. Generally, the approach taken by NICE seems to be more open and less restrictive as compared with G-BA/IQWiG.
Germany requires a higher level of evidence ..often 2 double blinded randomized , placebo controlled clinical trials So far R-IT is the only trial that met this standard . The CV data from MITIGATE may have helped if they had completed that trial . AMRN may come up with RWE ( real world evidence )...from say a Kaiser data base that also might help . And yes ...price is a factor. Germany is a large market so they would want a discount. JMO Kiwi