bluuebunny/crossref_metadata_2025_split huggingface dataset:
The financial impact of reducing drug waste with biosimilar transition of trastuzumab in the Oncology Care Model for the U.S. Oncology Network.
Authors: Fernandez Jennifer , Indurlal Puneeth , Garey Jody S. , Dave Neal , Cleveland Richard , Agena Jody , Malhotra Rajat , Wilfong Lalan S. 
Published: September 2022

11 Background: The Oncology Care Model (OCM), a 6-year long Medicare value-based care program, rewards practices for decreasing total cost of care (TCOC) compared to a benchmark price, while maintaining high quality cancer care. Care services for enrolled patients are divided into 6-month episodes within 1-year time intervals called Performance Periods (PP). One approach to reducing TCOC is reducing the expenditure for drug waste. In mid-2017, trastuzumab (HER2-targeted monoclonal antibody) 420 mg multi-dose vial (MDV) was discontinued and replaced with a 150 mg single-dose vial (SDV), leading to wastage of the remaining partial quantities of the SDV after preparation of a patient-defined dose. The increased drug waste led to an increase in the total drug cost of trastuzumab and TCOC. Late 2019, MDV and SDV biosimilar trastuzumab products were introduced, and The US Oncology Network (The Network) practices adopted the MDV biosimilar as a strategy to reduce drug waste and TCOC. This study highlights the impact of trastuzumab drug waste on TCOC. Methods: Claims data for 14 Network practices, participating in OCM, were assessed. The financial impact of drug waste and TCOC for The Network’s transition from MDV trastuzumab to SDV trastuzumab in 2017, and from SDV trastuzumab to the MDV biosimilar trastuzumab in 2020 was evaluated. Results: With the use of MDV trastuzumab during OCM PP1, drug waste accounted for 0.05% of the total dose of trastuzumab. After having to shift from MDV to SDV during PP2, as a result of the packaging change, trastuzumab drug waste increased to 10.25% of the total dose, with an increase in TCOC by 0.25% ($2M) per PP during PPs 3-7. As The Network practices adopted the use of MDV biosimilar trastuzumab starting in PP8, drug waste declined 57% to 4.4% of the total dose in PP9, reducing the drug waste component of TCOC by $1.4M (0.16%). Had all SDV trastuzumab doses been transitioned to the MDV biosimilar, an additional $600K (0.09%) in TCOC could have been reduced in PP9. Conclusions: TCOC fluctuations can be driven by not just increasing costs or increased utilization, but also by drug packaging and increasing drug waste. The discontinuation of MDV trastuzumab resulted in a substantial financial impact on drug waste, TCOC, and cost for patients. Swift transition to biosimilar MDV trastuzumab within The Network helped to significantly reduce drug waste and its impact on TCOC in the OCM. Trastuzumab biosimilars, in addition to being cost-effective alternatives to biological therapeutics, offer significant cost savings via drug waste reduction.
Real-world cost effectiveness of first-line pembrolizumab for advanced melanoma: A population-based study by the Canadian Real-world Evidence Value for Cancer Drugs (CanREValue) Collaboration.
Authors: Hanna Timothy , Aktar Suriya , Arciero Vanessa , Liu Ning , Chan Kelvin K. 
