New DiGA “levidex” is reimbursable as a digital therapy for MS
10.01.2023 14:33
Levidex, a new digital health application (DiGA), is intended to support MS patients in the long term to lead an active and self-determined life with MS.
With levidex, the MS experts at GAIA AG have created a new, innovative DiGA that represents a holistic, digital therapy for MS patients. levidex is now available to people with multiple sclerosis (MS) as a digital health application (DiGA) on prescription, which - according to a current press release from GAIA - has been approved by the Federal Institute for Drugs and Medical Devices (BfArM) as a prescription medical product and is therefore approved by the statutory health insurance is reimbursed. Another special feature: The one-time license is valid for a whole year, so that users do not have to apply for a prescription again after 90 days, as is usual. As a digital coach for at home, levidex offers competent and compassionate support - for an active and self-determined life with MS. It is the sixth DiGA from GAIA AG approved by the BfArM.
In dialogue with individual, digital MS therapy
The online program specifically accompanies MS patients with tips on how to deal with MS-related physical and psychological disorders. In dialogue with a virtual expert, levidex guides MS patients through the modules and sets individual priorities, which arise from the User answers result. The focus is on core topics such as nutrition, exercise, sleep quality and psychology. On the one hand, users learn important background knowledge about MS and, on the other hand, learn how they can better master the challenges of their disease individually with specific exercises and lifestyle changes[1]. Among other things, levidex offers MS-specific techniques for stress management, encourages regular exercise and a healthy diet and can thus help improve the immune health of MS patients. The program developed by medical professionals is ideal as a supplement to current treatment - regardless of how long the MS was diagnosed.
Holistic digital self-help for a better quality of life with MS
Research shows that in addition to healthy habits, positive emotions, social connections and good self-esteem support the immune system, while negative emotions such as stress and anxiety can harm it[2]. As an innovative DiGA for MS, levidex is based on cognitive behavioral therapy and the findings of psychoneuroimmunology - the interactions between the psyche, nervous system and immune system. Levidex thus provides an ideal digital therapy basis for all MS patients. In addition, the already available DiGA “elevida” is available for those affected who are particularly struggling with the accompanying symptom of fatigue (https://elevida.de/).
Efficacy of levidex confirmed in clinical study
The effectiveness of levidex was demonstrated in a randomized controlled trial[3], which was carried out in collaboration with the University Hospital of Hamburg (UKE) with 421 test subjects. After six months of use, study participants were able to significantly improve their cognition, mood and quality of life in general compared to the control group - important factors for a stable immune system and a favorable course of MS. In addition, levidex users had to take sick leave on significantly fewer days.
As part of a trial lasting up to 12 months, further scientific studies will now be carried out in order to permanently include the program in the BfArM's DiGA directory.
[1] On the subject of lifestyle and MS, see also the “NICE Guideline”. https://www.nice.org.uk/guidance/ng220/chapter/Recommendations#ms-symptom-management-and-rehabilitation
[2] Source: Schubert C. Psychoneuroimmunology and psychotherapy. Stuttgart: Schattauer. 2nd Edition. 2015
[3] DiQoLiMS study. Study ID DRKS00023023. Registered with the German Register of Clinical Studies