{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T01:53:02Z","timestamp":1790560382563,"version":"4.1.0"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Quality and Outcomes"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Proprotein convertase subtilisin\/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods and Results:<\/jats:title>\n            <jats:p>We conducted an analysis of 2016 formulary coverage and PA data from a large, proprietary database with information on policies governing &gt;95% of Americans with prescription drug coverage (275.3 million lives) within 3872 plans across the 4 major insurance segments (commercial, health insurance exchange, Medicare, and Medicaid). The key measures included administrative PA criteria (prescriber specialty, number of criteria in PA policy or number of fields on PA form, requirements for medical record submission, reauthorization requirements) and clinical\/diagnostic PA criteria (approved conditions, required laboratories or other tests, required concomitant therapy, step therapy requirements, continuation criteria) for each of 2 Food and Drug Administration\u2013approved PCSK9is. Select measures (eg, number of PA criteria\/fields, medical record submission requirements) were obtained for 2 comparator cardiometabolic drugs (ezetimibe and liraglutide). Between 82% and 97% of individuals were enrolled in plans implementing PA for PCSK9is (depending on insurance segment), and one third to two thirds of these enrollees faced PAs restricting PCSK9i prescribing to a specialist. For patients with familial hypercholesterolemia, diagnostic confirmation via genetic testing or meeting minimum clinical scores\/criteria was also required. PA requirements were more extensive for PCSK9is as compared with the other cardiometabolic drugs (ie, contained 3\u00d7\u201311\u00d7 the number of PA criteria or fields on PA forms and more frequently involved the submission of medical records as supporting documentation).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>PA requirements for PCSK9is are greater than for selected other drugs within the cardiometabolic disease area, raising concerns about whether payer policies to discourage inappropriate use may also be restricting access to these drugs in patients who need them.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circoutcomes.117.003939","type":"journal-article","created":{"date-parts":[[2018,1,12]],"date-time":"2018-01-12T01:11:31Z","timestamp":1515719491000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":40,"title":["Prior Authorization Requirements for Proprotein Convertase Subtilisin\/Kexin Type 9 Inhibitors Across US Private and Public Payers"],"prefix":"10.1161","volume":"11","author":[{"given":"Jalpa A.","family":"Doshi","sequence":"first","affiliation":[{"name":"From the Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Dr Doshi, J.T. Puckett, Dr Parmacek, and Dr Rader) and the Leonard Davis Institute of Health Economics, Philadelphia (Dr Doshi)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin T.","family":"Puckett","sequence":"additional","affiliation":[{"name":"From the Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Dr Doshi, J.T. Puckett, Dr Parmacek, and Dr Rader) and the Leonard Davis Institute of Health Economics, Philadelphia (Dr Doshi)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S.","family":"Parmacek","sequence":"additional","affiliation":[{"name":"From the Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Dr Doshi, J.T. Puckett, Dr Parmacek, and Dr Rader) and the Leonard Davis Institute of Health Economics, Philadelphia (Dr Doshi)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Rader","sequence":"additional","affiliation":[{"name":"From the Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Dr Doshi, J.T. Puckett, Dr Parmacek, and Dr Rader) and the Leonard Davis Institute of Health Economics, Philadelphia (Dr Doshi)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1508120"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1615664"},{"key":"e_1_3_4_4_2","unstructured":"Silverman ED. How much?! Those new cholesterol drugs could cost $23 billion a year. The Wall Street Journal. June 9 2015. Available at: http:\/\/blogs.wsj.com\/pharmalot\/2015\/06\/09\/how-much-those-new-cholesterol-drugs-could-cost-23-billion-a-year\/. Accessed April 5 2017."