Published: September 2022

17 Background: Randomized controlled trials (RCTs) demonstrate large survival benefits with anti-PD-1 checkpoint inhibitors compared to anti-CTLA4 therapy for advanced melanoma. However, it remains unclear if patients in routine practice derive a similar survival benefit or if real-world health utilization differs from trials. Outcomes are needed to inform life-cycle health technology reassessment (HTA) with real-world cost-effectiveness analysis. Methods: This study compared patients with advanced melanoma treated with publicly funded first-line ipilimumab (September 2012 - December 2014) or pembrolizumab (June 2016 - March 2018) in Ontario, Canada. These periods were chosen to reflect distinct eras of access to treatment. Linked administrative databases were used to identify cases, covariates, health-utilization and all-cause death. Inverse probability of treatment weighting (IPTW) with stabilizing weights was used to adjust for covariates (including: age, sex, melanoma site, rurality, income, comorbidity, stage at diagnosis, cancer history, prior brain metastasis treatment). Using a three-year time horizon, individual patient-level censoring-adjusted costs in 2019 Canadian dollars with a 1.5% annual discount rate were determined from the public payer’s perspective. The outcome was quality-adjusted life-years (QALY) measured at the individual patient level. Health utilities were based on accepted Canadian values from the initial HTA. The incremental cost-effectiveness ratio (ICER) was determined with bootstrap confidence intervals (CI). Results: Ninety patients treated with first-line ipilimumab, and 300 with pembrolizumab were identified. Those receiving pembrolizumab were older (median 70 vs.63 years), more likely to have multiple comorbidities (12% vs. 8%), and no prior brain radiation (83% vs. 74%). Covariates were balanced after weighting. Pembrolizumab was associated with improved OS (43.1% vs. 22.1% with ipilimumab at 3 years, IPTW adjusted hazard ratio: 0.52, 95% CI: 0.39-0.70; p < 0.001). Mean costs for pembrolizumab and ipilimumab were $212,706 (95% CI 196,122 - 229,290) and $158,352 ($143,218 - 173,484), and mean survival 1.20 QALY (95%CI 1.11 – 1.29) and 0.66 QALY (0.52 – 0.80) respectively. The ICER was $101,183/QALY (65,375 – 139,298). The probability of cost-effectiveness was 0%, 48% and 99% at willingness-to-pay thresholds of $50k, $100k and $150k respectively. Conclusions: In real-world patients, first-line pembrolizumab for advanced melanoma was associated with improved OS compared to ipilimumab. The real-world cost-effectiveness estimate of $101,183/QALY is similar to the model-based cost-effectiveness estimates ($114,389/QALY to $151,369/QALY) used in the initial health technology assessment recommendation prior to reimbursement.
Novel use of an objective scoring rubric to guide inpatient chemotherapy stewardship.
Authors: Bhardwaj Aarti Sonia , Jain Priya , Hernandez Damaris Peralta , Handa Shivani , Petrone Giulia , Anderson Justine , Chowdhury Nobel , Yum Kendra , Kwon Deukwoo , Mato John , Berger Natalie S , Smith Cardinale B. 
Published: September 2022

20 Background: The cost of cancer care is an enormous healthcare burden. Most inpatient chemotherapy is not reimbursed because of diagnosis-related group codes. We have previously reported inpatient chemotherapy and immunotherapy (IC) is associated with poorer outcomes for patients with advanced stage solid tumor (ST) vs hematologic malignancy (HM) patients. 1 We piloted the use of a novel objective scoring rubric to guide and automate IC stewardship at an academic cancer center to decrease the inappropriate use of inpatient administration of costly therapies in patients especially at the end of life. Methods: Using an iterative process, an interdisciplinary group of physicians, nurses and pharmacists developed objective criteria of patient, cancer and treatment factors to guide chemotherapy stewardship. IC that is on formulary and being given as standard of care (i.e., induction of leukemia) are automatically approved. IC that is non-formulary requires evaluation using the developed criteria. Treatment factors include information on the level of existing evidence to support use: type and phase of trial, FDA and NCCN approvals. Patient factors include: performance status, line and goal of therapy. The scoring rubric positively weights regimens with strong levels of evidence or positive patient factors and negatively weights regimens with poor levels of evidence and adverse patient factors. Clinicians must complete the criteria via a form in RedCap. Upon completion, a score is automatically calculated by the tool and 2 disease specific physicians and a clinical pharmacist review for accuracy. If the threshold score is met, IC is approved for inpatient administration and if it is not met, IC is not approved for administration. Results: From January 2022 until May 2022 there have been 30 cases reviewed. 50% were ST requests and 50% were for HM requests. 20 cases (67%) were approved and 8 cases (26%) were not. Two cases were retracted by the requestor. This resulted in cost savings of $63,920. Table illustrates clinical outcomes and characteristics of the approved cases. Conclusions: This pilot illustrates that 67% of the time our cancer physicians chose the administration of inpatient chemotherapy that aligned with objective criteria which is reassuring and serves to validate the use of this tool. Alternatively, this objective rubric prevented inappropriate administration of chemotherapy 26% of the time. Our pilot indicates that there is a role for an objective tool for automated inpatient chemotherapy stewardship. Reference: Evaluation of inpatient chemotherapy among patients with cancer. Petrone G et al. JCO.2022.40.16_suppl.6566.[Table: see text]
Confirming Choosing Wisely: Inpatient thrombophilia testing.
