Health technology appraisals have yielded mixed results for CAR-T therapies in Scotland as the Scottish Medicines Consortium said yes to Novartis’ Kymriah (tisagenlecleucel) but no to Gilead’s Yescarta (axicabtagene ciloleucel). In response to the decisions, a research charity warned that while CAR-T therapies could be game changing treatments, the high prices they command would be a reoccurring issue.
Mixed HTA Results As Scotland Says No To Yescarta But Yes To Kymriah
The Scottish Medicines Consortium has recommended one CAR-T therapy, Novartis’ Kymriah, for use on Scotland’s National Health Service but rejected another, Gilead’s Yescarta, claiming the company has failed to prove it would be cost-effective.
More from Europe
• By
Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.
• By
Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
• By
A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.
• By
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
More from Geography
• By
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
• By
Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.
• By
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.