Laboratory Fee Schedule Research Articles

(373) Economic Benefits of Patient Care for Prostate Cancer Survivors with Stress Urinary Incontinence and/or Erectile Dysfunction: A Physician Reimbursement Analysis

Abstract Introduction Reconstructive urological procedures play a vital role in enhancing the satisfaction and quality of life of patients with prostate cancer (PCa) following radical prostatectomy (RP). Providing comprehensive postoperative care for common side effects of post-RP, including stress urinary incontinence (SUI) and erectile dysfunction (ED), may result in a greater number of patients with PCa receiving needed consultations and therapies. This analysis sought to explore the potential economic benefits of offering men’s health consultations and reconstructive care for PCa survivors. Objective This study quantified the relative value units (RVUs) generated from providing patient care to PCa survivors covered by Medicare Fee-for-Service who may experience SUI and/or ED due to RP. Methods This physician reimbursement analysis was based on typical patient care pathway scenarios for patients at risk of developing SUI or ED post-RP. Current Procedural Terminology (CPT) codes were utilized to identify and describe the care provided to patients in each scenario, leading to an artificial urinary sphincter (AUS) or male sling for SUI and/or an inflatable penile prosthesis (IPP) for ED. The 2023 CMS Physician and Clinical Laboratory Fee Schedule and Medicare reimbursement rates were used to obtain the most recent RVUs and reimbursement for each CPT. RVUs represent the value assigned to a service or procedure performed by a physician and are used to capture the relative cost values associated with patient care. For each scenario, we reported the total RVUs, which include work, non-facility or facility, and malpractice RVUs, and the total physician reimbursement. The 2023 Physician Conversion Factor was used to calculate the Medicare physician reimbursement. The Medicare physician reimbursement was used as a conservative estimate. Results The four clinical pathway scenarios were patients who did not experience recurrent SUI or ED (no recurrent SUI/ED), patients who only experienced SUI (only SUI), patients who only experienced ED (only ED), and patients who experienced both SUI and ED (SUI + ED). For the no SUI/ED scenario, the total RVUs from providing patient care were 5.26 RVUs, resulting in $205 in physician reimbursement. For the only SUI scenario, the total RVUs were 56.20 RVUs with an average of $1,996 in physician reimbursement for those receiving AUS and 55.54 RVUs with an average of $1,974 in physician reimbursement for those receiving male sling. For the only ED scenario, the total RVUs were 42.51 RVUs, resulting in $1,550 in physician reimbursement. For the SUI + ED scenario, the total RVUs were 98.71 RVUs with an average of $3,547 in physician reimbursement for those receiving AUS and 98.05 RVUs with an average of $3,524 in physician reimbursement for those receiving male sling. Conclusions This study justified the economic benefits of expanding patient care to men who underwent RP for PCa and provided urology practice insight into the potential physician reimbursement when PCa survivors were seen by reconstructive urologists. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

An organization-wide analysis of laboratory test cost variables and costs as displayed in the electronic health record: first steps

Abstract Displaying the cost of laboratory tests and medications in the electronic health record (EHR) at the time of order may influence ordering practices. Our organization’s EHR was configured to display a semi-quantitative value adjacent to laboratory orders: “$” tests imply relatively little cost and “$$$$” tests imply resource intensive tests. Cost display is associated with charges from hospital or clinic fee schedules by default but can also be configured to reflect direct laboratory costs. To understand our system’s configuration and potentially improve the information being provided to our clinicians upon ordering, all the test ordering data was compiled and analyzed for all individual “orderable” tests within the year of 2021 (Jan 1st 2021 – Dec 31st 2021). Variables analyzed included frequency of test ordering, average test turnaround time, and each of the various possible measures of “cost”: direct costs based on labor and reagents/supplies (when available), reimbursement from the Clinical Laboratory Fee Schedule, and pricing from the fee schedule of the largest hospital in our organization (chargemaster). Results showed an extensive rightward skew in each of the “cost” variables, with most routine tests, like the complete blood count (CBC) or complete metabolic panel (CMP), falling in the lower price range and a number of outlier tests with much higher costs (newer forms of molecular testing). There was minimal linearity in correlations between the various price variables. Correlation between chargemaster price by quintile and actual dollar signs displayed in the EHR showed that the two often disagree. No definitive discernable logic was thus identified for the number of dollar signs shown in the EHR based on the possible “cost” variables analyzed here. Between the lab’s best estimate for direct costs and chargemaster pricing, a rough correlation with slope greater than 1 was identified, suggesting that chargemaster pricing is systematically higher than the cost of running each test. Between the cost of running each test and reimbursement via the Clinical Laboratory Fee Schedule, a rough correlation with slope less than 1 was identified, suggesting that lab costs are systematically higher than reimbursement. The current lack of strong correlations between these various “cost” variables is helpful as a first step in examining how to improve our organization’s EHR system, assessing our laboratory’s cost effectiveness, and discussing potential future considerations for hospital chargemaster pricing as well as the US system of reimbursement. Further work is needed to clarify the relationship between cost displays in EHR and physician ordering practices.

Health Care Resource Utilization (HCRU) and Cost of Management of Cytokine Release Syndrome (CRS) and Neurological Events (NEs) in Patients with R/R CLL/SLL Receiving Lisocabtagene Maraleucel (liso-cel) Treatment in the TRANSCEND CLL 004 Study