Authors: Kovalenko Iuliia , Golubykh Konstantin , Cuevas Velazquez Adan Martin , Ammari Nadim , Malik Maidah , Sandhu Manpreet , Qurashi Hafiz , Saleem Tabinda , Atrash Anas , Komanduri Saketram , Wert Yijin , Lu Kit 
Published: September 2022

22 Background: The American Society of Hematology (ASH) Choosing Wisely campaign have created thoughtful conversations between providers and patients in recommending care that is supported by evidence to reduce duplicative testing. However, some have raised concerns regarding the impact on patient care. We provide our institutional experience in exploring the clinical feasibility of the recommendation on reducing unnecessary inpatient thrombophilia testing. Methods: This was a retrospective review of patients admitted with a diagnosis of venous thromboembolism (VTE) across the 3 hospitals in Central PA from September 2021 to December 2021. Pregnancy was an exclusion criterion. Thrombophilia workup included tests for factor V Leiden mutation, activated protein C resistance, protein S activity, antithrombin deficiency, prothrombin gene mutation, anti-cardiolipin antibodies, dilute Russell viper venom time, lupus anticoagulant, anti-beta2-glycoprotein antibodies. The cost of testing was extrapolated by institutional hospital cost reports. Descriptive statistics included reporting the categorical variables as number and percent. The categorical variables were compared between groups with the use of Fisher’s exact test or the chi-square test. Results: During our study period, 310 patients had new VTE. Of those, 47.9% had pulmonary embolism, 33.7% upper or lower extremities deep vein thrombosis (DVT), 1.6% splanchnic DVT, 14.6% multiple DVTs, and 2.2% DVTs in other locations. The median age was 64. Provoked factors were found in 269 patients (86.7%) and 41 patients (13.2%) had unprovoked VTE. Overall, 33 out of 310 patients (10%) underwent thrombophilia workup with a total of 175 tests performed. More thrombophilia testing was ordered in unprovoked group (29.3% vs 7.8%, p = 0.0003) compared to provoked. There was no difference between the amount of inpatient hematology consults in both groups (33.83% vs 47.50%, p = 0.0920). Of the hematology consult, 19 out of 118 patients (16%) had thrombophilia testing recommended by hematologist. The cost of all tests ordered outside of hematology recommendation was $34,083 (avg $344 per person). Of the group that got tested regardless of provoking factors, there was no difference between hospital length of stay (2-12 days vs 3-12 days, p = 0.0665). Anticoagulation choice was also not affected by thrombophilia testing between the two groups. Conclusions: Our experience found that many thrombophilia work up were costly and did not impact quality patient care. Despite the relatively low frequency of inpatient workup (10%), eliminating testing could save our health system approximately $136,332 per year ($34,083 per quarter). Therefore, we support ASH’s campaign in reducing inpatient thrombophilia testing. We aim to work with our administration to provide education in reducing unnecessary testing.
Uptake in genetic testing in patients with pancreatic cancer with oncologist-driven testing protocol.
