The journal Clinical Drug Investigation recently published the article “New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing” which was co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. As the number of advanced therapy medicinal products (ATMPs), such as gene therapies, increases, it becomes clear that the existing health technology assessment (HTA) process is not sufficient anymore to give the right value to such treatments. The objectives of this article are to discuss why the current HTA process is inadequate for evaluating these new therapies, how evidence should be continuously generated and presented to regulators and payers to support their use, and to propose new approaches to pricing models. Without new approaches or adaptation of existing frameworks, certain ATMPs may not reach patients in some or all countries or be at risk of withdrawal from the market.
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