Integrated Delivery Network Research Articles

Cost Avoidance from Automated Dose Rounding of Biological and Cytotoxic Anticancer Drugs in an Integrated Delivery Network

Background: Projected costs of cancer care are expected to reach $172.8 billion dollars by 2020[1]. Cost of oncology drugs have outpaced other areas[2] with novel drugs priced at a median of $115,981/year between 2009 and 2013[3], making cost control an important priority. Rounding drug doses to the nearest vial size, as long as the difference is smaller than an accepted percentage, has been shown to reduce the cost of care[4]. This also allows workflow efficiency by simplifying compounding and decreasing waste documentation[5] and reduces the potential for medication errors[6]. Dose rounding has been recommended by the Hematology/Oncology Pharmacy Association (HOPA)[5] and the HOPA position paper was endorsed by NCCN[7]. Methods In accordance with HOPA position statement, an integrated community-based healthcare system comprised of 13 providers across 8 infusion centers implemented dose rounding to the nearest vial if within 10% based on actual calculated dose for biological and cytotoxic agents. Performed manually by oncology pharmacists at the time of initial introduction in January 2020, this was transitioned to automated dose rounding by the oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI) in June 2020. To facilitate provider adoption and maximize cost-savings, we compiled a list of 31 biological and chemotherapy agents that provided the greatest therapeutic margin and potential for cost savings. Dose rounding parameters for each agent was developed to standardize and facilitate automated dose rounding. Lower and upper bounds were set so that the vial size was within 10% of the actual calculated dose (e.g. doses between 91 mg and 111 mg to a 100 mg vial, Table 1). Cost avoidance was calculated based on the acquisition price of the lowest vial size available and necessary to make the pre-rounded dose. Results Total cost avoidance between January 2020 and July 2020 by dose rounding 31 different chemotherapy and biological agents was $679,780.02. Automated dose rounding drugs introduced in June 2020 high value drugs resulted in cost savings of $ 112,994.12 over a seven week period. Dose rounding of biological drugs accounted for 89.4% of the total cost savings. Rounding of cytotoxic drugs resulted in a cost saving of $71,588.35. Trastuzumab dose rounding was associated with the greatest amount of cost avoidance of $147,194.44, accounting for 21.65% of total cost avoidance. Dose rounding up to the nearest vial ranged between 0.13%-9.75% (median 3.52%). Dose rounding down to the nearest vial ranged between -0.10% -9.93% (median -3.36%). Conclusions: We demonstrate feasibility of implementing an automated EHR based dose rounding protocol in an integrated delivery network, widespread adoption across multiple centers and significant cost avoidance accrued from the intervention. Similar dose rounding protocols should prioritize biologics agents due to their high utilization and costs.

Evaluation of Multiple Myeloma Clinical Decision Support Tool Value When Populated with Community Health System Data