Authors: King Traci , Widick Page , Paredes Rodrigo , Klein Oliver , Krejdovsky Jill , Tung Nadine M. , Peters Mary Linton Bounetheau 
Published: September 2022

33 Background: The objective was to compare the uptake of genetic testing in patients with pancreatic adenocarcinoma (PDAC) seen at a single center (1) before the 2019 NCCN recommendation of universal screening for genetic mutations in all new PDAC diagnoses, (2) after this change in guideline, and (3) after transitioning to an oncologist-driven genetic testing protocol. Methods: A retrospective review of patient records seen for a new PDAC diagnosis at BIDMC between May 2018-May 2022 was performed. Patients were categorized into three groups by date of visit: pre-guideline change (5/2018-4/2019), post-guideline change (5/2019-12/ 2020), and after implementation of an oncologist-driven testing protocol (12/ 2020-5/2022). The primary outcome was the differences in rates of testing between each time period. Results: An increase in rates of genetic testing occurred between each successive time period. Pre-guideline change, 22% of patients had testing sent, and this increased to 32% post-guideline. With the oncologist-driven testing, this increased to 73%. There was an increase in referrals for genetic testing from the pre- to post-guideline change time periods (42% to 61%). However, in both groups, the number of patients who completed testing was approximately half of those who were referred (23% and 34%, respectively). Conclusions: Our cancer center moved to oncologist-driven testing to increase uptake in the wake of a guideline change recommending universal testing of all PDAC patients. By this protocol, germ-line testing is sent by the medical oncologist at the initial multidisciplinary clinic visit, rather than following a consultation with our genetic counseling team. With this change, there was a dramatic increase in genetic testing (32% to 73%), thereby capturing approximately 10 additional patients with actionable pathogenic variants. However, this change necessitated additional resources in the multidisciplinary clinic and time from the oncologist to consent for testing. In addition, the expertise of cancer genetics counselors was not provided to all patients. We attempted to address the latter via selective referral after positive results. Despite these trade-offs, oncologist-driven testing successfully met the goal of increasing our adherence with guideline-based genetic testing of all PDAC patients.[Table: see text]
Oncologist and primary care provider attitudes towards shared care in patients with cancer with chronic medical comorbidities.
Authors: Simmons Kristen , Jotwani Aparna Chakravarti , Parker Colbert , Xiang Ellen , Lu Lee , Mims Martha P. , Badr Hoda 
Published: September 2022

35 Background: Medical comorbidities pose challenges to the delivery of quality cancer care. Underserved cancer patients have the highest burden of chronic comorbidities, with increased risk for worse outcomes. Their health outcomes and care transitions might be improved by enhancing collaboration between oncologists and primary care providers (PCPs). Methods: This is a cross-sectional study of oncologists and PCPs in a large public safety-net hospital system in Houston, TX. Providers completed electronic surveys assessing demographics, attitudes, and satisfaction regarding the shared care of cancer patients with chronic comorbidities. Results: Eighteen oncologists (39% minority, 72% female) and 25 PCPs (23% minority, 77% female) completed the surveys. Independent samples t-tests revealed both oncologists and PCPs reported moderate levels of interprofessional collaboration, felt that existing processes to facilitate coordination of care were inadequate, and expressed moderate levels of dissatisfaction with the management of cancer patients with comorbidities within HHS (all p-values = n.s.). However, their attitudes toward care coordination differed significantly depending on the nature and timing of the care being provided. With regard to side effect management during cancer-directed therapy, 81% of PCPs preferred to co-manage side effects with oncologists, but 100% of oncologists preferred to be responsible for this activity (χ2= 23.08, p <.001). With regard to management of late-effects of cancer treatment, 40% of oncologists were either interested in co-managing late effects with PCPs or having PCPs be solely responsible for this activity. Conversely, 86% of PCPs preferred to co-manage late effects with oncologists (χ2= 26.74, p <.001). For cancer surveillance, oncologists and PCPs expressed interest in sharing responsibility depending on the patient’s risk for recurrence (χ2= 1.62, p =.30). Conclusions: Oncologists and PCPs were similarly dissatisfied with comorbidity management in cancer patients, but differed in their attitudes towards care coordination. Oncologists were more resistant to sharing responsibilities of toxicities during and after treatment. They were more accepting of PCPs assuming follow-up care for lower-risk patients. Further investigation is needed to determine specific areas of care coordination, barriers to provider collaboration, and knowledge and processes for effective shared care.
