Amarin Corp Plc (AMRN)

[Whalatane]

RMB. This is what Germany wants

In Germany, the level of evidence required for the reimbursement of new drugs is quite stringent and follows a systematic process. The German Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA) is responsible for evaluating the benefits and cost-effectiveness of new drugs to determine whether they should be reimbursed by the statutory health insurance system.

The G-BA typically considers evidence from clinical trials, health economic evaluations, patient-reported outcomes, and real-world data. The level of evidence required includes:

Clinical Trials: High-quality, randomized controlled trials (RCTs) are often required to demonstrate the efficacy and safety of a new drug. These trials should follow rigorous methodologies, including appropriate blinding, randomization, and control groups.
Health Economic Evaluations: Cost-effectiveness analyses are crucial to assess whether the new drug provides value for money compared to existing treatments. This involves comparing the costs of the new drug with its benefits in terms of improved health outcomes.
Patient-Reported Outcomes (PROs): The G-BA also considers patient-reported outcomes, which provide insights into how patients perceive the impact of the drug on their quality of life, symptoms, and overall well-being.
Real-World Data (RWD): Evidence from real-world studies, such as observational studies and post-marketing surveillance data, may also be required to evaluate the long-term effectiveness and safety of the drug in routine clinical practice.

So at least bring on the Real-World Data .
Kiwi