What Europe’s health systems will require to implement psychedelic therapies
A new article published in European Neuropsychopharmacology provides a critical assessment of what psychedelic therapies would need in order to be integrated into European healthcare systems. While regulatory approval from the EMA will be necessary, the authors stress that Health Technology Assessment (HTA) bodies across Europe — such as IQWiG, HAS and NICE — will ultimately determine whether these therapies are reimbursed and accessible.
HTA requirements pose several challenges. Evidence packages for psychedelics currently rely heavily on placebo-controlled trials, yet HTA agencies expect comparative data against established standard treatments. For depression, this means studies comparing psychedelics to recognised augmentation strategies, rather than placebo alone, with follow-up periods long enough to demonstrate sustained effect.
The paper also highlights a structural issue: psychedelic therapy is delivered with psychotherapeutic support. European guidelines for depression already recommend combination therapy — pharmacotherapy plus psychotherapy — as the preferred option for moderate to severe cases and for patients who do not respond to first-line antidepressants. In practice, this means psychedelic-assisted therapy will be evaluated not only as a drug but as a combined intervention involving psychological support. HTA bodies will expect clarity on how this therapeutic model is defined, delivered, and financed within routine care.
The authors argue that without comparator trials and defined psychotherapy components, psychedelic therapies may struggle to demonstrate “added therapeutic value,” limiting access even if EMA approval is granted. They point to recent examples, such as esketamine, to illustrate how HTA decisions can diverge significantly from initial regulatory approvals.
The publication concludes that early engagement with HTA agencies, robust comparator studies, and clear integration of psychotherapy into treatment models will be essential for ensuring that psychedelic therapies can move from promising trials to real-world availability in Europe.
