The dossier is due the day you launch in Germany, the negotiated price applies from month seven, and the industry puts the cost of one dossier at close to a million euros. The decisions that drive all three are made a year or more earlier.
A new medicine launched in Germany must submit a benefit dossier to the G-BA at market entry (§35a SGB V) — five modules, the core in German, filed through the G-BA portal. The assessment (usually by IQWiG) is published after 3 months, the G-BA decides after about 6 months, and the price negotiated with the statutory insurers applies from month 7. The G-BA charges for advice (EUR 3,200–16,000 per consultation), and early-advice slots are booked months ahead. The research-based industry association vfa puts a dossier at about EUR 800,000 and 12 months of work. About half of all procedures since 2011 found an added benefit, with a lower share in recent years.
Since 2011, every new active substance launched in Germany goes through an early benefit assessment. The dossier is the company’s case for an added benefit over the appropriate comparator — and the burden of proof is on the company.
It is due at first market launch, and for a new indication within four weeks of its approval. Orphan drugs are treated as having an added benefit by law until their statutory-insurance revenue passes EUR 30 million in 12 months; above that, a full dossier is due within three months of the G-BA’s request. For how the assessment shapes the price, see AMNOG explained.
| Step | When | Notes |
|---|---|---|
| G-BA early advice | 12–24+ months before launch | By law within 8 weeks of a complete request — but slots are booked out months ahead |
| Dossier submission | Day of launch | New indication: within 4 weeks of approval |
| Benefit assessment published | Month 3 | Usually by IQWiG on behalf of the G-BA |
| Written and oral hearing | Months 3–5 | Company, experts and associations comment |
| G-BA decision | About month 6 | Extent of added benefit per patient group |
| Price negotiation | Within 6 months of the decision | With the GKV-Spitzenverband; arbitration within 3 months if it fails |
| Negotiated price applies | From month 7 after launch | Settled retroactively; free pricing only in months 1–6 |
In October 2026 the G-BA showed advice slots booked out until spring 2027: the next free submission week was calendar week 15 of 2027, with meetings from week 25. Plan advice a year ahead of when you need the answer.
The cheapest dossier is the one whose comparator was fixed before Phase 3 started.
The GKV contribution-stabilisation act (BStabG), in force since late July 2026, changed the price side of AMNOG:
On 3 September 2026 the Health Ministry also floated an “AMNOG 2.0” concept for conditionally approved and orphan medicines, with mandatory re-assessment after three to four years. It is a proposal, not a bill. We follow it in the Regulatory Digest.
The vfa estimated about EUR 800,000 and 12 months of work per dossier in 2023. Costs rise with the number of indications and patient groups, indirect comparisons and statistical analyses. G-BA advice costs EUR 3,200 to 16,000 per consultation; we are not aware of a fee for the assessment itself.
At first market launch in Germany. For a new indication, within four weeks of its approval. Orphan drugs above EUR 30 million in statutory-insurance revenue must file a full dossier within three months of the G-BA’s request.
The benefit assessment is published three months after the dossier deadline, and the G-BA decides about three months later. The price negotiated with the GKV-Spitzenverband applies from month seven after launch.
Modules 1 to 4 and the checklist must be in German. Study reports in Module 5 can be in German or English.
The BStabG abolished the price guardrails and the combination discount in July 2026, raised the manufacturer rebate to 15.5% from January 2027 with an exemption for products with German trial sites, and made price-volume agreements mandatory.
Start with a fixed-price Snapshot, or book a session to plan advice, the dossier and the price negotiation together.