Introduction Clinical decision support (CDS) technology has the potential to improve health outcomes by offering physicians an informational resource to support review and application of best pratices.1 The Multiple Myeloma Research Foundation (MMRF) and Intermountain Healthcare (IMH) conducted a study to assess the suitability of a single health system's data for a myeloma-specific CDS tool that visualizes treatment pathways, and to assess the effort needed to support a CDS program.2 This research is part of a longer-term effort to explore how CDS technology can help: - increase awareness of and apply treatment guidelines by visualizing pathways for specific MM patient cohorts - improve understanding of treatment variation within health systems - improve outcomes research by showing relationships between treatments and outcomes Methods IA12 data from the CoMMpass study3 was used to create a CDS tool prototype. These data were aggregated into state and transition maps to identify nodes and pathways with corresponding outcomes, including response, progression-free survival (PFS), and overall survival (OS). Intervening patient states were displayed using Sankey diagrams [Fig. 1]. We also tested if EMR data from a community health system (i.e., IMH) could support such visualization. The team designed a study protocol and obtained IRB approval. Inclusion criteria included patients with active MM between January 2016-June 2018; adult aged 18 years to 89 years at diagnosis of active or smoldering MM. An IMH-specific data dictionary was assessed for variable importance, quantity, and ease of acquisition. [Table 1]. IMH then manually abstracted prioritized structured (eg: labs) and non-structured (eg: notes) data for use in the tool. Results Ninety-six of an initial 146 patients meeting eligibility criteria had sufficient data usable for the study, reflecting 44 unique drug combinations across 9 lines of therapy. The tool was able to associate and visualize all patients and their clinical states and transitions to their outcomes. Clinical data was typically complete (99% of the time), including key clinician-derived data, such as ECOG scores (78%) and treatment response (99%). 569 person-hours were required to conduct the abstraction activity on 96 cases, averaging 5.9 hours/patient Discussion The IMH portion of the study supports the hypothesis that a community health system can provide sufficient high-quality information to power a CDS tool with priority features. Only 65% (96/146) of the initial study group had usable data because some patients had received partial care outside of the IMH integrated delivery network (IDN) leaving associated data inaccessible. Initial biostatistical analysis suggests that roughly 750-1000 complete patient records would be required for statistically significant outcomes research with granularly stratified cohorts. The MMRF is currently recruiting 5-7 additional large IDNs to obtain the patients to power more generalizable functionality. References 1 McKie PM, Kor DJ, Cook DA, Kessler ME, Carter RE, Wilson PM, et al. Computerized advisory decision support for cardiovascular diseases in primary care: a cluster randomized trial. Am J Med [Internet]. 2019 Dec 18 [cited 2020 Mar 5]. Available from: https://doi.org/10.1016/j.amjmed.2019.10.039 2 Garcelon N, Burgun A, Salomon R, Neuraz A. Electronic health records for the diagnosis of rare diseases. Kidney Int [Internet]. 2020 Jan 14 [cited 2020 Mar 5]. Available from: https://doi.org/10.1016/ j.kint.2019.11.037 3 Christofferson A, Nasser S, Aldrich J, Penaherrera D, Legendre C, Benard B, et al. Integrative analysis of the genomic landscape underlying multiple myeloma at diagnosis: an Mmrf Commpass analysis. Blood. 2017 Dec 7; 130 (Supplement 1): 326. Disclosures No relevant conflicts of interest to declare.

Improvement in Clinic Efficiency, Patient Satisfaction, and Overcoming Unique Challenges in the Era of COVID-19 with Implementation of Subcutaneous Daratumumab in Patients with Multiple Myeloma (MM) and Light Chain (AL) Amyloidosis

