Pull to refresh
Logo
What Changed
Following Why Sign Up
Prescription apps build the case that software can treat disease

Prescription apps build the case that software can treat disease

New Capabilities

A 470-person German trial found levidex, a digital therapy for multiple sclerosis, improved quality of life — while the industry still fights to get paid.

August 13th, 2026: Coverage spotlights the LAMONT results

Overview

Updated Aug 13

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

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

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.

Voices

Curated perspectives — historical figures and your fellow readers.

Sign up to generate historical perspectives on this story.

Log in Sign Up

People Involved

Christoph Heesen
Christoph Heesen
Neurologist and MS researcher
Senior author on the levidex MS trials
 Björn Meyer
Björn Meyer
Psychologist, Director of Research at GAIA
Involved in developing and testing levidex

Organizations Involved

GAIA AG
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 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: August 13th, 2026 · 3 months ago
Tap a bar to jump to that date

  1. Coverage spotlights the LAMONT results

    Latest Statement

    New reporting summarized the trial: better MS-specific quality of life, fewer depressive symptoms, and improved social function in the app group.

  2. LAMONT trial results posted as a preprint

    Research

    Researchers posted the 470-patient LAMONT trial on medRxiv, reporting levidex improved MS quality of life at six months.

  3. levidex misses its endpoint in early MS

    Research

    The POWER@MS1 trial of levidex in newly diagnosed patients failed to meet its primary endpoint, a caution on where the app helps.

  4. US Medicare adds digital mental health codes

    Rule Change

    CMS created three billing codes for FDA-cleared digital mental health treatment devices, a first federal payment path in the US.

  5. First randomized levidex trial shows benefit

    Research

    A randomized trial published in BMC Neurology found levidex improved MS-specific quality of life versus usual care.

  6. US pioneer Pear Therapeutics files for bankruptcy

    Money Move

    The first company with an FDA-cleared prescription app collapsed after insurers wouldn't cover it. Its products were sold to PursueCare.

  7. levidex enters the reimbursed app directory

    Milestone

    GAIA's MS app was listed in Germany's DiGA directory, making it prescribable and payable by statutory health insurers.

  8. Germany passes its Digital Healthcare Act

    Rule Change

    The law created the DiGA pathway, letting doctors prescribe apps that insurers must reimburse. It was the first national system of its kind.

Scenarios

1

levidex trial clears peer review

Likely Resolves by Aug 13, 2027

Discussed by: The study authors; MS research community

The LAMONT results are a preprint, not yet vetted by outside reviewers. The same group's earlier levidex trial was published in BMC Neurology in 2024. If reviewers accept LAMONT, the finding gains standing with clinicians and payers.

2

Germany's reimbursed app list keeps growing

Possible Resolves by End of 2026

Discussed by: BfArM DiGA directory; npj Digital Medicine analyses

Germany's DiGA pathway had 59 reimbursed apps in 2025. Steady approvals would signal payers still see value despite cost scrutiny. New listings appear regularly in the BfArM directory.

3

Germany reins in app prices

Possible Resolves by Q2 2027

Discussed by: GKV-Spitzenverband (statutory insurers); German health policy press

German insurers have criticized DiGA pricing, and 2026 rule changes added reporting requirements. Pressure could force price cuts or caps, especially on costly listings like levidex, the most expensive app on the list.

4

US payers start covering prescription apps at scale

Uncertain Resolves by End of 2027

Discussed by: MedCity News; Fierce Healthcare; Healthcare Brew

US reimbursement has been the field's choke point. CMS created Medicare codes for digital mental health devices in 2025. Broad commercial coverage would revive a market that bankrupted its first movers.

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

(8)
+2
medRxiv BrightSurf BMC Neurology / PubMed Central NeurologyLive npj Digital Medicine Med Tech Reimbursement Consulting pharmaphorum AAPC Knowledge Center