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Individual Access to Medicines Intended to Treat Serious Diseases
Managed access provides patients with serious or life-threatening conditions access to investigational medical products for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Managed access is a term that encompasses compassionate use, expanded access, early access, named access (in Europe) and individual patient use.
Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable to managed access because clinical trials generate data regarding efficacy and safety.
The data help inform whether the benefits of the investigational medical product outweigh the risks, whether it should be approved by the regulatory authorities leading to wider availability and, if approved, when and how it should be used.
When it isn't possible for a patient to enroll in a clinical trial, we consider requests for access to the medical 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 medical 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 medical product.
Learn More About Gilead and Kite Clinical TrialsCell 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 medical 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 individually. We may provide physician-requested managed access to cell therapies for patients with no other available therapies and for patients who are not eligible to participate in a current Gilead clinical trial. We'll acknowledge receipt of the request via a call or email as soon as possible.
Managed Access Criteria
We use the following criteria to evaluate requests to provide access to individual patients for managed access. All patients must have a serious or life-threatening condition. In addition:
- There is a strong biological rationale or clinical data that support the possibility that the potential benefits of administration of the investigational medical product to the patient for the serious/life-threatening condition could outweigh the potential risks.
- The patient’s physician has determined that treating the patient with the investigational medical product is in the patient’s best interests.
- The investigational medical product will be administered in accordance with applicable laws and regulatory requirements of the country where the patient is treated, including importation requirements.
- The patient is not eligible or able to participate in a clinical trial or similar sponsored access programs.
- No therapeutic alternative is available.
How to Submit a Request
Physicians can submit managed access requests on behalf of patients and all requests must include the following information:
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 medical 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.
A response for managed access is typically provided to the requesting physician as soon as possible.
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.
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