Novel T-cell platform technology recommended for first time by EU authorities
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 CHMP recommendation to the European Commission foreshadows potential regulatory approval, which would usher in a new era of donor-based T-cell platform technology for patients.
Like predicate novel platform technologies before it (i.e. oncolytic viral therapy, autologous T-cell, mRNA based therapies, etc.), the scrutiny surrounding coverage and payment of Ebvallo™, from national health technology assessment through local pathways adoption, will be stringent and require close engagement with payers, key opinion leaders, and patient advocates market by market. There is no shortcut to patient access success, despite the promises of this remarkable technology.
At PHAROS, we help unlock European markets by providing access and reimbursement solutions through boutique country-focused teams, at scale, and have a particular strength in rare disease. The benefit is our clients have ONE turn-key solution via PHAROS to unlock the European continent through a diversified and deep bench of experts and our extended stakeholder network.