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Cost-Effectiveness Analysis of Pembrolizumab for Bacillus Calmette-Guérin-Unresponsive Carcinoma In Situ of the Bladder

医学 彭布罗利珠单抗 老年学 图书馆学 急诊科 内科学 家庭医学 免疫疗法 护理部 癌症 计算机科学
作者
Kevin Wymer,Vidit Sharma,Christopher S. Saigal,Karim Chamie,Mark S. Litwin,Vignesh T. Packiam,Matthew Mossanen,Lance C. Pagliaro,Bijan J. Borah,Stephen A. Boorjian
出处
期刊:The Journal of Urology [Lippincott Williams & Wilkins]
卷期号:205 (5): 1326-1335 被引量:18
标识
DOI:10.1097/ju.0000000000001515
摘要

No AccessJournal of UrologyAdult Urology1 May 2021Cost-Effectiveness Analysis of Pembrolizumab for Bacillus Calmette-Guérin-Unresponsive Carcinoma In Situ of the BladderThis article is commented on by the following:Editorial CommentEditorial Comment Kevin M. Wymer, Vidit Sharma, Christopher S. Saigal, Karim Chamie, Mark S. Litwin, Vignesh T. Packiam, Matthew Mossanen, Lance C. Pagliaro, Bijan J. Borah, and Stephen A. Boorjian Kevin M. WymerKevin M. Wymer Department of Urology, Mayo Clinic, Rochester, Minnesota Equal study contribution. More articles by this author , Vidit SharmaVidit Sharma Department of Urology, Mayo Clinic, Rochester, Minnesota Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Greater Los Angeles VA, Health Services Research and Development Program, Los Angeles, California Equal study contribution. More articles by this author , Christopher S. SaigalChristopher S. Saigal Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California More articles by this author , Karim ChamieKarim Chamie Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Financial interest and/or other relationship with Merck. More articles by this author , Mark S. LitwinMark S. Litwin Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Department of Health Policy and Management, Fielding School of Public Health; School of Nursing University of California, Los Angeles, California More articles by this author , Vignesh T. PackiamVignesh T. Packiam Department of Urology, Mayo Clinic, Rochester, Minnesota More articles by this author , Matthew MossanenMatthew Mossanen Division of Urologic Surgery, Brigham and Women's Hospital, Boston, Massachusetts Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts Dana-Farber Cancer Institute, Boston, Massachusetts Harvard Medical School, Boston, Massachusetts. More articles by this author , Lance C. PagliaroLance C. Pagliaro Department of Oncology, Mayo Clinic, Rochester, Minnesota More articles by this author , Bijan J. BorahBijan J. Borah Department of Health Services Research, Mayo Clinic, Rochester, Minnesota More articles by this author , and Stephen A. BoorjianStephen A. Boorjian §Correspondence: Department of Urology, Mayo Clinic, 200 1st Street SW, Rochester, Minnesota 55905 telephone: 507-284-4015; FAX: 507-284-4951; E-mail Address: [email protected] Department of Urology, Mayo Clinic, Rochester, Minnesota Financial interest and/or other relationship with Ferring, Sanofi, ArTara, and FerGene. More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001515AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Patients with bacillus Calmette-Guérin-unresponsive carcinoma in situ are treated with radical cystectomy or salvage intravesical chemotherapy. Recently, pembrolizumab was approved for bacillus Calmette-Guérin-unresponsive carcinoma in situ. Materials and Methods: We used a decision-analytic Markov model to compare pembrolizumab, salvage intravesical chemotherapy (with gemcitabine-docetaxel induction+monthly maintenance) and radical cystectomy for patients with bacillus Calmette-Guérin-unresponsive carcinoma in situ who are radical cystectomy candidates (index patient 1) or are unwilling/unable to undergo radical cystectomy (index patient 2). The model used a U.S. Medicare perspective with a 5-year time horizon. One-way and probabilistic sensitivity analyses were performed. Incremental cost-effectiveness ratios were compared using a willingness to pay threshold of $100,000/quality-adjusted life year. Results: For index patient 1, pembrolizumab was not cost-effective relative to radical cystectomy (incremental cost-effectiveness ratios $1,403,008/quality-adjusted life year) or salvage intravesical chemotherapy (incremental cost-effectiveness ratios $2,011,923/quality-adjusted life year). One-way sensitivity analysis revealed that pembrolizumab only became cost-effective relative to radical cystectomy with a >93% price reduction. Relative to radical cystectomy, salvage intravesical chemotherapy was cost-effective for time horizons <5 years and nearly cost-effective at 5 years (incremental cost-effectiveness ratios $118,324/quality-adjusted life year). One-way sensitivity analysis revealed that salvage intravesical chemotherapy became cost-effective relative to radical cystectomy if risk of recurrence or metastasis at 2 