Amarin Corp Plc (AMRN)

[Whalatane]

Denisk From BARD

Does the German Health Dept require more than 1 large independent randomized double blinded trial to prove efficacy before approving reimbursement for a new drug ?

Yes, the German Health Department requires more than one large independent randomized double-blind trial to prove efficacy before approving reimbursement for a new drug.

The German Health Department (G-BA) is responsible for approving the reimbursement of new drugs in Germany. The G-BA uses a process called the AMNOG (Arzneimittelmarktneuordnungsgesetz) process to assess the clinical and economic value of new drugs.

The AMNOG process requires the pharmaceutical company to submit data from at least two large independent randomized double-blind trials that demonstrate the efficacy and safety of the new drug. The trials must be conducted in accordance with Good Clinical Practice (GCP) guidelines.

The G-BA will also consider the results of other studies, such as post-marketing studies, when assessing the clinical and economic value of a new drug.

If the G-BA finds that the new drug provides a significant added benefit over existing therapies, it will be approved for reimbursement. However, if the G-BA finds that the new drug does not provide a significant added benefit, it will not be approved for reimbursement.

The AMNOG process is designed to ensure that new drugs that are reimbursed by the German health system provide a significant added benefit over existing therapies. This helps to ensure that patients have access to the most effective and safe treatments available.

Here are some additional details about the AMNOG process:

The G-BA has a deadline of 12 months after a new drug is launched to make a decision on reimbursement.
If the G-BA does not approve a new drug for reimbursement, the pharmaceutical company can appeal the decision.
The G-BA can also require the pharmaceutical company to conduct additional studies or to lower the price of the new drug before it will be approved for reimbursement.

------------------------
IMHO AMRN will need to provide more independent clinical data or acceptable real world data ...to get reimbursement in Germany at a level acceptable to AMRN

Kiwi