Access to Investigational Drugs
Here’s where you can learn all about our policies, eligibility guidelines and the process of gaining access.
Our Approach is Guided by Our human health care Mission
We give our first thought to patients and their families, and we’re committed to developing safe and effective drugs for the health and well-being of people worldwide. We conduct clinical trials to make sure that we have the scientific evidence needed for government health authorities to approve them. The information collected through clinical trials is important because it helps Eisai and health authorities confirm the safety and efficacy of our investigational drugs. Through this process, drugs are approved and then made available for physicians to prescribe for patients who may need them.
Before an investigational drug is approved, some patients can gain access to that drug by enrolling in a clinical trial. If patients don’t qualify for a clinical trial, Eisai believes that, in certain circumstances, it may be consistent with our human health care mission to provide access to an investigational or commercially unavailable drug through an individual or group program outside the context of a clinical trial. (This type of access is sometimes known as “compassionate use,” “expanded access” or “named patient,” depending on the type of program.)
For more information on expanded access programs sponsored by Eisai, please visit https://clinicaltrials.gov.
Patients Have to Meet Certain Requirements
Under limited circumstances, Eisai may consider providing investigational drugs to patients through an individual or group program. Applications need to be submitted by the patients’ treating physicians. We’ll review applications that meet the following criteria:
Disease/Treatment
The patient has a disease or condition that is “serious” or “immediately life-threatening,” and there’s no comparable or satisfactory alternative treatment available to them. Also, the patient must not be eligible for and must not have access to a current Eisai clinical trial.
Drug Development
Providing the investigational drug will not interfere with the initiation, conduct or completion of Eisai’s clinical trials or development of the drug. Also, the drug requested isn’t available in the patient’s country.
Risk/Benefit
Eisai determines that the potential benefits of treatment with the investigational drug outweigh the potential risks to the patient. This assessment takes into consideration the condition of the patient and the sufficiency of safety and efficacy data for the investigational drug. The potential risks must be reasonable given the disease or condition to be treated.
Legal, Regulatory and Other Requirements
Providing the investigational drug complies with applicable local, legal and regulatory requirements. This includes any necessary reviews and approvals by health authorities and institutional review boards/ethics committees, as well as use of the drug under the supervision of a licensed physician.
Here’s How to Take the Next Step Toward Gaining Access
If You’re a Physician and You Think Your Patient May Be Eligible:
Please call Eisai Medical Information at 888-274-2378 (Monday - Friday, 8:30 a.m. - 5:00 p.m. Eastern Time) or email us at Esi_medinfo@eisai.com (for Neurology) or Esi_oncmedinfo@eisai.com (for Oncology). We’ll get back to you within two business days to let you know we’ve received your request.
If You’re a Patient:
Please work through your treating physician to see if you’re eligible for access to Eisai’s investigational drugs under an individual or group program.
If You Have a Patient Who Can’t Afford a Commercially Available Drug:
Please look into Eisai’s reimbursement resources to see if your patient qualifies for one of our Patient Assistance Programs (PAPs).
Please note that neither this website, nor Eisai’s policies and procedures, are intended to provide, nor should be construed as providing, automatic access to the Company’s products.