Background:Liso-cel is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, which is currently being evaluated for treatment of patients with R/R CLL/SLL in the TRANSCEND CLL 004 study (NCT03331198). Initial study results suggested that a single infusion induced CRs or remission in patients with R/R CLL/SLL and had a manageable safety profile, with low to moderate incidence of severe CRS and NEs (Siddiqi T, et al. Lancet 2023). While the clinical consequences of CRS/NEs associated with CAR T cell therapies are well understood, limited data are available on the cost of management of these AEs. This analysis evaluated HCRU and estimated costs of managing CRS/NEs by grade in patients with R/R CLL/SLL who received liso-cel treatment in TRANSCEND CLL 004. Methods: Case report forms were analyzed from the trial database, capturing patient-level HCRU related to the management of CRS/NEs. Only patients that received liso-cel at a dose level of 100 × 10 6 CAR + T cells (dose level 2 [DL2]) and subsequently experienced treatment-emergent CRS and/or NEs were included in this study. Treatment-emergent AEs were defined as those initiated within a 90-day period of liso-cel administration. Costs for management of CRS/NEs were estimated using microcosting methodology. Relevant HCRU observed from the day of AE onset through resolution that was associated with the management of CRS/NEs per protocol management guidelines was identified; unit costs sourced from public databases were applied to each HCRU. Included HCRU categories were: facility (standard inpatient admission, ICU stay), diagnostics (laboratory, imaging), medications (tocilizumab, corticosteroids, vasopressors), and procedures (dialysis, intubation). Cost analyses were conducted from the United States (US) health care system perspective and adjusted to 2023 US dollars. Unit costs were obtained from the US Centers for Medicare & Medicaid Services Hospital Outpatient Prospective Payment System, laboratory and physician fee schedules, IBM ® Micromedex ® RED BOOK ®, and literature. Descriptive statistical analyses stratified by AE severity grade and type of AE experienced were performed. Results: Ninety-four of 108 (87%) patients who received liso-cel at DL2 experienced CRS and/or NEs; 68 (72%) were grade ≤ 2 and 26 (28%) were grade ≥ 3. Overall, 44 (47%) patients had CRS only, 1 (1%) had NEs only, and 49 (52%) experienced both CRS and NEs. The study sample had a mean (standard deviation) age of 64.5 y (7.9) and were predominantly male (69%), White (84%), and non-Hispanic or Latino (90%). HCRU and total length of stay (LOS; the sum of inpatient and ICU stay days) are shown in the Table. All patients had an inpatient stay. ICU admissions only occurred among patients who experienced both CRS and NEs (10/49 [20%]) and were more common among patients with grade ≥ 3 (29%) compared with grade ≤ 2 (12%) AEs. Among patients who had an ICU admission, the median duration of an ICU stay was 5 days. Median total LOS increased with increasing AE severity for patients who had CRS only (grade 1, 5 days; grade 2, 9 days; grade 3, 15 days) and for patients who experienced both CRS and NEs (grade ≤ 2, 12 days; grade ≥ 3, 15 days). Overall, 68% and 62% of patients received tocilizumab and corticosteroids, respectively. Patients with grade ≥ 3 CRS and/or NEs had higher rates of utilization of medications, diagnostics, and procedures than those with grade ≤ 2 (Table). Additionally, patients who experienced both CRS and NEs had higher rates of utilization across all HCRU categories compared with those who experienced CRS or NEs only (Table). Estimated median management costs for CRS or NEs ranged from $14,638 (CRS only grade 1) to $46,802 (experienced both CRS and NEs with CRS or NEs grade ≥ 3) (Figure). Facility-related costs were the largest contributor to median total costs. Conclusions: While most patients treated with liso-cel at DL2 in TRANSCEND CLL 004 experienced CRS and/or NEs, they were primarily of low severity. HCRU and associated costs for management of CRS and/or NEs after liso-cel infusion increased with AE severity.Although everyone in this study required hospitalization, ICU admissions were rare and only observed among patients who experienced both CRS and NEs. Overall, costs of managing CRS and/or NEs were modest.

Estimation of Postinfusion Resource Use and Total Costs of Care for Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, has previously demonstrated clinically meaningful responses in patients with R/R FL in the global phase 2 TRANSCEND FL study (NCT04245839). Limited evidence is published on estimates of health care resource utilization (HCRU) and cost of postinfusion care among patients with large B-cell lymphoma (LBCL) treated with liso-cel (Palomba ML, et al. Leuk Lymphoma 2021), and no evidence is currently available for patients with R/R FL. This analysis evaluated postinfusion HCRU and estimated cost of care across a 6-month period among patients treated with liso-cel in the TRANSCEND FL study. Methods: In this retrospective analysis, patient-level HCRU data from the TRANSCEND FL study database, including hospitalizations and length of hospital stay (LOS) for the entire hospitalization period postinfusion (standard inpatient [IP] and ICU days), diagnostics (eg, laboratory work and imaging), procedures (eg, dialysis and intubation), and medications (eg, oncology supportive care, prophylactics, and other AE management), were analyzed from the day of liso-cel infusion through 6 months of follow-up. Postinfusion costs (not including the cost of liso-cel) were estimated using a microcosting methodology in which HCRU in the 6-month period was identified and unit costs sourced from public databases or literature (adjusted to 2023 US dollars [USD] using the Consumer Price Index) were applied to each HCRU. Facility costs were sourced from the Healthcare Cost and Utilization Project National Inpatient Sample (2020) databases (Dasta JF, et al. Crit Care Med 2005), and the US Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (OPPS; 2023). Diagnostic and procedure costs were obtained from the CMS OPPS (2023), clinical laboratory fee schedule (2023), physician fee schedule (2023), durable medical fee schedule (2023), and Dasta 2005. Medication cost data were obtained from IBM ® Micromedex ® RED BOOK ® (2023) using wholesale acquisition cost and were uniformly applied across sites of care. Average total cost by month after liso-cel infusion was calculated among patients with ongoing status in that month. Patients censored due to data cutoff were excluded. Results: A total of 130 patients were treated with liso-cel in the TRANSCEND FL study, primarily in the fourth-line setting (45.4%). These patients had a median (range) age of 60 (23‒80) years and were predominantly male (83/130 [63.8%]) and White (69/130 [53.1%]); 45 (34.6%) had unknown race. Among patients who received liso-cel infusions, the estimated mean 6-month postinfusion total cost of care was $89,516 (Figure 1). Most 6-month costs ($77,088 [86.1%]) were incurred in Month 1 after infusion and were primarily driven by facility costs ($66,683 [74.5%]), namely standard IP hospitalization and ICU stays. HCRU and LOS (including standard IP hospitalization and ICU days) are shown in Table 1. Almost all patients were hospitalized in the standard IP setting (128/130 [98.5%]). Few patients were admitted to the ICU (4/130 [3.1%]), and 3/130 (2.3%) had an emergency department visit. Median (range) hospitalization time was 14 (3‒45) days for standard IP and 5 (3‒7) days for ICU stays. Some patients received corticosteroids (30/130 [23.1%]) or tocilizumab (31/130 [23.8%]), and few required intravenous immunoglobulin (11/130 [8.5%]), vasopressors (4/130 [3.1%]), lumbar puncture (2/130 [1.5%]), or mechanical ventilation (1/130 [0.8%]). No patients received dialysis. Conclusions: The majority of costs in the 6-month period after liso-cel infusion among patients with R/R FL in the TRANSCEND FL study were incurred in Month 1 and were facility related (IP and ICU hospitalizations and LOS). These findings, consistent with those previously reported for patients with LBCL treated with liso-cel, support that a single infusion of liso-cel is associated with significantly less HCRU and costs after the initial treatment period in the first month.

