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Whalatane

01/12/24 12:21 PM

#420299 RE: ziploc_1 #420264

Zip Its harder to get coverage for new drugs in Germany ( and France ) vs England ( NICE )
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4884042/

. 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