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Journal of clinical pathways : the foundation of value-based care最新文献

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Off-Label Use of Precision Oncology Therapeutics in Advanced Solid Cancers Following Identification of Associated Variants via Multicancer Next-Generation Sequencing Panel: A Real-World Evidence Pilot Study 通过多癌新一代测序小组确定相关变异后,在晚期实体癌中使用精确肿瘤治疗药物:一项真实世界证据试点研究
Pub Date : 2023-10-01 DOI: 10.25270/jcp.2023.09.02
Julie Wiedower, Nicole Zhang, Rebecca Nagy, Kathryn Lang, Jayati Saha
Background: Off-label use of pharmaceuticals, including in precision oncology, is common but not necessarily lacking in evidence of efficacy and safety. Concerns about payer coverage hindering comprehensive genomic profiling (CGP) in preci­sion oncology are raised, yet studies show that CGP rarely leads to prescribing of off-label therapies (2%-7%). We investigated off-label therapy utilization post- CGP via liquid biopsy using a clinicogenomic database. Variants associated with US Food and Drug Administration (FDA)-approved therapies were identified in patients. Methods: We reviewed clinical reports for FDA-approved therapy-asso­ciated variants, focusing on five genes (EGFR, PIK3CA, ATM, BRCA1, BRCA2) with >1% frequency. We then used the GuardantINFORM database (137 000+ patients) to assess off-label use impact, including variants of uncertain significance (VUSs) influence. Results: Among variants with an associated FDA-approved therapy in another indication (n = 18 660), only 0.8% had subsequent off-label therapy claims unrelated to on-label cancer types. Clinical trial enrollment post-CGP in the group receiving off-label therapy was 19%. For VUSs in five genes, 1.2% received off-label therapies (n = 21 606). Conclusions: CGP via validated liquid biopsy seems to result in minimal inappropriate use of off-label therapies. These findings can in­form payer coverage policies regarding CGP’s impact on advanced solid cancers.
背景:药物的超说明书使用,包括精确肿瘤学,是常见的,但不一定缺乏有效性和安全性的证据。人们担心,在精确肿瘤学中,付款人覆盖范围会阻碍全面基因组分析(CGP),但研究表明,CGP很少导致开出说明书外治疗的处方(2%-7%)。我们使用临床基因组数据库通过液体活检调查了CGP后适应症外治疗的使用情况。在患者中发现了与美国食品和药物管理局(FDA)批准的治疗相关的变异。方法:我们回顾了fda批准的治疗相关变异的临床报告,重点关注5个频率为1%的基因(EGFR、PIK3CA、ATM、BRCA1、BRCA2)。然后,我们使用GuardantINFORM数据库(137000 +患者)来评估说明书外用药的影响,包括不确定显著性(VUSs)影响的变体。结果:在与fda批准的其他适应症相关治疗的变异中(n = 18 660),只有0.8%的患者随后进行了与标签上的癌症类型无关的标签外治疗。接受标签外治疗组的cgp后临床试验入组率为19%。对于5个基因的VUSs, 1.2%接受了标签外治疗(n = 21,606)。结论:经验证的液体活检的CGP似乎导致了适应症外治疗的最小不适当使用。这些发现可以形成关于CGP对晚期实体癌影响的付款人覆盖政策。
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引用次数: 0
Artificial Intelligence in Oncology: The Wins, The Challenges, and How We Can Deliver on Personalized Cancer Care 肿瘤学中的人工智能:胜利,挑战,以及我们如何提供个性化的癌症治疗
Pub Date : 2023-10-01 DOI: 10.25270/jcp.2023.09.03
Matthew Biancalana, Tushar Pandey
The development of effective, targeted therapies for cancer remains one of the primary goals in precision medicine, requiring the input of multiple disciplines across the diagnostic and therapeutic landscape. Despite the signifi­cant role of cancer care in medicine, there is a forecasted shortfall of physicians able to diagnose and treat patients along their cancer diagnosis journey, which is only projected to worsen in the coming decades. Artificial intelligence (AI), and its manifestations in both machine learning and deep learning, are poised to un­burden physicians from many laborious and repetitive tasks in diagnostic anal­yses, while also providing insight into prospective therapeutic options. AI will increasingly facilitate decision-making as well as improve the accuracy and rel­evance of therapeutic recommendations. This collaborative interaction between algorithms and physicians promises to enhance the field of precision medicine and further enable optimal patient care.
