Zolgensma First To Be Subject To New German Data Collection Rules
Price & 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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The G-BA, the body in charge of Germany’s pricing and reimbursement process, has confirmed that Novartis’s gene therapy Zolgensma (onasemnogene abeparvovec) offers no additional benefit over Biogen’s Spinraza (nusinersen) for treating spinal muscular atrophy.
IQWiG, Germany’s health technology appraisal institute, has found that Novartis’s gene therapy Zolgensma offers no additional benefit compared with Biogen’s Spinraza for treating spinal muscular atrophy, while Roche’s Evrysdi offers a hint of benefit in one patient group.
Germany is for the first time to adopt national guidelines on prescribing biologics and biosimilars in a move towards increasing biosimilar uptake.