS-DI or Clinical Pharmacology is supportive, or

3. indication is listed in Lexi-Drugs as “Use: Off-Label” and rated as “Evidence Level
A”

A use is not medically accepted by a compendium if the:

1. indication is a Category 3 in NCCN or a Class III in DrugDex; or,

2. narrative text in AHFS or Clinical Pharmacology is “not supportive,” or

3. indication is listed in Lexi-Drugs as “Use: Unsupported”

The complete absence of narrative text on a use is considered neither supportive nor non-
supportive.

C. Use Supported by Clinical Research That Appears in Peer-Reviewed Medical
Literature

Contractors may also identify off-label uses that are supported by clinical research under the
conditions identified in this section. Peer-reviewed medical literature may appear in
scientific, medical, and pharmaceutical publications in which original manuscripts are
published, only after having been critically reviewed for scientific accuracy, validity, and
reliability by unbiased, independent experts prior to publication. In-house publications of
entities whose business relates to the manufacture, sale, or distribution of pharmaceutical
products are excluded from consideration. Abstracts (including meeting abstracts) are
excluded from consideration.

In determining whether an off-label use is supported, the contractors will evaluate the
evidence in published, peer-reviewed medical literature listed below. When evaluating this
literature, they will consider (among other things) the following:

• Whether the clinical characteristics of the beneficiary and the cancer are adequately
represented in the published evidence.

• Whether the administered chemotherapy regimen is adequately represented in the
published evidence.