If the medicine that might help is not approved for your cancer, there are legal ways in. Your oncologist starts most of them.
FDA Expanded Access (single patient)
U.S. Food and Drug Administration
Lets your doctor ask the maker and the FDA for a medicine that is still being tested, outside a clinical trial. It does not pay for the medicine; ask the maker and your insurer about cost.
You have a serious or life-threatening illness and no comparable or satisfactory treatment is left.
Ask your oncologist if there is a medicine you could try this way.
Your doctor asks the maker first, then sends the request to the FDA.
U.S. Food and Drug Administration (explains the law)
A way to ask a maker for an investigational medicine that has finished a Phase 1 trial and is not approved for any use. The maker decides whether to give it. It does not pay for the medicine.
You have a life-threatening disease or condition.
Talk with your oncologist about whether a medicine qualifies.
Medicare does not deny coverage only because the use is off-label, if a recognized compendium (drug reference book) supports it. The compendia named by CMS are AHFS-DI, NCCN Drugs and Biologics Compendium, Micromedex DrugDex, Clinical Pharmacology and Lexi-Drugs. Medicare may also look at peer-reviewed medical articles.
You have Medicare.
Ask your oncologist which compendium supports the use.
If Medicare denies it, ask your doctor to send the compendium page or articles, then appeal.
National Cancer Institute (describes federal programs)
Medicaid covers routine patient care costs in a trial. Medicare may reimburse some costs. TRICARE can reimburse medical costs in NCI-sponsored trials. Veterans can join NCI-sponsored trials at VA medical centers.
You have Medicaid, Medicare, TRICARE, or VA care and you are thinking of joining a cancer clinical trial.
Ask the trial's research coordinator or nurse how your health plan treats routine care costs.
Ask other participants whether they had problems getting plans to cover routine costs.