IntroductionIntravenous (IV) daratumumab has become a standard in the treatment of MM and AL amyloidosis largely due to its significant clinical benefit. Due to the high risk of infusion-related reactions (IRRs), it is associated with prolonged infusion times. These lengthy administrations can limit clinic capacity, require split dose infusions, increase chair time, decrease patient satisfaction, and create access barriers in the era of COVID-19. Recently, a fixed-dose subcutaneous (SC) formulation of daratumumab was approved for the treatment of MM, and the safety-run in results (N=28 patients) from a phase III, randomized trial in AL amyloidosis using the SC formulation were published. The SC formulation has the potential to mitigate some of the setbacks from IV formulation and help improve efficiency in the era of COVID-19, where most clinics are faced with limiting and spreading out volume due to space constraints and social distancing requirements. We present real world evidence from a large academic center's experience with adoption of SC formulation to help overcome current challenges.MethodsWe prospectively reviewed all patients being treated with IV daratumumab for MM and/or AL amyloidosis at Boston Medical Center Health System (a 500+ bed integrated delivery network) that would be candidates for the SC formulation. A protocol was designed to switch patients that were currently on IV daratumumab as well as patients newly initiating daratumumab to the SC formulation. Patients deemed eligible were switched to the SC formulation under pharmacy benefit (pending insurance authorization by a pharmacy liaison) at their next scheduled infusion visit. Rationale for switching patients to pharmacy benefit was to support home administration during future surge from COVID-19, using our specialty pharmacy travel RN program. Patients that were naïve to daratumumab, started their first dose as a SC injection. Patients were monitored for 30 minutes following the first SC dose and were pre-medicated with oral acetaminophen, dexamethasone, and diphenhydramine. Patient and nursing satisfaction were assessed after switching to SC daratumumab, using internally developed surveys. Using wholesale acquisition cost, cost analysis was performed between the two formulations. Infusion chair time, improvement in clinic efficiency (using our standard infusion time of 90 minutes for IV daratumumab infusions after the 2nd dose), and safety were assessed and compared.ResultsA total of 26 patients were treated with daratumumab for MM and AL amyloidosis from June 1, 2020 to August 1, 2020. 85% (22/26) of patients were administered the SC formulation. Of these 22 patients, 68% of patients were switched from the IV formulation (15/22) and 32% (7/22) were naïve to daratumumab. The majority (14/22) of SC administrations were patients receiving daratumumab monotherapy for relapsed MM. A breakdown of patient regimens and insurance type is seen in table 1. IRRs were reported in 0 patients starting [or transitioning to] SC daratumumab. Injection site reactions were not reported in any patient. One patient had facial and neck swelling 2 days after administration of SC daratumumab (with no other symptoms) but resolved within 24 hours of an additional dose of dexamethasone and did not recur upon re-challenge of SC daratumumab. Severe neutropenia (ANC less than 500) was reported in 9% of patients (2/22), both patients in the group naïve to daratumumab. Febrile neutropenia was not seen. One patient was being treated with concomitant pomalidomide and the second was treated with lenalidomide and had a baseline ANC of 500 prior to initiation of therapy. Adoption of SC daratumumab led to elimination of 133 hours of chair time and nursing time, or 1260 hours annualized for the year. Cost savings with the elimination of nursing time translates to approximately $100,000 to the institution and approximately $230,000 to the payer. The results compiled from patient and nursing satisfaction surveys are being analyzed and will be presented.ConclusionWe report a successful conversion and adoption of SC daratumumab at our ambulatory hematology/oncology clinic. Insurance authorization does not appear to limit the adoption of this therapy in clinic irrespective of diagnosis or regimen used. Furthermore, the reduction in chair time and patient convenience was largely beneficial in light of COVID-19 to minimize patient exposure in clinic.DisclosuresHughes:Rigel: Other: advisory board; Abbvie: Speakers Bureau; Amgen: Speakers Bureau; Karyopharm: Speakers Bureau. Blevins:Epizyme: Other: Focus Group. Sarosiek:Spectrum: Research Funding. Sloan:Abbvie: Consultancy; Stemline: Consultancy. Sanchorawala:Celgene: Research Funding; Takeda: Research Funding; Caleum: Other: advisory board; Proclara: Other: advisory board; Regeneron: Other: advisory board; Abbvie: Other: advisory board; Janssen: Research Funding; UpToDate: Patents & Royalties; Oncopeptide: Research Funding; Prothena: Research Funding; Caelum: Research Funding.

Incremental clinical and economic impact of recombinant zoster vaccination: real-world data in a budget impact model.

