EU Joint HTA will become reality for ATMPs and therapies in oncology by the end of 2024. Anyhow, methods and processes are not yet communicated and established as of March 2023. Furthermore, there are no opportunities for early consultation to plan clinical trials and/or EU joint HTA dossiers. The core question still remains for which endpoints and comparators data would need to be submitted and by when? What would happen if the EMA label changes last minute with an impact on joint HTA assessments. Furthermore, nobody yet knows how these results will be implemented by national payers. More established HTA systems such as France and Germany might only adopt (slightly), others might utilize the full report of the EU joint HTA and directly start with the price negotiations.
Many open questions which have been discussed between the reimbursement veteran Dr. Stefan Walzer and his guests on the podcast Priyanka Kiritharan and Chloe Sheppard.
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