[Pharmaceutical Directive/Annex XII: Cannabidiol - reassessment after expiry of the deadline (Lennox-Gastaut-Syndrome, ≥ 2 years, combination with clobazam)]

The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
Record ID 32018002134
English, German
Original Title: Arzneimittel-Richtlinie/Anlage XII: Cannabidiol (Neubewertung nach Fristablauf: Lennox-Gastaut-Syndrom, ≥ 2 Jahre, Kombination mit Clobazam)
Authors' objectives: The Federal Joint Committee [Gemeinsamer Bundesausschuss (G-BA)] has had the legal task of carrying out an (additional) benefit assessment for all newly approved drugs with new active ingredients immediately after market entry (§ 35a SGB V). The result of this assessment is the basis for deciding how much the statutory health insurance pays for a new drug with a new active ingredient. The G-BA was commissioned to carry out the benefit assessment through the Pharmaceuticals Market Reorganisation Act [Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG)]. In the context of the early benefit assessment of medicinal products containing new active substances, the following rules apply to orphan drugs: According to the legal requirements (§ 35a SGB V), the additional medical benefit of these drugs is already considered to be proven by the approval. The G-BA determines the extent of the additional benefit for orphan drugs that do not exceed a turnover of 50 million Euros in the last twelve calendar months, on the basis of the approval and the studies justifying the approval.
Details
Project Status: Completed
URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/599/#english
Year Published: 2020
URL for published report: https://www.g-ba.de/downloads/39-1464-4790/2021-04-15_AM-RL-XII_Cannabidiol%28LGS%29_D-596_EN.pdf
Requestor: The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/599/#nutzenbewertung
English language abstract: There is no English language summary available
Publication Type: Full HTA
Country: Germany
MeSH Terms
  • Lennox Gastaut Syndrome
  • Child
  • Child, Preschool
  • Cannabidiol
  • Clobazam
  • Anticonvulsants
  • Seizures
Keywords
  • Cannabidiol
  • Lennox Gastaut Syndrome
Contact
Organisation Name: The Federal Joint Committee
Contact Address: Gutenbergstr. 13, 10587 Berlin, Germany
Contact Name: Fachberatung Medizin [Department of Medical Consultancy]
Contact Email: Fachberatung-Medizin@g-ba.de
Copyright: https://www.g-ba.de/sys/impressum/
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