rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Psychedelics: the pathway to implementation in the European healthcare systems
  name:
    name part: Gründer, Gerhard
    role:
      role term: creator
    role:
      role term: VerfasserIn
    role:
      role term: aut
  name:
    name part: Mertens, Lea Julia
    name part: 1995-
    role:
      role term: VerfasserIn
    role:
      role term: aut
  name:
    name part: Spangemacher, Moritz
    role:
      role term: VerfasserIn
    role:
      role term: aut
  name:
    name part: Meyer-Lindenberg, Andreas
    name part: 1965-
    role:
      role term: VerfasserIn
    role:
      role term: aut
  name:
    name part: Jungaberle, Henrik
    name part: 1967-
    role:
      role term: VerfasserIn
    role:
      role term: aut
  type of resource: text
  origin info:
    place:
      place term: xx
    date issued: 2026
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: Diagramm
    extent: 8
  abstract: The integration of psychedelic therapies into European healthcare is a nuanced process that involves not only obtaining European Medicines Agency (EMA) approval but also successfully navigating Health Technology Assessment (HTA) evaluations across member states. After EMA approval, which focuses on the safety, efficacy, and quality of the therapeutic, HTA agencies assess these therapies for their “added therapeutic value,” considering factors like cost-effectiveness, clinical outcomes, and overall societal impact. Each country's HTA, including the UK’s National Institute for Health and Care Excellence (NICE), Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), and France’s Haute Autorité de Santé (HAS), plays a pivotal role in determining reimbursement and access to these treatments. An added challenge is that HTA bodies in Europe often require active comparator studies rather than just placebo controls to establish a treatment’s advantage over existing standard of care - a particular hurdle for psychedelic-assisted therapies, where controlled trials against active comparators are almost completely lacking. Furthermore, psychedelics are typically integrated with psychotherapy, adding complexity to HTA evaluations, as few frameworks currently assess the value of combination therapies within healthcare systems. Creating a standardized HTA approach or a unified European guideline for such novel treatments could promote equitable access across countries, helping to overcome the discrepancies in market access and patient reach across Europe.
  note: Gerhard Gründer, Lea J. Mertens, Moritz Spangemacher, Andreas Meyer-Lindenberg, Henrik Jungaberle
  note: Online verfügbar: 3. Dezember 2025, Artikelversion: 3. Dezember 2025
  note: Gesehen am 26.01.2026
  subject:
    topic: Approval
  subject:
    topic: Clinical trial methodology
  subject:
    topic: Health technology assessment
  subject:
    topic: Psychedelics
  classification: 11
  related item:
    title info:
      title: European neuropsychopharmacology
    name:
      name part: Psychedelics: the pathway to implementation in the European healthcare systems
    origin info:
      publisher: Amsterdam : Elsevier, 1990
    physical description:
      extent: Online-Ressource
    identifier: 1873-7862
    identifier: (DE-627)320594025
    identifier: (DE-600)2019305-1
    identifier: (DE-576)266224334
    part:
      text: 102(2026) vom: Jan., Seite 41-48
  related item:
    name:
      name part: Psychedelics: the pathway to implementation in the European healthcare systems
    part:
      text: volume:102
    part:
      text: year:2026
    part:
      text: month:01
    part:
      text: pages:41-48
    part:
      text: extent:8
  identifier: https://doi.org/10.1016/j.euroneuro.2025.11.007
  identifier: https://www.sciencedirect.com/science/article/pii/S0924977X25007862
  record info:
    record content source: DE-627
    record creation date: 260126
    record change date: 20260126123750.0
    record identifier: 195020331X
    language of cataloging:
      language term: ger