American Lung Association Launches Campaign to Educate Patients on Expanded Access Programs for Investigational Lung Disease Treatments
Key Insights
The American Lung Association (search) has launched a new educational campaign to raise awareness about expanded access programs (EAPs) for patients with severe lung diseases who have exhausted standard treatment options.
EAPs, also known as compassionate use, provide an alternative pathway to investigational treatments when clinical trial participation is not possible due to eligibility barriers or geographic limitations.
Findings from the Lung Association's social listening efforts reveal a significant awareness gap, with many patients and caregivers unaware that EAPs exist as a potential option.
For individuals living with severe and often rare lung diseases, the moment when standard treatments are no longer effective can be devastating. The American Lung Association (search) today launched a new campaign aimed at closing a critical knowledge gap: many patients and their caregivers are unaware that expanded access programs (EAPs)—also known as compassionate use—may offer a pathway to investigational treatments when all other options have been exhausted.
"Expanded access programs can offer hope to families facing serious or life-threatening lung diseases. While clinical trials are incredibly important to the advancement of new treatments for lung diseases, not everyone may have access to a clinical trial or qualify to participate," said Harold Wimmer, President and CEO of the American Lung Association (search). "This is where EAPs fit in. EAPs provide an alternative path for patients to consider."
The campaign comes in response to findings from the Lung Association's social listening efforts, which highlighted a significant awareness gap: many individuals and their caregivers simply do not know that EAPs exist as an option.
How Expanded Access Programs Work
EAPs require close coordination among multiple stakeholders, including a patient's licensed physician, the treatment manufacturer, an Institutional Review Board (IRB), and the U.S. Food and Drug Administration (FDA). A licensed U.S. physician must oversee the treatment, and the potential benefits of the investigational treatment must outweigh any potential risks for the patient.
These programs are typically considered when no approved treatment options remain, or when those options have been exhausted. They may also be pursued when participation in a clinical trial is not possible due to strict eligibility requirements, geographic barriers, or other limiting factors. Importantly, EAPs do not replace clinical trials and are not guaranteed to be available for every investigational treatment.
Financial Considerations
Costs for investigational treatments accessed through EAPs are typically not covered by insurance. The cost of treatment and medical oversight often represents an out-of-pocket expense for the patient, though the Lung Association notes that there may be options for treatment costs to be covered in certain circumstances. Individuals are encouraged to discuss potential costs with their healthcare provider.
A Patient's Journey Through EAPs
The campaign highlights the experience of Niki, who was diagnosed with pulmonary alveolar proteinosis (search) (PAP)—later identified as autoimmune pulmonary alveolar proteinosis (search) (aPAP)—at age 27 via an invasive open lung biopsy. "I started doing research to learn what I could about it because even the doctors didn't know much about this disease," Niki explained.
Over the years, Niki's disease management became increasingly complicated. She experienced several lung infections and eventually developed lung fibrosis (search). "There are limited treatment options for me, and the treatments that are available are no longer managing my disease," she said. After learning she did not qualify for a clinical trial underway for her specific disease, Niki worked closely with her specialist to explore whether an EAP was available.
"It was a very emotional time for me, because my treatment options were running out. When my specialist called to tell me the investigational treatment would be available through the EAP, I was all in to try it," Niki shared. Reflecting on the experience, she added, "This medication gives me hope that there may be a treatment to better manage my disease so I can continue doing the things I enjoy and living my life."
Educational Resources and Partnership
The American Lung Association (search) has partnered with Savara Inc. to provide support and educational resources designed to help individuals living with lung disease and their caregivers understand what EAPs are, determine if an EAP may be appropriate in their treatment journey, and work with their healthcare provider to consider and access these programs.
The Lung Association offers comprehensive resources, including the Lung HelpLine at 1-800-LUNGUSA, where a lung specialist can answer questions about EAPs and connect individuals with helpful resources.