The Alexion OneSource Copay Program provides financial assistance by covering eligible patients’ out-of-pocket medication and infusion costs associated with ULTOMIRIS up to $15,000 US dollars per calendar year Valid only for patients with commercial insurance who have a valid prescription for a US FDA-approved indication of ULTOMIRIS.
Full Answer
What is Alexion medicine?
Does Alexion have EAP?
Is there evidence to demonstrate a favorable benefit-risk ratio?
Does Alexion guarantee access?
Can you participate in Alexion clinical trials?
About this website
What is Alexion medicine?
Alexion is committed to serving people affected by rare diseases and devastating conditions through the discovery, development and commercialization 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. People living with certain rare diseases and devastating conditions often have few or no treatment options. Our work is marked by not only a commitment to the highest standards of preclinical and clinical research but also an acute sense of urgency. As such, we believe that the best way for patients to access our medicines in advance of commercial availability is by participating in a clinical trial. Alexion currently has approved and investigational medicines in clinical trials for a number of different diseases, which are listed in the Pipeline section of our website.
Does Alexion have EAP?
In recognition of the urgent needs of some patients and, in order to streamline the emergency access process, Alexion has opened emergency Expanded Access Programs (EAPs) in the U.S. and France for SOLIRIS in severe COVID-19 pneumonia. All requests for a hospital to be included in the EAP must be made by a treating physician and can be submitted to [email protected].
Is there evidence to demonstrate a favorable benefit-risk ratio?
There is sufficient evidence to demonstrate a favorable benefit-risk ratio. Providing access will not jeopardize existing clinical trials or potential regulatory approval of the investigational medicine. There is an adequate supply of the medicine for all ongoing clinical trials, as well as individual access requests.
Does Alexion guarantee access?
Alexion cannot guarantee that requests for access will be granted. Each request will be considered based on whether certain conditions are met. These conditions include, but are not limited to: The patient must have a serious or immediately life-threatening condition.
Can you participate in Alexion clinical trials?
We recognize that some critically ill patients may not be eligible for or able to participate in an Alexion clinical trial and that, for these patients, there may be no treatment options or clinical trials available. In these cases, Alexion will consider a physician’s request for access to an Alexion medicine outside of the clinical trial setting. All such requests must be made in accordance with local laws and regulations and must be submitted by a treating physician to [email protected]. Alexion will acknowledge receipt of all physician requests within 3 business days.
Alexion OneSource TM CoPay Program
The Alexion OneSource TM CoPay Program may help patients pay for eligible out-of-pocket medication and infusion costs.
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What is compassionate use request?
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.
How long does it take Alexion to approve a request?
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.
What is the physician's responsibility to comply with Alexion?
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.
What is cover axion?
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
What is the patient experience team?
Our global Patient Experience team is responsible for ensuring that patient perspectives and engagement with the rare disease community are always at the forefront of our work. We seek to understand and incorporate insights from people living with rare diseases and their caregivers into our development plans, medicines, and services. Our promise is to partner with the rare disease communities we support to better understand the journeys patients experience in their search for diagnosis, treatment, disease education, and management of their conditions. We do this through working closely with advocacy organizations and through direct patient engagements to realize shared ambitions while respecting health information privacy.
What is the approach to serving patients with rare diseases?
Our approach to serving patients with rare diseases focuses on disease awareness, diagnostic initiatives, and patient support. Every patient matters, and we hold ourselves accountable to serving each patient, and their family, every step of the way.
Can rare diseases be devastating?
Living With Rare Diseases. Rare diseases can be devastating to live with, and can be difficult for even the few physicians who are familiar with them to diagnose, so even getting an accurate diagnosis becomes a process of missed opportunities and delays.
How long do you have to be on antibiotics for soliris?
If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS.
How long do you have to carry a patient safety card with you?
confusion. muscle aches with flu-like symptoms. eyes sensitive to light. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose.
How long before you get your first shot of SOLIRIS?
You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine.
What is the most important information about Soliris?
What is the most important information I should know about SOLIRIS? SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections.
How long do you have to be on antibiotics before starting soliris?
have all recommended vaccinations before you start SOLIRIS. receive 2 weeks of antibiotics if you immediately start SOLIRIS. stay up-to-date with all recommended vaccinations during treatment with SOLIRIS. Know the medications you take and the vaccines you receive.
How to report side effects of a drug?
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.
Is Soliris safe for children?
It is not known if SOLIRIS is safe and effective in children with NMOSD. Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.
What is Alexion medicine?
Alexion is committed to serving people affected by rare diseases and devastating conditions through the discovery, development and commercialization 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. People living with certain rare diseases and devastating conditions often have few or no treatment options. Our work is marked by not only a commitment to the highest standards of preclinical and clinical research but also an acute sense of urgency. As such, we believe that the best way for patients to access our medicines in advance of commercial availability is by participating in a clinical trial. Alexion currently has approved and investigational medicines in clinical trials for a number of different diseases, which are listed in the Pipeline section of our website.
Does Alexion have EAP?
In recognition of the urgent needs of some patients and, in order to streamline the emergency access process, Alexion has opened emergency Expanded Access Programs (EAPs) in the U.S. and France for SOLIRIS in severe COVID-19 pneumonia. All requests for a hospital to be included in the EAP must be made by a treating physician and can be submitted to [email protected].
Is there evidence to demonstrate a favorable benefit-risk ratio?
There is sufficient evidence to demonstrate a favorable benefit-risk ratio. Providing access will not jeopardize existing clinical trials or potential regulatory approval of the investigational medicine. There is an adequate supply of the medicine for all ongoing clinical trials, as well as individual access requests.
Does Alexion guarantee access?
Alexion cannot guarantee that requests for access will be granted. Each request will be considered based on whether certain conditions are met. These conditions include, but are not limited to: The patient must have a serious or immediately life-threatening condition.
Can you participate in Alexion clinical trials?
We recognize that some critically ill patients may not be eligible for or able to participate in an Alexion clinical trial and that, for these patients, there may be no treatment options or clinical trials available. In these cases, Alexion will consider a physician’s request for access to an Alexion medicine outside of the clinical trial setting. All such requests must be made in accordance with local laws and regulations and must be submitted by a treating physician to [email protected]. Alexion will acknowledge receipt of all physician requests within 3 business days.
