Off-label Cancer Treatments Covered by Medicare

January 28, 2009
Julia Ernst, MS

Medicare has widened the scope of its coverage of drugs used as off-label treatments in cancer patients.

Medicare has widened the scope of its coverage of drugs used as off-label treatments in cancer patients, meeting a limited negative response from the public and providing a ray of hop to oncologists who say that the off-label uses of these medications are often a patient’s last chance of an effective treatment. They have also said that these drugs are critical if patients are to receive the most up-to-date treatment.

The off-label uses could significantly benefit patients with rare forms of cancer, since companies see little financial gain in pushing a drug that will not be widely used. As there are currently only two drugs that are approved by the FDA to treat brain cancer, according to the New York Times article, physicians with brain tumor patients, as well as those with other rare types of cancer, say that they should have the room to try other drugs or combinations of treatment. The American Society of Clinical Oncology is in favor of the new Medicare guidelines, according to the Times article, stating that off-label uses that are effective treatments will now definitely be covered.

Those who are opposed to the broader scope of coverage have said that treatments that may not even be known to work are now much easier to obtain. Critics have also said that the more expensive coverage may lead doctors to use patients as guinea pigs in testing these off-label uses. For example, Gemzar (gemcitabine Hcl), approved to treat four types of cancer, may now be more regularly used to treat several other cancers. Advanced cervical cancer has shown to have “inconclusive” results when treated with Gemzar, but the agent could now be used more routinely when treating that type of cancer. Also, Avastin (bevacizumab), one of the most widely used drugs in cancer treatment, was rejected by Medicare in 2007 for off-label use in treating ovarian cancer, according to the Times; with the new coverage, the drug could routinely be used in fighting ovarian, brain, and kidney cancers.

Some critics also fear that patients will not only be exposed to treatments that may not be effective, but that they might encounter serious side effects.