{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:40:35Z","timestamp":1786977635014,"version":"build-2736575974"},"reference-count":65,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,11,17]],"date-time":"2021-11-17T00:00:00Z","timestamp":1637107200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:p>\n                    Basic scientists and drug developers are accelerating innovations toward the goal of precision medicine. Regulators create pathways for timely patient access to precision medicines, including individualized therapies. Healthcare payors acknowledge the need for change but downstream innovation for coverage and reimbursement is only haltingly occurring. Performance uncertainty, high price\u2010tags, payment timing, and actuarial risk issues associated with precision medicines present novel financial challenges for payors. With traditional drug reimbursement frameworks, payment is based on an assumed randomized controlled trial (RCT) projection of real\u2010world effectiveness, a \u201ctrial\u2010and\u2010project\u201d strategy; the clinical benefit realized for patients is not usually ascertained\n                    <jats:italic>ex post<\/jats:italic>\n                    by collection of real\u2010world data (RWD). To mitigate financial risks resulting from clinical performance uncertainty, manufacturers and payors devised \u201ctrack\u2010and\u2010pay\u201d frameworks (i.e., the tracking of a pre\u2010agreed treatment outcome which is linked to financial consequences). Whereas some track\u2010and\u2010pay arrangements have been successful, inherent weaknesses include the potential for misalignment of incentives, the risk of channeling of patients, and a failure to use the RWD generated to enable continuous learning about treatments. \u201cPrecision reimbursement\u201d (PR) intends to overcome inherent weaknesses of simple track\u2010and\u2010pay schemes. In combining the collection of RWD with advanced analytics (e.g., artificial intelligence and machine learning) to generate actionable real\u2010world evidence, with prospective alignment of incentives across all stakeholders (including providers and patients), and with pre\u2010agreed use and dissemination of information generated, PR becomes a \u201clearn\u2010and\u2010predict\u201d model of payment for performance. We here describe in detail the concept of PR and lay out the next steps to make it a reality.\n                  <\/jats:p>","DOI":"10.1002\/cpt.2471","type":"journal-article","created":{"date-parts":[[2021,10,30]],"date-time":"2021-10-30T11:54:02Z","timestamp":1635594842000},"page":"52-62","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Precision Reimbursement for Precision Medicine: Using Real\u2010World Evidence to Evolve From Trial\u2010and\u2010Project to Track\u2010and\u2010Pay to Learn\u2010and\u2010Predict"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2186-4161","authenticated-orcid":false,"given":"Hans\u2010Georg","family":"Eichler","sequence":"first","affiliation":[{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6318-9037","authenticated-orcid":false,"given":"Mark","family":"Trusheim","sequence":"additional","affiliation":[{"name":"Massachusetts Institute of Technology Center for Biomedical Innovation Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigitte","family":"Schwarzer\u2010Daum","sequence":"additional","affiliation":[{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kay","family":"Larholt","sequence":"additional","affiliation":[{"name":"Massachusetts Institute of Technology Center for Biomedical Innovation Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Zeitlinger","sequence":"additional","affiliation":[{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Brunninger","sequence":"additional","affiliation":[{"name":"Dachverband der Sozialversicherungstr\u00e4ger Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Sherman","sequence":"additional","affiliation":[{"name":"Point32Health Wellesley Massachusetts USA"},{"name":"Department of Population Medicine Harvard Medical School Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Strutton","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc. Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5474-4628","authenticated-orcid":false,"given":"Gigi","family":"Hirsch","sequence":"additional","affiliation":[{"name":"Massachusetts Institute of Technology Center for Biomedical Innovation Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,17]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Wartman L.&Cavallo J.O.Without genomic sequencing I would not be alive today.The ASCO Post<https:\/\/ascopost.com\/issues\/november\u201010\u20102018\/without\u2010genomic\u2010sequencing\u2010i\u2010would\u2010not\u2010be\u2010alive\u2010today\/> (2018). Accessed August 2021. 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