Reimbursement & market-access updates

Germany's directory now tracks §20 SGB V prevention courses — and what five years of GKV spending show

DigiHealthAccess now tracks Germany's §20 SGB V prevention courses (Präventionskurse, certified under the GKV-Spitzenverband's Leitfaden Prävention) alongside DiGA, DiPA and telemonitoring — the fourth parallel German reimbursement pathway now fully represented in the product database.

A review of the past five years of official GKV/MD Präventionsbericht data puts the category in context. Statutory health insurers spent €218.4 million on individual behavioural prevention courses in 2024 — up 43 % from €152.3 million in 2020. A pandemic-driven decline to €143.3 million occurred in 2021 in between. Participation grew even more sharply: 1.89 million course enrolments in 2024 represent a 63 % increase over 2020.

Set against total GKV spending on prevention and health promotion (€686.2 million in 2024, across all three categories combined), §20 individual prevention's share has fluctuated between 27 % and 37 % over the period — highest in 2020, when overall spending collapsed during the pandemic, and lowest in 2021, before recovering to roughly a third of the total by 2024. Set against total GKV expenditure of all kinds (€327.4 billion in 2024), however, prevention and health promotion combined never exceeded roughly 0.21 % — up only marginally from 0.16 % in 2020.

The average cost per course enrolment swings more than the headline totals suggest: it peaked at €179.86 in 2021 — the pandemic year with the fewest enrolments — and has fallen steadily since, to €115.54 in 2024 as participation scaled back up.

Browse the individual §20 courses and other German pathways side by side in the Explorer — select the “Prevention” category there to filter down to this dataset.

Figures for the 2025 reporting year are not yet available. The GKV/MD Präventionsbericht is compiled from each insurer's annual documentation forms and carries a structural lag of roughly one year: the 2024 figures cited above were only published in December 2025. A report covering 2025 is not expected before the fourth quarter of 2026.

GKV-Spitzenverband & Medizinischer Dienst Bund, Praeventionsbericht 2025 (Berichtsjahr 2024), published Dec 2025, gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/praevention__selbsthilfe__beratung/praevention/praeventionsbericht/2025_GKV_MD_Praventionsbericht_barrierefrei.pdf (Kennziffern table, p.134); GKV-Spitzenverband & MDS, Praeventionsbericht 2022 (Berichtsjahr 2021), gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/praevention__selbsthilfe__beratung/praevention/praeventionsbericht/2022_GKV_MDS_Praeventionsbericht_barrierefrei.pdf (Kennziffern table, p.156).

Germany's DiGA directory adds Frieda Menova — a new digital therapeutic for menopause symptoms

BfArM has provisionally listed Frieda Menova, a new DiGA for menopause and climacteric symptoms (ICD-10 N95.1), developed by Frieda Health GmbH — a Hamburg-based femtech company founded in 2020 (originally as Loba Health GmbH).

The app delivers a 12-week cognitive behavioral therapy (CBT) programme — psychoeducation, cognitive restructuring, breathing/relaxation exercises, sleep hygiene and symptom tracking — developed under the medical direction of Prof. Dr. med. Petra Stute, president of the European Menopause and Andropause Society. It is provisionally listed from 7 Sep 2026 to 6 Sep 2027 at a manufacturer price of €490.00 per 90-day prescription, backed by a completed 100-patient pilot RCT (DRKS00036152) showing a statistically significant reduction in hot-flash/night-sweat burden versus standard care (Cohen's d=0.74, p<0.001).

Based on the Frieda Menova BfArM DiGA-Verzeichnis listing, vorlaeufig aufgenommen 07 Sep 2026 (diga.bfarm.de/de/verzeichnis/02895); DRKS00036152 trial registry; Monitor Versorgungsforschung, 11 Dec 2025.

