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Germany To Increase Data Requirements For Pricing Orphan And Other Drugs

 
• By Francesca Bruce

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.

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New Data Requirements Could Impact Some Drug Prices In Germany

Draft legislation in Germany proposes to allow the G-BA, the body in charge of the pricing and reimbursement process, to request additional registry data from companies marketing orphan drugs, exceptional use products and conditionally approved medicines.

The data will impact on pricing decisions and companies could bear heavy costs for collecting it, according to Eda Zhuleku,...

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