Growing concerns over proposed OMP legislation changes in Europe
Written by Iro Malekou, Senior Analyst & Srishti Gupta, Senior Consultant Emails: [email protected], [email protected] Over a year ago, the European Commission (EC) set out to
Written by Iro Malekou, Senior Analyst & Srishti Gupta, Senior Consultant Emails: [email protected], [email protected] Over a year ago, the European Commission (EC) set out to
Yescarta, Gilead’s CAR-T cell therapy recently underwent a full HTA assessment in Germany after breaching the annual sales threshold for orphan drugs. Upon reassessment, Germany’s lower HTA body IQWiG recommended downgrading Yescarta’s rating in one indication to ‘no added benefit’, which is likely to negatively impact pricing negotiations.
OD (orphan drug) privilege status under the AMNOG procedure means that ODs are currently exempt from providing comparative data for their assessment. They are assumed to have a positive added benefit (with the lowest rating possible being a positive but unquantifiable added benefit), even when the data is insufficient to support this. If sales over 12 months surpass the €30 million mark, this privilege is revoked, and a full assessment is performed based on comparative data.
Written by Andrea Bernardini, Associate Consultant & Marco Sancandi, Analyst Contacts: abernardini@partners4access; msancandi@partners4access In a significant step forward for healthcare in Italy, the National Rare
By Marco Sancandi, PhD; Analyst On the 31st of January 2023, the 6th joint report from the Orphan Drugs Observatory and the Italian Society of
By Fisentzos Stylianou, PhD; Senior Analyst The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point
By Fisentzos Stylianou, PhD; Senior Analyst Contact: [email protected] “I can say on behalf of the G-BA that it is possible that we will recognise some
By Fisentzos Stylianou, PhD Contact: [email protected] NICE’s launches a real-world evidence framework Closing knowledge gaps and advancing patient access to innovations are major aims of the
By Andrea Bernardini, Senior Analyst Email: [email protected] Nicola Magrini, the General Director of the Italian Medicines Agency’s (AIFA) has just suggested that significant changes are on
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