RF09 | PSAT94 Challenging the Status Quo: Are Routine Post-Operative Day 1 Non-Endocrine Labs Necessary After Adrenalectomy?

Abstract Background The Choosing Wisely campaign from the American Board of Internal Medicine (ABIM) Foundation has scrutinized the practice of routinely ordering tests that offer limited or no benefit to patients, and have the potential to cause harm. Although postoperative day 1 (POD1) hormonal testing is necessary for certain patients who undergo adrenalectomy (i.e. those with functional tumors), the clinical utility of routinely checking POD1 non-endocrine labs is unclear, particularly in patients with non-functional adenomas. We sought to investigate how often these non-endocrine labs were abnormal after adrenalectomy and whether they represent value-added care. Methods Patients who underwent open or laparoscopic adrenalectomy at our institution from 2011-2020 were identified, and those with non-endocrine serum labs (hemoglobin, potassium, creatinine, or glucose) obtained before 0800 on POD1 were analysed. The frequency of abnormal labs, and any associated intervention(s), was recorded. Exclusion criteria varied by lab type and included: preoperative hemoglobin <8 g/dL or intraoperative blood transfusion (hemoglobin analysis), presence of chronic kidney disease (potassium and creatinine analyses), diagnosis of primary aldosteronism (potassium analysis), and pheochromocytoma or diabetes mellitus (glucose analysis). Costs were calculated using the 2020 Medicare Clinical Laboratory Fee Schedule. Results Of 936 patients (56% female) who underwent adrenalectomy (92% laparoscopic), 91% (n=847) had ≥1 POD1 non-endocrine lab drawn. Only 0.4% (n=3) of 785 eligible patients had an abnormal POD1 hemoglobin (<8 g/dL), and 1 patient received a blood transfusion. Potassium abnormalities were present in 3.4% (n=21) of 624 eligible patients, including 9 with hypokalemia (<3.5 mmol/L) and 12 with mild hyperkalemia (5.5-5.9 mmol/L). Specific interventions for hypo/hyperkalemia were required in 5 patients (0.8% of all potassium values). AKI (creatinine increase of 0.3 g/dL or ≥1.5x baseline) was diagnosed in 4% of 759 eligible patients (n=28) and all were stage 1. Hyperglycemia (>180 mg/dL) was identified in 1% (n=6) of 577 eligible patients, and 1 patient received short-acting insulin. Of a total of 2,745 lab values, while only 2% were abnormal, the total aggregate cost of routine POD1 labs was ∼$17,000 during the study period. Conclusions Routine POD1 hemoglobin and creatinine testing are rarely abnormal after adrenalectomy and infrequently impact clinical management. Although patients with functional disease may require monitoring of electrolytes and/or glucose on POD1, in the current era of value-based healthcare, routine ordering of these labs may be unnecessary in selected patients with non-functioning tumors. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m., Saturday, June 11, 2022 1:18 p.m. - 1:23 p.m.

An Endorsement of the Removal of Race From GFR Estimation Equations: A Position Statement From the National Kidney Foundation Kidney Disease Outcomes Quality Initiative

An Endorsement of the Removal of Race From GFR Estimation Equations: A Position Statement From the National Kidney Foundation Kidney Disease Outcomes Quality Initiative

MP40-01 COST AND DIAGNOSTIC YIELD OF UPPER TRACT IMAGING IN HIGH RISK MICROHEMATURIA; ARE WE STILL DOING TOO MUCH?

You have accessJournal of UrologyCME1 May 2022MP40-01 COST AND DIAGNOSTIC YIELD OF UPPER TRACT IMAGING IN HIGH RISK MICROHEMATURIA; ARE WE STILL DOING TOO MUCH? Clay Martin, Eric Macdonald, Ella Taubenfeld, and Simon Hall Clay MartinClay Martin More articles by this author , Eric MacdonaldEric Macdonald More articles by this author , Ella TaubenfeldElla Taubenfeld More articles by this author , and Simon HallSimon Hall More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002600.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The 2020 AUA guidelines have brought some cost and potentially morbidity-saving changes to the workup and treatment of microhematuria (MH). With these changes comes a call for validating evidence. Herein the new guidelines have been applied to 1,906 patients. METHODS: All patients diagnosed with MH (RBC ≥3/hpf) at a single institution between 2010 and 2019 were retrospectively analyzed. Those with a complete workup including cystoscopy and upper tract imaging within 1 year of diagnosis were included. The new 2020 risk stratification was applied and cancer detection rates by risk group were assessed. A basic cost analysis was performed using the Centers for Medicare & Medicaid Services Physician and Clinical Laboratory Fee Schedule for 2021. RESULTS: Of the total MH cohort (n=1906), 1010 patients were stratified as high risk according to the 2020 guidelines. 770 of the 1010 (76.3%) had cross sectional imaging as part of their workup. Overall, 28 neoplasms were diagnosed in this patient group which corresponds to a detection rate of 2.77%. Of the 28 neoplasms identified, 18 were bladder tumors, 2 were upper tract urothelial malignancies and 8 were solid renal neoplasms. Cross-sectional imaging identified a total of 10 upper tract neoplasms (urothelial and renal) which corresponds to a 1.30% (10/770) detection rate. Furthermore, of the 8 solid renal masses, only 3 were of sufficient radiologic concern to warrant upfront surgical treatment. Additionally, 3 of these 8 patients had renal US in addition to their CT, 2 out of these 3 identified the solid renal mass. Cost analysis suggests that replacement of CT urography with renal US could decrease cost of workup by 38% ($433.04 vs $703.43). CONCLUSIONS: Cross sectional imaging in 770 patients with High-risk MH by the 2020 AUA guidelines yielded a detection rate of only 1.30% for upper tract neoplasms. Only 2 of these were urothelial malignancies that may not have been picked up via renal ultrasonography. Assuming most significant solid renal lesions could be identified by renal US, the utility of cross-sectional imaging is a positive finding in less than 1% of CT scans in this population. These data suggest that cross-sectional imaging may be unnecessary in the workup of MH, even in high-risk patients. Source of Funding: N/A © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e674 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Clay Martin More articles by this author Eric Macdonald More articles by this author Ella Taubenfeld More articles by this author Simon Hall More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD47-01 DIAGNOSTIC AND COST IMPLICATIONS OF THE 2020 AMERICAN UROLOGICAL ASSOCIATION (AUA) MICROHEMATURIA (MH) GUIDELINES: MODELING IMPACT IN A LARGE PUBLIC HEALTHCARE SYSTEM