开发针对癌症的有效靶向疗法仍然是精准医学的主要目标之一,这需要跨诊断和治疗领域的多个学科的投入。尽管癌症护理在医学中扮演着重要的角色,但据预测,能够在癌症诊断过程中诊断和治疗患者的医生数量不足,预计未来几十年这种情况只会恶化。人工智能(AI)及其在机器学习和深度学习方面的表现,将为医生减轻诊断分析中许多繁重和重复的任务的负担,同时也为前瞻性治疗方案提供见解。人工智能将越来越多地促进决策,并提高治疗建议的准确性和相关性。这种算法和医生之间的协作互动有望增强精准医疗领域,并进一步实现最佳的患者护理。
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引用次数: 0
NGS Testing in Non–Small Cell Lung Cancer NGS在非小细胞肺癌中的检测
Pub Date : 2023-10-01 DOI: 10.25270/jcp.2023.09.01
Winston Wong, Gordon Kuntz
Winston Wong, PharmD, and Gordon Kuntz provide an update on the current status of the research and barriers for using next-generation sequencing in NSCLC and summarize the discussion and next steps that the NGS Institute’s NSCLC Subcommittee identified as needing to be addressed.
Winston Wong, PharmD和Gordon Kuntz提供了在NSCLC中使用下一代测序的最新研究现状和障碍,并总结了NGS研究所NSCLC小组委员会确定需要解决的讨论和下一步措施。
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引用次数: 0
Leveraging Quality Measurement to Drive Equitable Cancer Care for Transgender Individuals 利用质量测量推动跨性别者公平的癌症治疗
Pub Date : 2023-08-01 DOI: 10.25270/jcp.2023.07.01
Elizabeth Donckels, Nina Regenold, T. Schmidt, W. Nolan, S. Scout, D. Dizon, T. Valuck
Transgender and gender-diverse populations face multiple cancer care inequities and disparities across the cancer care journey, such as delayed cancer diagnosis, denial of care, and worse clinical outcomes. Efforts to reduce inequities across the cancer care continuum generally must identify and address the specific care needs of transgender individuals. Quality measurement plays a key role in identifying gaps in care and monitoring progress toward high-quality, equitable cancer care and outcomes. This manu­script explores several measurement tactics to drive care quality improvement for transgender individuals: updating quality measures and clinical guidelines to be inclusive of transgender people, stratifying existing quality measures by gender identity to identify disparities, and developing new quality measures to address the specific care needs and outcome inequities experienced by trans­gender patients.
跨性别和性别多样化人群在整个癌症治疗过程中面临多种癌症治疗不公平和差异,例如癌症诊断延迟、拒绝治疗和临床结果恶化。减少癌症治疗连续体不平等的努力通常必须确定并解决跨性别个体的特殊护理需求。质量测量在确定护理差距和监测实现高质量、公平的癌症护理和结果的进展方面发挥着关键作用。本手册探讨了推动跨性别个体护理质量改善的几种测量策略:更新质量测量和临床指南以包括跨性别者,根据性别认同对现有质量测量进行分层以识别差异,并制定新的质量测量以解决跨性别患者的特定护理需求和结果不平等问题。
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引用次数: 0
https://www.hmpgloballearningnetwork.com/site/jcp/feature-story/oncology-pathways-drive-adoption-high-quality-treatment-regimens-and-deliver https://www.hmpgloballearningnetwork.com/site/jcp/feature-story/oncology-pathways-drive-adoption-high-quality-treatment-regimens-and-deliver
Pub Date : 2023-07-02 DOI: 10.25270/jcp.2023.07.02
Kathryn C. Christensen, T. Dollear, Ramma Al Ghannam, Eric J. Gratias, R. Ortiz, Stephen Hamilton
In an environment of rapid innovation and sharply rising costs, on­cology clinical pathways are a solution that can help bridge knowledge gaps for providers and ensure patients get quality, affordable cancer care. Cigna and evi­Core Healthcare developed an Oncology Value-based Pathways (VP) program by incorporating several value frameworks and considering the perspectives of multiple stakeholders, including patients, providers, and payers. Starting Janu­ary 1, 2021, the VP program was implemented for a large commercial population, spanning 51 clinical pathways and covering 50% of cancers. Over an 18-month period, the VP program increased the on-pathway regimen rate by 5.2%, leading to a cost savings of $24 million or $0.13 per member per month in a commercial managed population. Direct peer-to-peer conversations with providers who or­dered off-pathway regimens led to updated requests for on-pathway regimens in 18.3% of cases. Additionally, 28.3% of total cases were moved to on-pathway regimens, regardless of whether there was a peer-to-peer discussion with the provider, indicating the VP program’s durable educational impact.