Circle Health winds down — every reimbursement model carries its own overhead

Circle Health, a Berlin-based preventive-medicine startup, is winding down after three-plus years. It ran three clinics (Berlin, Munich and Düsseldorf) with a team of 50 at peak, built its own AI-native platform (CircleOS) to run holistic, diagnostics-plus-treatment preventive care, and treated over 12,000 patients at a 4.9★ Google rating. Announcing the wind-down, founder and CEO Jannik Tiedemann put the outcome plainly: “in venture terms: fail fast.”

The company closed a €9 million seed round — combining equity and debt — in February 2026 to fund expansion across Germany. In the same post, Tiedemann cited a final equity raise of €3 million roughly a year earlier, likely a different slice of the same fundraising history. Either way, the message was consistent: the clinical model worked, the business case around it didn't.

Self-pay isn't the only model that carries this risk, either. Several reimbursed DiGA makers — Aidhere (Zanadio), Vitadio Health Technologies and Perfood among them — have filed for insolvency over the past three years. A common thread across these cases: an organisation plans around a higher post-negotiation price than the arbitration board ultimately sets, and scales faster than the market that actually materialises can support — or underestimates what mandatory regulatory compliance costs, which operating revenue alone often can't carry. The full mechanics are their own story.

Jannik Tiedemann, Circle Health wind-down announcement, LinkedIn, https://www.linkedin.com/posts/jannik-tiedemann_after-more-than-3-years-circle-health-is-share-7499764140098650112--SmU/ (Aug 2026); Circle Health €9M seed-round announcement, circle.health newsroom, 11 Feb 2026; Ahead Health €8.7M funding-round coverage, eu-startups.com, Jul 2026; Aidhere/Zanadio preliminary insolvency, aerzteblatt.de, May 2023; Vitadio Health Technologies preliminary insolvency, verbraucherschutzforum.berlin, 23 Dec 2024; Perfood GmbH preliminary insolvency, der-indat.de, Nov 2024.

Germany's DiGA directory adds isi PMS App — a new digital therapeutic for premenstrual syndrome

BfArM has provisionally listed isi PMS App, a new DiGA for premenstrual syndrome (PMS, ICD-10 N94.3), developed by Endo Health GmbH — the Chemnitz-based company already behind Endo-App (endometriosis) and Vera-App (menopause symptoms). It is their third DiGA in the reproductive-health space.

The app delivers guideline-based, multimodal self-management content — mindfulness and relaxation exercises, movement and physiotherapy-style routines, psychological techniques, and nutrition guidance — as a companion to standard PMS care. It is provisionally listed from 10 Aug 2026 to 9 Aug 2027 at a manufacturer price of €598.95 per 90-day prescription, while Endo Health runs the MIPSI study (a waitlist-controlled RCT measuring symptom severity, quality of life and patient activation over 24 weeks) to support permanent listing.

Based on the isi PMS App BfArM DiGA-Verzeichnis listing, vorlaeufig aufgenommen 10 Aug 2026 (diga.bfarm.de/de/verzeichnis/02857).

China's DTx tracking now covers Hainan, Beijing, Shanghai and Guangdong

Our China coverage now tracks four regions instead of one: alongside Hainan's established provincial pilot, the timeline adds Beijing, Shanghai and Guangdong, each shown with what's documented for that region today.

Hainan runs China's only DTx-specific payment mechanism: a provincial Class II device fast-track (since Oct 2022) plus its own province-level billing framework (since May 2025), now covering 14 products under Hainan's own count.

Beijing has a hospital-backed depression app (Anding Hospital, since Sep 2023) and a TCM digital-therapeutics research platform (since Jul 2025); no DTx-specific notice has been published by the Beijing Medical Insurance Bureau.

Shanghai's 2024 CPPCC proposal on DTx cites Hainan as the model to follow, and the city's National Children's Medical Center opened a pediatric digital-diagnostics research centre in May 2025 — no Shanghai-specific reimbursement notice exists yet.

Guangdong's provincial regulator cleared Tencent's cognitive-training app as a Class II device in Jun 2025, and Shenzhen runs a free, public-health-funded cognitive-screening pilot for residents over 65 — neither carries an insurance-payment code.

