Expanded Access Programs in the US
All requests for access to a Boehringer Ingelheim investigational drug, including those under the Right-to-Try Act as described in the US Federal Food, Drug & Cosmetic Act (FFDCA) section 561B “Investigational Drugs for Use by Eligible Patients”, need to be sponsored by a health-care professional. In general, this will be during phase II clinical trials or later during the development and only for therapies with an active Investigational New Drug (IND) application.
Boehringer Ingelheim follows FDA regulations and guidance that describe criteria that must be met to authorize expanded access and lists requirements for expanded access submissions. One type of EAP is an Expanded Access Treatment Protocol, which provides access to an investigational medicine to a larger population.
An EAP is intended to allow patient access to an investigational medicine for a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists and when the potential benefit of the medicine justifies the potential risks and those risks are not unreasonable in the context of the disease or condition being treated.
Boehringer Ingelheim considers granting early access to investigational products when all the following criteria are met:
- A patient is diagnosed with a serious and/or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available to treat the disease or condition
- The patient is not eligible to participate in an active clinical trial.
- Sufficient data exists where the potential benefits of the treatment outweigh the potential risks for the disease to be treated.
- There is adequate supply of the investigational product, and providing the investigational product will not interfere with ongoing clinical trials or the overall development program.
- Investigational access provided in this setting is allowed per local laws and regulations.
For additional Information about Boehringer Ingelheim’s Clinical Trials and Expanded Access Programs (EAPs), including Expanded Access Treatment Protocols and Compassionate or Emergency Use of Boehringer Ingelheim Investigational medicines, please contact our Medical Information team at 1-800-542-6257.
Individual Patient Requests
In some cases, patients and/or caregivers may inquire about Compassionate or Emergency use of an investigational medicine for an individual patient. These types of Expanded Access would apply if a patient does not meet the Expanded Access Treatment Protocol qualification criteria but requests the medicine due to a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists.
If potential patient benefit justifies the potential risks of the medicine and those risks are not unreasonable in the context of the disease or condition being treated, Boehringer Ingelheim will communicate with the patient’s individual healthcare provider regarding potential use of the investigational medicine(s).
- A Boehringer Ingelheim team of medical and scientific experts familiar with the investigational product in question will evaluate all individual patient early access treatment requests. The individual patient requests, also called Out Of Scope (OOS) requests at Boehringer, are requests that a Healthcare Professional can initiate, seeking treatment for a single patient with a high unmet need and who does not have any or has exhausted all treatment options and is not able to enroll in a clinical trial.
- The Boehringer Ingelheim team may also elect to consult with external experts for the purposes of further review.
- Availability of the investigational product will also be considered.
- Not all individual patient early access/OOS requests may be granted.
Boehringer Ingelheim will strive to respond to requests for Individual Patient Requests of an investigational drug within seven business days of receiving a complete request that includes all necessary documentation. However, complicated requests may require additional consultation and discussion, and this may mean we need more time.
DISCLAIMER: Individual Patient Early Access Treatment also called Out Of Scope (OOS) treatment can only be provided within limited circumstances, meaning that Boehringer Ingelheim will not be able to fulfill all requests. Patients themselves cannot make a request for Out Of Scope treatment due to early access regulations and always need to contact their Licensed Treating Healthcare Professional.
If you are a Healthcare Professional interested in submitting an Individual Early Access Treatment (Out Of Scope) Request, please click here to access the BOOST Platform
Individual Early Access Treatment (Out Of Scope) requests
For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions
Frequently Asked Questions
Boehringer Clinical Trials
Clinical Trials
Frequently Asked Questions (FAQ)
Requests on behalf of patients with serious, life-threatening diseases can only be considered for Expanded Access Programs if there are no currently authorized therapies available to treat that disease or condition, or all available treatments have been exhausted and if the patient is not eligible for an ongoing clinical trial. Boehringer Ingelheim will consider requests from patients in a fair, compassionate, and thoughtful manner. We endeavor to respond to all requests with appropriate urgency. We aim to use our best efforts to respond to most requests within 7 days of receipt of a fully completed request. However, complicated requests may require additional consultation and discussion, and this may mean we need more time.
Furthermore, the complexity of distribution of some investigational therapies may prevent access in some countries for patients in the pre-approval setting. Boehringer Ingelheim will only be able to make compassionate supplies available through appropriate distribution channels. Depending on the jurisdiction, this may mean we can only supply through authorized manufacturers, authorized distributors, pharmacies, hospitals, or clinics.
DISCLAIMER: Please, note this does not include the shipment time.
Single patient Early Access Treatment, also called Out Of Scope Treatments at Boehringer, is always initiated by a licensed Healthcare Professional and under his/her direct responsibility.
