{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T15:05:42Z","timestamp":1784905542361,"version":"3.55.0"},"reference-count":66,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Mark. Access Health Policy","JMAHP"],"abstract":"<jats:p>The practice of Health Technology Assessment (HTA) inherently involves moral, epistemological, and ontological commitments, which shape how assessments are conducted, interpreted, and used for decision-making [...]<\/jats:p>","DOI":"10.3390\/jmahp14030040","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T13:53:26Z","timestamp":1784901206000},"page":"40","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Epistemological Tensions in the EU HTA Joint Clinical Assessment: The Illusion of Judgment-Free Evaluation"],"prefix":"10.3390","volume":"14","author":[{"given":"Mondher","family":"Toumi","sequence":"first","affiliation":[{"name":"CEReSS\/UR3279\u2014Health Services Research and Quality of Life Center, Aix-Marseille University, 13385 Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Falissard","sequence":"additional","affiliation":[{"name":"CESP, INSERM U1018, Universit\u00e9 Paris-Saclay, 94800 Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-3595-6303","authenticated-orcid":false,"given":"Asma","family":"Jouini","sequence":"additional","affiliation":[{"name":"Clever Access, Tunis 1058, Tunisia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imen","family":"Soussi","sequence":"additional","affiliation":[{"name":"Clever Access, Tunis 1058, Tunisia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9512-2005","authenticated-orcid":false,"given":"Steven","family":"Simoens","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maarten","family":"Postma","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University Medical Center Groningen, University of Groningen, 9700 AB Groningen, The Netherlands"},{"name":"Department of Economics, Econometrics & Finance, Faculty of Economics & Business, University of Groningen, 9713 AB Groningen, The Netherlands"},{"name":"Center of Excellence in Higher Education for Pharmaceutical Care Innovation, Universitas Padjadjaran, Bandung 40132, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1229-6622","authenticated-orcid":false,"given":"Laurent","family":"Boyer","sequence":"additional","affiliation":[{"name":"CEReSS\/UR3279\u2014Health Services Research and Quality of Life Center, Aix-Marseille University, 13385 Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1711-0284","authenticated-orcid":false,"given":"Borislav","family":"Borissov","sequence":"additional","affiliation":[{"name":"Department of Health Technology Assessment, Faculty of Public Health, Medical University of Sofia, 1527 Sofia, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renato","family":"Bernardini","sequence":"additional","affiliation":[{"name":"Section of Pharmacology, Department of Biomedical and Biotechnological Sciences (BIOMETEC), University of Catania, 95124 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4633-4420","authenticated-orcid":false,"given":"Stefano","family":"Capri","sequence":"additional","affiliation":[{"name":"School of Economics and Management, Cattaneo-LIUC University, 21053 Castellanza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Danko","sequence":"additional","affiliation":[{"name":"Ideas & Solutions Ltd., H-1114 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude","family":"Dussart","sequence":"additional","affiliation":[{"name":"UR 4129 P2S Parcours Sant\u00e9 Syst\u00e9mique, Universit\u00e9 Claude Bernard Lyon 1, 7-11 Rue Guilllaume Paradin, 69008 Lyon, France"},{"name":"Pharmacie Centrale, Hospices Civils de Lyon, 57 Rue Francisque Darcieux, Saint-Genis-Laval, 69230 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank-Ulrich","family":"Fricke","sequence":"additional","affiliation":[{"name":"Faculty of Business Administration, Technische Hochschule N\u00fcrnberg, 90489 N\u00fcrnberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3496-1996","authenticated-orcid":false,"given":"Pascal","family":"Auquier","sequence":"additional","affiliation":[{"name":"CEReSS\/UR3279\u2014Health Services Research and Quality of Life Center, Aix-Marseille University, 13385 Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Bloemen, B., Oortwijn, W., and van der Wilt, G.J. (2024). Understanding the Normativity of Health Technology Assessment: Ontological, Moral, and Epistemological Commitments. Health Care Anal., Epub ahead of print.","DOI":"10.1007\/s10728-024-00487-x"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e39","DOI":"10.1017\/S0266462324000394","article-title":"Ethical