Summary: When trying to access a drug that is not FDA-approved for your patient's cancer type start by submitting a request to the insurance first then try a patient assistance program or clinical trial. When trying to access a drug that is not FDA-approved for ANY cancer type start with a clinical trial then try expanded access.
Because off-label drugs have been FDA-approved, a patient’s insurance company may cover them. If not, pharmaceutical companies or clinical trials are an option.
Submit the drug for insurance coverage. In some cases, insurance companies will approve the drug without requiring any additional information.
If coverage is denied, submit supporting materials which can include:
Learn more about appealing denials in this resource from Patient Advocate Foundation.
If your patient’s insurance has denied coverage, your patient has a high deductible, or your patient does not have insurance, they may be eligible for patient assistance through the pharmaceutical company. These programs provide drugs at reduced or no cost if your patient meets certain criteria. Each company sets its own eligibility criteria. Search this directory from Triage Cancer to find information about a specific company’s patient assistance program, including the process to apply.
Learn more about patient assistance programs from the Centers for Medicare & Medicaid Services website.
If the patient is unable to access a drug through insurance or a patient assistance program or the patient is trying to access an experimental drug, it may be available through a clinical trial. Each clinical trial has its own eligibility criteria and requirements for participation, which can include travel to the study site. Search for possible clinical trials on www.clinicalTrials.gov.
There are assistance programs that can help cover costs associated with clinical trials including
Experimental drugs are being researched to determine their effectiveness and are not FDA-approved. They are only available through a research study or expanded access.
If the patient is unable to access a drug through insurance or a patient assistance program or the patient is trying to access an experimental drug, it may be available through a clinical trial. Each clinical trial has its own eligibility criteria and requirements for participation, which can include travel to the study site. Search for possible clinical trials on www.clinicalTrials.gov.
There are assistance programs that can help cover costs associated with clinical trials including
If your patient cannot access an experimental treatment through a clinical trial, expanded access (EA) (also called “compassionate use”) is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access.
The FDA and the Reagan-Udall Foundation have step-by-step guides to help you submit a request for EA.
Patient Advocate Foundation can assist with case management, co-pay relief, and other financial assistance.
Interpreting Cancer Biomarker Testing – When is Additional Testing Needed? (CME | CNE). Learn when additional cancer biomarker testing is indicated for further evaluation of genome-informed therapy.
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