{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T08:42:37Z","timestamp":1788597757578,"version":"build-2803163510"},"reference-count":70,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T00:00:00Z","timestamp":1733702400000},"content-version":"unspecified","delay-in-days":343,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int J Technol Assess Health Care"],"published-print":{"date-parts":[[2024]]},"abstract":"<jats:title>Abstract<\/jats:title>\n\t  <jats:p>Antimicrobial resistance (AMR) has become a worldwide growing concern over the past decades. Thus, encouraging manufacturers to develop new antibiotics is needed. We hypothesised that transparency on the regulatory appraisals of antibiotics would provide an incentive to pharmaceutical development. We thus aimed at reporting the French health technology assessment (HTA) opinions and reimbursement decision on antibiotics to those German (G-BA) and English (NICE) HTA bodies.<\/jats:p>\n\t  <jats:p>A qualitative analysis of the Transparency Committee of the French National Authority for Health (TC-HAS) opinions regarding antibiotics assessment between 2016 and 2020 was performed. Decisions of reimbursement by TC-HAS were compared to those from G-BA and NICE when available. TC-HAS recognized a clinical benefit (CB) for 15\/15 evaluated indications, a clinical added value for 9\/15, and a public health interest for 8\/15. Among the valued antibiotics by HAS, 5 were recommended for restricted use as a \u201creserve\u201d to protect against the risk of resistance emergence. A comparison of HTA opinions was possible across HTA for only 8 antibiotics. The G-BA granted a reserve status for 4 drugs and NICE a reserve with restricted use for 5 antibiotics. Three of these antibiotics were positioned similarly by the English, German, and French HTA bodies. This qualitative analysis of HTA opinions between different European HTA bodies shows a consistent reimbursement decision of antibiotics against MDR bacteria and tuberculosis besides the differences in the applied assessment methods. This work also shows how HTA bodies could recognize a clinical added value in a context of the emergence of antibiotic resistance.<\/jats:p>","DOI":"10.1017\/s0266462324000552","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T11:31:13Z","timestamp":1733743873000},"source":"Crossref","is-referenced-by-count":3,"title":["How do we respond to the threat of multidrug-resistant bacteria? Comparison of antibiotic appraisals from 2016 to 2020 of the French, English, and German HTA agencies"],"prefix":"10.1017","volume":"40","author":[{"given":"R\u00e9my","family":"Dumont","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0965-6615","authenticated-orcid":false,"given":"Etienne","family":"Lenglin\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clara","family":"Delorme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Pierre","family":"Bru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9v\u00e9rine","family":"Ansart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Aslangul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Kelley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Cochat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Chevret","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierno","family":"Diatta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2024,12,9]]},"reference":[{"key":"S0266462324000552_r48","unstructured":"48. 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Avis de la Commission de la transparence relatif \u00e0 TYGACIL (tig\u00e9cycline) [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2016 juill, p. 22. Available from: https:\/\/www.has-sante.fr\/jcms\/c_2661383\/fr\/tygacil-tigecycline-glycylcyclines"},{"key":"S0266462324000552_r52","unstructured":"52. Nutzenbewertungsverfahren zum Wirkstoff Imipenem\/ Cilastatin\/ Relebactam. (Bakterielle Infektionen, mehrere Anwendungsgebiete) [Internet]. Gemeinsamer Bundesausschuss; 2022 nov . p. 11. Available from: https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/825\/#beschluesse"},{"key":"S0266462324000552_r26","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa153"},{"key":"S0266462324000552_r29","unstructured":"29. European Medicines Agency. Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections [Internet]. Committee for Medicinal Products for Human Use (CHMP); 2022 mai, p. 30. 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Gemeinsamer Bundesausschuss; 2021 sept . p. 11. Available from: https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/676\/#beschluesse"},{"key":"S0266462324000552_r46","unstructured":"46. Avis de la Commission de la transparence relatif \u00e0 SIRTURO (bedaquiline) [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2020 sept, p. 23. Available from: https:\/\/www.has-sante.fr\/jcms\/p_3202354\/fr\/sirturo-bedaquiline"},{"key":"S0266462324000552_r3","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(17)30753-3"},{"key":"S0266462324000552_r15","unstructured":"15. Transparency Committee doctrine\u00a0: Principles of medicinal product assessments and appraisal for reimbursement purposes [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2020. Available from: https:\/\/www.has-sante.fr\/jcms\/c_412210\/fr\/commission-de-la-transparence"},{"key":"S0266462324000552_r14","unstructured":"14. Doctrine de la commission de la transparence (CT) Principes d\u2019\u00e9valuation de la CT relatifs aux m\u00e9dicaments en vue de leur acc\u00e8s au remboursement [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2023. p. 35. Available from: https:\/\/www.has-sante.fr\/jcms\/c_412210\/fr\/commission-de-la-transparence"},{"key":"S0266462324000552_r64","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1093\/cid\/ciac268","article-title":"Infectious Diseases Society of America 2022 Guidance on the Treatment of Extended-Spectrum \u03b2-lactamase Producing Enterobacterales (ESBL-E), Carbapenem-Resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with Difficult-to-Treat Resistance (DTR-P. aeruginosa)","volume":"75","author":"Tamma","year":"2022","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am."},{"key":"S0266462324000552_r70","unstructured":"70. Parkinson, J. 237 Organizations Cosign Letter to Congress Supporting Pasteur Act. 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Available from: https:\/\/www.bmel.de\/EN\/topics\/animals\/animal-health\/DART2020.html"},{"key":"S0266462324000552_r13","unstructured":"13. IQVIA. Le march\u00e9 du m\u00e9dicament\u00a0: bilan 2020 et perspectives 2021 [Internet]. 2021 avr 13. Available from: https:\/\/www.iqvia.com\/fr-fr\/locations\/france\/library\/presentations\/drug-market-2020-review-and-2021-outlook"},{"key":"S0266462324000552_r22","unstructured":"22. NICE. Models for the evaluation and purchase of antimicrobials. 2024. [Internet]. Available from: https:\/\/www.nice.org.uk\/about\/what-we-do\/life-sciences\/nice-advice-service\/models-for-the-evaluation-and-purchase-of-antimicrobials"},{"key":"S0266462324000552_r43","unstructured":"43. Avis de la Commission de la transparence relatif \u00e0 QUOFENIX (d\u00e9lafloxacine) [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2020 d\u00e9c, p. 35. Available from: https:\/\/www.has-sante.fr\/jcms\/p_3224934\/fr\/quofenix-delafloxacine"},{"key":"S0266462324000552_r10","unstructured":"10. French Ministry of Health and Solidarity. Strat\u00e9gie nationale 2022\u20132025 de pr\u00e9vention des infections et de l\u2019antibior\u00e9sistance sant\u00e9 humaine [Internet]. 2022. Available from: https:\/\/solidarites-sante.gouv.fr\/prevention-en-sante\/les-antibiotiques-des-medicaments-essentiels-a-preserver\/des-politiques-publiques-pour-preserver-l-efficacite-des-antibiotiques\/article\/lutte-et-prevention-en-france"},{"key":"S0266462324000552_r28","unstructured":"28. Pr\u00e9vention de la r\u00e9sistance aux antibiotiques\u00a0: une d\u00e9marche \u00ab\u00a0Une seule sant\u00e9\u00a0\u00bb [Internet]. Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des produits de sant\u00e9 (ANSM); 2023 nov, p. 32. Available from: https:\/\/ansm.sante.fr\/dossiers-thematiques\/lantibioresistance#:~:text=La%20r%C3%A9sistance%20aux%20antibiotiques%20concerne,(%C2%AB%20One%20Health%20%C2%BB)."},{"key":"S0266462324000552_r59","unstructured":"59. Evidence Summary [ES22]. Antimicrobial prescribing: ceftolozane with tazobactam for treating hospital-acquired pneumonia, including ventilator-associated pneumonia [Internet]. National Institute for Health and Care Excellence; 2019 d\u00e9c . p. 27. Available from: https:\/\/www.nice.org.uk\/advice\/es22\/chapter\/Key-messages"},{"key":"S0266462324000552_r66","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciad428"},{"key":"S0266462324000552_r69","unstructured":"69. Regulation (EU) 2021\/2282 of the European Parliament and of the Council of 15\u00a0December 2021 on health technology assessment and amending Directive 2011\/24\/EU (Text with EEA relevance) [Internet]. OJ L d\u00e9c 15, 2021. Available from: http:\/\/data.europa.eu\/eli\/reg\/2021\/2282\/oj\/eng"},{"key":"S0266462324000552_r16","unstructured":"16. Commission de la transparence (Articles R163\u201315 \u00e0 R163\u201321-1) [Internet]. Code de la S\u00e9curit\u00e9 Sociale. Sect. 2, Article R163\u201318 ao\u00fbt 28, 2020. Available from: https:\/\/www.legifrance.gouv.fr\/codes\/article_lc\/LEGIARTI000042270966"},{"key":"S0266462324000552_r1","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1016\/S0140-6736(21)02724-0","article-title":"Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis","volume":"399","year":"2022","journal-title":"Lancet Lond Engl"},{"key":"S0266462324000552_r56","unstructured":"56. Antimicrobial Health Technology Evaluation Guidance. Ceftazidime with avibactam for treating severe drug-resistant gram-negative bacterial infections [Internet]. National Institute for Health and Care Excellence; 2022 ao\u00fbt p. 31. Available from: https:\/\/www.nice.org.uk\/about\/what-we-do\/life-sciences\/scientific-advice\/models-for-the-evaluation-and-purchase-of-antimicrobials\/ceftazidime-with-avibactam"},{"key":"S0266462324000552_r38","unstructured":"38. Avis de la Commission de la transparence relatif \u00e0 ZERBAXA (ceftolozane\/tazobactam) 2016 [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2016 juill p. 26. Available from: https:\/\/www.has-sante.fr\/jcms\/c_2658642\/fr\/zerbaxa-ceftolozane\/tazobactam-cephalosporine-et-inhibiteur-de-lactamase"},{"key":"S0266462324000552_r30","unstructured":"30. NICE health technology evaluation topic selection: the manual [Internet]. National Institute for Health and Care Excellence; 2022 janv p. 34. Available from: https:\/\/www.nice.org.uk\/process\/pmg37\/chapter\/about-this-guide"},{"key":"S0266462324000552_r19","unstructured":"19. Verfahrensordnung: \u00c4nderung des 5. 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Nutzenbewertungsverfahren zum Wirkstoff Delamanid. (Aufhebung der Freistellung: Multiresistente pulmonale Tuberkulose, \u2265 10 kg) [Internet]. Gemeinsamer Bundesausschuss; 2022 mai . p. 19. Available from: https:\/\/www.g-ba.de\/bewertungsverfahren\/nutzenbewertung\/754\/#beschluesse"},{"key":"S0266462324000552_r37","unstructured":"37. Avis de la Commission de la transparence relatif \u00e0 XYDALBA (dalbavancine) [Internet]. Haute Autorit\u00e9 de Sant\u00e9; 2016 d\u00e9c, p. 25. Available from: https:\/\/www.has-sante.fr\/jcms\/c_2735208\/fr\/xydalba-dalbavancine-antibiotique-de-la-classe-des-glycopeptides"},{"key":"S0266462324000552_r68","first-page":"312","article-title":"\u00c9pid\u00e9miologie, d\u00e9tection et identification des ent\u00e9robact\u00e9ries productrices de carbap\u00e9n\u00e8mases","volume":"1","author":"Dortet","year":"2013","journal-title":"Feuillet Biol"},{"key":"S0266462324000552_r9","unstructured":"9. Towse, A , Bonnifield, RS . 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