Brief · Use case · Market Access
HTA Process Overview.
LiveOverviewUnderstand how a country assesses a new medicine and sets its price: the steps, the bodies involved, the terms and what would change how the process works.
HTA Process Overview is a ready-made use case for Market Access. It ships under the Overview template.
For market access leads new to a country. The overview explains the process in plain words, defines each term once, shows how the steps and bodies fit together and names what to watch. Process facts are cited to official 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
How does Germany’s AMNOG process assess a new medicine’s added benefit and set its price, for a market access lead who is new to Germany?
The steps of the process
AMNOG, the German law on the reorganization of the medicines market, is a sequence of steps with fixed time limits. The overview walks through them as the Federal Joint Committee describes them, and defines each term once.
| Step | What happens | The body involved |
|---|---|---|
| Dossier | The company submits a dossier based on its authorization documents and all studies, showing added benefit over the comparator the committee sets. It must be sent electronically no later than the day the product is first marketed.1 | The Federal Joint Committee (the G-BA). |
| Benefit assessment | Within six months of market authorization the committee assesses the claimed added benefit, and may delegate the work to the Institute for Quality and Efficiency in Health Care. The results are published within three months.1 | The G-BA, often with the Institute. |
| Hearing and resolution | Companies, associations and experts can comment. Three months after publication the committee passes a resolution on the extent of added benefit, the patient groups concerned and the treatment costs.1 | The G-BA. |
| Price negotiation | Within six months the company and the statutory health insurance funds’ central association negotiate the reimbursement price, as a rebate on the company’s original price. If they do not agree, an arbitration board sets it using European pricing levels.1 | The GKV-Spitzenverband, the company, and an arbitration board. |
What the overview does
The steps in the committee’s own words. The G-BA’s English page describes the process under section 35a of the Fifth Book of the Social Code: the dossier, the assessment, the hearing, the resolution and the negotiation. The overview follows that sequence and uses the committee’s terms, defined once in a table.1
What changes if there is no added benefit. If the committee finds no added benefit, the product is placed in the reference price system within six months of launch, and its annual treatment costs may not exceed those of the comparator. The overview shows this branch next to the negotiation branch.1
The European layer. The EU health technology assessment regulation phases in joint clinical assessments from 12 January 2025. The overview says whether and when the product class falls under it and how the national process sits beside it.2
What would change how the process works. The overview names the legal changes and the EU phase-in dates that would alter the steps, and says where the committee’s published procedure is the source.1,2
Recommended length
Comprehensive
The process is a sequence of steps and bodies with terms a newcomer must learn. Comprehensive adds the how-it-works section and the terms table.
You can pick another length on the form. The other two stay available.
Assumptions the overview checks
The overview says which assumptions its conclusions rest on and names the most fragile one in its first paragraph. Examples for this subject:
- The product is a new medicine that falls within the scope of the benefit assessment.
- The time limits stated on the committee’s page are the current ones.
- The EU phase-in dates in the overview apply to the product’s class.
Standards, guidance and sources
Germany
- The G-BA’s English page on the benefit assessment of medicinal products, under section 35a of the Fifth Book of the Social Code (SGB V).1
The EU layer
- Regulation (EU) 2021/2282 on health technology assessment: joint clinical assessments, phased in from 12 January 2025.2
The decision practice behind the memo itself is on the template page.
What gets flagged
Any time limit that is not on the committee’s page, any step that is described from a secondary source, and any change in the law that took effect after the committee’s page was last updated.
What arrives
- Bottom line
- Why it matters now
- What we know
- How it works
- What it means
- Terms and actors
- What would change this
What it will not do
It explains and does not recommend. If you need a recommendation on what to do next, the Decision Memo is the template for it.
It does not predict the committee’s benefit rating for a product, and it is not legal advice on the dossier.
It does not recommend an action. An overview explains; it does not decide. When you have a choice to make, a Decision Memo is the template for it.
It is one specialist’s reading of public sources. Check any figure you will act on against its primary source.
It does not replace reading the regulation, the filing or the guideline it cites.
References
- [1] Gemeinsamer Bundesausschuss (Federal Joint Committee). Benefit assessment of medicinal products. English page. Read in full on 9 October 2026. The page gives no overall timeline, so the figures are the ones it states step by step.
- [2] 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.
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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