You have accessJournal of UrologyBladder Cancer: Epidemiology & Evaluation II (PD47)1 Sep 2021PD47-01 DIAGNOSTIC AND COST IMPLICATIONS OF THE 2020 AMERICAN UROLOGICAL ASSOCIATION (AUA) MICROHEMATURIA (MH) GUIDELINES: MODELING IMPACT IN A LARGE PUBLIC HEALTHCARE SYSTEM Samuel Gold, Alexander Kenigsberg, Gianpaolo Carpinito, and Yair Lotan Samuel GoldSamuel Gold More articles by this author , Alexander KenigsbergAlexander Kenigsberg More articles by this author , Gianpaolo CarpinitoGianpaolo Carpinito More articles by this author , and Yair LotanYair Lotan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002069.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The AUA released new MH guidelines in which risk of bladder cancer (BC) or upper tract urothelial carcinoma (UTUC) dictates subsequent work-up with increasing levels of invasiveness and cost. We sought to assess practical and financial impacts of the Microhematuria: AUA/SUFU Guideline (2020) via retroactive application to patients in a large public healthcare system. By comparing to prior AUA MH guidelines (2012), we modeled differences in imaging and procedure utilization, as well as associated costs. METHODS: Patients (≥18 years old) with MH on urinalysis (UA) (≥3 red blood cells/high-powered field) or gross hematuria (GH) were identified on retrospective chart review—initial encounter data was collected from January 2017-May 2018 from a multi-site healthcare system. Those with alternative MH etiologies (i.e. urinary tract infection, benign urologic conditions, gynecologic pathology, etc.) were excluded. Patients were retroactively risk stratified, then hypothetical work-ups were compared based on 2020 vs 2012 guidelines. Cost data was sourced from CMS Medicare Physician Fee Schedule and Clinical Laboratory Fee Schedule for 2020 localized to study site. RESULTS: 3789 patients were included for analysis: 1382 (36.5%), 1026 (27.1%), and 1381 (36.4%) patients were retroactively stratified as low-(LoR), intermediate-(InR), and high-risk (HiR). In LoR patients, 956 repeat UAs were done that would have re-stratified 91 patients to InR and 95 to HiR. Accordingly, the 2020 guidelines would have recommended 1117 renal ultrasounds (RUS) for InR, 1476 computed tomography urograms (CTU) for HiR, and 2593 cystoscopies for InR and HiR (assuming 100% guideline adherence). This compares to 3189 CTU and cystoscopies (2012 guidelines). CTU-specific costs decreased to 44% (2020) from 64% (2012) of total costs. Total costs were $1,260,677 (2020) vs $1,905,236 (2012), a difference of $644,558 (Figure 1). Costs were $332 (2020) vs $597 (2012) per patient. CONCLUSIONS: In practice, the AUA 2020 MH guidelines would result in significant changes to volumes of diagnostic and procedural studies, while substantially reducing costs in total and on a per-patient basis. Changes in CTU volumes, in particular, represent a major driver of cost difference. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e832-e832 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Samuel Gold More articles by this author Alexander Kenigsberg More articles by this author Gianpaolo Carpinito More articles by this author Yair Lotan More articles by this author Expand All Advertisement Loading ...

Diagnostic and Cost Implications of the 2020 AUA Microhematuria Guidelines: Modeling Impact in a Large Public Health Care System.

We sought to model the diagnostic recommendations and associated costs of new hematuria guidelines regarding referral patterns, procedure utilization and urothelial cell carcinoma (UCC) detection. Patients with microhematuria were identified retrospectively. Initial encounter data were collected from January 2017 to May 2018 from a large public health care system; followup was continued to December 2020. Risk stratification was performed based on the American Urological Association 2020 microhematuria guidelines, and disease outcomes were analyzed within this framework. The guideline-recommended workups and costs were modeled; cost data were sourced from the Centers for Medicare & Medicaid Services Medicare Physician Fee Schedule and Clinical Laboratory Fee Schedule for 2020. Modeled diagnostic volumes and costs were assessed for 2020 and 2012 microhematuria guidelines, respectively. Of the 3,789 patients included for analysis, 1,382 (36.5%), 1,026 (27.1%) and 1,381 (36.4%) were retroactively stratified as low risk, intermediate risk (InR) and high risk (HiR), respectively. A total of 19 cases of UCC (17 bladder, 2 upper tract) were diagnosed, of which 84% were HiR. For high-grade UCC, 92% of cases were HiR. The 2020 guidelines recommended renal ultrasound for 1,117 InR cases, computerized tomography urogram (CTU) for 1,476 HiR cases, and cystoscopy for 2,593 InR and HiR cases combined. Total costs were $1,905,236 (2012) versus $1,260,677 (2020), driven mainly by CTU costs. Per-cancer detected costs were $100,276 (2012) versus $61,760 (2020). In retrospect, the 2020 guidelines would have effectively risk-stratified microhematuria cases for detection of malignancies. As compared to the 2012 guidelines, application of the 2020 guidelines would result in significant changes to diagnostic and procedural volumes, while substantially reducing total and per-patient costs.

Economic Model Shows That Guideline Recommended Testing of Patients with Early Symptoms of Myeloma Results in Improved Patient Outcomes and Decreased Hospital Costs

