Answers for health care professionals and patients

What is “compassionate use”

Compassionate Use is a term generally used to indicate the use of medications for serious diseases before they achieve approval from the country regulatory authority. “Compassionate use” may also be called “expanded access” or by other names. Based on the laws of your country, Pharmaceutical companies such as Boehringer Ingelheim may be permitted to provide an unregistered treatment for a life threatening disease. Boehringer Ingelheim has a process that adheres to the country laws and regulations where this is allowed although we may not have a compassionate use program for all medications that we are researching. If you are a patient, we encourage you to speak with your doctor regarding your treatment options. If you are a Health care Professional and would like to discuss a request with a Boehringer Ingelheim Medical Professional, please contact our medical department.

1. How do I find out if I can receive compassionate use medication for a family member or myself?
   
   Boehringer Ingelheim may only provide investigational medications to a licensed Medical Practitioner who by their training and experience is skilled to treat the requesting patient’s disease. We encourage you to speak with your doctor. If she or he agrees that compassionate use therapy is appropriate, they can contact a Boehringer Ingelheim Medical Professional.

2. Who may be eligible for compassionate use treatment?
   
   To be eligible for compassionate use treatment of an unregistered 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. They must 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). The patient must have failed the currently approved or accepted treatment for the condition. Furthermore, the patient may need to meet other minimal medical criteria that could be in place for that particular treatment, such as kidney or liver function. Finally, the laws and regulations in your country must allow compassionate use of medications.

3. How can I obtain compassionate use medication for my patient?
   
   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 submit request for compassionate use treatment by contacting a local Boehringer Ingelheim Medical Professional. Please ensure that we have your contact information in case we need to contact you during the review of the request. 

4. Who will determine whether I can obtain Compassionate use medication and how long will it take to get a response?
   
   Boehringer Ingelheim has established a process for reviewing requests for compassionate use. Based on the information that your physician has filled in the request form and any additional questions we have regarding your disease, a small committee of experts within Boehringer Ingelheim will review the request. We will provide an answer as quickly as possible. In some cases, we may consult an external panel of experts and this could take longer. In all cases, we strive to answer all requests within 7 calendar days. Additionally, there may be a requirement for review of an independent Ethics Committee or a review by the local Health Authority. In each case, we will work closely with the requesting physician to ensure that we provide what information is necessary for those approvals to be obtained.

5. If my request is approved, how long will it take to receive the medication?
   
   We understand that you 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 BI 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 your requesting physician if we see any delay.