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Gene Therapy Pricing To Come Under Microscope In Germany

Executive Summary

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.

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Germany is drastically squeezing orphan drug pricing while new US laws protect rare diseases drugs from price negotiations. These contrasting moves fuel the longstanding debate over whether orphans still deserve special incentives.

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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.

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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.

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