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At Biogen, our goal is to improve the lives of patients by researching and developing new and innovative therapies.? Before these therapies are commercially available to patients, they must go through clinical trials and be approved by a regulatory authority — such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe — to treat a specific disease.
Approval by regulatory authorities around the world is the fastest way to help the largest number of people with a specific disease. For most patients, the only way to access these “investigational therapies” is to participate in a clinical trial.? However, patients with serious or life-threatening diseases may not be eligible or able to participate in clinical trials – and their physicians may determine that they have no other appropriate treatment options.? In these situations – and when other essential criteria are met – patients may have access to investigational therapies through expanded use, which includes expanded access programs (EAPs) and single patient access (including emergency use).
The number of people who want access to a particular investigational therapy may be greater than the number of people who can receive it. At Biogen, we work with stakeholders, including patient advocacy organizations, ethicists, regulators, and physicians to determine how best to provide access to investigational therapies in an ethical manner consistent with our commitment to all patients. It is important to us that patients and caregivers can easily understand the methods by which we provide access. Learn more about access to and eligibility requirements for investigational therapies in this section.?
Types of Access
Patients may potentially gain access to an investigational therapy three ways: through clinical trials, expanded access programs (EAPs), and single patient access or emergency use.
Biogen’s clinical trials are conducted to test the safety and effectiveness of investigational therapies so that regulatory authorities – such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe – can decide whether or not these therapies can be approved as a treatment for a disease. Biogen strives to design and run clinical trials that will provide these regulatory agencies with the data they need to determine if an investigational therapy is beneficial to patients.
To be eligible to participate in a clinical trial, a patient must meet the inclusion / exclusion (eligibility) criteria.? These criteria are important because they help researchers identify patients who can participate.? The criteria also help researchers identify a group of patients with similar characteristics of a disease, making it easier and quicker for the researchers to evaluate the investigational therapy – potentially leading to faster review and approval.??
Expanded Access Programs, or EAPs, provide investigational therapies to patients who are not eligible or able to participate in a clinical trial – but who have a serious or life-threatening disease for which their physician has determined there are no appropriate treatment options. EAPs provide a limited number of patients, who meet specific criteria, with access to an investigational therapy.
To participate in an EAP, the patient’s physician must make a formal request on behalf of the patient to Biogen or to Biogen’s EAP partner company. The patient’s physician is responsible for the patient’s care and all legal and regulatory requirements for medically monitoring the patient while that patient is receiving the investigational therapy. In addition, enrollment in an EAP must be approved by the regulatory authority in the physician’s country. Participation in an EAP typically ends once the investigational therapy has been approved and is commercially available in the patient’s country.
At Biogen, we understand that the number of people who want access to a particular investigational therapy may be greater than the number of people who can receive it and that is why we have developed principles that shape the foundation of our EAPs, and criteria that govern access to investigational therapies.
Single Patient Access or Emergency Use
Patients who are not eligible or able to participate in a clinical trial – and where an expanded access program (EAP) does not exist – may request single patient access.? This type of access outside of a clinical trial is based on humanitarian or compassionate grounds.?
The patient’s physician must make a formal request on behalf of the patient to Biogen or to Biogen’s EAP partner company.? The patient’s physician is responsible for the patient’s care and all legal and regulatory requirements while the patient is receiving the investigational therapy.? Similar to EAPs, single patient access or emergency use must be approved by the regulatory authority in the physician’s country.
At Biogen, we have developed principles that shape the foundation of our EAPs, and criteria that govern access to investigational therapies.?
At Biogen, our expanded access programs (EAPs) and single patient access are guided by a set of principles that reflect our commitment to providing ethical access to investigational therapies. When developing an EAP, we:
Listen to those who represent the community affected by the disease?
When designing an EAP, we speak with patient groups and physicians to clearly understand the experiences and needs of patients affected by the disease.
Identify eligibility criteria that are reasonable and clearly understood?
We consult with physicians, patient groups and medical experts to help determine the eligibility criteria for an EAP. They are based, in part, on what we have learned about the potential risks and benefits of the investigational therapy.
Allocate investigational therapies in an ethical manner?
We consult with key individuals, including bioethicists, to ensure that the distribution of investigational therapies is done in an ethical manner. We recognize that not everyone who wants access to an investigational therapy will receive it; therefore we make our decisions with an effort to be fair and just to the entire patient population.
Honor our responsibility to patients participating in our placebo-controlled clinical trials?
Patients who participate in placebo-controlled clinical trials often do so with the understanding that the only benefit they may receive is their contribution to improving medical knowledge. At Biogen, we respect the sacrifice of those participating in our placebo-controlled clinical trials and will not allow access to an investigational therapy until the Phase III placebo-controlled trial(s) are closed.
There are several criteria that affect the decision to provide access to an investigational therapy.
Patients must meet the inclusion / exclusion (eligibility) criteria to be considered for participation. Biogen works with medical and scientific experts, as well as regulatory authorities from around the world, to develop the protocol for a clinical trial, which includes the eligibility criteria.
The principal investigator (study doctor) determines whether a patient meets the eligibility criteria.
Patients must be informed of potential risks and benefits of the investigational therapy. Patients who decide to participate must sign an Informed Consent Form.
Expanded Access Programs (EAPs) and Single Patient Access?
Biogen will only consider requests for expanded access programs and single patient access when all of the following criteria are met.
There must be enough evidence that the investigational therapy would likely benefit the patient. Scientific data from clinical trials must show that the potential benefits to the patient from the investigational therapy are greater than the potential risks.
There must be an unmet medical need. The patient 1) must have a serious or life-threatening condition; 2) must have no appropriate treatment options as determined by a physician; and 3) must not be eligible and able to participate in a clinical trial of the investigational therapy.
Clinical development of the investigational therapy must not be affected. Because our goal is to help as many patients as possible, as quickly as possible, access to the investigational therapy outside of a clinical trial must not adversely impact or delay the clinical trials involving the investigational therapy. This is important because the data generated from clinical trials is used by regulatory authorities to determine whether the drug is safe and effective and can be approved for use.
The patient and / or caregiver must be informed of potential risks and benefits of the investigational therapy. The sharing of this information is an essential component of the informed consent process.
The physician must be responsible for his / her patient’s care. The patient’s physician must understand the risks and benefits of the investigational therapy, be prepared to follow all legal and regulatory authority requirements, and be willing to conduct all necessary medical monitoring, safety reporting and data collection.
Note: requests for expanded access programs (EAPs) and single patient access or emergency use will always be reviewed and decided on by Biogen based on these criteria.
How to Request Access
For Patients / Caregivers / Patient Advocates?
If you are a patient and would like to request to participate in an expanded access program (EAPs) and single patient access or emergency use, the licensed physician overseeing your care must submit this request.
For more information on this process for any of Biogen's investigational drugs, please contact Biogen's Patient Center. Requests submitted to this email address will be acknowledged within one business day.
For Healthcare Professionals?
Patients who are not eligible to access the therapies in a clinical trial setting may be able to have access through either an expanded access program (EAP) or a named patient program (NPP).? Please note that an EAP typically ends once the therapy is commercially available in a country or at a specified date, as agreed upon with local authorities.
Listed below are Biogen’s current access programs:
Nusinersen - Spinal muscular atrophy (SMA)
If you are a healthcare professional and would like to learn more about these programs for nusinersen, please contact our partner Clinigen.
For information about access to other Biogen therapies that are not available to patients in the commercial or clinical trial setting, please contact?Biogen Medical Information.
If you are a distributor or wholesaler and would like further information, please contact Biogen's Patient Center.
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