Regulatory and reimbursement landscape for Cell and Gene Therapies across Europe

23 December 2022

Cell and gene therapies (CGTs) offer potentially curative options for previously incurable diseases; however, this comes at a high financial cost. As more CGTs enter the European market, it is important for manufacturers and payers to understand the implications of the evolving landscape. This research focused on the regulatory and reimbursement landscape of CGTs in France, Germany, Italy, and the UK.

Regulatory and reimbursement landscape of CGTs

Objective

The aim of this study was to:

• Identify approved CGTs by EMA in France, Germany, Italy, and MHRA in the UK

• Explore the reimbursement landscape of CGTs across four countries including key outcomes of HTA assessments and time to reimbursement (TTR)

• Assess the use of early access schemes for CGTs across scope countries

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