challenges for Health Technology Assessment (HTA) in the evolving evidence landscape","volume":"40","author":"Refolo","year":"2024","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e52","DOI":"10.1017\/S0266462321001768","article-title":"Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment: The Values in Doing Assessments of Health Technologies Approach","volume":"38","author":"Bloemen","year":"2022","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_4","unstructured":"European Commission (2026, February 17). Defining Value in \u201cValue-Based Healthcare\u201d. Available online: https:\/\/health.ec.europa.eu\/system\/files\/2019-11\/2019_defining-value-vbhc_factsheet_en_0.pdf."},{"key":"ref_5","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2024, December 30). Guidance on the Validity of Clinical Studies for Joint Clinical Assessments. V1.0. Available online: https:\/\/health.ec.europa.eu\/document\/download\/9f9dbfe4-078b-4959-9a07-df9167258772_en?filename=hta_clinical-studies-validity_guidance_en.pdf."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1016\/j.jclinepi.2019.12.020","article-title":"GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy","volume":"122","author":"Mustafa","year":"2020","journal-title":"J. Clin. Epidemiol."},{"key":"ref_7","unstructured":"Popper, K. (2026, February 17). The Logic of Scientific Discovery. Routledge Classics, 2002 (Originally Published 1959). Available online: http:\/\/philotextes.info\/spip\/IMG\/pdf\/popper-logic-scientific-discovery.pdf."},{"key":"ref_8","unstructured":"Internet Encyclopedia of Philosophy (2026, February 17). Karl Popper: Critical Rationalism. Available online: https:\/\/iep.utm.edu\/karl-popper-critical-ratiotionalism\/."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1016\/j.jval.2011.01.011","article-title":"Conducting Indirect-Treatment-Comparison and Network-Meta-Analysis Studies: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part 2","volume":"14","author":"Hoaglin","year":"2011","journal-title":"Value Health"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Pennestr\u00ec, F., and Banfi, G. (2022). The Experience of Patients in Chronic Care Management: Applications in Health Technology Assessment (HTA) and Value for Public Health. Int. J. Environ. Res. Public Health, 19.","DOI":"10.3390\/ijerph19169868"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1017\/S1744133123000038","article-title":"We need to talk about values: A proposed framework for the articulation of normative reasoning in health technology assessment","volume":"19","author":"Charlton","year":"2024","journal-title":"Health Econ. Policy Law"},{"key":"ref_12","unstructured":"European Commission (2024, December 18). Regulation (EU) 2021\/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011\/24\/EU. Available online: https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32021R2282."},{"key":"ref_13","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, May 02). Guidance on the Scoping Process. Available online: https:\/\/health.ec.europa.eu\/document\/download\/7be11d76-9a78-426c-8e32-79d30a115a64_en?filename=hta_jca_scoping-process_en.pdf."},{"key":"ref_14","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, February 26). PICO Exercises. Available online: https:\/\/health.ec.europa.eu\/publications\/pico-exercises_en."},{"key":"ref_15","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, July 11). Guidance on Outcomes for Joint Clinical Assessments. Available online: https:\/\/health.ec.europa.eu\/document\/download\/a70a62c7-325c-401e-ba42-66174b656ab8_en?filename=hta_outcomes_jca_guidance_en.pdf."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"S332","DOI":"10.1016\/j.jval.2023.09.1755","article-title":"HTA71 Bridging the Gap: Exploring the PICO Vs Estimand Frameworks in EU Health Technology Assessment (HTA)","volume":"26","author":"Sieverding","year":"2023","journal-title":"Value Health"},{"key":"ref_17","unstructured":"European Medicines Agency (EMA) (2025, January 07). ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e9-r1-addendum-estimands-and-sensitivity-analysis-clinical-trials-guideline-statistical-principles-clinical-trials-step-5_en.pdf."},{"key":"ref_18","unstructured":"The Institute for Quality and Efficiency in Healthcare (IQWiG) (2025, January 16). 2018: Do the New \u201cEstimand\u201d Strategies Compromise the Standards of Benefit Assessments?. Available online: https:\/\/www.iqwig.de\/en\/about-us\/events\/iqwig-in-dialogue\/2018-do-the-new-estimand-strategies-compromise-the-standards-of-benefit-assessments.html."