Pre-Approval Access to Investigational Drugs Policy
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.
Frequently Asked Questions
In general, only those investigational drugs that are part of existing or planned clinical trials would be considered for access under this policy. You can consult the U.S. National Institutes of Health for their current list of abbvie’s clinical trials or other local programs detailing clinical trials.
It’s important to understand that there are circumstances in which we would be unable to provide access to some of these investigational drugs even though they are being studied in clinical trials.
In general, only conditions for which there is evidence of potential application of an investigational drug that is part of existing or planned clinical trials would be considered for access under this policy. You can consult the U.S. National Institutes of Health for their current list of AbbVie’s clinical trials or other local programs detailing clinical trials.
It’s important to understand that there are circumstances in which we would be unable to provide access to some of these investigational drugs even though they are being studied in clinical trials. Such decisions are made on a case-by-case basis.
We accept requests only from the doctor who is treating you for the disease or condition. Your doctor should review the above information about how to contact us.
There’s no way for us to know. It will depend on your insurance and many other factors. The best thing to do is talk to your doctor.
All Pre-Approval Access requests and programs are managed within AbbVie’s research and development function. Only medical personnel can make decisions about these requests and all other AbbVie employees are specifically prohibited from having any involvement in the decision making process.
We will acknowledge receipt of the request from your doctor within two business days. We also will contact your doctor with any additional questions about the request. We are committed to make an appropriate medical decision about access to investigational drugs as quickly and as fairly as possible and we will notify your doctor as soon as we have reached a decision.
Your doctor was provided an explanation of our decision. You should discuss this with your doctor. For both medical and privacy reasons, AbbVie does not directly contact patients.
We consider each request individually, and no two requests are identical. In addition, because there are limited supplies of investigational drugs, there may simply not be enough to meet all the requests we receive.
Your physician would need to contact AbbVie to initiate an appeal. All appeals will be reviewed.
It’s important to consider the clinical trial option first, because patients who are eligible for an ongoing clinical trial do not qualify for access to investigational drugs under AbbVie’s policy.
Each clinical trial has its own rules, procedures and enrollment process. Please review the information on current list of abbvie's clinical trials and discuss it with your treating physician.
If you and your doctor identify a clinical trial for which you might qualify, work with your doctor to begin the application process.