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

{"title":"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","authors":"Julie Wiedower, Nicole Zhang, Rebecca Nagy, Kathryn Lang, Jayati Saha","doi":"10.25270/jcp.2023.09.02","DOIUrl":"https://doi.org/10.25270/jcp.2023.09.02","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135369126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Intelligence in Oncology: The Wins, The Challenges, and How We Can Deliver on Personalized Cancer Care","authors":"Matthew Biancalana, Tushar Pandey","doi":"10.25270/jcp.2023.09.03","DOIUrl":"https://doi.org/10.25270/jcp.2023.09.03","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"47 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135369125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"NGS Testing in Non–Small Cell Lung Cancer","authors":"Winston Wong, Gordon Kuntz","doi":"10.25270/jcp.2023.09.01","DOIUrl":"https://doi.org/10.25270/jcp.2023.09.01","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"116 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135369132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leveraging Quality Measurement to Drive Equitable Cancer Care for Transgender Individuals","authors":"Elizabeth Donckels, Nina Regenold, T. Schmidt, W. Nolan, S. Scout, D. Dizon, T. Valuck","doi":"10.25270/jcp.2023.07.01","DOIUrl":"https://doi.org/10.25270/jcp.2023.07.01","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80382200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"https://www.hmpgloballearningnetwork.com/site/jcp/feature-story/oncology-pathways-drive-adoption-high-quality-treatment-regimens-and-deliver","authors":"Kathryn C. Christensen, T. Dollear, Ramma Al Ghannam, Eric J. Gratias, R. Ortiz, Stephen Hamilton","doi":"10.25270/jcp.2023.07.02","DOIUrl":"https://doi.org/10.25270/jcp.2023.07.02","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"125 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83723383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pegfilgrastim Home Redirection Outcomes: Effectiveness and Timing of Administration in Primary Prophylaxis of Chemotherapy-Induced Neutropenia","authors":"Lavanya J. Raj, P. McManus","doi":"10.25270/jcp.2023.05.03","DOIUrl":"https://doi.org/10.25270/jcp.2023.05.03","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80825441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Duration, Adherence, Interruptions, and Discontinuations Associated With Maintenance Regimens for Recurrent Ovarian Cancer","authors":"E. Barber, A. Saiz, N. Engel-Nitz, S. Bunner, K. Wallace","doi":"10.25270/jcp.2023.05.01","DOIUrl":"https://doi.org/10.25270/jcp.2023.05.01","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"69 4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85948218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can We Fill in the Gaps? Authoring Custom Oncology Pathways vs Surfacing NCCN Preferred Recommendations Alone","authors":"R. Maniago, Marcello Ricottone, G. Calip, Taylor Dias-Foundas, James R. Hamrick","doi":"10.25270/jcp.2023.05.02","DOIUrl":"https://doi.org/10.25270/jcp.2023.05.02","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"71 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74949965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Perspectives About Cancer Clinical Pathways and Care Coordination","authors":"D. Collyar","doi":"10.25270/jcp.2023.03.02","DOIUrl":"https://doi.org/10.25270/jcp.2023.03.02","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"41 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78902456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bone-Modifying Agent Utilization: An Analysis in Patients With Metastatic Cancer and Bone Involvement at an NCI-Designated Cancer Center","authors":"Poorni M. Manohar, Kyle Bastys, M. Tratt, J. Gralow, K. Eaton","doi":"10.25270/jcp.2023.03.01","DOIUrl":"https://doi.org/10.25270/jcp.2023.03.01","url":null,"abstract":"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.","PeriodicalId":73670,"journal":{"name":"Journal of clinical pathways : the foundation of value-based care","volume":"2008 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86243491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}