Germany is Europe's largest pharmaceutical market. It offers early access and broad coverage for new therapies, which makes it attractive to many international companies. But the system is more complex than it looks from the outside.

Companies often approach Germany with assumptions based on their experience in other EU countries. Here are three common misunderstandings we frequently encounter when advising clients, along with a few things to keep in mind of you're preparing for launch.

1. “Once we have EMA approval, we're good to go"

This is probably the most common misconception. EMA approval gives you market authorisation across the EU, but each country handles reimbursement and pricing separately. in Germany, this happens through a process called AMNOG.

What is AMNOG?
The Arzneimittelmarktneuordnungsgesetz, or AMNOG, has shaped drug pricing in Germany since 2011. Under this system:

• New prescription drugs can launch immediately after EMA approval and set a free price during the first 12 months.

• During this year, the manufacturer must submit a benefit dossier to the G-BA, Germany's central decision-making body for health policy.

• The G-BA assesses the added benefit of the drug compared to a selected comparator, usually the current standard of care.

• The assessment forms the basis for formal price negotiations with the GKV-SV, which represents the statutory health insurers.

• The outcome of those talks determines the reimbursed price from year two onwards.

• Even orphan drugs are assessed, although under slightly different rules. In short: EMA approval lets you enter the market quickly, but it doesn't guarantee a favourable price from year two post launch onwards. If the added benefit is unclear or unsupported, the product could end up with a low negotiated price and/or a negative impact on future reimbursement in other countries.

2. “ A good HTA result means good uptake"

A positive G-BA assessment is definitely helpful. But in practice, it's not enough. Reimbursement does not automatically lead to real-world usage.

Several things can limit uptake even after a solid HTA outcome:

• Regional physician associations (KVen) and local formularies can influence prescribing decisions.

• Health insurers may impose restrictions, such as prescription quotas.

• Physicians might not be fully informed on how to justify the prescription of the product.

• Without clear communication and educational materials, products may sit unused despite full access on paper.

A good HTA result is just one part of the puzzle. But so is implementation, physician confidence and payer alignment across all relevant levels. Companies that plan only for regulatory success risk missing the more practical barrier that come later.

3. "We can handle Germany just like any other large EU market"

Germany is often seen as a scaled-up version of smaller European markets, but this underestimates how distinct the system is.

For example:

• Germany allows immediate market entry after EMA approval, without waiting for national reimbursement decision. That makes launch planning faster, but also riskier.

• The pricing system is complex. The list price is public, but real prices are sometimes shaped by mandatory discounts, confidential rebate contracts and reference pricing mechanisms. Confidential net pricing is not common yet, so there is payer pressure on the list price.

• G-BA assessments are widely watched by payers across Europe. A “no added benefit“ rating can make later decisions harder in countries like Austria or Belgium.

The key takeaway:
Germany requires a tailored approach. You need coordination between global teams, local affiliates and external partners. Treating it like any other EU country usually leads to friction and frustration.

Final thought

Germany remains a high-potential launch market for new therapies, especially for innovative or firs-in-class products. But success depends on more than regulatory approval.

If you're planning on a launch here, make sure to think beyond the HTA. Align your pricing strategy with your clinical evidence. Engage payers early. Prepare for the regional rollout and make sure physicians are ready to prescribe.

Avoiding the mistakes above can save you time, money and lost momentum.

Want to talk strategy?

We support companies at every stage of their entry into the German market, from AMNOG planning to rollout and uptake. Get in toch if you'd like to discuss your next step.