An American Lung Association initiative aims to educate patients and healthcare providers about investigational treatment options for severe and rare lung diseases.


RT’s Three Key Takeaways:

  1. Treatment Alternative: Expanded access programs, also known as compassionate use, provide a pathway for patients with life-threatening lung diseases to access investigational medications or devices when clinical trials are not an option.
  2. Regulatory Oversight: These programs require coordination and approval from the patient’s physician, the manufacturer, an Institutional Review Board (IRB), and the Food and Drug Administration (FDA).
  3. Awareness Gap: Social listening data from the American Lung Association indicates that many patients and caregivers remain unaware of these programs, highlighting a need for increased education within the healthcare community.


The American Lung Association (ALA) has launched a new educational campaign to increase awareness of expanded access programs (EAPs) for individuals with serious or rare lung diseases who have exhausted all other treatment options, according to a news release.

Also known as compassionate use, EAPs provide access to investigational products and treatments, including medications and medical devices, for patients who do not qualify for or have access to clinical trials. The ALA identified a significant awareness gap regarding these programs through social listening efforts.

“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, in a news release. “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 ALA has partnered with Savara Inc to provide educational resources to help patients and their caregivers understand EAPs, determine if they are an appropriate option, and work with their healthcare provider to access them.

Individuals can also contact the Lung HelpLine to speak with a lung specialist who can answer questions about the programs and connect them with resources, according to the ALA.

For more information, visit Lung.org/EAP.