Introduction : Multiple myeloma (MM) is a hematologic cancer of the plasma cells, which are found in the bone marrow. The early symptoms of MM are often vague and non-specific, such as fatigue, bone pain and back pain. These vague symptoms lead patients to present first to their primary care physician and often delay diagnosis resulting in progressive disease [MayoClinic.org]. The median time for MM diagnosis (163 days) is longer than for most other hematologic cancers including leukemias and lymphomas [Howell et al, BMC Hematol, 2013]. Delayed diagnosis of MM is commonly associated with the development of chronic complications such as renal impairment, infections, neurological disease, bone disease and anemia [Kariyawasan et al, Q J Med, 2007]. Therefore, early detection and diagnosis of MM are essential to avoid downstream complications, and may significantly reduce the treatment costs associated with these complications. In the assessment of symptomatic patients, National Comprehensive Cancer Network (NCCN) practice guidelines recommend using three tests to maximize sensitivity and specificity: serum protein electrophoresis (SPE), serum immunofixation electrophoresis (SIFE) and serum free light chains (SFLC) [NCCN Multiple Myeloma Guidelines Version 3.2017]. However, physician compliance with these guidelines is hampered by the many different test options available and the low visibility of Myeloma on the list of possible causes for the primary care physician. In the current study, we modeled the effect of converting a hospital system over to guideline compliance in testing for Multiple Myeloma.Methods : A decision analytic model was developed to estimate the total costs and annual budget impact when using the guideline recommended panel for early diagnosis of MM patients. Using a US hospital (i.e., integrated delivery network [IDN]) model perspective, a decision algorithm was developed based on NCCN and IMWG clinical practice guidelines and further validated by clinicians [Rajkumar et al, Lancet Oncol. 2014]. Comparators include SPE alone, SPE+SFLC, SPE+UPE (urine protein electrophoresis), SPE+SIFE and SPE+SFLC+SIFE. Epidemiology estimates were from the SEER database [Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat]. Test sensitivity and specificity and downstream complication rates were based on published sources [Katzmann et al, Clin Biochem Rev, 2009 and McTaggart et al. Am J Clin Pathol, 2013]. Lab and imaging costs were collected from the CMS laboratory fee schedule and downstream complication treatment costs from the HCUP National Inpatient Sample database.Results : For an average IDN, a total of 967 patients are estimated to undergo evaluation for MM each year. Conversion from typical current practice to guideline compliance is estimated to reduce the time to MM diagnosis from 159 days to 45 days per patient (64% reduction). The number of correct MM diagnoses increases from 949 to 967 per year. Hospital laboratories would expect to invest $37,680 per year in additional diagnostic costs in order to save the hospital system a total of $74,135 annually in averted complications (24% reduction in complications) resulting from earlier diagnosis. From a cost-benefit perspective, this translates to a reduced cost/correct diagnosis of about $48 and savings per averted complication of $3,975 for the hospital system.Conclusions: Guideline recommended testing of patients with early symptoms of Multiple Myeloma can help reduce costs, improve patient outcomes and increase efficiency of care. Hematologists, as stewards of the guidelines, should help in educating primary care physicians on warning signs of MM and appropriate diagnostic tests. [Display omitted] DisclosuresWu:Celator/Jazz: Consultancy. Jensen:Celator/Jazz: Consultancy. Cyr:Celator/Jazz: Consultancy.

Costs of Postinfusion Monitoring By Site of Care for Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Who Received Third-Line or Later Treatment with Lisocabtagene Maraleucel (liso-cel) in the Transcend NHL 001 and Outreach Trials

Background: Chimeric antigen receptor (CAR) T cell therapy is generally limited to inpatient settings; yet, exploration of outpatient infusion and monitoring is ongoing. Information on health care resource utilization (HCRU) and costs associated with CAR T cell therapy administration is limited and may differ by postinfusion monitoring site. Liso-cel is an investigational, CD19-directed, defined composition, 4-1BB CAR T cell product administered at equal target doses of CD8+ and CD4+ CAR+ T cells. An interim analysis from the OUTREACH study (NCT03744676) observed lower HCRU with outpatient vs inpatient administration (Bachier et al. J Clin Oncol 2020;38:8037). The patient journey after CAR T cell therapy administration may differ for patients with outpatient vs inpatient monitoring and may result in varying costs of care. This study estimated the cost of postinfusion monitoring by site of care for patients with R/R LBCL who received third-line or later treatment with liso-cel in the TRANSCEND NHL 001 (TRANSCEND; NCT02631044) and OUTREACH clinical trials. Methods: This retrospective study analyzed HCRU reported in clinical trial databases from TRANSCEND and OUTREACH. A 2-step microcosting method was used to identify key HCRU and to estimate postinfusion costs: (1) HCRU was analyzed from the index date (day of liso-cel infusion) through the 6-month follow-up; and (2) costs were applied to each HCRU. HCRU included standard inpatient and intensive care unit (ICU) length of stay (LOS), diagnostics (laboratory work and imaging), procedures (dialysis and intubation), and medications (supportive care, prophylactic treatment, and adverse event management). Unit costs were obtained from the health care system (provider) perspective and adjusted to 2020 US dollars. Cost per standard inpatient day ($2,542) was estimated from Healthcare Cost and Utilization Project databases, and cost per ICU day ($7,556) was sourced from Dasta et al (Crit Care Med. 2005;33:1266-77). All medication costs were obtained from REDBOOK (IBM Micromedex) using wholesale acquisition costs. Diagnostic and procedure costs were obtained from the Centers for Medicare & Medicaid Services laboratory fee schedule, physician fee schedule, or outpatient prospective payment system. A payment-to-cost ratio was applied to Medicare payment rates to estimate unit costs. Costs were adjusted to reflect the site of care where the HCRU occurred. A cost ratio was applied to adjust costs from the physician's office/community oncology clinic to the hospital outpatient department (Winfield, Muhlestein, Leavitt Partners; 2017) and from outpatient to inpatient (Meisenberg et al. Bone Marrow Transplant. 1998;21:927-32). Costs were aggregated by HCRU category, specifically medications, diagnostics, procedures, and facility costs. An average total cost by post-liso-cel infusion month was calculated for patients with ongoing status in that month (patients censored due to data cutoff were not included). Analyses were stratified by site of postinfusion monitoring (inpatients vs outpatients). Results: A total of 303 patients with R/R LBCL across the 2 trials received liso-cel and postinfusion monitoring (inpatients, n = 256; outpatients, n = 47). HCRU and LOS, including standard inpatient and ICU days, are shown in the Table. Inpatients had higher rates of inpatient stays (<100% vs 62%) and tocilizumab use (for CRS and/or NE; 20% vs 9%) than outpatients, respectively. Rates of ICU admission, corticosteroid use, vasopressor use, dialysis, and intubation were similar between groups. Median and average LOS in standard inpatient and ICU settings were higher among inpatients. Median (range) total LOS for inpatients and outpatients was 15 (0-88) and 4 (0-77) days, respectively. The estimated mean postinfusion cost of care was $89,535 for inpatients and $36,702 for outpatients. Over 6 months, most costs were incurred in the first month after infusion ($50,369 [56%] for inpatients and $19,837 [54%] for outpatients). Costs were largely driven by facility costs, namely standard inpatient and ICU stays (Figure). Conclusions: Lower overall HCRU was observed with outpatient liso-cel postinfusion monitoring, primarily due to hospitalizations, which resulted in a mean 6-month cost savings of $52,833 (59%) compared with inpatient monitoring. These results are based on national average costs and may not be generalizable to specific institutions. Disclosures Palomba: Regeneron: Research Funding; Juno Therapeutics, a Bristol-Meyers Squibb Company: Honoraria, Research Funding; Genentech: Research Funding; Merck: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Pharmacyclics: Honoraria. Jun:Bristol-Myers Squibb Company: Current Employment, Current equity holder in publicly-traded company. Garcia:Bristol-Myers Squibb Company: Current equity holder in publicly-traded company; Juno Therapeutics, a Bristol-Myers Squibb Company: Current Employment. Lymp:Bristol-Myers Squibb Company: Current equity holder in publicly-traded company; Juno Therapeutics, a Bristol-Myers Squibb Company: Current Employment. McGarvey:Pfizer, Inc.: Ended employment in the past 24 months; BluePath Solutions: Current Employment. Gitlin:BMS: Research Funding. Pelletier:BMS: Current Employment, Current equity holder in publicly-traded company. Nguyen:BluePath Solutions: Current Employment.

