NICE Rejects Tecentriq For Small-Cell Lung Cancer In England

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.