},{"key":"ref_19","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, January 08). Guidance on Reporting Requirements for Multiplicity Issues and Subgroup, Sensitivity and post hoc Analyses in Joint Clinical Assessments. Available online: https:\/\/health.ec.europa.eu\/document\/download\/f2f00444-2427-4db9-8370-d984b7148653_en?filename=hta_multiplicity_jca_guidance_en.pdf."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"S376","DOI":"10.1016\/j.jval.2023.09.1974","article-title":"HTA291 How Are Patients Involved in Health Technology Assessment? A Comparative Analysis of European Markets for Advanced Therapies and Implications for Joint Clinical Assessment","volume":"26","author":"Lucion","year":"2023","journal-title":"Value Health"},{"key":"ref_21","unstructured":"European Patient Organisations (2025, July 11). 10 Key Recommendations from Patient Organisations on Joint Clinical Assessments Under the EU HTA Regulation. Available online: https:\/\/ehc.eu\/wp-content\/uploads\/2024\/10\/10-Key-Recomendations-from-Patient-Organisations-on-JCAs_-20240610.pdf."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1111\/cts.12617","article-title":"Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non-orphan, Non-oncology Drugs in the European Union and United States from 2012\u20132016","volume":"12","author":"Morant","year":"2019","journal-title":"Clin. Transl. Sci."},{"key":"ref_23","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, March 08). Methodological Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons. Available online: https:\/\/health.ec.europa.eu\/document\/download\/4ec8288e-6d15-49c5-a490-d8ad7748578f_en?filename=hta_methodological-guideline_direct-indirect-comparisons_en.pdf."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Perezgonzalez, J.D. (2015). Fisher, Neyman-Pearson or NHST? A tutorial for teaching data testing. Front. Psychol., 6.","DOI":"10.3389\/fpsyg.2015.00223"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"93","DOI":"10.2307\/2983471","article-title":"Multiplicity considerations in the design and analysis of clinical trials","volume":"159","author":"Cook","year":"1996","journal-title":"J. R. Stat. Soc. Ser. A (Stat. Soc.)"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"5172","DOI":"10.1002\/sim.5990","article-title":"Traditional multiplicity adjustment methods in clinical trials","volume":"32","author":"Dmitrienko","year":"2013","journal-title":"Stat. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1592\/phco.21.5.405.34503","article-title":"Post hoc power analysis: An idea whose time has passed?","volume":"21","author":"Levine","year":"2001","journal-title":"Pharmacother. J. Hum. Pharmacol. Drug Ther."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Bays, H.E. (2019). Alirocumab, Decreased Mortality, Nominal Significance, p Values, Bayesian Statistics, and the Duplicity of Multiplicity: A Bays-on-Bayes Editorial, Lippincott Williams & Wilkins.","DOI":"10.1161\/CIRCULATIONAHA.119.041496"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"250","DOI":"10.5334\/pme.1324","article-title":"How to Use and Report on p-values","volume":"13","author":"Boscardin","year":"2024","journal-title":"Perspect. Med. Educ."},{"key":"ref_30","unstructured":"French National Authority for Health (HAS) (2025, February 26). Doctrine of the Commission de la Transparence (CT). Available online: https:\/\/www.has-sante.fr\/upload\/docs\/application\/pdf\/2021-03\/doctrine_ct.pdf#page=32."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Craver, C.F. (2014). The ontic account of scientific explanation. Explanation in the Special Sciences: The Case of Biology and History, Springer.","DOI":"10.1007\/978-94-007-7563-3_2"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"551","DOI":"10.5840\/jphil2007104111","article-title":"Causes that make a difference","volume":"104","author":"Waters","year":"2007","journal-title":"J. Philos."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1007\/s10539-010-9200-z","article-title":"Causation in biology: Stability, specificity, and the choice of levels of explanation","volume":"25","author":"Woodward","year":"2010","journal-title":"Biol. Philos."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"639","DOI":"10.5840\/jphil20071041240","article-title":"Three kinds of idealization","volume":"104","author":"Weisberg","year":"2007","journal-title":"J. Philos."},{"key":"ref_35","unstructured":"Winsberg, E. (2019). Science in the Age of Computer Simulation, University of Chicago Press."