What Patients Should Know About Expanded Access Programs

(StatePoint) Expanded Access Programs (EAPs) – sometimes referred to as “compassionate use” – can be a possible path to treatment for some people living with a serious or life-threatening illness.

The American Lung Association with support from Savara, Inc., has launched a campaign to raise awareness about EAPs and chronic lung disease. Here’s what they want you to know:

What are EAPs and who qualifies for them?

EAPs offer access to investigational medical products like drugs or medical devices, when standard treatment options are no longer effective and you cannot participate in a clinical trial, either because you do not qualify or there is not one available to you. In order to be considered for an EAP, you have to meet certain eligibility criteria. You must have a life-threatening or serious illness. Additionally, your licensed physician must also believe the benefits of the investigational treatment outweigh the risks.

Niki, who has been living with a rare chronic lung disease called autoimmune pulmonary alveolar proteinosis (aPAP) for over 20 years, pursued an EAP with the help of her physician. “I don’t have as many options for treatment at this point,” she said.

Expanded Access Programs vs. Clinical Trials

Both EAPs and clinical trials offer experimental treatment and both require certain steps to qualify, but they are not the same. Clinical trials are designed to answer research questions and provide data. EAPs are intended to provide potential treatment options to patients when standard therapies aren’t working and a clinical trial isn’t an option.

While clinical trials have strict eligibility criteria and enrollment limits, expanded access may be available to patients who do not qualify for a trial or who cannot access one.

In Niki’s case, she states, “My physician knew about the clinical trial for this investigational treatment, but I didn’t qualify. When it was offered for expanded access, I knew I wanted to see if I qualified.”

Talking With Your Healthcare Provider is Important

Your licensed physician can help you determine if there is an expanded access treatment available and if it is right for you. They can also help you request approval for it, which requires coordination between them, the treatment manufacturer, an Institutional Review Board and the U.S. Food and Drug Administration.

“I worked closely with my healthcare team to take the steps needed to see if I could receive the treatment. They knew my medical background and helped with the paperwork necessary to apply, so that was very helpful,” says Niki.

For more information about EAPs, visit Lung.org/EAP.

For patients who feel they have run out of options, EAPs may offer another path forward. “This medication gives me hope that there is going to be a treatment to better manage my disease,” says Niki.

Photo Credit: (c) fizkes / iStock via Getty Images Plus