At AbbVie, we are passionate about developing advanced therapies to help address the world’s greatest health challenges. We also are committed to providing access to therapies that are not yet approved for use to people who are suffering from a serious or life-threatening illness or condition and might potentially benefit from these medicines.
To do that, AbbVie has developed a Pre-Approval Access to Investigational Drugs Policy. It outlines important considerations we take into account when evaluating a doctor’s request to use investigational drugs in a patient with a serious or life-threatening illness or condition.
Why we did this
We created this policy so we can make an appropriate medical decision about access to investigational drugs as quickly and as fairly as possible. We also want patients and doctors to better understand what guides our decisions.
Who this policy covers
Our policy applies to requests on behalf of individual patients
(Single-Patient Access) and to certain groups of patients with similar
characteristics (Multi-Patient Protocol Access). The Pre-Approval
Access program may also be referred to as Expanded Access,
Compassionate Use or Named Patient Basis programs, as defined by local
regulations. While our policy outlines the general criteria for
consideration, each case is unique and will be considered on an
individual basis.
Criteria for consideration
The primary option for patients to get access to investigational drugs is to participate in a clinical trial. Patients and physicians can learn more by reviewing information on current or planned clinical trials that is maintained by the U.S. National Institutes of Health.
We recognize, though, that there are extraordinary circumstances where access to these investigational drugs outside of a clinical trial is appropriate. Under our Access to Investigational Drugs Policy, a patient’s doctor can request consideration for access if three basic criteria are met:
- The patient suffers from a serious or life-threatening illness or condition
- There are no other suitable treatment options
- The patient does not qualify for ongoing clinical trials
Other things we consider
Two other important factors play a role in our consideration of each patient request.
The first is to ensure that the potential benefits of the drug outweigh the risks to the individual patient. Physicians consider this before they prescribe any therapy for a patient; it’s absolutely vital in these serious cases that an investigational drug doesn’t add new or unreasonable risks for a patient.
The second is to ensure that providing access under this policy doesn’t have a negative impact on clinical trials. Such an impact would potentially put the patients in those trials at risk, or delay approval and broad access to a new drug maybe offered to as many patients as possible.
Making a request
Requests for access to investigational drugs under development and prior to approval under this policy must be made by Treating Physicians. Treating Physicians should contact us via this link. complete the necessary fields and submit. following submission, you can expect to receive the necessary forms to begin the request process.
Our commitment
Because we are committed to addressing the world’s greatest health challenges, AbbVie takes requests for access under this policy very seriously. We will treat every request with respect, dignity and in a way that protects the privacy of the patient. We will consider each request carefully, individually and fairly. And once we have all the necessary information, we will strive to provide a decision as soon as we can.
If you have questions about our policy, please consult the below FAQ.