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Prescription apps build the case that software can treat disease
New CapabilitiesA 470-person German trial found levidex, a digital therapy for multiple sclerosis, improved quality of life — while the industry still fights to get paid.
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Overview
People with multiple sclerosis often lose ground on the things drugs don't fix: mood, daily function, the feel of a life worth living. A German trial now reports that a prescribed app, used alongside standard care, measurably improved that quality of life.
The result lands at a hard moment for digital therapeutics, meaning software prescribed like medicine. The science is starting to hold up. The business model has not — the field's US pioneer went bankrupt in 2023 after insurers refused to pay for its apps.
Why it matters
If prescribed apps reliably ease symptoms, millions with chronic illness could gain low-cost treatment that works alongside their existing medication.
Questions about this story
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Key Indicators
470
Trial participants
People with MS randomly assigned to levidex plus usual care or usual care alone.
d = 0.26
Effect size on MS quality of life
A small but statistically significant improvement at six months (p = 0.008).
2 vs 6
Median sick days
App group reported fewer sick days than the usual-care group over six months.
59
Reimbursed apps in Germany
Digital health applications payers covered under Germany's DiGA pathway as of 2025.
€2,077
levidex quarterly price
Germany's most expensive reimbursed app, prescribed for people with MS.
Related Media
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First Alert 6
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Prescription apps build the case that software can treat disease
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People Involved
Organizations Involved
GAIA AG
Digital health company
Developer of levidex
Hamburg company that builds digital therapy programs based on cognitive behavioral therapy.
Federal Institute for Drugs and Medical Devices (BfArM)
Federal Agency (Germany)
Runs Germany's reimbursed app pathway
German regulator that reviews and lists digital health apps eligible for insurance reimbursement.
Timeline
November 2019 August 2026
8 events
Latest: Today
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-
Coverage spotlights the LAMONT results
Today StatementNew reporting summarized the trial: better MS-specific quality of life, fewer depressive symptoms, and improved social function in the app group.
-
LAMONT trial results posted as a preprint
ResearchResearchers posted the 470-patient LAMONT trial on medRxiv, reporting levidex improved MS quality of life at six months.
-
levidex misses its endpoint in early MS
ResearchThe POWER@MS1 trial of levidex in newly diagnosed patients failed to meet its primary endpoint, a caution on where the app helps.
-
US Medicare adds digital mental health codes
Rule ChangeCMS created three billing codes for FDA-cleared digital mental health treatment devices, a first federal payment path in the US.
-
First randomized levidex trial shows benefit
ResearchA randomized trial published in BMC Neurology found levidex improved MS-specific quality of life versus usual care.
-
US pioneer Pear Therapeutics files for bankruptcy
Money MoveThe first company with an FDA-cleared prescription app collapsed after insurers wouldn't cover it. Its products were sold to PursueCare.
-
levidex enters the reimbursed app directory
MilestoneGAIA's MS app was listed in Germany's DiGA directory, making it prescribable and payable by statutory health insurers.
-
Germany passes its Digital Healthcare Act
Rule ChangeThe law created the DiGA pathway, letting doctors prescribe apps that insurers must reimburse. It was the first national system of its kind.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
April 2023
Pear Therapeutics collapse (2023)
Pear built reSET, the first FDA-cleared prescription app, for substance use disorder. It won clearance in 2017 and priced its apps above $1,000. Insurers largely refused to pay, and the company filed for bankruptcy in April 2023.
Then
Pear's assets, including reSET and reSET-O, were sold to digital treatment provider PursueCare.
Now
The failure became the cautionary tale of the field: regulatory clearance did not guarantee anyone would pay.
Why this matters now
It shows the gap this MS trial does not close. Proving an app works and getting it funded are separate battles.
2019–2020
Germany's DiGA fast track (2019–2020)
Germany's Digital Healthcare Act created the world's first national system to prescribe and reimburse health apps. Companies could get provisional listing, then had to prove benefit within a set window to stay covered.
Then
The first apps were listed in 2020, and doctors could prescribe them like drugs.
Now
By 2025 the directory held 59 reimbursed apps across many conditions, from depression to MS.
Why this matters now
This pathway is why levidex exists as a paid, prescribable product. It is the market the trial's evidence feeds into.
2020–2024
Akili's EndeavorRx pivot (2020–2024)
Akili won FDA clearance in 2020 for EndeavorRx, a video-game therapy for childhood ADHD backed by a randomized trial. Sales stayed weak. In 2023 the company dropped the prescription model for over-the-counter, then sold its assets in 2024.
Then
Akili shed the prescription label and much of its value in a slow market.
Now
Its arc reinforced that strong trial data does not translate into commercial survival on its own.
Why this matters now
Like levidex, EndeavorRx had real evidence. The question for both is whether payers and patients follow the science.
Sources
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