Hainan regulator counts (amr.hainan.gov.cn); Beijing Municipal Medical Insurance Bureau site search (数字疗法); Shanghai CPPCC proposal, Mar 2024; Guangdong Provincial Medical Products Administration device registration, Jun 2025; Shenzhen Municipal Health Commission pilot notices, 2024-2025.

Switzerland's digital-health chapter goes live — the dGA route is now open

The MiGeL Chapter 40 for digital health applications (dGA) took effect on 1 July 2026, turning last December's announcement into a live reimbursement route. Prescribed, CE-marked dGAs listed by the Federal Office of Public Health are now covered by compulsory basic insurance (OKP/AOS), with GAIA's deprexis as the first listed product.

The chapter opens under a “coverage with evidence development” status running to the end of 2026 — a deliberately gated start while Switzerland watches how the first listings perform.

Based on MiGeL Chapter 40 taking effect, 1 July 2026.

DiGA turns outcome-based — a fifth of the price now rides on results

From 1 July 2026, Germany's DiGA scheme puts real money on performance: at least 20% of a DiGA's reimbursement price is contingent on success measures, backed by mandatory outcomes monitoring. Eligibility also extends to higher-risk class IIb applications, and the G-BA (Federal Joint Committee) takes over benefit evaluations — a signal that evidence standards are tightening.

Based on the DiGA outcome-based-pricing rules taking effect, 1 July 2026.

🇫🇷 France: Axomove Therapy becomes the first PECAN musculoskeletal product to reach permanent LATM reimbursement

France's Haute Autorite de Sante (HAS/CNEDiMTS) has given Axomove Therapy, developed by the Lille-based startup Axomove SAS, a favourable opinion for permanent listing on the LATM (telesurveillance medicale) reimbursement line -- published 7 May 2026. The digital rehabilitation and telemonitoring platform prescribes personalised exercise programmes and remotely monitors adults with subacute or chronic low back pain (lombalgie) after hospital-based functional rehabilitation.

Axomove first entered French reimbursement via PECAN (Prise En Charge Anticipee Numerique), with a favourable CNEDiMTS opinion on 22 Oct 2024. To convert that one-year, provisional access into durable reimbursement, the company ran a prospective, multicentre, randomised controlled trial across 8 rehabilitation centres (including 4 CHU teaching hospitals) with roughly 190 randomised patients (NCT05910463): the Axomove arm improved on the Oswestry Disability Index by -9 points, versus -4.4 points for the conventional-care control arm.

Context: PECAN was designed as a bridge, not a destination -- most digital medical devices that enter via early access never make the jump to permanent listing. Axomove is now among the first musculoskeletal/rehabilitation products to complete that transition, alongside the cardiac and renal telemonitoring products that have so far dominated France's PECAN-to-LATM pipeline.

Axomove Therapy is now tracked in our directory alongside France's other PECAN and LATM-listed products -- browse them all in the Explorer.

has-sante.fr (avis CNEDiMTS 22 Oct 2024 & 7 May 2026); clinicaltrials.gov/NCT05910463; ticpharma.com; mind.eu.com; eurasante.com

France's PECAN hits its three-year mark — first therapeutics head for permanent LPPR listing

Three years after PECAN launched, France's early-access scheme has reached the point where its first cohort must convert to permanent reimbursement. Digital therapeutics that entered via PECAN now pursue listing on the LPPR (manufacturers must file the follow-up dossier within six months of their PECAN decision), while telemonitoring products route to the LATM line.

Uptake has stayed measured — around eleven dossiers over the cycle, weighted toward telemonitoring — but the transition to LPPR is the real test: temporary access becoming durable, priced reimbursement.

Based on the PECAN framework reaching its three-year milestone, spring 2026.

US sharpens digital-therapeutics billing for 2026

Entering their second year, Medicare's digital mental-health treatment (DMHT) G-codes are joined by additional Remote Therapeutic Monitoring (RTM) codes for 2026, giving clinicians flexibility for shorter monitoring periods and briefer interactions. Momentum also continues behind federal efforts to formalise broader prescription-digital-therapeutic coverage under Medicare and Medicaid.