在快速创新和成本急剧上升的环境中,非肿瘤学临床途径是一种解决方案,可以帮助弥合提供者的知识差距,并确保患者获得高质量、负担得起的癌症治疗。Cigna和evi-Core Healthcare通过整合多个价值框架并考虑多个利益相关者(包括患者、提供者和付款人)的观点,开发了基于肿瘤价值的途径(VP)计划。从2021年1月1日开始,VP项目在大量商业人群中实施,涵盖51个临床途径,覆盖50%的癌症。在18个月的时间里,VP计划将通路治疗率提高了5.2%,从而节省了2400万美元的成本,即在商业管理人群中,每个成员每月节省0.13美元。在18.3%的病例中,直接与订购非通路治疗方案的医疗服务提供者进行点对点对话导致更新了对非通路治疗方案的请求。此外,无论是否与提供者进行了点对点的讨论,总病例中有28.3%被转移到通路治疗方案,这表明副总裁计划的持久教育影响。
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引用次数: 0
Pegfilgrastim Home Redirection Outcomes: Effectiveness and Timing of Administration in Primary Prophylaxis of Chemotherapy-Induced Neutropenia 聚非格司汀家庭重定向结果:化疗性中性粒细胞减少初级预防的有效性和给药时机
Pub Date : 2023-06-01 DOI: 10.25270/jcp.2023.05.03
Lavanya J. Raj, P. McManus
The purpose of this study was to examine the impact of Cigna’s site-of-care home-redirection program on pegfilgrastim effectiveness and timing of administration in preventing complications from chemotherapy-induced neutro­penia among Cigna’s commercially managed patients receiving myelosuppres­sive chemotherapy. Commercial medical claims data from Cigna were used for the study. The sample consisted of 13,493 patients receiving chemotherapy be­tween September 1, 2020, and August 31, 2022. Descriptive and chi-square sta­tistics and logistic regression were conducted to estimate the magnitude and di­rection of associations between pegfilgrastim home redirection and outcomes, such as pegfilgrastim effectiveness and timing of administration. Logistic re­gression analyses revealed that the incidence of neutropenia, fever, pneumo­nia, and sepsis was 32% less likely in patients that underwent home redirection vs those who did not. Similarly, the odds of same-day pegfilgrastim administra­tion were 43% lower in patients that underwent home redirection. This retro­spective, real-world claims study presents significant evidence supporting fa­vorable clinical outcomes associated with Cigna’s site-of-care home-redirection program for pegfilgrastim.