In 2017, the FDA approved the adjuvanted recombinant zoster vaccine (RZV) for the prevention of herpes zoster (HZ) in immunocompetent adults aged 50 years and older. RZV joined zoster vaccine live (ZVL) as U.S.-marketed vaccines against HZ. The Advisory Committee on Immunization Practices preferentially recommended use of RZV over ZVL. In order to inform population-based decision makers (PBDMs) about the incremental clinical and economic impact of RZV adoption, budget impact (BI) models may be used. Populating such models with national data can inform PBDMs about the incremental value of RZV adoption nationally; however, heterogeneity across health plans requires the inclusion of plan-specific data to ensure the relevance of modeling outcomes for plan-specific decision makers. To investigate the clinical and economic outcomes associated with the adoption of RZV in nationally representative populations with commercial and Medicare coverage and to demonstrate the effect of the heterogeneity of health plans using real-world data from a large, integrated delivery network (IDN). We used a publicly available BI model. The model accounts for national and IDN-collected population characteristics (size, age distribution) and epidemiological data (incidence of HZ and complications, HZ recurrence rate), vaccine characteristics from randomized controlled trials and observational studies (efficacy, waning, second dose compliance for RZV, adverse event rate), national costs (vaccine, direct medical for HZ, complications, and vaccine adverse events), and current and anticipated vaccine coverage. We assessed incremental clinical (HZ cases and complications) and economic (per-member-per-month [PMPM] costs) impact at 5-year to 15-year time horizons, comparing scenarios where RZV is solely implemented with one where only ZVL is utilized. Following the adoption of RZV, the incremental HZ cases avoided over 5 and 15 years were estimated to be 1,800 and 15,000 for a commercial plan, 3,800 and 21,000 for a Medicare plan, and 8,600 and 71,000 for a specific IDN. The incremental PMPM budget impact over the same time horizons was estimated to be $0.42 and $0.31, respectively, for a commercial plan, $0.35 and $0.10 for a Medicare plan, and $0.39 and $0.25 for a specific IDN. The differences in results across plans resulted from the population age distribution, the vaccine copay (applied in the Medicare scenario only), the vaccine coverage in the plan, and other plan-specific factors affecting disease epidemiology and costs per case of HZ. Model projections indicated that RZV adoption avoided HZ cases and related complications, with the PMPM budget impact dependent on plan-specific factors. As health gains increased over time, the incremental costs incurred were found to decrease as the shorter-term costs of adopting the new vaccine were increasingly offset by the longer-term benefits of vaccination. GlaxoSmithKline Biologicals SA funded this study (GSK study identifier: HO-17-18378) and was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and publication of this manuscript. Patterson, Van Oorschot, and Curran are employees of the GSK group of companies and hold shares in the GSK group of companies. Herring, Carrico, and Zhang are employees of RTI Health Solutions, which received funding via a contractual agreement with the GSK group of companies to perform the work contributing to this research. Ackerson, Bruxvoort, Sy, and Tseng are employees of Kaiser Permanente Southern California, which was contracted by the GSK group of companies for the conduct of this study and were members of the KPSC study team. Ackerson, Bruxvoort, Sy, and Tseng report research contracts with the following pharmaceutical companies unrelated to this study: Dynavax (Ackerson, Bruxvoort, and Sy); the GSK group of companies (Ackerson, Bruxvoort, Sy, and Tseng); Novavax (Ackerson, Sy, and Tseng); and Seqirus (Ackerson, Bruxvoort, Sy, and Tseng). Tseng reports having served as a paid consultant for the GSK group of companies. The authors declare no other financial and nonfinancial relationships and activities. Findings from this study were presented at AMCP Nexus 2019; October 29-November 1, 2019; National Harbor, MD.

Predicting Incident Treatment-Resistant Depression: A Model Designed for Health Systems of Care.