Levine Cancer Institute Financial Toxicity Control Program: Expanding the program to reduce fiscal vulnerability of patients.
Authors: Wayman Megan , Feild Donna , Goodnight Jennifer , Wise Jeffrey , Ford Ashley , Raghavan Derek 
Published: September 2022

43 Background: It is well known that financial toxicity is becoming one of the most substantial problems encountered by patients receiving cancer care, and active solutions are required to address this (JCO Oncol. Pract., 2021, 17: e 1433-39). We have established a Financial Toxicity Tumor Board to address specific issues that cause out-of-pocket costs for patients and have saved more than $55 million per year in such costs to patients. A major contributor to patient-centric costs is denials from health insurance companies. We have developed an innovative, pharmacy technician program to assess and understand such denials and to avoid them proactively. Methods: Pharmacy technicians were inserted into an additional site’s treatment team to ensure appropriate prior authorizations were in place prior to patient infusion. Sequential and unselected data were collected over by the prior authorization technician. Medication denial reports generated by the financial clearance team were analyzed to identify issues that might be improved by changes in standard operating procedures in order to avoid recurrent concerns and these solutions were implemented. Results: The approach adopted by the LCI Financial Toxicity Tumor Board, with the use of additional pharmacy technicians to manage and preplan documentation, has resulted in a reduction of denials over a one-year period of from 16-18/month to 3-4/month with a concomitant additional saving to patients of $5,720,753. The expansion to an additional site over the evaluation period has preliminarily resulted in a 48% decrease in financial toxicity for patients as compared to the previous year. Conclusions: A reality of clinical practice is an ever-present fiscal tension between payers, patients and providers, with payers adopting increasingly complex rules and regulations to avoid payment of charges. When this occurs, patients inevitably sustain increased out-of-pocket charges and anxiety, contributing to the pattern of financial toxicity. The approach of using technical support staff to prospectively avoid insurance denials can be scaled universally to ensure that health insurance payers, while adhering to their defined rules and regulations, are held accountable for their contractual obligations.
Reducing the wastage of fresh frozen plasma in a hospital blood bank through the use of Six Sigma principles.
Authors: Hester Robert Harrison , Castillo Estella , Casteel Kelly , Natividad Lorenz , Aung Fleur M. , Martinez Fernando , Vadhan-Raj Saroj 
Published: September 2022

45 Background: MD Anderson Cancer Center is one of the largest users of blood products in the United States, with approximately 3,600 units of blood (PRBCs) transfused per month, and over 500 units of fresh frozen plasma (FFP) transfused per month. The wastage of blood products has both financial and patient care implications, as well as implications to donors. Decreasing blood product wastage is an institutional priority in terms of both resource utilization and cost savings. Methods: Outside metrics for the waste of blood products published by the American Association of Blood Banks (AABB) were compared to current data on the percentage wastage of blood products for fiscal year 2020. A dedicated project team set an aim to reduce the wastage of FFP by 25% from Q4 2020 to Q3 2021. Using Six Sigma principles, a run chart was developed to track units FFP ordered and transfused from October 2020 – March 2021. Minitab software was used to calculate mean FFP ordered, the upper confidence interval, as well as 2 standard deviations above the mean to determine a new maximum FFP thaw level. Results: The historical FFP “thaw level” was 32 units of FFP thawed per day. From October 2020 – March 2021, the average number of FFP units ordered per day was 8. The upper confidence level was 32, and 2 standard deviations was 24 units. After identifying 3 data points that were “out of control” and unrepresentative of actual usage, these values were adjusted to 7.5 units and 19.5 units, respectively. Based on this data, the daily thaw level was adjusted from 32 units per day to 20 units per day on June 21st 2021. As of Q3 2021, this has resulted in a 40.7% decrease in the wastage of FFP. Conclusions: The application of Six Sigma principles was an effective way to identify variation in the ordering of fresh frozen plasma (FFP), and allowed for a sizeable reduction in the daily thaw level of this blood product. Post-intervention, there has been a dramatic decline in the wastage of FFP, resulting in cost savings for our institution and better stewardship of this scare resource.