Patient involvement in health technology assessment (HTA) has come a long way. Once seen as an optional add-on, it is now a key element of
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.
By Fisentzos Stylianou, PhD; Senior Analyst Contact: Fstylianou@partners4access.com “I can say on behalf of the G-BA that it is possible that we will recognise some
By Andrea Bernardini, Senior Analyst Email: abernardini@partners4access.com Intensifying pressure to implement cost savings due to COVID induced economic downturn and the current ruling coalition, seem
By Jens Leutloff, Senior Consultant Email jleutloff@partner4access.com The discussion of cost containment measures in the German healthcare system does not seem to stop, and could
