Zolgensma First To Be Subject To New German Data Collection Rules
Pricing And Reimbursement Body Sets Out New Process
The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.
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A new bill going through the German legislative process could oblige manufacturers of orphan drugs and certain other products to submit real-world data from registries that would impact pricing.
Insurers argue that better use of real world data and multiple pricing assessments could help lower drug prices in Germany.
To keep investors happy, companies will have to start showing that their high-priced advanced therapies offset costs elsewhere in the health care system.