The practical picture is unchanged for now: clinician-billed codes plus a fast-growing employer/self-insured channel, rather than a single DiGA-style national tariff.

Based on the CMS 2026 fee-schedule updates effective 1 January 2026.

Switzerland switches on digital-health reimbursement — deprexis goes first

The Swiss Federal Office of Public Health has confirmed a new Chapter 40 for “digital health applications (dGA)” on the MiGeL medical-aids list, effective 1 July 2026. GAIA's depression programme deprexis is the first listed product, covered by compulsory basic insurance (OKP/AOS) for adults with mild-to-moderate depression.

The listing runs under a “coverage with evidence development” status — in evaluation until the end of 2026 — signalling that Switzerland wants to test the mechanism on a single, proven product before widening the chapter.

Based on the official FOPH announcement of 3 December 2025.

GKV-SV's DiGA-Bericht 2024: €234m and 861,000 prescriptions since 2020

The GKV-Spitzenverband's DiGA-Bericht 2024 puts hard numbers on four years of Germany's “apps on prescription” scheme: €234 million reimbursed and 861,000 prescriptions, cumulatively, since the DiGA pathway opened on 1 September 2020 through the end of 2024.

Growth has accelerated sharply: spending on health apps rose 71% from 2023 to 2024 alone, reflecting both a growing catalogue of listed DiGA and rising prescriber familiarity with the pathway.

GKV-Spitzenverband DiGA-Bericht 2024 (published 31 March 2025); cumulative figures, 1 September 2020 to 31 December 2024.

🇫🇷 France: Glooko XT (Candiss) secures the country's first gestational-diabetes telemonitoring reimbursement

Glooko XT, marketed in France under the brand Candiss by Glooko SAS (the Paris-based French subsidiary of Glooko, Inc., Mountain View, USA), has been listed on France's LATM (telesurveillance medicale) reimbursement line -- published in the Journal Officiel on 26 Dec 2024. The remote-monitoring platform is reimbursed for non-insulin-treated gestational diabetes: pregnant women with a positive oral glucose tolerance test between weeks 24-28, or a fasting glucose of >=0.92 g/L in the first trimester alongside a risk factor.

The listing carries a base tariff of roughly EUR28 per patient per month. It makes Glooko XT one of only two solutions currently reimbursed in France specifically for gestational-diabetes telemonitoring -- a narrower, and until now largely uncovered, corner of France's PECAN/LATM landscape, which has so far been dominated by cardiac and renal remote monitoring.

Context: the underlying clinical evidence here is platform-level, not indication-specific -- Glooko's broader remote-monitoring evidence base spans diabetes management generally, and HAS/CNEDiMTS recognised Glooko XT as a valuable complementary monitoring option alongside conventional gestational-diabetes follow-up, rather than citing a dedicated randomised trial for this indication.

Glooko XT (Candiss) is now tracked in our directory -- browse it alongside France's other PECAN and LATM-listed products in the Explorer.

glooko.com; ticpharma.com; prnewswire.com; legifrance.gouv.fr (Arrete du 26 decembre 2024)

US Medicare creates its first digital mental-health treatment codes

CMS's 2025 Physician Fee Schedule final rule established HCPCS codes G0552–G0554 for FDA-cleared digital mental-health treatment (DMHT) devices — Medicare's first explicit line for a prescription digital therapeutic. The codes are billed by the prescribing clinician alongside a behavioural-health treatment plan, effective January 2025.

G0553/G0554 pay roughly $20 per 20-minute monthly management increment; the device-supply code G0552 is contractor-priced, reflecting how much device costs still vary.

Based on the CMS CY2025 Medicare Physician Fee Schedule final rule (1 November 2024).

France opens PECAN — early-access reimbursement for digital medical devices

France's PECAN scheme became operational, offering a digital medical device (DMD) one year of transitional reimbursement while it completes full evaluation for permanent listing via LPPR (therapeutics) or the LATM telemonitoring line. Inspired by Germany's DiGA, it's built to accelerate patient access to useful innovation.

