{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T09:23:26Z","timestamp":1793179406421,"version":"4.5.0"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T00:00:00Z","timestamp":1773705600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"\n Introduction<\/jats:title>\n The rising cost of cancer drugs places a heavy burden on patients and public healthcare systems, posing an ongoing challenge of balancing access with efficient resource allocation. Health technology assessment (HTA) serves as a critical basis for reimbursement decisions, evaluating both clinical and economic value. Although the Federal Joint Committee (G-BA) and the National Institute for Health and Care Excellence (NICE) have established standardized HTA frameworks, differences in their assessment methods and decision-making processes may lead to divergent outcomes. This study compares key factors influencing cancer drug assessments by G-BA and NICE and identifies drivers of discrepancies between the two agencies.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We reviewed 171 matched drug-indication pairs of cancer drugs assessed by G-BA and NICE between 1 January 2020 and 1 June 2025. Logistic regression identified key factors influencing outcomes, while decision tree models explored pathways through which these factors shaped results. The first regression further examined determinants of discordant HTA outcomes between the two agencies.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among analyzed drugs, NICE issued positive recommendations in 90.64% of cases, whereas G-BA granted an additional benefit in only 59.06%. G-BA outcomes were significantly associated with improvements in mortality (\n P<\/jats:italic>\n = 0.018), side effects (\n P<\/jats:italic>\n = 0.043), and orphan drug designation (\n P<\/jats:italic>\n &lt; 0.0001). NICE recommendations were primarily influenced by low risk of bias (\n P<\/jats:italic>\n = 0.028) and incremental cost-effectiveness ratios (ICERs) \u2264 \u00a330,000 per QALY (\n P<\/jats:italic>\n = 0.054). Concordant HTA outcomes between G-BA and NICE were more likely when evidence was derived from randomized controlled trials (RCTs;\n P<\/jats:italic>\n = 0.0003), demonstrated a low risk of bias (\n P<\/jats:italic>\n = 0.003), or showed improvements in mortality (\n P<\/jats:italic>\n = 0.003) and morbidity (\n P<\/jats:italic>\n = 0.009).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Despite differences in evaluation frameworks and institutional settings across countries, high-quality clinical evidence remains the central foundation for concordant HTA decisions. The findings provide policy-relevant insights for optimizing reimbursement policies and improving the efficiency of healthcare resource allocation. Moreover, they offer important implications for policymakers and manufacturers by clarifying the key drivers of HTA decision-making.<\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fpubh.2026.1733239","type":"journal-article","created":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T14:10:04Z","timestamp":1773756604000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A comparative analysis of health technology assessment decision-making for cancer drugs in Germany and England"],"prefix":"10.3389","volume":"14","author":[{"given":"Jiaqi","family":"He","sequence":"first","affiliation":[{"name":"School of Business Administration, Shenyang Pharmaceutical University","place":["Shenyang, China"]},{"name":"School of Pharmaceutical Sciences, Tsinghua University","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haibo","family":"Wei","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Tsinghua University","place":["Beijing, China"]},{"name":"School of Biomedical Engineering, Hainan University","place":["Sanya, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qihui","family":"Mo","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Tsinghua University","place":["Beijing, China"]},{"name":"School of Biomedical Engineering, Hainan University","place":["Sanya, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxi","family":"Liu","sequence":"additional","affiliation":[{"name":"College of Letters and Science, University of California","place":["Davis, Davis, CA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyu","family":"Li","sequence":"additional","affiliation":[{"name":"College of Pharmaceutical Sciences, Soochow University","place":["Suzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yue","family":"Yang","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Tsinghua University","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijuan","family":"Tian","sequence":"additional","affiliation":[{"name":"School of Business Administration, Shenyang Pharmaceutical University","place":["Shenyang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,3,17]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1262","DOI":"10.1016\/S1470-2045(24)00516-3","article-title":"Rising costs of cancer medicines","volume":"25","author":"Devi","year":"2024","journal-title":"Lancet Oncol."},{"key":"B2","doi-asserted-by":"publisher","first-page":"465","DOI":"10.1001\/jamaoncol.2022.7826","article-title":"Estimates and projections of the global economic cost of 29 cancers in 204 countries and territories from 2020 to 2050","volume":"9","author":"Chen","year":"2023","journal-title":"JAMA Oncol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"e38","DOI":"10.1017\/S0266462324000424","article-title":"The newcomer's guide to health technology assessment: a collection of resources for early career professionals","volume":"40","author":"Migliore","year":"2024","journal-title":"Int J Technol Assess Health Care."},{"key":"B4","unstructured":"Regulation (EU)2021\/2282of the European parliament and of the council of 15 December 2021 on health technology assessment and amending directive 2011\/24\/EU"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1032","DOI":"10.1016\/j.jval.2023.02.018","article-title":"Health technology assessment\u2013informed decision making by the federal joint committee\/institute for quality and efficiency in health care in Germany and the National institute for health and care excellence in England: the role of budget impact","volume":"26","author":"Schaefer","year":"2023","journal-title":"Value in Health."},{"key":"B6","doi-asserted-by":"publisher","first-page":"e089418","DOI":"10.1136\/bmjopen-2024-089418","article-title":"Evidence quality and uncertainties considered in appraisal documents of drugs for rare diseases in England and Germany: a data extraction protocol","volume":"15","author":"Wiedmann","year":"2025","journal-title":"BMJ Open."