Early Health Technology Assessment during Nonalcoholic Steatohepatitis Drug Development: A Two-Round, Cross-Country, Multicriteria Decision Analysis
| Autor: | Pascal Lecomte, Aris Angelis, Mark Thursz, Ingolf Schiefke, Panos Kanavos, João C. Bana e Costa, Lawrence Serfaty, Ali Canbay, Vlad Ratziu, Alistair O'Brien |
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| Přispěvatelé: | London School of Economics and Political Science (LSE), Imperial College London, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University College of London [London] (UCL), Hôpital de Hautepierre [Strasbourg], Otto-von-Guericke University [Magdeburg] (OVGU), Ruhr University Bochum (RUB) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
early HTA
Technology Assessment Biomedical Representativeness heuristic Decision Support Techniques 03 medical and health sciences 0302 clinical medicine decision conference Non-alcoholic Fatty Liver Disease Comparative research Health care Humans comparative research 030212 general & internal medicine Valuation (finance) Actuarial science business.industry 030503 health policy & services Health Policy NASH Stakeholder Reproducibility of Results Health technology [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology Original Articles MCDA [INFO.INFO-RO]Computer Science [cs]/Operations Research [cs.RO] [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences Multiple-criteria decision analysis drug development RM Therapeutics. Pharmacology 3. Good health Value theory value assessment [SDV.IB]Life Sciences [q-bio]/Bioengineering 0305 other medical science business Psychology |
| Zdroj: | Medical Decision Making Medical Decision Making, SAGE Publications, 2020, 40 (6), pp.830-845. ⟨10.1177/0272989x20940672⟩ |
| ISSN: | 0272-989X |
| DOI: | 10.1177/0272989x20940672⟩ |
| Popis: | International audience; Background. The assessment of value along the clinical development of new biopharmaceutical compounds is a challenging task. Complex and uncertain evidence has to be analyzed, considering a multitude of value preferences from different stakeholders. Objective. To investigate the use of multicriteria decision analysis (MCDA) to support decision making during drug development while considering payer and health technology assessment (HTA) value concerns, by applying the Advance Value Framework in nonalcoholic steatohepatitis (NASH) and testing for the consistency of the results. Design. A multiattribute value theory methodology was applied and 2 rounds of decision conferences (DCs) were organized in 3 countries (England, France, and Germany), with the participation of national key experts and stakeholders using the MACBETH questioning protocol and algorithm. A total of 51 health care professionals, patient advocates, and methodologists, including (ex-) committee members or assessors from national HTA bodies, participated in 6 DCs in the study countries. Target Population. NASH patients in fibrosis stages F2 to 3 were considered. Interventions. The value of a hypothetical product profile was assessed against 3 compounds under development using their phase 2 results. Outcome Measures. DC participants' value preferences were elicited involving criteria selection, options scoring, and criteria weighting. Results. Highly consistent valuation rankings were observed in all DCs, always favoring the same compound. Highly consistent rankings of criteria clusters were observed, favoring therapeutic benefit criteria, followed by safety profile and innovation level criteria. Limitations. There was a lack of comparative treatment effects, early evidence on surrogate endpoints was used, and stakeholder representativeness was limited in some DCs. Conclusions. The use of MCDA is promising in supporting early HTA, illustrating high consistency in results across countries and between study rounds. |
| Databáze: | OpenAIRE |
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