Requests on behalf of patients with serious, life-threatening diseases can only be considered if:
- A patient suffers from a life-threatening or seriously debilitating disease and
- There are no currently authorized therapies available to treat that disease or condition, or all available treatments have been exhausted and
- The patient is not eligible to enroll in an ongoing clinical trial and
- There is sufficient data available for a positive benefit-risk evaluation
DISCLAIMER: Out Of Scope request treatment can only be provided within limited circumstances, meaning that Boehringer Ingelheim will not be able to fulfill all requests. Patients themselves cannot make a request for Out Of Scope treatment due to early access regulations and always need to contact their Healthcare Professional or Treating Physician.
Boehringer Ingelheim has processes that adheres to country laws and regulations where this is allowed, although we may not have an expanded access program option for all the medications that we are researching. If you are a patient, we suggest you speak with your doctor regarding your treatment options. If you are a Healthcare Professional and would like to have more information about our Early Access Treatment programs for patient cohorts, please review Expanded Access Programs in the US. Additionally, if you are a Healthcare Professional and want to request a Boehringer Ingelheim investigational medicine for a single patient use (Out of Scope request) please review Individual Patient Requests and initiate your request by accessing BOOST platform.
In general, only conditions for which there is evidence of potential application of an investigational product that is part of existing or planned clinical trials would be considered for access under this policy. Or the use of the requested product may be considered with justification by the product mechanism of action or by published clinical data for the disease or condition. You can consult EU Clinical Trials Register website, ClinicalTrials or Boehringer Clinical trials.
It is important to understand that there are circumstances in which we would be unable to provide access to some of these unlicensed products even though they are being studied in clinical trials. Such decisions are made on a case-by-case basis.
Boehringer Ingelheim may only provide unlicensed medications through a licensed Healthcare Professional request who by their training and experience is skilled to treat the requesting patient’s disease. If you are a patient, we advise you to speak with your doctor. If she or he agrees that compassionate use therapy is appropriate, they can contact Boehringer Ingelheim through this website.
To be eligible for compassionate use treatment of an unlicensed product (or a product not approved for the patient’s disease) the patient must:
- suffer from a serious or immediately life-threatening disease or condition.
- not be eligible to participate in a clinical trial that is currently enrolling patients (click here to see a list of Boehringer Ingelheim clinical trials or here for clinical trials worldwide on ClinicalTrials.gov
- not have any currently authorized therapies available to treat their disease or condition in a satisfactory way.
- in addition, the patient may need to meet other minimal medical criteria that could be in place for that particular treatment.
- the laws and regulations in your country must allow compassionate use of medications.
In general, those unlicensed products that are part of existing or planned clinical trials (but not limited) would be considered for access under this policy.
If you are a physician licensed to practice medicine and by training and experience proficient in the specialty that normally treats the disease that the patient suffers from, you may consider submitting a patient’s OOS request by clicking here. If you are a patient, we suggest you speak with your doctor regarding your treatment options.
Boehringer Ingelheim has established a process for reviewing individually all requests for Out of Scope. Based on the medical information included in the request form and any additional questions requested to fully understand the patient's situation, a small committee of experts within Boehringer Ingelheim will review the request. As we review the application, we will respect patient confidentiality. We comply with national privacy laws and will not share details outside of the decision-making team without your permission. Boehringer Ingelheim will assess case-by-case the requests, considering requests from patients in a fair, compassionate, and thoughtful manner. We know how important it is to receive a fast response. Patient’s safety and wellbeing, however, is our priority. We aim to use our best efforts to respond to most requests within 7 days of receipt of a fully completed request. However, complicated requests may require additional consultation and discussion, and this may mean we need more time. Boehringer can only agree to provide an investigational medicine to your doctor if we agree with their medical evaluation that the possible benefits of the drug outweigh the potential risks.
DISCLAIMER: Please, note this does not include the shipment time.
If you are a health care professional who has submitted a single patient request (Out Of Scope) you can check the status of your request here: BOOST platform
We understand that you or your patient may urgently require the treatment. Once your request is approved by Boehringer Ingelheim and other required approvals are obtained (your government, an ethics committee, local hospital) as needed, Boehringer Ingelheim will strive to get the medication to your requesting physician as quickly as possible. Factors that may affect how quickly this occurs include where Boehringer Ingelheim is storing the drug supply, whether it must be imported into your country and whether it requires shipping under special conditions, such as refrigeration. At the time we communicate the approval of the request, we will provide our best assessment of how quickly we can send the medication and will stay in contact with the requesting physician if we see any delay.
All rejected requests include an explanation of our decision. If you are a patient, you should discuss this with your doctor. Please remember that we evaluate all the requests in a case-by-case basis as there are not two identical cases.
Clinical trials should remain the first option to treat patients with unlicensed medicines, because patients who are eligible for an ongoing clinical trial do not qualify for access to investigational products under Boehringer policy.
Each clinical trial has its own eligibility criteria, procedures, and enrollment process. Please, if you are a patient, discuss it with your treating physician what is the best option for you. And if you are a Healthcare Professional, you can check our current open clinical trials here: Boehringer Clinical Trials and/or here: ClinicalTrials