Major depressive disorder (MDD) is a prevalent and debilitating condition. While numerous treatment options are available, low treatment response and high remission rates remain common, leading to the concept of treatment-resistant depression (TRD): a classification applied to patients who fail multiple courses of therapy. A patient with TRD can only be identified after repeated, and often prolonged, therapeutic efforts. To use data readily available to integrated delivery networks to identify characteristics predictive of TRD among patients initiating pharmacotherapy for MDD. Decision Resources Group Real-World Data, an integrated medical/pharmacy claims and electronic health record dataset, was used to conduct a retrospective, longitudinal cohort study of patients with MDD who initiated antidepressant treatment between July 1, 2014, and December 31, 2015. Individuals were followed for 24 months to determine treatment resistance. Eligible individuals had integrated claims and electronic health record data available, completed at least 1 course of therapy of adequate dose and duration to achieve response, and had 30 months of continuous benefits eligibility (6 months before and 24 months after treatment initiation). Stepwise logistic regression and demographic, health history, health care utilization, medication, provider, and related characteristics were used to predict onset of TRD. 35,246 people met eligibility and 7,098 (20.1%) met TRD criteria after an average of 402 days. Significant predictors of TRD included patient age, diagnosis of insomnia and hypertension, psychiatric office visits, nurse telephonic encounters, anticonvulsant medication use, suicidality, physician specialty associated with index prescription, total prescription drug claims, unique antidepressants attempted, and duration of untreated illness (the lag between diagnosis and index prescription). The final model achieved an area under the curve (AUC) = 0.83. Structured patient-generated health data, specifically, the Patient Health Questionnaire-2 and the Patient Health Questionnaire-9 were only reported for 542 patients (1.5%). TRD transition occurs after a prolonged treatment period, suggesting clinical inertia. Using data routinely available to integrated delivery networks and accountable care organizations, it is feasible to identify patients likely to qualify as treatment resistant. Monitoring risk factors may allow health systems to identify patients at risk for TRD earlier, potentially improving outcomes. Early identification of this at-risk population can allow for targeted resources for earlier intervention, more aggressive follow-up, and alternative treatment options. Furthermore, this model can be used to estimate future demand for specialized care resources, such as those delivered by mood disorder clinics. This project was sponsored by Janssen Scientific Affairs. Pesa, Chow, and Verbanac are employed by Janssen Scientific Affairs and report stock ownership in Johnson & Johnson. Liberman, Davis, Heverly-Fitt, and Ruetsch are employed by Health Analytics, which received funding from Janssen Scientific Affairs for work on this project. This study was presented as a poster at the U.S. Psych Congress; October 3-6, 2019; San Diego, CA.

How can we partner with electronic health record vendors on the complex journey to safer health care?

The Office of the National Coordinator for Health Information Technology released the Safety Assurance Factors for EHR Resilience (SAFER) guides in 2014. Our group developed these guides covering key facets of both electronic health record (EHR) infrastructure (eg, system configuration, contingency planning for downtime, and system-to-system interfaces) and clinical processes (eg, computer-based provider order entry with clinical decision support, test result reporting, patient identification, and clinician-to-clinician communication). The SAFER guides encourage healthy relationships between EHR vendors and users. We conducted a qualitative study over 12 months. We visited 9 health care organizations ranging in size from 1-doctor outpatient clinics to large, multisite, multihospital integrated delivery networks. We interviewed and observed clinicians, IT professionals, and administrators. From the interview transcripts and observation field notes, we identified overarching themes: technical functionality, usability, standards, testing, workflow processes, personnel to support implementation and use, infrastructure, and clinical content. In addition, we identified health care organization-EHR vendor working relationships: marine drill sergeant, mentor, development partner, seller, and parasite. We encourage health care organizations and EHR vendors to develop healthy working relationships to help address the tasks required to design, develop, implement, and maintain EHRs required to achieve safer and higher quality health care.

Abstract 28: Identification of multisite real-world patient cohorts to enable immunotherapy utilization and safety assessment

