Off-label use of drugs can raise financial and
logistical concerns for patients. By law, Medicare
is required to cover any off-label treatment that is
supported by one of five compendia. These reference guides, published by private organizations
such as the NCCN, recommend therapies based on
clinical evidence. Private insurers determine which
drugs they will cover off-label on a case-by-case
basis, but they usually do cover treatments that are
Patients whose claims for off-label drugs are
denied can go through the appeals process with
their insurance company. This may include provid-
ing evidence of the drug’s effectiveness in the form
of research papers or conference presentations.
At the same time, patients may want to apply for
financial assistance from the drug manufacturer.
Each drug company handles financial assistance
differently, but patients may need to supply information on their finances and income.
The Targeted Agent and Profiling Utilization
Registry (TAPUR) study, sponsored by ASCO, is
taking another approach, hoping to help patients
access appropriate off-label cancer drugs while
testing whether they work. “The drugs are expensive, they’re not standard of care and insurance is
generally unwilling to pay for them,” says Richard
Schilsky, chief medical officer of ASCO. If patients
do manage to get off-label treatments, there is no
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