Brief · Use case · Market Access
Market Entry Sequencing.
LiveDecision MemoDecide which market to enter first and in what order, comparing access routes, the evidence each requires, time to reimbursement and execution risk.
Market Entry Sequencing is a ready-made use case for Market Access. It ships under the Decision Memo template.
For market-access and commercial leads sequencing a launch. You get the recommended order, a scored comparison of the entry routes, the evidence each market will ask for, and the fact that would reverse the order. Estimates are cited to HTA and reimbursement sources or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Which European market should a prescription digital therapeutic enter first: Germany through the DiGA fast track, France through early access, or England through the NICE evidence framework? The memo also scores entering in parallel and delaying entry.
The three markets on the table
Each market asks for a different kind of evidence on a different clock. The memo puts them side by side and scores them, with parallel entry and delay, on the same five criteria.
| Route | What it asks of you | It fits when | What decides the timing |
|---|---|---|---|
| Germany: DiGA fast track | Apply to the BfArM with evidence that the app improves a patient’s health or ability to cope with the disease. The BfArM also examines data protection, interoperability and usability. If the evidence is not yet complete, you can apply for provisional listing and generate it during a trial phase.1 | You hold, or can finish within the trial phase, evidence of a positive healthcare effect, and the product meets the German data protection and interoperability requirements. | BfArM decides within three months of a complete application |
| France: early access (PECAN) | File in parallel with the national digital agency (interoperability and security certification) and with the health technology agency, whose committee assesses clinical benefit. If approved, the product is covered for one year while you finish proving its benefit.2 | The product is mature, you can show a presumed clinical benefit or organizational progress, and you can file for permanent listing before the year ends. | One year of early coverage; permanent listing to be requested within six months for a digital therapeutic |
| England: NICE evidence standards | Meet the evidence standards that match what the product does. The framework sorts digital health technologies into tiers, with the evidence required rising with the risk of the function. A technology that treats or manages a condition sits in the highest tier.3,4 | You can show effectiveness and economic impact to the level of the product’s tier, and a commissioner is ready to use that evidence. | The framework sets evidence standards, not a payment route; the commissioning route is confirmed in the memo or marked as a gap |
What the memo does with them
The evidence each market asks for, side by side. Germany looks for a positive healthcare effect plus data protection, interoperability and usability. France assesses clinical benefit, with interoperability and security checked separately by the digital agency. England expects evidence that rises with the risk of the product’s function. The memo sets what you hold against each and names the gaps.1,2,4
Time to money, not time to approval. A listing is not revenue. The memo separates the time to a decision from the time to reimbursed use, and it marks any price or volume estimate as a gap unless a public source supports it. It does not carry over figures from one market to another.
Parallel, sequential or delayed, scored honestly. Entering two markets at once costs more and splits the team; entering one after the other delays revenue and can leave the second market to a competitor. The memo scores both, along with delaying entry, on the same criteria as the three markets.
Five criteria, scored the same way. The evidence each market requires, time to reimbursement, price and volume potential, cost to enter and execution risk. The scores are analyst judgment, labeled as such.
How it could fail. The pre-mortem probes the failures this decision invites: evidence that falls short of the first market’s bar, a decision that arrives after the launch budget is spent, a data protection or interoperability requirement met late, or a first market that does not fund the second. Each gets an early warning and an owner.
Recommended length
Standard
The order can be adjusted once the first market reports, so this is largely a reversible decision. Standard gives the evidence each market needs, the scored comparison and the conditions that would flip the order in about 1,700 words.
You can pick another length on the form. The other two stay available.
Assumptions the memo tests
A Comprehensive memo lists the assumptions that carry the answer, each with a test and a date. A Standard memo carries the main ones in its section on what would change the answer. Examples for this decision:
- The evidence you hold meets the first market’s bar, or its route leaves time to finish it.
- The first market’s decision arrives in time to help fund the second.
- The product can meet the first market’s data protection and interoperability requirements within the filing timeline.
- The launch budget set on 30 June 2027 leaves time for the application steps of the chosen route.
Standards, guidance and sources
Germany
- The BfArM’s DiGA fast-track process: three months at most from a complete application, evidence of a positive healthcare effect, and provisional listing while final evidence is generated. The DiGA Guide, version 3.6 of 10 December 2025, is the BfArM’s reference.1
France
- The early-access route for digital medical devices (PECAN): one year of exceptional coverage, assessment by the HAS and its committee after the national digital agency has checked interoperability and security, and a decision by the health and social security ministers.2
England
The decision practice behind the memo itself is on the template page.
What gets flagged
Any evidence requirement the product does not yet meet, every price, volume or reimbursement-time figure with no public source, whether England has a payment route for the product at all, and the one fact that would reverse the order.
What arrives
- Decision requested
- Recommendation
- Context and framing
- Options considered
- Why this option wins
- What must be true
- What would change the answer
- Risks and the pre-mortem
- Path and what we do not know
What it will not do
It does not file anything, and it does not predict what the BfArM, the HAS or NICE will decide.
It covers the three markets in the question. It does not assess other markets unless you ask for them.
It does not make the decision. The named decider does.
Scores and weights are analyst judgment from an AI specialist, not measurements. They show how the options compare on the criteria you chose; change the weights and the ranking can change.
It is one specialist’s answer. When you need several specialists to disagree in the open, run a Panel.
Facts the specialist could not source appear as gaps. Regulatory fees, review goals, reference prices and probabilities are cited to their sources or left open. Check any figure you will act on against its primary source.
References
- [1] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. Statistics as of 9 September 2026; DiGA Guide version 3.6, 10 December 2025. The DiGA Guide itself holds the detailed evidence standards; it was not read for this page.
- [2] Agence du Numérique en Santé (G_NIUS). Advance Digital Care (PECAN): early access reimbursement for digital medical devices. Run by the national digital health agency. The HAS filing guide of March 2026 was found but not read.
- [3] 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; its content here is taken from the peer-reviewed account in reference 4 and from NICE’s search listing. Check the current version.
- [4] Unsworth, H. et al. The NICE Evidence Standards Framework for digital health and care technologies: developing and maintaining an innovative evidence framework with global impact. Digital Health, 2021;7. DOI 10.1177/20552076211018617. Describes the 2021 version of the framework; NICE has revised it since.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
To edit a saved template, open New → Brief → From template, or the library rail on the service form.