For clarity, this blog post is not specific to any ongoing EAPs, including the recent NIH awarded EAP for which Synapticure might participate, such as the Columbia - Clene EAP award. As part of the standard course of care at Synapticure, we ensure patients have access to clinical trials not just at their primary care site, but any clinical trial that may benefit their care, including EAPs. Synapticure has facilitated patient access to clinical trials and EAPs for numerous patients and will continue to do so. As more opportunities emerge to participate in clinical trials and EAPs, we aim to provide a single point of access for patients to indicate interest and, for diagnosed patients under our care, facilitate their enrollment in those programs as feasible.
In regards to the Columbia - Clene EAP, we plan to announce further details as soon as we are aware of them, with a target date for an update announcement by December 15th.
What is an EAP?
EAP stands for Expanded Access Program. EAPs allows people living with ALS, who do not qualify for a traditional research study, access to an investigational drug. An ‘investigational drug’ is one that is still being researched as a potential therapy, and has not been approved by the FDA. In simple terms, typically these are therapies that have shown to be tolerable to patients in early studies and have promise enough to move towards a Phase III Clinical Trial, if they have not done so already. The study design of the EAP must be submitted to appropriate regulatory agencies, like the FDA, and approved by an independent Institutional Review Board (IRB) before it starts. Similar to traditional research studies, data is collected throughout the study to monitor safety and other drug effects. People with ALS are selected for the EAP using a set of prespecified criteria. The criteria are used to ensure that people who enroll in the program are able to contribute to the program’s objectives.
Synapticure has been committed to providing patients with access to EAPs since our inception. We firmly believe that every patient should have the opportunity to benefit from EAPs whenever possible, and we are dedicated to supporting healthcare providers in their efforts to make EAPs accessible to their patients. Throughout our history, we have consistently extended our support to both healthcare providers and patients alike, and will continue to do so.
How can patients sign up for EAPs that Synapticure supports?
Synapticure will launch a sign-up form on Nov 15th for inquiries regarding access to EAPs. This form will be routed to our care coordination staff. Typically, the only criteria for joining an EAP with Synapticure is that (1) you have established care with us and (2) you are not eligible for, or currently participating in, an ongoing research study. Each EAP may also have specific criteria that will need to be met. In addition, some EAPs may allow you to participate in different research studies at the same time. Synapticure’s national virtual care network provides patients the unique opportunity to participate in these types of programs without the constraints typically associated with participation. We can see a patient for an EAP anywhere in the US, so long as that patient has mail and internet access and the ability to complete virtual visits.
There are two additional points of clarification that we should cover here.
- In the event an EAP program has more interested patients than available spots, Synapticure will randomly select patients from the database to avoid enrollment bias.
- Should both Synapticure and your local neurologist participate in the same EAP, we will consult with your clinician regarding where the application for the EAP should be managed.
What is the cost to participate in a Synapticure EAP?
Depending on the research study, access to the investigational drug and the associated research visits are often provided at no cost to patients. However, with us or any other clinical site, a new patient will first need to establish care and be seen outside the research study which may be charged to insurance. Establishing care allows us to confirm your diagnosis and medical history before participating in any kind of research study or EAP. The clinicians at Synpaticure have the obligation and responsibility to ensure that patients meet certain eligibility criteria and can comply with regulatory requirements including regular labs and monitoring when conducting clinical trials.
There is a standard disclaimer for any clinical study we should note: Aspects of care and services outside the research study may be billed to insurance for which you may be responsible to cover any deductible or co-payments—specific details around this issue will be addressed for those who are registered to participate.
How do I sign up?
Sign up form will be linked here on November 15th at Noon ET. We will do our best to update this or subsequent FAQs in response to your questions.