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Individual Access to Medicines Intended to Treat Serious Diseases
Healthcare providers who care for patients facing serious or life-threatening conditions may have questions about whether investigational medicines from Gilead can be accessed outside of clinical trials, especially when no other satisfactory treatment options are available.
This type of access is called managed access, which includes programs such as compassionate use, expanded access, early access, named patient access (in Europe), and individual patient use. These programs are designed to provide potential treatment options when standard therapies are not suitable or available.
Wherever possible, use of an investigational medicinal product by a patient as part of a clinical trial is preferable to managed access because clinical trials generate data regarding efficacy and safety. When it isn't possible for a patient to enroll in a clinical trial, we consider requests for access to the medicinal products for individual patient use or through an expanded access protocol when appropriate. Various regulatory mechanisms exist in different countries to provide managed access to medicinal products and, as a result, local and/or regional variations in managed access will occur.
Investigational medicinal products have not yet received regulatory approval for specific indications; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product.
View Managed Access Position StatementCell Therapy Managed Access
Our managed access program for cell therapy varies regionally as a result of the unique regulatory mechanisms in different areas and countries worldwide. Since investigational medicinal products have not yet received regulatory approval, their potential risks and benefits are not yet established. It is important for physicians and patients to consider all possible benefits and risks when seeking access to an investigational medicinal product.
Gilead will evaluate these requests on a case-by-case basis. While access to investigational cell therapies outside of clinical trials remains extremely limited and approval is not guaranteed, we are committed to considering requests for patients who have exhausted all other treatment options and are not eligible for ongoing Gilead clinical trials. We will acknowledge receipt of the request via a call or email as soon as possible.
How to Submit a Request
Physicians can submit managed access requests on behalf of patients and all requests must include the following information:
- Date of request, requesting physician’s name, contact information, and professional designation (i.e., MD) or qualifications.
- Name of the requested investigational medicinal product, including therapeutic indication.
Review Process
Medical professionals at Gilead who are familiar with the data collected on the medicinal product evaluate each request and respond based on the scientific evidence available at the time of the request and the criteria listed above.
Gilead aims to be transparent in external communication of its Managed Access Position Statement. In conjunction with the
21st Century Cures Act, Gilead supports ethical and industry standards around transparency related to managed access. To that end, Gilead will acknowledge receipt of such requests within 24 hours. Pursuant to the 21st Century Cures Act, the posting of policies by manufacturers and distributors shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.
We have programs in the U.S. and in many countries around the world to help ease the burden for patients and families navigating the healthcare landscape.
These programs enhance access to medicines that have been approved by regulatory authorities across our therapeutic areas, providing options such as co-pay assistance, counseling and low-cost or free therapies.
Learn More