years was less than 55% or 5.9%, respectively. For index patient 2, pembrolizumab required >90% price reduction to be cost-effective (incremental cost-effectiveness ratios $1,073,240/quality-adjusted life year). Pembrolizumab was cost-effective in 0% of 100,000 microsimulations in probabilistic sensitivity analyses for both index patients. Conclusions: At its current price, pembrolizumab is not cost-effective for bacillus Calmette-Guérin-unresponsive carcinoma in situ relative to radical cystectomy or salvage intravesical chemotherapy. Although gemcitabine-docetaxel is not cost-effective relative to radical cystectomy at 5 years, further studies may validate its cost-effectiveness if recurrence and metastasis thresholds are met. References 1. : Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol 2016; 196: 1021. Link, Google Scholar 2. : Additional bacillus Calmette-Guérin therapy for recurrent transitional cell carcinoma after an initial complete response. Urology 1997; 49: 687. Google Scholar 3. : Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the international bladder cancer group. J Clin Oncol 2016; 34: 1935. 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Google Scholar 27. : Phase 3 study of vicinium in bcg-unresponsive non-muscle invasive bladder cancer: initial results (abstract LBA27). J Urol, suppl., 2018; 199: e1167. Link, Google Scholar 28. : Phase II trial of atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer: SWOG S1605 (NCT #02844816). J Clin Oncol 2020; 38: 5022. Google Scholar 29. : Effectiveness of two different dose administration regimens of an IL-15 superagonist complex (ALT-803) in an orthotopic bladder cancer mouse model. J Transl Med 2019; 17: 29. Google Scholar 30. U.S. Food and Drug Administration: FDA Approves New Dosing Regimen For Pembrolizumab. U.S. Food and Drug Administration 2020. Available at https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-dosing-regimen-pembrolizumab. Accessed July 29, 2020. Google Scholar References 31 to 49 available at https://www.jurology.com. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySmith J (2021) This Month in Adult UrologyJournal of Urology, VOL. 205, NO. 5, (1247-1249), Online publication date: 1-May-2021.Related articlesJournal of UrologyMar 3, 2021, 12:00:00 AMEditorial CommentJournal of UrologyMar 3, 2021, 12:00:00 AMEditorial Comment Volume 205Issue 5May 2021Page: 1326-1335Supplementary Materials Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.Keywordscost-benefit analysisimmunotherapybladder cancercancer of urinary tractAcknowledgmentsWe would like to acknowledge the Veterans Affairs' Health Services Research and Development Fellowship for its generous support of Vidit Sharma.MetricsAuthor Information Kevin M. Wymer Department of Urology, Mayo Clinic, Rochester, Minnesota Equal study contribution. More articles by this author Vidit Sharma Department of Urology, Mayo Clinic, Rochester, Minnesota Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Greater Los Angeles VA, Health Services Research and Development Program, Los Angeles, California Equal study contribution. More articles by this author Christopher S. Saigal Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California More articles by this author Karim Chamie Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Financial interest and/or other relationship with Merck. More articles by this author Mark S. Litwin Department of Urology, David Geffen School of Medicine; University of California, Los Angeles, California Department of Health Policy and Management, Fielding School of Public Health; School of Nursing University of California, Los Angeles, California More articles by this author Vignesh T. Packiam Department of Urology, Mayo Clinic, Rochester, Minnesota More articles by this author Matthew Mossanen Division of Urologic Surgery, Brigham and Women's Hospital, Boston, Massachusetts Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts Dana-Farber Cancer Institute, Boston, Massachusetts Harvard Medical School, Boston, Massachusetts. More articles by this author Lance C. Pagliaro Department of Oncology, Mayo Clinic, Rochester, Minnesota More articles by this author Bijan J. Borah Department of Health Services Research, Mayo Clinic, Rochester, Minnesota More articles by this author Stephen A. Boorjian Department of Urology, Mayo Clinic, Rochester, Minnesota §Correspondence: Department of Urology, Mayo Clinic, 200 1st Street SW, Rochester, Minnesota 55905 telephone: 507-284-4015; FAX: 507-284-4951; E-mail Address: [email protected] Financial interest and/or other relationship with Ferring, Sanofi, ArTara, and FerGene. More articles by this author Expand All References 31 to 49 available at https://www.jurology.com. Advertisement Loading ...

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