Brief · Use case · Market Access
EU Market Access Plan.
LivePlanPlan the path from HTA submission to the first reimbursed patient in one European market, with the external clocks and gates.
EU Market Access Plan is a ready-made use case for Market Access. It ships under the Plan template.
For market access leads planning a launch. You get the objective and critical path, the milestones with exit criteria, the HTA and pricing clocks you cannot compress, the go or no-go gates and the first move. Dates are cited or marked as gaps.
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The decision
What is the plan for market access in one European market for a newly approved specialty therapy, from health technology assessment submission to the first reimbursed patient?
The steps of the plan
The plan follows the market’s own process. Germany is the worked example here because its steps and periods are published; the plan states the market it uses.
| Step | What it involves | The clock or source |
|---|---|---|
| Submit the dossier | In Germany the dossier must be sent electronically no later than the day the product is first marketed, and may be sent earlier for a completeness check.1 | The G-BA’s English page on the benefit assessment. |
| Benefit assessment | The committee assesses the claimed added benefit within six months of market authorization, and the results are published within three months of that.1 | The G-BA’s English page. |
| Hearing and resolution | Three months after publication the committee passes a resolution, which includes the pricing decision basis.1 | The G-BA’s English page. |
| Price negotiation | Within six months the company and the statutory health insurance funds negotiate the price, and an arbitration board sets it if they do not agree. EU rules limit national price and reimbursement decisions to 90 days each, or 180 days when handled together.1,2 | The G-BA’s page and Council Directive 89/105/EEC. |
What the plan does
External clocks, in their own column. The plan lists each step’s published period and marks which are statutory and which are the committee’s procedure. It does not carry a period over from another market.1,2
EU joint assessments may apply. Joint clinical assessments under the EU HTA Regulation began on 12 January 2025 for new cancer medicines and advanced therapies, extend to orphan medicines from 13 January 2028 and to all medicines from 13 January 2030. The plan says whether the product is in scope.3
Time to patient, not time to decision. The EFPIA Patients W.A.I.T. Indicator measures days from marketing authorization to availability, which for most countries means reimbursement listing. The plan sets its own timeline beside that measure, as context only.4
How it could fail. The pre-mortem probes the failures this plan invites: a dossier that must be amended, a comparator the committee sets differently from the one assumed, a negotiation that goes to arbitration, or a joint assessment that changes the steps.
Recommended length
Comprehensive
Several parties are involved and decisions have to be taken along the way. Comprehensive adds the gates, the responsibility table and the risk map.
You can pick another length on the form. The other two stay available.
Assumptions the plan checks
The plan states the assumptions its dates rest on and says which one would move the finish if it failed. Examples for this plan:
- The product follows the standard assessment route in the chosen market.
- The comparator the committee sets matches the one the dossier used.
- The published periods are the ones that apply in the year of submission.
Standards, guidance and sources
The market’s process
- G-BA, benefit assessment of medicinal products, under section 35a of the Fifth Book of the Social Code (Germany).1
EU rules
Access context
- EFPIA Patients W.A.I.T. Indicator: days from authorization to availability.4
The decision practice behind the memo itself is on the template page.
What gets flagged
Any period taken from a different market, any step the plan could not source, and any joint assessment that could change the order of steps.
What arrives
- The objective
- The sequence
- Gates and decisions
- Who is needed
- Dependencies and external clocks
- What could derail it
- The first move
What it will not do
It does not promise dates. Each duration is sourced or marked as an estimate, and an unpublished deadline is a gap.
It does not predict the benefit rating or the price.
It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.
It does not invent an agency’s deadlines. A deadline that is not published is a gap.
It does not run the plan. It gives an owner the first move and the criteria for the next gate.
References
- [1] Gemeinsamer Bundesausschuss (Federal Joint Committee). Benefit assessment of medicinal products. English page. Read in full on 9 October 2026.
- [2] Council of the European Communities. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems. Check the national rules that implement it.
- [3] European Parliament and Council. Regulation (EU) 2021/2282 on health technology assessment. Application dates for medicinal products: 12 January 2025, 13 January 2028 and 13 January 2030. The phase-in dates are as given in the European Commission’s factsheet and EUR-Lex summaries; the regulation’s text was not read in full for this page.
- [4] EFPIA. EFPIA Patients W.A.I.T. Indicator survey. Successive editions. An industry association’s survey; the edition cited here is the 2024 report. For most countries, availability is the date of listing for reimbursement.
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.
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