GLOBAL ACCESS TO MEDICINES PROGRAM
Treating Around the World, Every Day
Alexion collaborates with government agencies, policymakers, patient advocacy organizations, and health insurers to establish regulatory approval and access to our medicines. We recognize that for certain periods of time and in some parts of the world, access to medicines can be challenging. Through the company’s Global Access to Medicines (“GATM”) program, physicians can apply for access to Alexion therapies for patients that meet the program criteria while we work toward the development of long-term, sustainable access solutions in the geographies in which Alexion has operations.
GATM is designed to:
- Cover temporary gaps in funded access to treatment for limited time periods when no alternate funding mechanisms are available
- Cover Alexion therapies, for which advanced clinical studies have demonstrated a positive benefit/risk profile, and the application has been accepted for review by a major regulatory authority
- Provide access to our therapies in countries where regulatory approval and/or reimbursement are not yet established, but where Alexion plans to pursue approval and reimbursement within a defined time frame following marketing authorization
- Provide access to our therapies in countries where Alexion or our partners have operational capabilities to safely and sustainably supply our medicines and ensure patient safety
All requests must be submitted by the patient’s treating physician through the My Access Programs website. Requests can only be considered if the patient’s diagnosis has been confirmed by their physician and are unsolicited.
Once registered in the My Access Programs system, treating physicians will receive additional information on next steps for submitting access requests.
Requests will be assessed based on the appropriate and complete information provided by the treating physician. In addition to the criteria set forth above, requests must meet the following conditions:
- The disease or condition is life-threatening or seriously debilitating
- There are no satisfactory alternative therapies or clinical trials available to the patient or the patient has not responded to the alternative therapies
- The request is for an approved use of a medicine by at least one regulatory agency, except for compassionate use requests in rare instances, which provide access to therapies for investigational uses or extenuating circumstances for Alexion medicines that have established safety profiles
- The treating physician reasonably expects that the patient will benefit from the treatment without undue safety risks
- The physician agrees in writing to comply with Alexion requirements in terms of medical criteria, safety reporting and medicine supply/use, and protection of Alexion proprietary information and/or intellectual property and performs such duties on a continued basis while receiving the medicine
- The request originates from a country where Alexion has a physical presence or an established contracted partnership distributor and can guarantee a sustainable and stable supply chain. Alexion’s partners can provide additional support in certain geographies, however, not all partnerships are able to provide coverage for all medicines
- The request originates in a country that has a legal mechanism to provide an access program and will comply with all applicable local and national laws and regulations, including importation and fiscal requirements and other ethical and regulatory requirements
Evaluation of Requests
Alexion is committed to assessing every access request responsibly and swiftly. Acknowledgement of all requests will be sent within 24 hours. If approval is granted, there may be additional activities that need to be completed to submit the necessary documentation to the competent health authorities, which may extend timelines. Alexion cannot guarantee that all requests for access will be granted.
I don’t define myself as having a rare disease. It’s part of my life but it’s certainly not who I am.”CHELSEY LIVING WITH NMOSD