HTA changes at EU lev­el could slow the up­take of new cell and gene ther­a­pies, in­dus­try group warns

If a cell or gene ther­a­py de­vel­op­er wants to bring a new prod­uct to mar­ket in Eu­rope, first they have to clear the EMA, and then they have to nav­i­gate the of­ten di­ver­gent, du­plica­tive coun­try-lev­el re­im­burse­ments de­ci­sions that law­mak­ers at the EU lev­el have now sought to make more equal, but may end up adding an­oth­er bar­ri­er to ac­cess.

Start­ing in 2025, mil­lion-dol­lar-plus ad­vanced ther­a­py med­i­c­i­nal prod­ucts (ATMPs), will be­gin to go through a new Eu­ro­pean-wide HTA process pri­or to coun­try-lev­el re­im­burse­ment de­ci­sions, but for now the ground rules around the method­olo­gies are be­ing hashed out and the Al­liance for Re­gen­er­a­tive Med­i­cine (ARM) is tak­ing is­sue.

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