本研究的目的是检查Cigna的护理地点家庭重定向计划对pegfilgrastim的有效性和给药时间的影响,以防止化疗诱导的中性粒细胞减少症在Cigna商业管理的接受骨髓抑制化疗的患者中的并发症。该研究使用了信诺(Cigna)的商业医疗索赔数据。样本包括在2020年9月1日至2022年8月31日期间接受化疗的13493名患者。进行描述性、卡方统计和逻辑回归来估计pegfilgrastim家庭重定向与结果(如pegfilgrastim有效性和给药时间)之间的关联的大小和方向。Logistic回归分析显示,与未接受家庭重定向的患者相比,接受家庭重定向的患者中性粒细胞减少、发热、肺炎和败血症的发生率降低了32%。同样,在接受家庭重定向的患者中,当天给药pegfilgrastim的几率降低了43%。这项回顾性的、真实世界的索赔研究提供了重要的证据,支持信诺的pegfilgrastim护理地点家庭重定向项目相关的良好临床结果。
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引用次数: 0
Treatment Duration, Adherence, Interruptions, and Discontinuations Associated With Maintenance Regimens for Recurrent Ovarian Cancer 复发性卵巢癌维持方案的治疗持续时间、依从性、中断和中断
Pub Date : 2023-06-01 DOI: 10.25270/jcp.2023.05.01
E. Barber, A. Saiz, N. Engel-Nitz, S. Bunner, K. Wallace
Clinical trials have shown that maintenance therapy for ovarian can­cer after response to platinum chemotherapy prolongs progression-free survival. We sought to examine the real-world use of various maintenance therapies for recurrent ovarian cancer. Methods. We conducted a retrospective cohort study of US patients ≥18 years old with recurrent ovarian cancer utilizing diagnoses from claims data. Patients were identified using a two-step algorithm and if they had ≥2 diagnoses ≥30 days apart between July 1, 2010, and December 31, 2019, a subsequent systemic chemotherapy, and a second-line maintenance thera­py with a poly (ADP-ribose) polymerase (PARP) inhibitor or bevacizumab. Prev­alence of use for all second-line maintenance therapies was calculated. Treat­ment duration, adherence to treatment, dose decreases, and the time without dose interruption or treatment discontinuation were analyzed between thera­py groups. Results. A total of 1,092 patients met the inclusion criteria. Among these, 446 (40.8%) subsequently received second-line maintenance treatment: 38 (8.5%) received rucaparib, 110 (24.7%) niraparib, 114 (25.6%) olaparib, and 184 (41.3%) bevacizumab. Average durations of maintenance treatment in days were as follows: olaparib, 187.6 (SD, 178.7); bevacizumab, 185.2 (SD, 149.2); ruca­parib, 147.2 (SD, 155.4); and niraparib, 124.2 (SD, 122.9). Treatment adherence was similar across all therapies (86%-88%). Dose decreases were numerically more common in the niraparib group (28.1%) than in the rucaparib (21.1%) or olapar­ib (20.2%) groups but were not statistically significant (both P > .10). Compared with rucaparib, niraparib was associated with a shorter time to dose interrup­tion or discontinuation (hazard ratio: 3.7; 95% confidence interval: 1.1%-12.6%; P = .03). Conclusions. In this cohort, less than half of patients with recurrent ovarian cancer received second-line maintenance therapy with a PARP inhibitor or bevacizumab. Adherence was similar in all PARP inhibitor regimens regardless of dosing schedule, with dose reductions and discontinuations varying between treatments. Niraparib was associated with the shortest time to dose interruption or discontinuation among the agents evaluated.
临床试验表明,对铂类化疗有反应的卵巢癌维持治疗可延长无进展生存期。我们试图研究各种维持疗法对复发性卵巢癌的实际应用。方法。我们对美国≥18岁的复发性卵巢癌患者进行了一项回顾性队列研究,利用索赔数据进行诊断。使用两步算法确定患者,如果他们在2010年7月1日至2019年12月31日之间间隔≥30天诊断≥2次,则随后进行全身化疗,并进行二线维持治疗-使用聚(adp -核糖)聚合酶(PARP)抑制剂或贝伐单抗。计算所有二线维持治疗的使用率。分析两组患者的治疗时间、治疗依从性、剂量减少、未中断或停止治疗的时间。结果。共有1092名患者符合纳入标准。其中,446人(40.8%)随后接受了二线维持治疗:38人(8.5%)接受了鲁卡帕尼,110人(24.7%)接受了尼拉帕尼,114人(25.6%)接受了奥拉帕尼,184人(41.3%)接受了贝伐单抗。维持治疗的平均持续时间(天)如下:奥拉帕尼,187.6天(SD, 178.7天);贝伐单抗,185.2 (SD, 149.2);ruca-parib, 147.2 (SD, 155.4);尼拉帕尼,124.2 (SD, 122.9)。所有疗法的治疗依从性相似(86%-88%)。剂量减少在尼拉帕尼组(28.1%)比鲁卡帕尼组(21.1%)或奥拉帕尼组(20.2%)更常见,但没有统计学意义(P均为0.10)。与rucaparib相比,niraparib与更短的剂量中断或停药时间相关(风险比:3.7;95%置信区间:1.1%-12.6%;P = .03)。结论。在该队列中,不到一半的复发性卵巢癌患者接受了PARP抑制剂或贝伐单抗的二线维持治疗。无论给药方案如何,所有PARP抑制剂方案的依从性相似,不同治疗的剂量减少和停药情况不同。在评估的药物中,尼拉帕尼与中断或停药的时间最短相关。
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引用次数: 0