Telemonitoring under PECAN is set at roughly €50 per patient per month; individual-use DTx use a front-loaded first-quarter package plus capped monthly fees.

Based on the launch of the PECAN early-access scheme, April 2023.

South Korea approves its first digital therapeutic

The MFDS granted approval to Somzz, a cognitive-behavioural-therapy-for-insomnia (CBT-I) programme — the country's first authorised DTx, followed weeks later by WELT-I. Revised insurance rules later in 2023 allowed temporary NHI reimbursement for up to three years before full evidence.

Somzz holds a formal HIRA non-covered (“bigeubyeo”) billing code with a reference price inside the NHI claims framework — though in practice hospitals charge patients well above that reference, so it operates largely as self-pay.

Based on the MFDS approval of Somzz, 15 February 2023.

Japan reimburses the world's first hypertension therapeutic app

Japan's Chuikyo (Central Social Insurance Medical Council) approved NHI coverage for CureApp HT, a therapeutic app for hypertension — the first time a country reimbursed a prescription app in that field. Coverage began in September 2022 at an NHI-set price.

It followed CureApp's 2020 smoking-cessation app through the same route: clear PMDA device approval, then have Chuikyo assign an NHI price like any other reimbursed medical technology.

Based on the Chuikyo coverage decision of 3 August 2022.

NICE gives a digital therapeutic its first positive appraisal

NICE published guidance MTG70 recommending Sleepio (Big Health) as a cost-saving option for insomnia in primary care — the first-ever digital therapeutic to receive a positive NICE appraisal. It set the template for NICE's Early Value Assessment route into the NHS.

Rather than a DiGA-style national tariff, UK access flows through NICE recommendations plus NHS commissioning and service contracts — a different mechanism aimed at stretching limited clinical capacity.

Based on NICE guidance MTG70, published 20 May 2022.

Belgium opens its reimbursement tier with a “validation pyramid”

Belgium activated level M3 of the mHealthBELGIUM validation pyramid — the tier at which INAMI-RIZIV can fund apps that prove clinical and socio-economic value. Products climb from M1 (CE-marking + data-security basics) through M2 (interoperability/security) to M3.

The graduated on-ramp has since supported heart-failure and cancer telemonitoring, knee/hip rehab, Holter and sleep-apnoea pathways.

Based on the roll-out of validation-pyramid level M3, 20 January 2021.

Japan reimburses its first digital therapeutic, CureApp SC, for smoking cessation

CureApp's smoking-cessation therapeutic, CureApp SC, went on sale on 1 December 2020 with public health-insurance coverage — the first digital therapeutic in the smoking-cessation field to be reimbursed by a national health-insurance system anywhere in the world, and Japan's first nationally reimbursed digital therapeutic overall. It pairs an app with a connected CO checker.

Regulatory approval from the MHLW had come earlier, in August 2020; the NHI price decision is what unlocked reimbursed, prescribable use.

Based on the start of NHI coverage / launch, 1 December 2020.

The first “apps on prescription” go live in Germany

The DiGA directory opened with its first entries — velibra (anxiety), Kalmeda (tinnitus) and somnio (insomnia) — making them prescribable by physicians and psychotherapists and reimbursed by statutory insurers. Germany's fast-track had turned law into live product in under a year.

Manufacturers set their own price for the first 12 months, after which a negotiated rate with the national association of statutory insurers applies.

Based on the first DiGA listings in the BfArM directory, early October 2020.

Germany writes the world's first national DTx reimbursement law

The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) entered into force, creating the “app on prescription” — the first legal entitlement for a statutory-insured population to receive prescribed, reimbursed software. It set up the DiGA fast-track that BfArM would operationalise in 2020.

Around 73 million people covered by German statutory insurance became eligible to have a prescribed DiGA reimbursed like any other therapy.

Based on the DVG entering into force, 19 December 2019.