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"355","DOI":"10.1007\/s11229-006-9097-x","article-title":"When mechanistic models explain","volume":"153","author":"Craver","year":"2006","journal-title":"Synthese"},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Koh\u00e1r, M., and Krickel, B. (2021). Compare and contrast: How to assess the completeness of mechanistic explanation. Neural Mechanisms: New Challenges in the Philosophy of Neuroscience, Springer International Publishing.","DOI":"10.1007\/978-3-030-54092-0_17"},{"key":"ref_38","unstructured":"Povich, M.A. (2017). Model and World: Generalizing the Ontic Conception of Scientific Explanation. [Ph.D. Thesis, Washington University in St. Louis]."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1016\/j.shpsa.2010.11.040","article-title":"Trade-offs in model-building: A more target-oriented approach","volume":"42","author":"Matthewson","year":"2011","journal-title":"Stud. Hist. Philos. Sci. Part A"},{"key":"ref_40","doi-asserted-by":"crossref","unstructured":"Toumi, M., Fallissard, B., Jouini, A., Auquier, P., Dussart, C., and Boyer, L. (2025). Guidance on Multiplicity Analysis in Single-Trial Assessments: A No-Solution Equation. Preprints.","DOI":"10.20944\/preprints202504.2463.v1"},{"key":"ref_41","doi-asserted-by":"crossref","unstructured":"Aball\u00e9a, S., Toumi, M., Wojciechowski, P., Clay, E., Falissard, B., Simoens, S., Auquier, P., Capri, S., Ruof, J., and Fricke, F.-U. (2025). Between Rigor and Relevance: Why the EU HTA Guidelines on Indirect Comparisons Miss the Mark. Preprints.","DOI":"10.20944\/preprints202506.0161.v1"},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Smela, B., Toumi, M., Aball\u00e9a, S., Simoens, S., Boyer, L., Falissard, B., Bernardini, R., Capri, S., and Auquier, P. (2025). The EU-Joint Clinical Assessment Guidance Documents Fail to Address the Significance of Systematic Literature Reviews and Deviate from the State of the Art. Preprints.","DOI":"10.20944\/preprints202505.0904.v1"},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Toumi, M., Falissard, B., Jouini, A., Aball\u00e9a, S., and Boyer, L. (2025). Clinical Trial Validity Guidance from the HTACG: Looking for Chicken Teeth. J. Mark. Access Health Policy, 13.","DOI":"10.3390\/jmahp13020015"},{"key":"ref_44","unstructured":"The Independent Institute for Quality and Efficiency in Health Care (IQWiG) (2025, February 26). General Methods Version 8.0. Available online: https:\/\/www.iqwig.de\/methoden\/allgemeine-methoden_entwurf-fuer-version-8-0.pdf."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1080\/11287462.2004.10800844","article-title":"Uncertainty and Precaution 1: Certainty and uncertainty in science","volume":"17","author":"Kaiser","year":"2004","journal-title":"Glob. Bioeth."},{"key":"ref_46","unstructured":"Wittgenstein, L., Anscombe, G., and Von Wright, G. (1986). On Certainty\/Uber Gewissheit, Harper Collins."},{"key":"ref_47","unstructured":"B\u00e4umel, M. (2015). \u2018On Certainty\u2019and Formal Epistemology. [Master\u2019s Thesis, University of Amsterdam]."},{"key":"ref_48","first-page":"7377E","article-title":"Degree of certainty in scientific advice: Implications for risk management and communication: Event report on a training workshop on uncertainty with risk managers","volume":"19","author":"Authority","year":"2022","journal-title":"EFSA Support. Publ."},{"key":"ref_49","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, July 11). Procedural Guidance for JCA Medicinal Products. Available online: https:\/\/health.ec.europa.eu\/document\/download\/0929cd01-619d-4456-a1c4-d8e33f9e36bf_en?filename=hta_jca_mp_procedural-guidance_en.pdf."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"312","DOI":"10.1017\/S0266462305050415","article-title":"Toward a procedure for integrating moral issues in health technology assessment","volume":"21","author":"Hofmann","year":"2005","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1017\/S0266462315000276","article-title":"Integrating ethics in health technology assessment: Many ways to Rome","volume":"31","author":"Hofmann","year":"2015","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_52","first-page":"e6","article-title":"The extent and quality of qualitative evidence included in health technology assessments: A review of submissions to NICE and CADTH","volume":"40","author":"Szabo","year":"2023","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1007\/s00431-017-3085-7","article-title":"Reconstructing normality following the diagnosis of a childhood chronic disease: Does \u201crare\u201d make a difference?","volume":"177","author":"Germeni","year":"2018","journal-title":"Eur. J. Pediatr."