Rare Diseases: European Market Access ‘Better Organized’ Than US, Says Rhythm
Rhythm is working with country-level authorities and centers of excellence in Europe to gain reimbursement and access for its obesity treatment Imcivree.
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Rare disease advocates push for National Academies of Sciences, Engineering and Medicine study on how or whether ultra-rare should be defined, which could create legislative pressure. In an interview, Ultragenyx CEO Emil Kakkis suggests patient thresholds, accelerated approval triggers.
The members of a new group aiming to boost rare disease R&D say that Europe needs a “solid pro-innovation ecosystem” supported by a stable intellectual property framework and a “world-class” regulatory system.
France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.