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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