Reimbursement policies constrain the practice of oncology
T. Laetz and G. Silberman
US General Accounting Office, Washington, DC.
OBJECTIVE--To determine the prevalence of off-label anticancer drug use
(ie, using drugs to treat conditions other than those listed on the Food
and Drug Administration's approved drug label), the extent of reimbursement
denials for these uses, and the effect of denials on the treatment of
cancer patients. DESIGN, SETTING, AND PARTICIPANTS--A three-part
questionnaire was sent to a randomized sample of oncologists taken from the
1990 membership of the American Society of Clinical Oncology in March 1990.
A response rate of 56% yielded information from 681 oncologists on the
drugs they prescribed to 2018 new cancer patients and on those they
frequently use in treating 11 specific types of cancer. MAIN OUTCOME
MEASURES--The labeled uses of the drugs prescribed and frequently used in
chemotherapies were checked against the indications treated to determine
whether they were prescribed for off-label uses. Three drug compendia were
used as cited sources of off-label drug uses. The extent of reimbursement
denials over the last 12 months and their effects on treatments were based
on respondent opinions. MAIN RESULTS--Off-label drug use is prevalent and
dominates the chemotherapy regimens of cancers that are more difficult to
treat and for which there are no cures or agreements on standardized
treatment. Most oncologists reported frustration with shifting
reimbursement policies in general and with an increasing rate of denials
for some off-label drug uses. Indeed, a surprising number of oncologists
claimed that these policies caused them to alter preferred treatments and
site of care. CONCLUSION--These findings suggest the need for public
discussion of off-label drug use issues so that appropriate policies can be
developed.
