MANAGED ACCESS PROGRAMS
Treating Around the World, Every Day
Commitment to Patients
Alexion is committed to serving people affected by rare diseases through the discovery, development and access of life-changing medicines. Our goal is to bring safe and effective medicines to as many patients as possible by conducting rigorous clinical trials and obtaining marketing approval by regulatory authorities around the world. Our work is marked by a commitment to the highest standards of preclinical and clinical research, and an acute sense of urgency. As such, we prioritize access to our investigational medicines through participation in a clinical trial. Alexion has ongoing clinical trials for many different diseases, which are listed in the Pipeline section of our website. For a list of clinical trials currently recruiting patients, please visit www.clinicaltrials.gov. To inquire about a clinical trial, please contact firstname.lastname@example.org.
We recognize there are circumstances where patients with serious or life-threatening diseases have exhausted other comparable or satisfactory alternative therapeutic options and may not be eligible or able to participate in a clinical trial. In such circumstances, subject to the criteria set forth below and country specific regulations, patients may be eligible for managed access to Alexion’s medicines.
Criteria for Consideration
All requests for access to medicine must be unsolicited and made by the patient’s treating physician. Each request will be assessed on a case-by-case basis. Alexion will consider granting managed access to its medicines when the following criteria are met:
- The disease or condition is serious or life-threatening
- The patient is under the care of a physician qualified to administer the medicine at a suitable medical establishment
- The patient has exhausted all other comparable treatment options and is not eligible or able to participate in available clinical trials
- There is sufficient evidence to anticipate a favorable benefit-risk ratio with respect to both the medicine and the condition for which it is being sought and that the patient may benefit from the treatment without undue safety risk
- Providing access will not impede or compromise existing clinical trials or potential regulatory approvals of the medicine.
- The patient resides in a country in which Alexion has pursued or plans to pursue both regulatory approval and reimbursement for the medicine, and where Alexion has operational capabilities to safely and sustainably supply the medicine.
- Access can be provided in a manner that is compliant with applicable local laws and regulations, including importation and fiscal requirements
- The physician agrees in writing to comply with Alexion requirements related to patient confidentiality and data privacy, medical criteria, adverse event/safety reporting, treatment monitoring, medicine supply handling and use, and protection of Alexion proprietary information and/or intellectual property, and to perform such duties on a continued basis while the patient is receiving the medicine
Evaluation of Requests
Alexion is committed to assessing every access request in a fair and impartial manner, with every effort made to provide a response promptly once we have all the required relevant information.
How to Request Access
Where a medicine has been approved for at least one indication by the regulatory agency in their country, a treating physician may be able to request access through the My Access Programs website. Once registered in the My Access Programs portal, a treating physician will receive additional information on how to submit an access request for a specific patient.
For investigational medicines that have not yet been approved by the regulatory agency in their country, the treating physician should submit a request by email to email@example.com. Patient-identifying information should not be included in the request.
For general inquires related to managed access to medicines, please contact the Alexion Managed Access team at firstname.lastname@example.org