Gilead Sciences has secured temporary reimbursement in France and Germany and in parts of the UK for its potentially transformative and high-cost CAR-T therapy Yescarta but has yet to secure reimbursement in other larger EU markets such as Italy.
Payment For Outcomes Key To EU Market Access for Yescarta
Payment for outcomes has played an important role in enabling Gilead to secure reimbursement for Yescarta in some EU markets. It is likely to be the key focus for the company as it works to expand patient access to the potentially transformative CAR-T therapy across Europe.

More from Europe
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Geography
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.