Zolgensma Loses Orphan Benefit in Germany After 'Very High Sales'
Novartis Calls For Change In How Germany Assesses Orphan Benefit
Zolgensma has exceeded the orphan sales threshold in the six months it has been on the market in Germany and the gene therapy must now undergo a full benefit assessment.
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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.
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.