Improving Medical Students' OSCE Performance in Telehealth: The Effects of a Telephone Medicine Curriculum.

To report on the implementation of a telephone medicine curriculum as part of the core clerkship in pediatrics for students at Johns Hopkins University School of Medicine and evaluate the curriculum's effect on student performance on a telephone medicine case as part of a required objective structured clinical exam (OSCE). Using a prospective cohort design with a convenience sample of third-year medical students during the 2016-2017 and 2017-2018 academic years, the authors compared the OSCE scores of students assigned to the curriculum with both historical and concurrent control groups of students who had not received the curriculum. Additionally, the authors compared the costs of the recommended testing by students in each group using the 2018 Centers for Medicare and Medicaid Services Clinical Laboratory Fee Schedule. Students assigned to the telephone medicine curriculum (students in the intervention group) had a significantly higher mean overall score on the simulated OSCE telephone medicine case compared with the students in the control groups who did not receive the curriculum (the mean score for students in the intervention group was 7.38 vs 6.92 for students in the control groups, P = .02). Additionally, the intervention group had statistically significantly lower costs for their recommended testing compared with the control groups (the median value for tests ordered by students in the intervention group was $27.91 vs $51.23 for students in the control groups, P = .03). Implementing a dedicated telephone medicine curriculum for medical students improves their overall performance and delivery of high-value care via telephone medicine as part of an OSCE. Medical educators should pursue ongoing research into effective methods for teaching medical students and residents how to navigate digital encounters.

Abstract P6-13-01: Cost-effectiveness of ado-trastuzumab emtansine (T-DM1) versus trastuzumab (H) for the adjuvant treatment of patients with residual invasive HER2+ early breast cancer in the US

Abstract Objectives: Ado-trastuzumab emtansine (T-DM1) is a HER2-targeted antibody drug conjugate (ADC) indicated for the adjuvant treatment of patients with HER2+ early breast cancer (eBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. In a phase 3 clinical trial (KATHERINE, NCT01772472), T-DM1 demonstrated a statistically significant 50% reduction in the risk of invasive BC recurrence or death compared with trastuzumab (H) (HR= 0.5, 95% CI 0.39-0.64; p<0.001). This study explored the cost-effectiveness of T-DM1 use versus H from a US third-party payer perspective. Methods: A Markov-based cost-effectiveness model with a lifetime horizon was developed to compare the clinical and cost outcomes of T-DM1 versus H from the US payer perspective. The model considered the population from the KATHERINE trial and included six health states: invasive disease-free, non-metastatic (locoregional) recurrence, remission, first- and second-line metastatic breast cancer (mBC), and death. Invasive disease-free survival (iDFS) projections over patients' lifetimes were derived from statistical extrapolation of the KATHERINE clinical trial data, while overall survival, estimated as the risk of death in each health state, was derived from several BC clinical trials and US life tables. The model included costs for treatments in all health states, except for remission and death. Dosing and treatment duration was from product prescribing information and/or published literature. Drug costs were estimated using the wholesale acquisition cost (WAC) for drugs from Medispan PriceRx. Additional costs included health state-related medical resource use, adverse events during iDFS, and costs associated with end of life. These costs were derived from Medicare physician and laboratory fee schedules, prescribing information for adverse event rates and the published literature for both adverse event and end of life costs. Health state utilities were derived from the KATHERINE clinical trial and the published literature. All costs were adjusted to 2019 US dollars. Results: In the base case, T-DM1 dominated H (incremental costs: -$41,003, incremental quality-adjusted life years [QALYs]: 1.79, incremental life years [LYs]: 2.22). Results were driven by cost offsets observed in health states beyond iDFS. T-DM1 produced cost savings due to fewer patients with invasive recurrence, and hence, fewer patients undergoing first- and second-line mBC (e.g., $1,540 vs $6,684, $49,512 vs $85,795, and $35,204 vs $62,435 lifetime costs for T-DM1 and H in non-metastatic recurrence, first- and second-line mBC, respectively). The probabilistic sensitivity analysis found consistent cost savings in all iterations (T-DM1 was dominant 96.6% of the simulations). Scenario analyses showed that base case results remain robust across input variations. Conclusions: The cost-effectiveness analysis shows that T-DM1 as an adjuvant therapy for patients with HER2-positive eBC who have residual invasive disease after neoadjuvant therapy is a dominant treatment option (less costly, more effective) compared to H in the US. Citation Format: Hans-Peter Goertz, Oscar Herrera-Restrepo, Elizabeth Wehler, Pinar Bilir, Vincent Antao, Gurleen Singh Jhuti. Cost-effectiveness of ado-trastuzumab emtansine (T-DM1) versus trastuzumab (H) for the adjuvant treatment of patients with residual invasive HER2+ early breast cancer in the US [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-13-01.

185 Impact of Eliminating a Urinalysis With Reflex to Urine Culture on Urine Testing Patterns in the Emergency Department

