The editorial points out the most likely outcome of this change will be higher costs for Medicare without additional benefit to patients. In addition, there are concerns that treating patients with drugs not approved for their specific cancer could raise safety risks.
NYT Editorial Link
Current data for the drugs included in this rule change were reviewed by the Agency for Healthcare Research and Quality and found there was no evidence of benefit for their use for cancers other than the ones FDA has approved .
"That might be fine if one could be confident that the compendiums were
authoritative and unbiased, but analysts have found that compendium
recommendations are often supported by little clinical evidence and are
by experts with financial ties to the drug industry.
Off-label uses are vitally important in cancer care and probably
constitute a majority of cancer drug treatments. But the danger in expanding
usage without strong evidence of safety and effectiveness is that patients
be harmed — and costs may be driven up
The solution — and an essential component of
health care reform — is to
establish centers for comparing the effectiveness
of drugs and treatments and
the cost-effectiveness of using them. That would
help make coverage decisions
more rational for all patients."
Breast cancer patients considering the use of off label drugs for treatment should have a thorough discussion with their oncologist about the potential benefits and risks of doing so.