},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2016.06.011"},{"key":"e_1_3_4_6_2","unstructured":"Tice JA Ollendorf DA Cunningham C Pearson SD Kazi DS Coxson PG. PCSK9 inhibitors for treatment of high cholesterol: effectiveness value and value-based price benchmarks. Institute for Clinical and Economic Review. Available at: https:\/\/icer-review.org\/wp-content\/uploads\/2016\/01\/Final-Report-for-Posting-11-24-15-1.pdf. Accessed April 5 2017."},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.11004"},{"key":"e_1_3_4_8_2","first-page":"297","article-title":"Prior authorization programs: a critical review of the literature.","volume":"7","author":"MacKinnon NJ","year":"2001","unstructured":"MacKinnon NJ, Kumar R. Prior authorization programs: a critical review of the literature. J Manag Care Spec Pharm. 2001;7:297\u2013303.","journal-title":"J Manag Care Spec Pharm"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/clc.22713"},{"key":"e_1_3_4_10_2","unstructured":"Kolata G. Study shows promise for expensive cholesterol drugs but they are still hard to obtain. The New York Times. November 15 2016. Available at: https:\/\/www.nytimes.com\/2016\/11\/16\/health\/cholesterol-drugs-pcsk9-inhibitors.html? _r=0. Accessed April 21 2017."},{"key":"e_1_3_4_11_2","unstructured":"Berkrot B. Amgen cholesterol drug reduces artery-clogging plaque in study. Reuters. November 15 2016. Available at: http:\/\/www.reuters.com\/article\/us-heartamgen-cholesterol-idUSKBN13A27Q. Accessed April 21 2017."},{"key":"e_1_3_4_12_2","unstructured":"Chen C Cortez M. Amgen\u2019s Repatha unclogs arteries in good sign for future sales. Bloomberg Markets. November 15 2016. Available at: https:\/\/www.bloomberg.com\/news\/articles\/2016-11-15\/amgen-s-repatha-unclogs-arteries-in-good-sign-for-future-sales. Accessed April 21 2017."},{"key":"e_1_3_4_13_2","unstructured":"Pierson R. New cholesterol drugs won\u2019t be budget busters: Express Scripts. Reuters. September 30 2015. Available at: http:\/\/www.reuters.com\/article\/us-express-scr-cholesterol-idUSKCN0RU2PL20150930. Accessed April 5 2017."},{"key":"e_1_3_4_14_2","volume-title":"Paper presented at:66th Scientific Session of the American College of Cardiology","author":"Baum SJ","unstructured":"Baum SJ, Chen CC, Rane PB. Characteristics of patients approved and denied access in PCSK9i therapy by payers. Paper presented at: 66th Scientific Session of the American College of Cardiology; March 17\u201319, 2017; Washington, DC."},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2017.3451"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.027705"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.03.519"},{"key":"e_1_3_4_18_2","unstructured":"American Medical Association. 2016 AMA Prior Authorization Physician Survey. 2017. Available at: https:\/\/www.ama-assn.org\/sites\/default\/files\/media-browser\/public\/government\/advocacy\/2016-pa-survey-results.pdf. Accessed April 26 2017."},{"key":"e_1_3_4_19_2","unstructured":"American Medical Association. Prior authorization and utilization management reform principles. Available at: https:\/\/www.ama-assn.org\/sites\/default\/files\/media-browser\/principles-with-signatory-page-for-slsc.pdf. 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Available at: https:\/\/www.acponline.org\/system\/files\/documents\/advocacy\/current_policy_papers\/assets\/racial_disparities.pdf. Accessed April 26 2017."},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.24.4.1128"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2014.07.028"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.9924"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2017.2762"}],"container-title":["Circulation: Cardiovascular Quality and Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCOUTCOMES.117.003939","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T03:51:50Z","timestamp":1715572310000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCOUTCOMES.117.003939"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1]]},"references-count":25,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1161\/CIRCOUTCOMES.117.003939"],"URL":"https:\/\/doi.org\/10.1161\/circoutcomes.117.003939","relation":{},"ISSN":["1941-7713","1941-7705"],"issn-type":[{"value":"1941-7713","type":"print"},{"value":"1941-7705","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1]]},"assertion":[{"value":"2017-05-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-11-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-01-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e003939"}}