Patient care navigator aims to simplify healthcare options

When things seem hopeless, the search for medical options can be time consuming and emotionally draining. But a new online tool is aimed at helping caregivers, doctors and patients find treatments that would otherwise not be available.  It's called the Expanded Access Navigator.

The EA Navigator was created by the Reagan-Udall Foundation, an independent 501c3 created by Congress in the 21st Century Cures Act, to assist the FDA.

The foundation was named posthumously after Pres. Ronald Reagan, a Republican who suffered from Alzheimer's disease, and Congressman Morris Udall, a Democrat from Arizona with Parkinson's Disease -- both incurable neurological disorders.  

The navigator hopes to be a one-stop shop for people with terminal or chronic or recurrent diseases that interfere with day-to-day life, who have exhausted treatment options.  

According to their website, the foundation “…works collaboratively…” with both public and private stakeholders “…including academia, patient groups, industry groups, and FDA scientists…”, and is funded in part by private organizations such as the Bill and Melinda Gates and Susan G. Komen foundations.

The site directs patients, health care professionals, and caregivers through a step-by-step process, including links to clinical trials.

Links to advocacy groups can also help patients identify promising treatments and additional assistance with locating specific treatment options.  While the site mainly lists oncology drugs, expanded use also applies to biologics and medical devices for other conditions.

Teresa Bruce, director of marketing and communications for the foundation, says the process is patient driven in most cases, but ultimately, their physician must make the formal request and basically, " send."

Physician involvement also ensures that the risks of the treatment don't outweigh the risks of the disease itself.

Since its official launch on July 24, 2017, she says they are already seeing and increased interest from industry, with companies like Novartis adding to their profile on the website.

For patients seeking individual expanded access (compassionate use), there are also links for emergency requests.

Bruce says generally, when physicians make single patient requests to the FDA on behalf of their patients, they are granted 99 percent of the time.