As antibiotic resistance has increased as a public health threat, attention has focused on interventions aimed at reducing unnecessary antibiotic prescribing. This includes the overtreatment of asymptomatic bacteriuria (ASB), due to unnecessary urine testing with subsequent diagnosis of urinary tract infection (UTI) despite absence of clinical symptoms. With ASB common in some populations, such as older adults, stewardship programs should seek to reduce unnecessary urine testing on asymptomatic patients. A reflex urinalysis (UA) (defined as WBC> 5/hpf = urine culture) order is commonly used in the emergency department (ED) setting due to perceived operational efficiency benefits; however, this can result in unnecessary diagnosis and treatment of UTI. The objective of the study was to evaluate the impact of removing reflex UA from the computerized physician order entry system (CPOE) on overall urine testing patterns in an academic ED. We conducted a retrospective study of all patients who received any urine test in the ED within the six month pre- and post-intervention periods. A one-month washout period was used surrounding reflex UA removal. The intervention consisted of a notification to providers via e-mail who frequently used reflex UA (academic detailing) and removal of reflex UA from personal and ED preference lists and order sets (systems approach). A positive culture was defined as growth of one or more pathogenic organisms at 104 CFU/ml or greater. Patient demographic and urine testing data were extracted from the electronic health record and analyzed using STATA SE15. Primary outcomes were the rates of total cultures and contaminated cultures per 1000 ED visits. Patient safety was assessed by analysis of any missed urine cultures in pyelonephritis or urosepsis cases. Urine culture cost was estimated from the Medicare Clinical Laboratory Fee Schedule. The study included 17,061 patients with 20,029 urine tests (mean age, 45.7 years; 85.0% white; 60.8% female). The six-month average urine culture order rate fell from 63.2 per 1000 ED visits to 35.3 per 1000 post-intervention, a 41% overall reduction (P<0.001). The rate of contaminated cultures was 16.0 per 1000 ED visits before the intervention compared to only 6.9 after (P<0.001) (see Figure). Of those diagnosed with pyelonephritis or sepsis, 72.8% received a urine culture before intervention in contrast to 56.9% after intervention (P<0.001). Cost savings from reduction in urine cultures was estimated to be $10,830. Removal of reflex UA from the CPOE led to significant reductions in the rates of total cultures performed as well as contaminated cultures. However, there was also a significant decrease in urine cultures obtained for conditions where a culture is typically recommended. Ordering systems greatly impact urine testing practices and could have future implications in reducing overtreatment of ASB. Any intervention or change to eliminate reflex UA orders should be accompanied with robust provider education emphasizing the need to separately order urine cultures when indicated.

The cost of repetitive laboratory testing for chronic disease.

Interval laboratory investigations are necessary for monitoring chronic diseases. However, testing too frequently may not be beneficial clinically and can be considered low-value care. We examined the frequency of glycosylated haemoglobin, lipids, iron panels (serum iron, ferritin, transferrin, iron binding) thyroid function (free T4 and thyroid stimulating hormone) and 25-OH vitamin D tests in a 1290-bed tertiary hospital in Singapore. All tests done over a 20-month period (January 2016 to August 2017) were retrieved from the laboratory database. Of the 275 565 tests done for 115 971 patients, 5.2% were repeat tests done at intervals shorter than the minimum retesting interval, as defined by the Royal College of Pathologist and Irish Guidelines on the Use of the Laboratory. Using the Centers for Medicare and Medicaid Services Clinical Laboratory Fee Schedule, we estimated a cost burden of US$222 096 per year. Strategies to reduce unnecessary repetitive testing can result in significant cost savings.

What the Protecting Access to Medicare Act Means for Clinical Laboratories.

In 2014 Congress passed the Protecting Access to Medicare Act (PAMA),10 which required the Centers for Medicare and Medicaid Services (CMS) to revise the Clinical Laboratory Fee Schedule (CLFS) to reflect private sector payment rates. This change was in response to Government Accountability Office and Department of Health and Human Services Office of the Inspector General reports that indicated that Medicare was paying substantially more for testing than private insurers paid. Legislators projected the new law would reduce laboratory payments by $3 billion over 5 years. To minimize the immediate impact on clinical laboratories, Congress directed CMS to phase in anticipated rate cuts. Payment reductions were limited to 10% annually for the first 3 years, 15% per annum for the following 3 years, and no limits thereafter. The new CLFS took effect on January 1, 2018. That year, cuts were applied to 75% of laboratory tests. CMS expects 58% of tests to have further reductions in 2019. Many in the laboratory community have asserted that the CMS cuts are too deep. CMS estimates the new fee schedule will reduce Medicare payment to laboratories by $5 billion over 5 years—$2 billion more than Congress intended. Healthcare groups suggest that one reason for this discrepancy is that >90% of the payment information used by CMS to set the new rates came from high-volume, large commercial laboratories that offer volume discounts, thereby skewing the payment data toward lower-than-average rates. Laboratory and manufacturer groups have urged CMS to expand the number and types of laboratories required to submit payment data to more accurately reflect the spectrum of laboratories that provide testing for patients. CMS, however, asserts that its current data collection model accounts for most laboratory tests and payments and that expanding the number of reporting facilities will not greatly alter the fees …

Economic impact of post-progression treatment in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients previously treated with octreotide monotherapy.

e18366 Background: For unresectable, well-differentiated, advanced GEP-NET patients somatostatin analogs octreotide LAR (OCT) and lanreotide depot (LAN) are recommended as first-line systemic therapy. Recent evidence suggests that GEP-NET patients may benefit from LAN after OCT prior to modifying treatment class. The goal of this analysis is to quantify treatment escalation costs among patients who progress on OCT. Methods: A decision-tree model was used to assess the cost of treating GEP-NET patients over a 6-month time horizon after they progress on OCT. Drug acquisition (Wholesale Acquisition Costs), administration, grade 3/4 adverse event (AE) management, and patient monitoring costs were considered. Patients could utilize either OCT escalation (30 mg every 3 weeks or 40 or 60 mg every 4 weeks), OCT + peptide receptor radionuclide therapy (PRRT), OCT + liver directed therapy (e.g. transarterial chemoembolization (TACE)), everolimus, or LAN 120mg every 4 weeks. Administration and monitoring test costs were based on CMS physician and laboratory fee schedules, respectively. AE management costs were determined from the CMS Inpatient prospective payment system based on reimbursements corresponding to the associated DRG codes. Results: LAN ($44,462) was found to be cost-saving versus alternatives when used post-OCT. OCT escalations to 30mg every 3 weeks, 40mg every 4 weeks, and its use with liver directed therapy were 2nd, 3rd, and 4th lowest cost treatment options ($52,873, $53,041, and $72,152, respectively); all three had higher drug acquisition and AE management costs. Drug acquisition costs for everolimus were more than twice those of LAN and for PRRT + OCT nearly 4 times that amount. GA-68 Dotatate PET/CT imaging greatly increased the monitoring costs of PRRT + OCT, which were $3,682 higher than the nearest alternative. Conclusions: LAN was the lowest cost treatment option over a 6-month interval for GEP-NET patients who progressed on OCT, however clinical appropriateness must be considered when transitioning patients. Evidence for the appropriate clinical strategy of sequencing of patients is still needed.

New Paradigm, New Opportunities: Laboratory Stewardship

AbstractOver the years, there has been a dramatic and unsustainable increase in health care (HC) expenditures in the United States. By the year 2024, an estimated $4 trillion will be spent for HC. So, what role do laboratories play in increasing HC costs? Some 4 to 5 billion laboratory tests are performed annually, but 30% have been deemed unnecessary. Medicare has been reimbursing for tests based on fee for service without regard to clinical necessity. To address this high rate of reimbursement and waste, in 2014, the Protecting Access to Medicare Act (PAMA) became law. Under PAMA, a lower fee for tests ordered under the Part B Clinical Laboratory Fee Schedule will be phased in. Laboratories covered under alternative insurance plans are no longer compensated for each test performed. Instead, value-based reimbursement will be progressively introduced, eliminating waste and ensuring the right tests are ordered to improve patient care. As a result, laboratories are responding to these changes by developing laboratory stewardship programs.