Can We Fill in the Gaps? Authoring Custom Oncology Pathways vs Surfacing NCCN Preferred Recommendations Alone 我们能填补空白吗?编写自定义肿瘤途径vs单独提出NCCN首选建议
Pub Date : 2023-06-01 DOI: 10.25270/jcp.2023.05.02
R. Maniago, Marcello Ricottone, G. Calip, Taylor Dias-Foundas, James R. Hamrick
The use of clinical decision support (CDS) tools may help to optimize the delivery of value-based cancer care and reduce variations in treatment. Flat­iron Assist (FA) is an electronic health record (EHR)-embedded CDS tool that is locally customizable and designed to aid medical oncologists in selecting and documenting National Comprehensive Cancer Network (NCCN) Guideline–con­cordant, NCCN Preferred, and/or customized treatment regimens. The study aimed to compare the availability of NCCN Preferred recommendations to cus­tom preferred pathways in FA, and to assess provider concordance with the pre­ferred suggestions. This retrospective, observational, real-world study analyzed 16,722 orders for breast, non-small cell lung, and colon cancers over 11 months, placed at 12 US-based sites of care by 522 clinicians in hospital and community-based cancer clinics. Of the 13,140 orders placed at sites where NCCN Preferred was available, an NCCN Preferred option existed for 7,680 orders, resulting in 58.5% relative coverage for the clinical scenarios in scope. Of the 3,261 orders placed where a custom preferred pathway was available, a custom preferred op­tion existed for 2,320 orders, resulting in 71.1% relative coverage for the clinical scenarios in scope (rate ratio 1.22, 95% confidence interval 1.19-1.25; P < .001 fa­voring custom preferred pathways). When a preferred option was available, pro­viders’ selection rates were similar. The study highlights the opportunity for cus­tom preferred pathways to guide oncologists and provide clearer guidance in cases where NCCN Preferred is not available. FA’s design, with the ability to pro­vide a local preference, and the option to highlight treatment regimens based on efficacy, safety, and affordability, makes it a valuable tool for oncologists to navigate the complex treatment landscape. The study emphasizes the need for accessible and accurate information to ensure high-quality cancer care delivery.
临床决策支持(CDS)工具的使用可能有助于优化基于价值的癌症护理的提供,并减少治疗的变化。Flat-iron Assist (FA)是一种嵌入电子健康记录(EHR)的CDS工具,可在当地定制,旨在帮助医学肿瘤学家选择和记录国家综合癌症网络(NCCN)指南一致、NCCN首选和/或定制的治疗方案。本研究旨在比较NCCN优选建议与FA患者自定义优选途径的可用性,并评估提供者与优选建议的一致性。这项回顾性、观察性、真实世界的研究分析了11个月内美国12个医院和社区癌症诊所的522名临床医生对乳腺癌、非小细胞肺癌和结肠癌的16,722份医嘱。在提供NCCN首选方案的站点下的13,140份订单中,有7,680份订单中存在NCCN首选方案,因此在范围内临床方案的相对覆盖率为58.5%。在提供自定义首选途径的3261个订单中,有2320个订单存在自定义首选选项,导致范围内临床场景的相对覆盖率为71.1%(比率比1.22,95%置信区间1.19-1.25;P < 0.001支持自定义首选途径)。当有首选方案时,供应商的选择率相似。该研究强调了自定义首选途径指导肿瘤学家的机会,并在无法获得NCCN首选途径的情况下提供更清晰的指导。FA的设计能够提供本地偏好,并根据疗效、安全性和可负担性突出治疗方案,使其成为肿瘤学家在复杂的治疗前景中导航的宝贵工具。该研究强调了获取准确信息的必要性,以确保提供高质量的癌症治疗。
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引用次数: 0
Patient Perspectives About Cancer Clinical Pathways and Care Coordination 患者对癌症临床途径和护理协调的看法
Pub Date : 2023-04-01 DOI: 10.25270/jcp.2023.03.02
D. Collyar
While health care leaders may ultimately want to create better care for patients, systemic goals can be at odds with individual patient needs. Before finalizing clinical pathways, patient needs must be intentionally assessed to en­sure pathways that work for providers can also deliver flexible and effective pa­tient care for the entire spectrum of patients and their families. Tools should en­compass the entire patient experience, from ways to avoid cancer, how to obtain a diagnosis and biomarker testing, and participation in clinical trials, to treatment decisions, survivorship plans, and end-of-life support. This article discusses how patients feel through their cancer experience and suggests ways to incorporate important components like social determinants of health; diversity, equity, and inclusion strategies; and cost considerations so patients can live full lives.
