{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:03:05Z","timestamp":1789948985263,"version":"4.0.1"},"reference-count":28,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Key Points<\/jats:title>\n                  <jats:p>\n                    <jats:list list-type=\"bullet\">\n                      <jats:list-item>\n                        <jats:p>The FDA's accelerated approval pathway was designed to get promising drugs to patients faster, approving them based on surrogate endpoints before confirmatory evidence of clinical benefit is available.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>Sponsors are required to complete confirmatory trials after approval; however, Medicare pays for these therapies immediately, regardless of where those trials are met. Public dollars, in other words, are already moving while the fundamental question of whether these drugs actually work remains unanswered.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>Financial incentives for manufacturers further complicate this issue; revenue is generated regardless of the trial's progress, reducing the urgency to complete them.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>We propose extending Coverage with Evidence Development (CED), an existing CMS policy tool, to drugs approved through the accelerated approval pathway. Under this framework, Medicare coverage would continue following FDA approval but would be contingent on participation in evidence\u2010development activities, including disease registries, real\u2010world data collection, and confirmatory trials.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>This approach operates within existing CMS authority and requires no new legislation. Linking reimbursement to evidence generation would better align financial incentives with the public interest and strengthen accountability during the confirmatory trial phase without restricting patient access.<\/jats:p>\n                      <\/jats:list-item>\n                    <\/jats:list>\n                  <\/jats:p>","DOI":"10.1002\/pds.70464","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T23:29:46Z","timestamp":1787095786000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Proposing a Coverage With Evidence Development Framework for Accelerated Approval at the U.S. Food and Drug Administration"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-3927-1793","authenticated-orcid":false,"given":"Dhanush","family":"Bearelly","sequence":"first","affiliation":[{"name":"College of Humanities &amp; Sciences Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Purav","family":"Desai","sequence":"additional","affiliation":[{"name":"College of Humanities &amp; Sciences Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0173-495X","authenticated-orcid":false,"given":"David T.","family":"Zhu","sequence":"additional","affiliation":[{"name":"Medical Scientist Training Program, School of Medicine Virginia Commonwealth University  Richmond Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9363-9257","authenticated-orcid":false,"given":"Rajesh","family":"Balkrishnan","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, School of Medicine University of Virginia  Charlottesville Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"U.S. Food and Drug Administration \u201cAccelerated Approval Program \u201d(2023) https:\/\/www.fda.gov\/drugs\/nda\u2010and\u2010bla\u2010approvals\/accelerated\u2010approval\u2010program."},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.18239"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.0462"},{"key":"e_1_2_10_5_1","unstructured":"Centers for Medicare & Medicaid Services \u201cMedicare Part D Prescription Drug Benefit Manual: Chapter\u00a06\u2014Protected Classes \u201d(2022) https:\/\/www.cms.gov\/medicare\/prescription\u2010drug\u2010coverage\/prescriptiondrugcovcontra\/downloads\/part\u2010d\u2010benefits\u2010manual\u2010chapter\u20106.pdf."},{"key":"e_1_2_10_6_1","unstructured":"Cancer Action Network \u201cMedicare's Six Protected Classes Explained \u201d(2018) https:\/\/www.fightcancer.org\/sites\/default\/files\/Medicare%20Six%20Protected%20Classes%20Fact%20Sheet%2007202018.pdf."},{"key":"e_1_2_10_7_1","unstructured":"KFF \u201cA Current Snapshot of the Medicare Part D Prescription Drug Benefit \u201d(2023) https:\/\/www.kff.org\/medicare\/a\u2010current\u2010snapshot\u2010of\u2010the\u2010medicare\u2010part\u2010d\u2010prescription\u2010drug\u2010benefit\/."},{"key":"e_1_2_10_8_1","unstructured":"Medicare Payment Advisory Commission \u201cReport to the Congress: Medicare and the FDA Accelerated Approval Pathway \u201d(2022) https:\/\/www.medpac.gov\/wp\u2010content\/uploads\/2022\/03\/Mar22_MedPAC_ReportToCongress_v3_SEC.pdf."},{"key":"e_1_2_10_9_1","unstructured":"Food and Drug Omnibus Reform Act \u201cFood and Drug Omnibus Reform Act \u201d(2022) Pub. 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No. 117\u2010328 136 Stat. 4459."},{"key":"e_1_2_10_10_1","unstructured":"The FDA Law Blog \u201cFDA Flexes Its New FDORA Muscles in Withdrawing an Accelerated Approval \u201d(2024) https:\/\/www.thefdalawblog.com\/2024\/02\/fda\u2010flexes\u2010its\u2010new\u2010fdora\u2010muscles\u2010in\u2010withdrawing\u2010an\u2010accelerated\u2010approval\/."},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.9415"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj\u20102021\u2010067207"},{"key":"e_1_2_10_13_1","unstructured":"U.S. Department of Health & Human Services Office of Inspector General \u201cDelays in Confirmatory Trials for Drug Applications Granted the FDA's Accelerated Approval Raise Concerns (OEI\u201001\u201021\u201000401) \u201d(2022) https:\/\/oig.hhs.gov\/reports\/all\/2022\/delays\u2010in\u2010confirmatory\u2010trials\u2010for\u2010drug\u2010applications\u2010granted\u2010fdas\u2010accelerated\u2010approval\u2010raise\u2010concerns\/."},{"issue":"25","key":"e_1_2_10_14_1","first-page":"2473","article-title":"The 21st Century Cures Act\u2014Will It Take Us Back in Time?","volume":"376","author":"Avorn J.","year":"2017","journal-title":"New England Journal of Medicine"},{"key":"e_1_2_10_15_1","article-title":"Trends in Utilization of FDA Accelerated Approval","volume":"368","author":"Kesselheim A. 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