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The European (EU) Regulation on Health Technology Assessment (HTA) came into force in January 2022 and will apply from January 2025 starting with oncology medicines and Advanced Therapy Medicinal Products (ATMPs). The three-year application period aims to set up the organizational framework and methodological guidelines of the common assessment and, to give health technology developers time to anticipate the requirements of the new framework.

A first in class allogeneic T-cell therapy, Ebvallo™ (tabelecleucel), was recommended by Europe’s Committee for Medicinal Products for Human Use (CHMP) on October 14th, 2022 for the treatment of refractory Epstein Barr virus positive post transplant lymphoproliferative disease in patients who have received at least one prior therapy.

The Swedish Government has requested that the Dental and Pharmaceutical Benefits Agency (TLV) develop new methods for health economic evaluation and payment methods for Advanced Therapy Medicinal Products (ATMP). The current system and payment methods present challenges, as ATMP often have limited evidence and high upfront one-time costs.

The European (EU) Regulation on Health Technology Assessment (HTA) came into force in January 2022 and creates a permanent framework for cooperation between member states in JCA regarding certain new therapies. This article aims to provide an overview of the current understanding time frame of implementation and some implications for the JCA industry.