{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T21:05:19Z","timestamp":1789592719021,"version":"build-2803163510"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Transthyretin amyloid cardiomyopathy (ATTR-CM) causes heart failure with substantial morbidity, mortality, and healthcare utilization. ATTRibute-CM [Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy (Phase 3 trial)] showed that acoramidis improves clinical outcomes, but its cost-effectiveness and budget impact in the German statutory health insurance (SHI) system remain uncertain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>We developed a cohort Markov model (lifetime horizon) discounting costs and outcomes at 3% annually. Overall survival was modelled with recalibrated Weibull functions fitted to randomized-phase ATTRibute-CM data and anchored to match Month 30 survival. Health-related quality of life used Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) trajectories mapped to EQ-5D utilities, with a plateau after 30 months in the base case. Direct medical costs (2025\u20ac) included drug, background management, and hospitalization costs. Uncertainty was assessed with sensitivity analyses, scenario analyses, and a budget impact analysis. Discounted mean lifetime costs were \u20ac13 881.50 (placebo) and \u20ac828 127.07 (acoramidis), for an incremental \u20ac814 245.57. Quality-adjusted life-years (QALYs) increased from 2.743 to 4.029 (incremental 1.286) and life-years from 4.023 to 6.045 (incremental 2.022), yielding an incremental cost-effectiveness ratio (ICER) of \u20ac633 081 per QALY. Survival scenario analyses produced lifetime ICERs from \u20ac458 953\/QALY in an optimistic scenario to \u20ac2 139 712\/QALY in a pessimistic waning-benefit scenario. At a willingness-to-pay (WTP) of \u20ac100 000\/QALY, the probability of cost-effectiveness was very low and the results were driven primarily by acoramidis acquisition cost. In the budget impact analysis, Year 1 SHI expenditure was \u20ac80 813 995, \u20ac134 689 992, and \u20ac269 379 983 for 30, 50, and 100% uptake, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Despite benefits, acoramidis is unlikely to be cost-effective at current prices in Germany and could increase SHI spending. Price reductions could better align value with affordability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ehjqcco\/qcag093","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T11:24:04Z","timestamp":1780313044000},"page":"1053-1064","source":"Crossref","is-referenced-by-count":2,"title":["Affordability of innovation: cost-effectiveness and budget impact analysis of acoramidis in transthyretin amyloid cardiomyopathy in the German healthcare system"],"prefix":"10.1093","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2043-4557","authenticated-orcid":false,"given":"Bent","family":"Estler","sequence":"first","affiliation":[{"name":"Department of Cardiology, Angiology and Pulmology, University Hospital Heidelberg , Im Neuenheimer Feld 410, 69120 Heidelberg 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