支付方和提供方对胆固醇管理看法的区域性分析:以 PCSK9 抑制剂为例的协同作用模式。
A regional analysis of payer and provider views on cholesterol management: PCSK9 inhibitors as an illustrative alignment model.
机构信息
Blue Cross Blue Shield of Texas, Richardson, TX.
Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA.
出版信息
J Manag Care Spec Pharm. 2020 Dec;26(12):1517-1528. doi: 10.18553/jmcp.2020.26.12.1517.
Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i. Local groups of 3 payers and 3 providers met in 6 separate locations across the United States through a collaborative project of AMCP and PRIME Education. Responses to selected pre- and postmeeting survey questions measured changes in attitudes and beliefs regarding treatment barriers, lipid thresholds for considering PCSK9i therapy, and tactics for improving PA processes. Statistical analysis of inter- and intragroup changes in attitudes were performed by Cox proportional hazards test and Fisher's exact test for < 5 variables. The majority of providers and payers (67%-78%) agreed that high patient copayments and inadequate PA documentation were significant barriers to PCSK9i usage. However, payers and providers differed on beliefs that current evidence does not support PCSK9i cost-effectiveness (6% providers, 56% payers; = 0.003) and that PA presents excessive administrative burden (72% providers, 44% payers; = 0.09) Average increases pre- to postmeeting were noted in provider beliefs that properly documented PA forms expedite access to PCSK9i (22%-50% increase) and current authorization criteria accurately distinguish patients who benefit most from PCSK9i (6%-22%). Payers decreased in their belief that current authorization criteria accurately distinguish benefiting patients (72%-50%). Providers and payers increased in their belief that PCSK9i are cost-effective (44%-61% and 28%-50%, respectively) and were more willing to consider PCSK9i at the low-density lipoprotein cholesterol threshold of > 70 mg/dL for patients with ASCVD (78%-83% and 44%-67%, respectively) or FH (22%-39% and 22%-33%). Payers were more agreeable to less stringent PA requirements for patients with FH (33%-72%, = 0.019) and need for standardized PA requirements (50%-83%, = 0.034); these considerations remained high (89%) among providers after the meeting. Most participants supported educational programs for patient treatment adherence (83%) and physician/staff PA processes (83%-94%). Provider and payer representatives in 6 distinct geographic locations provided recommendations to improve quality of care in patients eligible for PCSK9i. Participants also provided tactical recommendations for streamlining PA documentation processes and improving awareness of PCSK9i cost-effectiveness and clinical efficacy. The majority of participants supported development of universal, standardized patient eligibility criteria and PA forms. The study reported in this article was part of a continuing education program funded by an independent educational grant awarded by Sanofi US and Regeneron Pharmaceuticals to PRIME Education. The grantor had no role in the study design, execution, analysis, or reporting. AMCP received grant funding from PRIME to assist in the study, as well as in writing the manuscript. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad received an honorarium from PRIME for serving as faculty for the continuing education program. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad were involved as participants in the study. Bhatt discloses the following relationships: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; American Heart Association Quality Oversight Committee; Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; , ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, ), (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, ), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Elsevier (Editor, ); Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; American College of Cardiology; FlowCo, Merck, Novo Nordisk, Takeda. Bays' research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. Bays has served as a consultant/advisor for 89Bio, Amarin, Esperion, Matinas, and Gelesis, and speaker for Esperion. McCormick, Caldwell, Guerin, Ahmad, Singh, Moreo, Carter, Heggen, and Sapir have nothing to disclose.
尽管采用标准疗法后,仍有许多动脉粥样硬化性心血管疾病 (ASCVD) 或家族性高胆固醇血症 (FH) 患者的胆固醇水平控制不佳,但在使用前蛋白转化酶枯草溶菌素 9 型抑制剂 (PCSK9i) 时存在多种障碍。其中,高拒付率和提供者事先授权 (PA) 文件准备不足,阻碍了 PCSK9i 的最佳使用。(a) 确定并讨论临床和真实世界证据中基于临床和真实世界证据的授权和使用 PCSK9i 的障碍;(b) 协调对 PCSK9i 的临床、成本、安全性和疗效数据的理解和应用。通过 AMCP 和 PRIME 教育的合作项目,在美国 6 个不同地点,由 3 名支付方代表和 3 名提供者代表参加了 6 次单独的会议。选定的会前和会后调查问题的回答衡量了对治疗障碍、考虑使用 PCSK9i 治疗的血脂阈值和改善 PA 流程的策略的态度和信念的变化。通过 Cox 比例风险检验和 Fisher 确切检验,对组内和组间态度变化进行了统计学分析。对于 < 5 个变量。大多数提供者和支付方 (67%-78%) 同意高患者自付额和 PA 文件准备不足是使用 PCSK9i 的重大障碍。然而,支付方和提供者对当前证据不支持 PCSK9i 的成本效益 (6%的提供者,56%的支付方;= 0.003) 和 PA 带来过度行政负担 (72%的提供者,44%的支付方;= 0.09) 的看法存在分歧。在提供者的信念中,有适当记录的 PA 表格可以加快获得 PCSK9i 的机会 (22%-50%) 和当前授权标准准确区分最受益于 PCSK9i 的患者 (6%-22%)。支付方降低了对当前授权标准准确区分受益患者的信心 (72%-50%)。提供者和支付方增加了对 PCSK9i 的成本效益的信心 (44%-61%和 28%-50%),并且更愿意考虑在 ASCVD 患者的低密度脂蛋白胆固醇阈值 > 70 mg/dL 时使用 PCSK9i (78%-83%和 44%-67%)或 FH (22%-39%和 22%-33%)。支付方更愿意放宽 FH 患者的 PA 要求 (33%-72%,= 0.019) 和标准化 PA 要求 (50%-83%,= 0.034);这些考虑因素在会议结束后仍然很高 (89%)。大多数参与者支持患者治疗依从性 (83%)和医生/员工 PA 流程 (83%-94%)的教育计划。代表还提供了简化 PA 文件流程和提高对 PCSK9i 的成本效益和临床疗效的认识的策略建议。大多数参与者支持制定通用的、标准化的患者资格标准和 PA 表格。本文报道的研究是一项继续教育计划的一部分,该计划由 Sanofi US 和 Regeneron Pharmaceuticals 为 PRIME 教育机构提供的独立教育赠款资助。赠款人在研究设计、执行、分析或报告方面没有任何作用。AMCP 从 PRIME 获得资助,以协助该研究以及撰写手稿。McCormick、Bhatt、Bays、Taub、Caldwell、Guerin、Steinhoff 和 Ahmad 因担任继续教育计划的教师而获得 PRIME 的酬金。McCormick、Bhatt、Bays、Taub、Caldwell、Guerin、Steinhoff 和 Ahmad 作为参与者参加了这项研究。Bhatt 披露了以下关系:Cardax、CellProthera、Cereno Scientific、Elsevier Practice Update Cardiology、Level Ex、Medscape Cardiology、PhaseBio、PLx Pharma、Regado Biosciences;波士顿退伍军人事务部研究所以及 TobeSoft;美国心脏协会质量监督委员会;Baim 研究所临床研究 (前身为哈佛临床研究学院,负责 PORTICO 试验,由圣犹达医学公司资助,现为雅培公司)、克利夫兰诊所 (包括 EXCEED 试验,由爱德华兹资助)、Contego Medical (主席,PERFORMANCE 2)、杜克临床研究所、梅奥诊所、西奈山医学院 (负责 ENVISAGE 试验,由 Daiichi Sankyo 资助)、人口健康研究所;美国心脏病学院 (临床实践和新闻的高级副编辑,ACC.org;ACC 认证委员会),Baim 研究所临床研究 (前身为哈佛临床研究学院;RE-DUAL PCI 临床试验指导委员会由百时美施贵宝公司资助;执行委员会由 CSL Behring 资助),Belvoir 出版物 (哈佛心脏信笺的总编辑),杜克临床研究所 (临床试验指导委员会,包括 PRONOUNCE 试验,由费森尤斯制药公司资助),HMP 全球 (总编辑,),(客座编辑;副编辑),K2P(跨学科课程联合主席),Level Ex,Medtelligence/ReachMD (CME 指导委员会),MJH 生命科学,人口健康研究所 (用于 COMPASS 运营委员会、出版委员会、指导委员会和美国全国联合负责人,由拜耳公司资助),Slack 出版物 (首席医学编辑),社会心血管患者护理 (秘书/财务主管),WebMD (CME 指导委员会);临床心脏病学 (副编辑),NCDR-ACTION 注册表指导委员会 (主席),VA CART 研究和出版物委员会 (主席);雅培、Afimmune、Amarin、Amgen、阿斯利康、拜耳、百时美施贵宝、Cardax、Chiesi、CSL Behring、Eisai、Ethicon、费森尤斯制药公司、Forest Laboratories、Fractyl、Idorsia、Ironwood、Ischemix、Lexicon、礼来、美敦力、辉瑞、PhaseBio、PLx Pharma、Regeneron、罗氏、Sanofi Aventis、Synaptic、The Medicines Company;Elsevier (编辑,);百特、波士顿科学、CSI、圣犹达医学公司 (现为雅培公司)、Svelte;美国心脏病学院;FlowCo、默克、诺和诺德、武田制药。Bays 的研究机构已从 89Bio、Acasti、Akcea、Allergan、Alon Medtech/Epitomee、Amarin、Amgen、阿斯利康、Axsome、百时美施贵宝、Civi、Eli Lilly、 Esperion、Evidera、Gan 和 Lee、Home Access、 Janssen、Johnson and Johnson、Lexicon、Matinas、Merck、Metavant、诺华、诺和诺德、辉瑞、Regeneron、Sanofi、Selecta、TIMI 和 Urovant 获得研究资助。Bays 担任过 89Bio、Amarin、Esperion、Matinas 和 Gelesis 的顾问/顾问,也是 Esperion 的发言人。McCormick、Caldwell、Guerin、Ahmad、Singh、Moreo、Carter、Heggen 和 Sapir 没有任何需要披露的信息。
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