Magnitude of Potentially Inappropriate Thrombophilia Testing in the Inpatient Hospital Setting.

Laboratory costs of thrombophilia testing exceed an estimated $650 million (in US dollars) annually. Quantifying the prevalence and financial impact of potentially inappropriate testing in the inpatient hospital setting represents an integral component of the effort to reduce healthcare expenditures. We conducted a retrospective analysis of our electronic medical record to evaluate 2 years' worth of inpatient thrombophilia testing measured against preformulated appropriateness criteria. Cost data were obtained from the Centers for Medicare and Medicaid Services 2016 Clinical Laboratory Fee Schedule. Of the 1817 orders analyzed, 777 (42.7%) were potentially inappropriate, with an associated cost of $40,422. The tests most frequently inappropriately ordered were Factor V Leiden, prothrombin gene mutation, protein C and S activity levels, antithrombin activity levels, and the lupus anticoagulant. Potentially inappropriate thrombophilia testing is common and costly. These data demonstrate a need for institution-wide changes in order to reduce unnecessary expenditures and improve patient care.

Cost per Treatment Success of Thrombopoietin Receptor Agonists Vs "Watch and Rescue" Strategy for Treating Adult Non-Splenectomized Patients with Chronic Immune Thrombocytopenia: A US Payer Perspective

Background:Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count level and increased risk of bleeding. Non-splenectomized patients account for the vast majority of adult patients with ITP in US clinical practice (Cetin et al, Blood, 2014).Two thrombopoietin receptor agonists (TPO-RAs, romiplostim [once-weekly subcutaneous injection] and eltrombopag [once-daily oral agent]) are indicated for the treatment of non-splenectomized adults with chronic ITP who have had an insufficient response to corticosteroids or immunoglobulins. Both TPO-RAs have been shown to increase and maintain platelet counts and reduce the incidence of bleeding-related episode (BRE, defined as a bleeding event and/or use of rescue therapy).Using a US payer perspective and recent price and cost data, this analysis estimates the cost relative to treatment success (measured as overall platelet response) of the two TPO-RAs and a "watch and rescue" strategy (monitoring patients until rescue therapies [eg, intravenous immunoglobulin] are required) in non-splenectomized adults with chronic ITP.Methods:The analysis was conducted based on time horizon (24 weeks) and data for non-splenectomized patients of phase 3 registrational trials of romiplostim (Kuter et al, Lancet, 2008) and eltrombopag (Cheng et al, Lancet, 2011) in adult patients with chronic ITP.Rates of overall platelet response (see definitions based on number of weeks with platelet count ≥ 50 x 109/L in Cooper et al, Int J Technol Assess Health Care, 2014) were estimated using trial data (Kuter et al, Lancet, 2008; NICE Appraisal of Eltrombopag, 2012): 87.8% for romiplostim, 71.8% for eltrombopag, and 14.5% for "watch and rescue" (from pooled data for placebo arms).Drug acquisition cost was calculated using wholesale acquisition cost values as of July 16, 2015 ($5.8256 per mcg for romiplostim, $4.0824 per mg for eltrombopag 25 mg tablet, $3.9875 per mg for eltrombopag 50 or 75 mg tablet) and average dose in the trials (317 mcg/week for romiplostim [assuming 100% wastage of unused dose in an opened vial], 55 mg/day for eltrombopag).Costs for drug administration (for romiplostim only, once per week), physician visit and platelet count monitoring (for all three strategies, once per week in weeks 1-4 and once every 4 weeks in weeks 5-24), and liver function monitoring (for eltrombopag only, once every 2 weeks in weeks 1-4 and once every 4 weeks in weeks 5-24) were obtained from CMS Physician Fee Schedule (July 2015 release) and Clinical Laboratory Fee Schedule (January 2015 release).Cost of BREs (ie, cost for treating bleeding events and/or cost for rescue therapy) was derived on the basis of incidence rates of BRE (0.128 per patient-week for non-responder and 0.031 per patient-week for responder, calculated from data reported in Weitz et al, Curr Med Res Opin, 2012) and average treatment cost per BRE ($6,006, in inflation-adjusted June 2015 $) estimated from BREs identified during 2007-2013 in a study of a large US administrative healthcare claims database (Cetin et al, Blood, 2014).Cost per response was computed as total cost (summation of all the cost items aforementioned) divided by overall platelet response rate.Results:The cost per response results by treatment strategy are summarized in the Table. Compared to the "watch and rescue" strategy, use of any of the two TPO-RAs is associated with a fewer number of BREs, a lower cost for treating BREs, and a lower cost per response. Cost per response estimates of the two TPO-RAs are broadly comparable, with romiplostim associated with lower cost per response than eltrombopag.Conclusion:In non-splenectomized adults with chronic ITP, the use of TPO-RAs represents an efficient way in achieving treatment success, with lower cost per treatment success than the "watch and rescue" strategy.Table 1Cost per Response by Treatment Strategy (time horizon: 24 weeks; 2015 $)RomiplostimEltrombopag"Watch and rescue"Drug acquisition cost$44,321$37,0330Drug administration cost$60000Physician visit and platelet count monitoring cost$711$711$711Liver function monitoring cost0$770Average number of BREs1.031.402.74Cost of BREs$6,164$8,418$16,464Total cost$51,796$46,239$17,175Overall response rate87.8%71.8%14.5%Cost per response$58,990$64,432$118,314 DisclosuresLi:Amgen, Inc.: Employment, Equity Ownership. Sharma:Amgen Inc.: Employment, Other: stock ownership. Zhang:Amgen Inc.: Other: Internship. Campioni:Amgen Inc.: Employment, Other: stock ownership. Fust:Amgen Inc.: Consultancy, Research Funding; Optum: Employment. Lin:Amgen Inc.: Employment, Other: stock ownership. Parthan:Optum: Employment; Amgen Inc.: Consultancy, Research Funding. Wang:Amgen Inc.: Employment, Other: stock ownership. Zur:Optum: Employment; Amgen Inc.: Consultancy, Research Funding. Cetin:Amgen, Inc: Employment, Equity Ownership. Eisen:Amgen Inc: Employment, Other: stock ownership.