Abstract Currently, five classes of Immunotherapy (IT) agents are available for over 20 cancer types, including a powerful new class utilizing T cells genetically engineered to express a chimeric antigen receptor (CAR-T). Additional classes include bi-specific T-cell engagers (BiTEs), immune checkpoint inhibitors (ICIs), cancer vaccines, and oncolytic viruses. Despite promising antitumor activity, significant immune-related adverse events (irAE) have been reported. The most common CAR-T toxicity is cytokine release syndrome (CRS), and management typically includes supportive care and immunosuppression with corticosteroids or the IL-6 inhibitor tocilizumab. Documented CRS and tocilizumab use outside of CAR-T is rare, but recent evidence suggests that tocilizumab is emerging for management of other steroid-refractory irAE. Given the rapid evolution of this field, there remains a need to understand the utilization of IT and the pathophysiology of irAE in real-world settings. To identify cohorts of interest, a retrospective, multicenter review was conducted using Health Catalyst’s extended real-world data database, Touchstone, which includes >300 sources of data and over 70 multipayer and geographically diverse provider clients. Cohorts were selected from representative provider networks, including large and specialty academic medical centers (AMCs), integrated delivery networks, accountable care organizations, and community hospitals in the US. A total of 10 clients’ de-identified electronic medical records were searched for presence of cancer-associated diagnosis codes. The cohort was then restricted by the presence of medication order or administration of any IT-class drug, and among these, first administration of tocilizumab within 21 days. Across ten provider networks containing data for ~5.6 million cancer patients, 9,029 patients were identified: CAR-T, 116 patients (0-102); BiTEs, 112 patients (0-64); ICIs, 8,402 patients (0-4520); cancer vaccines, 182 patients (0-143); and oncolytic viruses, 217 patients (0-214). As expected, CAR-T administration was limited to approved treatment centers. Among the other classes, an average of 26% of identified patients were from the community setting. Additionally, of the 116 patients receiving CAR-T therapy, 75 patients (64.7%) were administered tocilizumab within 21 days. Evidence of tocilizumab use outside of CAR-T irAE was also identified, occurring in 21 patients (0.3%) receiving another class of IT within AMCs, and did not occur at other provider types. Together this analysis identified several real-world IT patient cohorts comprising diverse populations from a range of provider types, with corresponding access to rich patient-level clinical, molecular, and financial real-world data (RWD) elements. Immediate downstream applications will involve developing integrated methods for the real-time identification of patients who may be at risk for adverse events and standardization of toxicity management guidelines. Citation Format: Catherine Del Vecchio Fitz, Elizabeth Eldridge, Alyssa Antonopoulos, Paula Petrone, Will Caldwell, Ed Corbett, Amy Flaster, Holly Rimmasch, Adem Albayrak, Dale Sanders, Sadiqa Mahmood, Elia Stupka. Identification of multisite real-world patient cohorts to enable immunotherapy utilization and safety assessment [abstract]. In: Proceedings of the AACR Special Conference on Advancing Precision Medicine Drug Development: Incorporation of Real-World Data and Other Novel Strategies; Jan 9-12, 2020; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(12_Suppl_1):Abstract nr 28.

Healthcare resource utilization among commercially insured patients with cold agglutinin disease in the United States

Aims: Cold agglutinin disease (CAD) is a rare subtype of autoimmune hemolytic anemia associated with increased thromboembolism risk and early mortality. Healthcare resource utilization (HRU) in CAD has not been reported. We aimed to compare HRU of patients with CAD with a matched non-CAD cohort in the United States.Materials and methods: Patients with CAD were identified from 2006 to 2016 in the Optum-Humedica database using CAD terms in clinical notes and hematologist review. Patients were required to have Integrated Delivery Network records and ≥6 months’ follow-up before and after the first CAD mention date (index date). Patients with CAD were matched to a non-CAD cohort based on demographics. Multivariate analyses assessed inpatient hospitalizations, outpatient visits, emergency room visits, and transfusion use between cohorts 6 months before and 12 months after the index date.Results: Of 814 patients with CAD, 410 met inclusion criteria and were matched to 3,390 patients without CAD. Mean age of patients with CAD was 68.0 years; approximately 62% were female. In the 12 months after the index date, mean inpatient hospitalizations (0.83 vs. 0.25), outpatient visits (17.26 vs. 6.77), emergency room visits (0.55 vs. 0.32), and transfusion days (1.05 vs. 0.05) were higher for patients with CAD than the matched non-CAD cohort (all p < .0001). Similarly, in the 6 months before the index date, patients with CAD had higher HRU than matched patients without CAD for all measures evaluated.Limitations: Results of this study are based on patient information from the Optum-Humedica database, which is limited to commercially insured patients and may not represent the overall CAD population.Conclusions: CAD places a substantial burden on patients and healthcare systems. In addition, the high HRU for patients with CAD observed in the 6 months before diagnosis indicates that disease awareness and better diagnostic practices may be needed.