},{"key":"B7","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1007\/s10198-017-0871-0","article-title":"Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries","volume":"19","author":"Angelis","year":"2018","journal-title":"Eur J Health Econ."},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2020.100625","article-title":"Cost-effectiveness of cancer drugs: comparative analysis of the United States and England","author":"Cherla","year":"2020","journal-title":"EClinicalMedicine"},{"key":"B9","doi-asserted-by":"publisher","first-page":"733","DOI":"10.2165\/00019053-200826090-00004","article-title":"The NICE cost-effectiveness threshold: what it is and what that means","volume":"26","author":"McCabe","year":"2008","journal-title":"Pharmacoeconomics."},{"key":"B10","unstructured":"NICE health technology evaluations: the manual"},{"key":"B11","doi-asserted-by":"publisher","first-page":"1738","DOI":"10.1093\/annonc\/mdx110","article-title":"Do patient access schemes for high-cost cancer drugs deliver value to society?","volume":"28","author":"Aggarwal","year":"2017"},{"key":"B12","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1186\/s12913-018-3162-2","article-title":"Will the reformed cancer drugs fund address the most common types of uncertainty? An analysis of NICE cancer drug appraisals","volume":"18","author":"Morrell","year":"2018","journal-title":"BMC Health Serv Res."},{"key":"B13","unstructured":"\u00a7 130b SGB V: Agreements between the national association of statutory health insurance funds and pharmaceutical companies on reimbursement rates for medicinal products\n \n \n \n Social\n Code Book"},{"key":"B14","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1186\/s13561-016-0109-3","article-title":"Benefit assessment in Germany: implications for price discounts","volume":"6","author":"Theidel","year":"2016","journal-title":"Health Econ Rev."},{"key":"B15","doi-asserted-by":"publisher","first-page":"577","DOI":"10.1007\/s10198-013-0495-y","article-title":"Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation","volume":"15","author":"Ruof","year":"2014","journal-title":"Eur J Health Econ."},{"key":"B16","doi-asserted-by":"publisher","first-page":"104282","DOI":"10.1016\/j.lpm.2025.104282","article-title":"Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation","volume":"54","author":"Fernandez","year":"2025","journal-title":"La Presse M\u00e9dicale."},{"key":"B17","doi-asserted-by":"publisher","first-page":"1016","DOI":"10.1016\/j.jval.2016.05.016","article-title":"Arbitration board setting reimbursement amounts for pharmaceutical innovations in germany when price negations between payers and manufacturers fail: an empirical analysis of 5 years' experience","volume":"19","author":"Ludwig","year":"2016","journal-title":"Value Health."},{"key":"B18","doi-asserted-by":"publisher","first-page":"216","DOI":"10.1017\/S1744133123000117","article-title":"Ten years of German benefit assessment: price analysis for drugs with unproven additional benefit","volume":"19","author":"Kleining","year":"2024","journal-title":"Health Econ Policy Law."},{"key":"B19","unstructured":"Benefit assessment pursuant to \u00a7 35a SGB V - Federal joint committee\n \n \n \n Federal\n Joint Committee"},{"key":"B20","unstructured":"Published guidance, NICE advice and quality standards"},{"key":"B21","doi-asserted-by":"publisher","first-page":"715","DOI":"10.1007\/s40273-022-01161-7","article-title":"Prices and clinical benefit of national price-negotiated anticancer medicines in China","volume":"40","author":"Zhang","year":"2022","journal-title":"Pharmacoeconomics."},{"key":"B22","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1016\/S1470-2045(20)30139-X","article-title":"Prices and clinical benefit of cancer drugs in the USA and Europe: a cost-benefit analysis","volume":"21","author":"Vokinger","year":"2020","journal-title":"Lancet Oncol."},{"key":"B23","doi-asserted-by":"publisher","first-page":"453","DOI":"10.1080\/14737167.2019.1559732","article-title":"Is the National Institute for Health and Care Excellence (NICE) in England more \u2018innovation-friendly' than the federal joint committee (G-BA) in Germany?","volume":"19","author":"Schaefer","year":"2019","journal-title":"Expert Rev Pharmacoecon Outcomes Res."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1187","DOI":"10.2217\/cer-2021-0047","article-title":"Health technology assessment (HTA) in England, France and Germany: what do matched drug pairs tell us about recommendations by national HTA agencies?","volume":"10","author":"Schaefer","year":"2021","journal-title":"J Comp Eff Res."},{"key":"B25","unstructured":"General methods draft for version 8.0"},{"key":"B26","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1007\/s11136-015-1092-6","article-title":"The definition and role of quality of life in Germany's early assessment of drug benefit: a qualitative approach","volume":"25","author":"Lohrberg","year":"2016","journal-title":"Qual Life Res."},{"key":"B27","doi-asserted-by":"publisher","first-page":"954","DOI":"10.1016\/j.jval.2012.04.010","article-title":"Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions","volume":"15","author":"Kleijnen","year":"2012","journal-title":"Value Health."},{"key":"B28","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1186\/s13561-014-0031-5","article-title":"Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland","volume":"4","author":"Lebioda","year":"2014","journal-title":"Health Econ Rev."},{"key":"B29","doi-asserted-by":"publisher","first-page":"101382","DOI":"10.1016\/j.lanepe.2025.101382","article-title":"Primary endpoint acceptance and its association with benefit ratings and market access in German health technology assessments: a retrospective cohort study","volume":"55","author":"M\u00fcller","year":"2025","journal-title":"Lancet Reg Health Eur."}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1733239\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T14:10:12Z","timestamp":1773756612000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1733239\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,17]]},"references-count":29,"alternative-id":["10.3389\/fpubh.2026.1733239"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2026.1733239","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,17]]},"article-number":"1733239"}}