German company says German healthcare system is covering its digital therapeutic called Elevida, which is based on cognitive behavioral therapy.
A digital therapeutic that effectively treated fatigue experienced by multiple sclerosis (MS) patients, is now covered by Germany’s healthcare system.
The therapeutic, which is based on cognitive behavioral therapy, is called Elevida and was developed by Gaia, a German company headquartered in Hamburg.
Matthias Zenker, chief medical solutions officer at Gaia, showed data during a presentation in June that showed the digital therapeutic reduced MS-related fatigue.
In a randomized controlled trial with 275 patients, Elevida reduced fatigue in MS patients over the course of 12 and up to 24 weeks. At week 12, there was a 2.74 points difference in the Chalder fatigue scale in the Elevida group. Effects were sustained at week 24, with a mean difference 2.19 points.
“Based on these findings and after a thorough review by the German Federal Institute for Drugs and Medical Devices, Elevida has become the first digital therapeutic for MS to be included permanently in the German government’s directory of reimbursable digital health applications, the ‘DiGA Verzeichnis’,” Zenker said during the presentation.
There are no prescription drugs that treat MS-related fatigue, Zenker told Managed Healthcare Executive®. "This is why providing reimbursed access to Elevida is so important and significant.”
Fatigue is often noted as the most disabling symptom of living with MS, and 70% of MS patients will develop fatigue symptoms in the course of their disease, Zenker said.
Psychotherapeutic interventions such as cognitive behavioral therapy have been shown to be an effective treatment to treat the fatigue but such treatment is “rarely available to patients due to a shortage of trained therapists and other barriers, such as mobility impairments, cost, cognitive impairment, or the fatigue itself,” Zenker said.
“Elevida closes a gap in the care of MS patients and offers a valuable supplement to drug therapy,” he noted.
Cognitive therapy-based digital therapy programs could improve the quality of treatment for MS fatigue because they can be delivered flexibly and at low cost to large numbers of patients via the internet, according to Zenker. Demand for more accessible medical care is growing due to the rise in chronic diseases, people growing older, fewer specialists, and long waiting times, Zenker said.
After success with Elevida in Germany, Gaia is testing two other digital therapeutic solutions for MS, including one that is designed to improve the quality of life of people The company plans to seek FDA approval over the next years for its neurological solutions, as well as those for oncology, rheumatology, skin disorder and diabetes, Zenker told Managed Healthcare Executive®.
Gais’s most researched digital therapeutic for mild to severe depression, deprexis, has been approved by the FDA since 2015. The product is now marketed by Orexis.