},{"key":"ref_54","doi-asserted-by":"crossref","unstructured":"Ioannidis, J.P. (2005). Why most published research findings are false. PLoS Med., 2.","DOI":"10.1371\/journal.pmed.0020124"},{"key":"ref_55","doi-asserted-by":"crossref","unstructured":"Cartwright, N., and Hardie, J. (2012). Evidence-Based Policy: A Practical Guide to Doing it Better, Oxford University Press.","DOI":"10.1093\/acprof:osobl\/9780199841608.001.0001"},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"k4645","DOI":"10.1136\/bmj.k4645","article-title":"Research waste is still a scandal\u2014An essay by Paul Glasziou and Iain Chalmers","volume":"363","author":"Glasziou","year":"2018","journal-title":"BMJ"},{"key":"ref_57","doi-asserted-by":"crossref","unstructured":"Desmet, T., Brijs, M., Vanderdonck, F., Tops, S., Simoens, S., and Huys, I. (2024). Implementing the EU HTA Regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks. Front. Pharmacol., 15.","DOI":"10.3389\/fphar.2024.1369508"},{"key":"ref_58","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, March 08). Practical Guideline for Quantitative Evidence Synthesis: Direct and Indirect Comparisons. Available online: https:\/\/health.ec.europa.eu\/document\/download\/1f6b8a70-5ce0-404e-9066-120dc9a8df75_en?filename=hta_practical-guideline_direct-and-indirect-comparisons_en.pdf."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1097\/PRS.0b013e318219c171","article-title":"The levels of evidence and their role in evidence-based medicine","volume":"128","author":"Burns","year":"2011","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_60","unstructured":"European Federation of Pharmaceutical Industries and Associations (EFPIA) (2025, June 11). EFPIA Response to \u2018Guidance on Outcomes for Joint Clinical Assessments\u2019. Available online: https:\/\/www.efpia.eu\/news-events\/the-efpia-view\/blog-articles\/efpia-response-to-guidance-on-outcomes-for-joint-clinical-assessments\/."},{"key":"ref_61","unstructured":"European Access Academy (EAA) (2025, June 11). Open Letter to DG Sant\u00e9 and the Member State Coordination Group on HTA. Available online: https:\/\/irp.cdn-website.com\/e52b6f19\/files\/uploaded\/Open_Letter_Methods_EU_HTA.pdf."},{"key":"ref_62","doi-asserted-by":"crossref","first-page":"1266","DOI":"10.1111\/j.1467-8276.2009.01295.x","article-title":"Internal and external validity in economics research: Tradeoffs between experiments, field experiments, natural experiments, and field data","volume":"91","author":"Roe","year":"2009","journal-title":"Am. J. Agric. Econ."},{"key":"ref_63","unstructured":"The Member State Coordination Group on Health Technology Assessment (HTACG) (2025, June 11). Guidance on Filling in the Joint Clinical Assessment (JCA) Dossier Template\u2014Medicinal Products. Available online: https:\/\/health.ec.europa.eu\/document\/download\/3943ae6a-1bca-4afd-b05c-fd9a54a252d7_en?filename=hta_jca_mp_dossier-template_guidance_en.pdf."},{"key":"ref_64","doi-asserted-by":"crossref","first-page":"831","DOI":"10.1016\/j.jval.2019.11.009","article-title":"Health preference research in Europe: A review of its use in marketing authorization, reimbursement, and pricing decisions\u2014Report of the ISPOR stated preference research special interest group","volume":"23","author":"Marsh","year":"2020","journal-title":"Value Health"},{"key":"ref_65","doi-asserted-by":"crossref","first-page":"e53","DOI":"10.1017\/S0266462322000101","article-title":"Health technology assessment: A matter of facts and values","volume":"38","author":"Oortwijn","year":"2022","journal-title":"Int. J. Technol. Assess. Health Care"},{"key":"ref_66","first-page":"4202","article-title":"Why is it so difficult to integrate ethics in Health Technology Assessment (HTA)? The epistemological viewpoint","volume":"20","author":"Refolo","year":"2016","journal-title":"Eur. Rev. Med. Pharmacol. Sci."}],"container-title":["Journal of Market Access &amp; Health Policy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2001-6689\/14\/3\/40\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T14:22:16Z","timestamp":1784902936000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2001-6689\/14\/3\/40"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,24]]},"references-count":66,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,9]]}},"alternative-id":["jmahp14030040"],"URL":"https:\/\/doi.org\/10.3390\/jmahp14030040","relation":{},"ISSN":["2001-6689"],"issn-type":[{"value":"2001-6689","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,24]]}}}