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
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. W...
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| Veröffentlicht in: | International journal of technology assessment in health care 2024-12, Vol.40 (1), p.e72, Article e72 |
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| creator | Dumont, Rémy Lengliné, Etienne Delorme, Clara Bru, Jean-Pierre Ansart, Sévérine Aslangul, Elisabeth Kelley, Sophie Cochat, Pierre Chevret, Sylvie Diatta, Thierno |
| description | 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. 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 “reserve” 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. |
| doi_str_mv | 10.1017/S0266462324000552 |
| format | Article |
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Comparison of antibiotic appraisals from 2016 to 2020 of the French, English, and German HTA agencies</title><title>International journal of technology assessment in health care</title><addtitle>Int J Technol Assess Health Care</addtitle><description>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. 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. 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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 “reserve” 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. 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| subjects | Anti-Bacterial Agents Antibiotic resistance Antibiotics Antimicrobial agents Antimicrobial resistance Appraisals Bacteria Bacterial infections Classification Commentary Committees Disease prevention Drug resistance Drug Resistance, Multiple, Bacterial France Germany Health insurance Health technology assessment Humans Marketing Multidrug resistance Multidrug resistant organisms Pathogens Patients Pharmaceutical industry Public health Qualitative analysis R&D Reimbursement Mechanisms Research & development Technology Assessment, Biomedical - organization & administration |
| 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 |
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