虽然医疗保健领导者最终可能希望为患者创造更好的护理,但系统目标可能与患者的个人需求不一致。在最终确定临床路径之前,必须有意识地评估患者的需求,以确保服务提供者的路径也可以为整个患者及其家属提供灵活有效的患者护理。工具应该涵盖整个患者体验,从避免癌症的方法,如何获得诊断和生物标志物测试,参与临床试验,到治疗决策,生存计划和临终支持。这篇文章讨论了患者在癌症经历中的感受,并提出了将健康的社会决定因素等重要因素纳入其中的方法;多元化、公平和包容战略;同时考虑到成本问题,这样病人就能过上完整的生活。
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引用次数: 0
Bone-Modifying Agent Utilization: An Analysis in Patients With Metastatic Cancer and Bone Involvement at an NCI-Designated Cancer Center 骨调节剂的使用:在nci指定的癌症中心对转移性癌症和骨累及患者的分析
Pub Date : 2023-04-01 DOI: 10.25270/jcp.2023.03.01
Poorni M. Manohar, Kyle Bastys, M. Tratt, J. Gralow, K. Eaton
We assessed bone-modifying agent (BMA) utilization and cost in patients with metastatic cancer and bone involvement at a National Cancer Institute–designated cancer center. We performed a retrospective review of BMA (zoledronic acid [ZA] or denosumab [DB]) utilization for fiscal years 2015 to 2020 (N = 1,421 patients; 14,545 administrations); a 60-day cutoff defined treatment interval (Q1 vs Q3). Wholesale acquisition and administration costs were esti­mated from the Centers for Medicare & Medicaid Services–allowed charges. We calculated total costs and projected potential savings for switching from Q1 to Q3 ZA administration. There were 8,247 ZA administrations (1,003 patients) and 6,308 DB administrations (536 patients), and an increase in the proportion of Q3 ZA administrations in patients with breast cancer or multiple myeloma. Total costs on BMA utilization were estimated as $14.3 million, 90% attributable to DB. The projected savings for switching from Q1 to Q3 ZA administration among all tumor types was $1.0 million. Awareness of BMA prescribing patterns provides the opportunity to create institutional pathways, align practice with best avail­able evidence, and realize substantial savings.
我们在美国国家癌症研究所指定的癌症中心评估了骨修饰剂(BMA)在转移性癌症和骨骼受损伤患者中的使用和成本。我们对2015 - 2020财年BMA(唑来膦酸[ZA]或地诺单抗[DB])的使用情况进行了回顾性分析(N = 1421例患者;14545年政府);60天的治疗间隔(Q1 vs Q3)。批发采购和管理成本是根据医疗保险和医疗补助服务中心允许的收费估算的。我们计算了从第一季度到第三季度ZA管理转换的总成本和预计的潜在节省。有8247次ZA给药(1003例患者)和6308次DB给药(536例患者),Q3次ZA给药在乳腺癌或多发性骨髓瘤患者中的比例增加。BMA利用的总成本估计为1430万美元,其中90%归因于DB。预计在所有肿瘤类型中,从第一季度到第三季度的ZA治疗将节省100万美元。对BMA处方模式的认识提供了创建机构途径的机会,使实践与最佳可用证据保持一致,并实现大量节省。
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引用次数: 0
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Journal of clinical pathways : the foundation of value-based care
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