Brief · Use case · Innovation
DTx Reimbursement Outlook.
LiveOutlookProject whether a prescription digital therapeutic reaches national reimbursement in one European market within two years, with scenarios and signposts.
DTx Reimbursement Outlook is a ready-made use case for Innovation. It ships under the Outlook template.
For digital health and market access leads. You get the projected event and resolution test, the reference class of earlier listings, a central path with a range, scenarios and early signposts. Claims are cited or marked as gaps.
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The decision
Will a prescription digital therapeutic reach national reimbursement in one named European market within 24 months, and how likely is it?
What the outlook examines
Germany and France publish routes with fixed steps, and Germany publishes how products have fared. The outlook uses that record as its reference class and says which market it is for.
| Part of the outlook | What it asks | Where it looks |
|---|---|---|
| Germany: the DiGA fast track | The BfArM assesses a complete application within three months at most. A product can be listed provisionally while it generates final evidence, or permanently. The statutory insurers’ report to the end of 2025 counts 58 products in the directory, 48 permanent and 10 provisional.1,2 | The BfArM’s DiGA page and the GKV-Spitzenverband’s fifth DiGA report. |
| France: early access (PECAN) | One year of early coverage, after which the manufacturer must request permanent listing, within six months for a digital therapeutic.3 | The national digital health agency’s description of PECAN. |
| England: evidence standards | Evidence standards that rise with the risk of the product’s function. The framework does not itself set a payment route.4 | The NICE Evidence Standards Framework. |
What the outlook does
A base rate from the German record. The GKV-Spitzenverband’s report covers 1 September 2020 to 31 December 2025. Of 74 products added to the directory in that period, 14, or 19 percent, could show a benefit at the time of admission, and 16, or 22 percent, have since been removed for lacking proven care effects. The outlook uses these as a reference class for Germany and says they come from the insurers’ association, which has a stated position on the fast track.2
Time is part of the question. The BfArM’s decision is due within three months of a complete application, and a provisional listing allows the final evidence to follow. In France the early coverage lasts a year. The outlook sets the 24-month horizon against those clocks and says what share of the time is the sponsor’s.1,3
Reimbursement is not the same as use. The report counts redemption of an activation code as use, and does not measure how actively patients use the app afterward. The outlook keeps coverage and use apart.2
Scenarios. At Comprehensive length the outlook sets out the scenarios: provisional listing within the horizon, permanent listing within the horizon, or neither, each with a likelihood.
Recommended length
Comprehensive
The future could go several ways. Comprehensive adds the table of scenarios with their likelihoods.
You can pick another length on the form. The other two stay available.
Assumptions the outlook checks
The outlook states the assumptions its likelihood rests on and names the weakest one. Examples for this question:
- The product’s evidence base is at least what a provisional listing requires.
- The market’s route and its clocks are those described in the sources.
- The product meets the market’s data protection and interoperability requirements in time.
Standards, guidance and sources
What gets flagged
Any figure that comes from the insurers’ association and not from the BfArM, any reference class for a market other than the one asked about, and any likelihood that rests on judgment.
What arrives
- The projection
- Starting point and base rate
- What is already in motion
- The most likely path
- Scenarios
- What would change it
- Signposts
- Confidence, and where it is weakest
What it will not do
It does not predict with certainty or recommend an action. The likelihood carries a range, confidence is stated separately, and a Decision Memo uses the outlook as an input.
It does not predict a listing decision, and it does not advise on the application.
It does not predict with certainty. A likelihood is a statement about the evidence, with a range, and the outlook says how sure it is separately.
It does not make a base rate from nothing. Where no reference class exists, the base rate table says so and the likelihood is labeled analyst judgment.
It does not recommend an action. A Decision Memo takes the outlook as an input.
References
- [1] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025. Read on 9 October 2026.
- [2] GKV-Spitzenverband. DiGA-Bericht des GKV-Spitzenverbandes 2025, report under section 33a(6) SGB V, covering 1 September 2020 to 31 December 2025. Figures as given in search excerpts summarizing the report; the report was not read. The association is a payer body with a stated position on the fast track.
- [3] Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices. Read on 9 October 2026.
- [4] National Institute for Health and Care Excellence. Evidence standards framework for digital health technologies (ECD7). NICE’s page could not be opened from our tools; content is from the peer-reviewed account (Unsworth et al., Digital Health, 2021) and NICE’s listing. Check the current version.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
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