Page 68 - Medicare Benefit Policy Manual

• Whether the reported study outcomes represent clinically meaningful outcomes
experienced by patients.

• Whether the study is appropriate to address the clinical question. The contractor will
consider:

1. whether the experimental design, in light of the drugs and conditions under
investigation, is appropriate to address the investigative question. (For example,
in some clinical studies, it may be unnecessary or not feasible to use
randomization, double blind trials, placebos, or crossover.);

2. that non-randomized clinical trials with a significant number of subjects may be a
basis for supportive clinical evidence for determining accepted uses of drugs;
and,

3. that case reports are generally considered uncontrolled and anecdotal information
and do not provide adequate supportive clinical evidence for determining
accepted uses of drugs.

The contractor will use peer-reviewed medical literature appearing in the regular editions of
the following publications, not to include supplement editions privately funded by parties
with a vested interest in the recommendations of the authors:

American Journal of Medicine;
Annals of Internal Medicine;
Annals of Oncology;
Annals of Surgical Oncology;
Biology of Blood and Marrow Transplantation;
Blood;
Bone Marrow Transplantation;
British Journal of Cancer;
British Journal of Hematology;
British Medical Journal;
Cancer;
Clinical Cancer Research;
Drugs;
European Journal of Cancer (formerly the European Journal of Cancer and Clinical
Oncology);
Gynecologic Oncology;
International Journal of Radiation, Oncology, Biology, and Physics;
The Journal of the American Medical Association;
Journal of Clinical Oncology;
Journal of the National Cancer Institute;
Journal of the National Comprehensive Cancer Network (NCCN);
Journal of Urology;
Lancet;
Lancet Oncology;
Leukemia;
The New England Journal of Medicine; or