Early Access Treatments & Compassionate Use Programs

Requests on behalf of patients with serious, life-threatening diseases can only be considered for compassionate use 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 do 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 a compassionate use 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 Early Access Programs: Expanded access or Compassionate Use request. 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 Single Patient Requests: Out Of Scope 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 read more about Boehringer Ingelheim clinical trials or here for clinical trials worldwide on ClinicalTrials or Search for clinical trials - EMA (euclinicaltrials.eu) to search for clinical trials in Europe). 
• 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 BOOST Platform. 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 do not include the shipment time.

If you are a health care professional who has submitted a compassionate use 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 Search for clinical trials - EMA (euclinicaltrials.eu)