{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T17:02:15Z","timestamp":1753894935571,"version":"3.41.2"},"reference-count":13,"publisher":"Becaris Publishing Limited","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            To evaluate the availability of published comparative real-world evidence (RWE) studies in Medicare patients for the ten drugs set to undergo Centers for Medicare and Medicaid Services (CMS) price negotiations in 2026.\n            <jats:bold>Materials &amp; methods:<\/jats:bold>\n            A scoping review was completed in MEDLINE\/PubMed to evaluate the availability of comparative RWE investigations conducted among Medicare-eligible patient populations in the\u00a0US for the following drugs: apixaban, rivaroxaban, sitagliptin, ibrutinib, empagliflozin, etanercept, dapagliflozin, sacubitril\/valsartan, ustekinumab and insulin aspart.\n            <jats:bold>Results:<\/jats:bold>\n            Of the 170 real-world comparative studies identified, 55 (32.4%) used Medicare real-world data (RWD) while 34 (20.0%) used commercial claims data in conjunction with either Medicare Advantage or Medicare Supplementary databases. The number of studies varied considerably by drug with apixaban and rivaroxaban studies accounting for the majority (i.e., 67.1%) of comparative RWE studies. Approximately a third or less of the comparative RWE studies were conducted in CMS RWD per drug.\n            <jats:bold>Conclusion:<\/jats:bold>\n            Our results demonstrate there is a considerable amount of comparative RWE for apixaban, rivaroxaban, and etanercept but limited comparative RWE for the other drugs set to undergo CMS price negotiations in 2026; additionally, our findings set up a number of next steps (e.g., risk of bias assessments) for further exploration of the available evidence base. Overall, CMS and manufacturers should consider proactively generating high-quality comparative RWE studies in the Medicare population to ensure that future price negotiations are based on robust evidence.\n          <\/jats:p>","DOI":"10.57264\/cer-2023-0125","type":"journal-article","created":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T15:12:09Z","timestamp":1696950729000},"source":"Crossref","is-referenced-by-count":1,"title":["Availability of comparative real-world evidence research in Medicare patients: implications for Centers for Medicare and Medicaid Services drug price negotiations"],"prefix":"10.57264","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3571-3345","authenticated-orcid":false,"given":"Ashley","family":"Jaksa","sequence":"first","affiliation":[{"name":"Scientific Research &amp; Strategy, Aetion Inc., Boston, MA\u00a002109, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3024-771X","authenticated-orcid":false,"given":"Patrick J","family":"Arena","sequence":"additional","affiliation":[{"name":"Scientific Research &amp; Strategy, Aetion Inc., Boston, MA\u00a002109, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9659-7811","authenticated-orcid":false,"given":"Nicolle","family":"Gatto","sequence":"additional","affiliation":[{"name":"Scientific Research &amp; Strategy, Aetion Inc., New York, NY\u00a010001, USA"},{"name":"Columbia Mailman School of Public Health, New York, NY\u00a010032, USA"},{"name":"Tulane School of Public Health &amp; Tropical Medicine, New Orleans, LA\u00a070112, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36897","reference":[{"key":"e_1_3_9_3_2","unstructured":"The White House. FACT SHEET: Biden-Harris Administration Announces First Ten Drugs Selected for Medicare Price Negotiation. (2023). https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2023\/08\/29\/fact-sheet-biden-harris-administration-announces-first-ten-drugs-selected-for-medicare-price-negotiation\/"},{"key":"e_1_3_9_4_2","volume-title":"Drug Pricing Reform In The Inflation Reduction Act: What Are The Implications? Part 1.","author":"Arad N","year":"2022","unstructured":"Arad N, McClellan MB. Drug Pricing Reform In The Inflation Reduction Act: What Are The Implications? Part 1. Health Affairs Forefront (2022). https:\/\/www.healthaffairs.org\/content\/forefront\/drug-pricing-reform-inflation-reduction-act-implications-part-1"},{"key":"e_1_3_9_5_2","unstructured":"Seshamani M. Medicare Drug Price Negotiation Program: Initial Memorandum Implementation of Sections 1191\u20131198 of the Social Security Act for Initial Price Applicability Year 2026 and Solicitation of Comments. (2023). https:\/\/www.cms.gov\/files\/document\/medicare-drug-price-negotiation-program-initial-guidance.pdf"},{"key":"e_1_3_9_6_2","unstructured":"Food and Drug Administration. Real-World