Hope with EAPs: 3 Things to Know About Expanded Access Programs for People with No Other Treatment Options

Some people with severe and often rare lung diseases may reach a point where there are no remaining effective treatment options available, and they may not qualify for or have access to a clinical trial. For these individuals, expanded access programs (EAPs), also called compassionate use, may offer access to new and investigational products and treatments, such as medications or medical devices. Unfortunately, not enough people know about this option, so today, the American Lung Association launched a new campaign to educate people about EAPs.

“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. “This is where EAPs fit in. EAPs provide an alternative path for patients to consider.”

Here are three things to know about EAPs:

1. Close Coordination and Oversight: EAPs require coordination among and oversight by a person’s licensed physician, the treatment manufacturer, an Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA). A licensed physician from the U.S. oversees the treatment. The potential benefits of the EAP treatment must outweigh any potential risks for the patient.
2. Costs for Treatment: Costs for investigational treatments are typically not covered by insurance. The cost of treatment and medical oversight is often an out-of-pocket expense for the patient; however, there may be options for treatment costs to be covered. Individuals should talk to their healthcare provider about the potential cost of an EAP treatment.
3. Most Are Not Aware of EAPs as an Option: Findings from the Lung Association’s social listening efforts highlight a significant awareness gap: many individuals and their caregivers are unaware of EAPs.

The American Lung Association has partnered with Savara Inc. to provide support and educational resources to help individuals living with lung disease and their caregivers to:

• Understand EAPs—what they are and how to access these treatments.
• Determine if an EAP may be an appropriate option in their treatment journey. 
• Work with their healthcare provider to consider and access EAPs.

The Lung Association offers comprehensive educational and support resources, including the Lung HelpLine at 1-800-LUNGUSA. A lung specialist can answer questions about EAPs and connect a person with helpful resources.

For more information, visit Lung.org/EAP.