GLOBAL ACCESS TO MEDICINES
Treating Around the World, Every Day
We are committed to providing patients with access to our medicines. We work with policymakers, governments and private health care organizations around the world so that patients with rare and devastating diseases have access to the therapies they need.
We recognize, however, that access to medicines can be challenging and our Global Access to Medicines Program is committed to enabling eligible patients to receive our therapies while we work toward the development of long-term, sustainable access solutions in the geographies in which Alexion has operations around the world.
Treating physicians seeking access to an approved or investigational Alexion medicine on behalf of a patient should submit their requests via the My Access Programs website. The list of our ongoing clinical trials for both approved and investigational therapies can be found at clinicaltrials.gov.
Emergency Treatment for COVID-19:
Alexion is actively monitoring the spread of COVID-19 and is prepared to support the appropriate government agencies in their efforts to address this public health crisis. We are in the process of discussing possible options to investigate SOLIRIS®(eculizumab) in COVID-19 with global health authorities in order to better understand the role of terminal complement inhibition in managing the severe pneumonia associated with the virus. While these discussions are underway, at the request of physicians, and in accordance with relevant national regulatory agencies, Alexion will consider unsolicited requests for SOLIRIS as an experimental emergency treatment via Expanded Access Programs (EAPs) in the U.S. and France for a small number of patients with COVID-19 infection and severe pneumonia or acute respiratory distress syndrome (ARDS). Above all, we remain committed to the patients who currently rely on our medicines and providing continuous supply to these patients.
Requests will be considered outside of the existing Global Access to Medicines program and should not be made via the My Access Programs website. EAP requests must be made by a treating physician and can be submitted to firstname.lastname@example.org.
Alexion’s Global Access to Medicines Programs:
- Are available when the patient’s licensed physician submits an unsolicited request for access to Alexion therapies through the My Access Programs website
- Provide access to our therapies in geographies where regulatory approval and/or reimbursement are not yet established, but where Alexion is pursuing or currently plans to pursue approval and reimbursement for specific indications, and where Alexion has operational capabilities to safely and sustainably deliver commercial supply, and where site administration needs can be met
- Cover temporary gaps in funded access to treatment for limited time periods
- Will be available following regulatory approval and reimbursement for such time as to allow patients a safe transition to coverage and access
- In limited instances, enable patients to access investigational therapies that are actively being explored by Alexion
Process and Eligibility Criteria:
- All requests for access must be submitted by a patient’s treating physician and must be unsolicited
- A patient’s diagnosis must be confirmed by a licensed physician and supported with appropriate documentation (such as a prescription for an indication that is authorized by Global Access to Medicines)
- Treating physicians must register for the Global Access to Medicines program via the My Access Programs website
- Once registered in the My Access Programs system, treating physicians will receive additional information on next steps for submitting access requests
Every request for access will be carefully considered. Requests will be assessed for inclusion in the access programs 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 underlying disease or condition is life-threatening or seriously debilitating
- There are no satisfactory alternative therapies available to the patient
- The patient is not eligible for enrollment in other ongoing Alexion-sponsored studies for that particular product and indication
- The request is for an approved use of a product. The exception may be compassionate use requests, which provide, in limited instances, access to therapies for investigational uses when other paths for compassionate use do not exist. Such decisions will be based on a compelling risk-benefit assessment by the treating physician and Alexion’s internal risk assessment.
- The treating physician reasonably expects that the patient will benefit from the treatment without undue safety risks
- The treating physician agrees in writing to comply with Alexion requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of Alexion proprietary information and/or intellectual property, and performs such duties on a continued basis during the course of the supply
In addition to these criteria, a number of factors will be considered in determining whether access can be provided, including available clinical data for the proposed use and any potential implications regarding clinical development, regulatory or commercial approval and supply of the requested product.
Alexion is committed to assessing every access request with the highest degree of ethical responsibility. Every request will receive a receipt of the request within 3 business days, but we cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
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