Evidence. (2023). https:\/\/www.fda.gov\/science-research\/science-and-research-special-topics\/real-world-evidence"},{"issue":"5","key":"e_1_3_9_7_2","doi-asserted-by":"crossref","first-page":"1212","DOI":"10.1002\/cpt.2083","article-title":"Randomized controlled trials versus real world evidence: neither magic nor myth","volume":"109","author":"Eichler H-G","year":"2021","unstructured":"Eichler H-G, Pignatti F, Schwarzer-Daum B Randomized controlled trials versus real world evidence: neither magic nor myth. Clin. Pharmacol. Ther. 109(5), 1212\u20131218 (2021).","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_3_9_8_2","volume-title":"Public Workshop: Evaluating inclusion and exclusion criteria in clinical trials","author":"Food and Drug Administration","year":"2018","unstructured":"Food and Drug Administration. Public Workshop: Evaluating inclusion and exclusion criteria in clinical trials The National Press Club, Washington, DC (2018). https:\/\/www.fda.gov\/media\/134754\/download"},{"issue":"2","key":"e_1_3_9_9_2","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1002\/cpt.1835","article-title":"Decision making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the United States and Europe","volume":"108","author":"Vreman RA","year":"2020","unstructured":"Vreman RA, Naci H, Goettsch WG Decision making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the United States and Europe. Clin. Pharmacol. Ther. 108(2), 350\u2013357 (2020).","journal-title":"Clin. Pharmacol. Ther."},{"issue":"1","key":"e_1_3_9_10_2","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1186\/s12874-018-0611-x","article-title":"Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach","volume":"18","author":"Munn Z","year":"2018","unstructured":"Munn Z, Peters MDJ, Stern C, Tufanaru C, McArthur A, Aromataris E. Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med. Res. Methodol. 18(1), 143 (2018).","journal-title":"BMC Med. Res. Methodol."},{"issue":"3","key":"e_1_3_9_11_2","doi-asserted-by":"crossref","first-page":"A12","DOI":"10.7326\/ACPJC-1995-123-3-A12","article-title":"The well-built clinical question: a key to evidence-based decisions","volume":"123","author":"Richardson WS","year":"1995","unstructured":"Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J. Club 123(3), A12\u2013A13 (1995).","journal-title":"ACP J. Club"},{"key":"e_1_3_9_12_2","volume-title":"CMS National Coverage Analysis Evidence Review; Proposed Guidance Document","author":"Centers for Medicare & Medicaid Services","year":"2023","unstructured":"Centers for Medicare & Medicaid Services. CMS National Coverage Analysis Evidence Review; Proposed Guidance Document Centers for Medicare & Medicaid Services (2023). https:\/\/www.cms.gov\/files\/document\/proposed-cms-evidence-review.pdf"},{"issue":"1","key":"e_1_3_9_13_2","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1002\/cpt.2364","article-title":"Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness","volume":"111","author":"Bykov K","year":"2022","unstructured":"Bykov K, Patorno E, D'Andrea E Prevalence of avoidable and bias-inflicting methodological pitfalls in real-world studies of medication safety and effectiveness. Clin. Pharmacol. Ther. 111(1), 209\u2013217 (2022).","journal-title":"Clin. Pharmacol. Ther."},{"issue":"25","key":"e_1_3_9_14_2","doi-asserted-by":"crossref","first-page":"1887","DOI":"10.1056\/NEJM200006223422507","article-title":"Randomized, controlled trials, observational studies, and the hierarchy of research designs","volume":"342","author":"Concato J","year":"2000","unstructured":"Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N. Engl. J. Med. 342(25), 1887\u20131892 (2000).","journal-title":"N. Engl. J. Med."},{"key":"e_1_3_9_15_2","doi-asserted-by":"crossref","first-page":"i4919","DOI":"10.1136\/bmj.i4919","article-title":"ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions","volume":"355","author":"Sterne JA","year":"2016","unstructured":"Sterne JA, Hern\u00e1n MA, Reeves BC ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 355, i4919 (2016).","journal-title":"BMJ"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.57264\/cer-2023-0125","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,31]],"date-time":"2023-10-31T10:12:54Z","timestamp":1698747174000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.57264\/cer-2023-0125"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":13,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.57264\/cer-2023-0125"],"URL":"https:\/\/doi.org\/10.57264\/cer-2023-0125","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"type":"print","value":"2042-6305"},{"type":"electronic","value":"2042-6313"}],"subject":[],"published":{"date-parts":[[2023,11]]},"article-number":"e230125"}}