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.
You may also be interested in...
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.
Gene Therapy Pricing To Come Under Microscope In Germany
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.
Zolgensma Provides No Proven Benefit Over Spinraza In SMA, Says German HTA
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.