[Pharmaceutical Directive/Annex XII: Delamanid (repeal of the exemption: pulmonary multi-drug resistant tuberculosis, ≥ 10 kg)]

The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
Record ID 32018002475
English, German
Original Title: Arzneimittel-Richtlinie/Anlage XII: Delamanid (Aufhebung der Freistellung: Multiresistente pulmonale Tuberkulose, ≥ 10 kg)
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.
Authors' results and conclusions: This assessment refers to the use of Delamanid as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. For the benefit assessment of Delamanid in the adult MDR-TB population, data of the multi-center, randomized, double-blind, placebo-controlled trial 213 are used as the best available evidence. Study 213 was planned as a confirmatory study to the pivotal Delamanid study 242-07-204. Based on study 213, there was no effect of Delamanid compared to placebo on the patient-relvant endpoints of all-cause mortality, healing as well on safety endpoints in adults with MRD-TB. The risk of bias was low. The effect of Delamanid on the quality of life cannot be assessed as there are no data are available. For the benefit assessment of delamanid in the paediatric population, the subgroup of 3- to 5-year-olds of study 233 was taken into account. Study 233 is an uncontrolled open-label study to investigate the efficacy, safety and pharmacokinetics of delamanid in four different age groups. Due to the small sample size, small number of events and lack of comparison, the effect of delamanid on mortality and safety in the paediatric population cannot be assessed conclusively. Due to limitations in the operationalisation of the endpoints, no results on patient-relevant morbidity endpoints could be included in the assessment. Quality of life was not evaluated in study 233.
Project Status: Completed
Year Published: 2022
Requestor: The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Germany
MeSH Terms
  • Tuberculosis, Multidrug-Resistant
  • Tuberculosis, Pulmonary
  • Nitroimidazoles
  • Oxazoles
  • Antitubercular Agents
  • multi-drug resistant tuberculosis
  • MDR-TB
  • adult
  • Delamanid
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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