Libmeldy Gene Therapy Brings Considerable Extra Benefit, Says German Body
With talks to form a new coalition progressing in Germany, the new government, which could take office in early December, is expected to introduce measures to curb pharmaceutical spending. Orphan drugs could be among products targeted.
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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.
Alexander Natz, secretary general of EUCOPE, warns that changes to a pricing and reimbursement system that has so far worked well, particularly for orphans, could dissuade advanced therapy medicinal products manufacturers from launching in Germany.
Health technology assessment body NICE has welcomed further discussion between Orchard Therapeutics and the National Health Service to resolve its concerns over the company’s one-time gene therapy for the neurodegenerative disorder, metachromatic leukodystrophy, in children.