PCN148 BUDGET IMPACT OF IMPROVING ADHERENCE TO COLORECTAL CANCER SCREENING

Screening is essential to the prevention, early detection, and successful treatment of colorectal cancer (CRC). Providing options, including non-invasive modalities increases uptake of CRC screening. In order to maximize the benefit of screening, stakeholders must consider the probability that eligible patients will or will not screen. With the aim of examining the clinical and economic consequences of varying adherence levels, a budget impact model was developed from the payer and integrated delivery network (IDN) perspectives. Over a 10-year time horizon, mt-sDNA utilization increased from 6% to 28% among those screened by mt-sDNA, FIT and colonoscopy. The payer perspective included direct medical costs, such as stool-based tests, procedures, adverse events, and CRC treatment. In addition to CRC screening program costs, the IDN perspective also included all the aforementioned costs, with the exception of stool-based tests. Worst- and best-case adherence scenarios based on published estimates were simulated. For mt-sDNA, FIT, and colonoscopy, initial screening uptake ranged from 67.5%-71.1%, 48%-64.7%, and 38%-64%, whereas repeat adherence ranged from 54%-86.1% for stool-based screening and from 38%-64% for colonoscopy. Follow-up diagnostic colonoscopy adherence for non-invasive screening ranged from 55.6%-98.6%. With a hypothetical population of 1 million members and an assumed screening eligible population of ages 50-75 at average risk for CRC, best- and worst-case adherence scenarios yielded approximately 11,000 and 19,000 fewer colonoscopies compared to the status quo. The payer savings ranged from $3M-$6M with $0.02-$0.05 per-member-per-month (PMPM) and the IDN incurred savings from $16M-$31M with $0.13-$0.26 PMPM for the best- and worst-case compliance adherence scenarios. Due to the decrease in screening and surveillance colonoscopies as well as related adverse events, increased mt-sDNA use may lead to significant averted costs for payers and IDNs. Although increased adherence decreases aggregate averted costs, savings may persist with increased mt-sDNA use.

PNS94 2018 AND 2019 OUTCOMES BASED CONTRACTING TRENDS EXPLORED BY TA, PAYER TYPE AND RISK SHARING MECHANISM IN THE US

As prescription drug costs continue to rise, health insurers in the US struggle to implement novel pricing approaches to enable affordable access to innovative therapies. Value based risk-sharing agreements are growing in popularity among US health insurers as payers attempt to find a strategy to provide the most cost-effective solution in return for maximum quality and clinical benefit. Given the complexity and feasibility of these agreements, variation exists among the types of contracts and components health insurers consider implementing. This abstract assesses the contracting elements adopted by US health plans, integrated delivery networks (IDNs) and pharmacy benefit managers (PBMs) in outcomes-based contracting (OBC). We assessed all publicly available OBCs. The OBCs assessed were between pharmaceutical manufacturers and payers in the US, and the analysis focused on deals from 2018/2019, with sub-analysis from 2016/2017. This analysis reviewed 53 agreements implemented by 20 health insurers and 20 manufacturers. The most common contracts in the US were for metabolic and CNS indications. Regional health insurance plans were participants in the most publicly available contracts (52%), followed by PBMs (21%). This varied when compared to contracts initiated in 2016/2017, where new deals were led by IDNs and national healthcare insurers. Additionally, majority of contracts were payment by result agreements (79%), and regional plans were the only payers to adopt subscription-based agreements. While the structure of the deals were disclosed in this limited sample, the results and impact were largely not. Findings demonstrate a continued, and likely expanding use of OBCs to drive coverage of, access to, and affordability for innovative therapies. However, lack of transparency of the deals leads to limited knowledge of their value and how widespread their use is. As the industry increasingly leverages OBCs, more work is needed to understand their comparative impact and what types of deals are performing best.

Cardiovascular Outcomes Among Patients with Type 2 Diabetes Newly Initiated on Sodium-Glucose Cotransporter-2 Inhibitors, Glucagon-Like Peptide-1 Receptor Agonists, and Other Antidiabetic Medications.

Cardiovascular disease (CVD) remains the most prevalent cause of morbidity and mortality in patients with type 2 diabetes (T2D) and is a primary driver for health care costs associated with diabetes management. Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated significant reductions in cardiovascular endpoints in clinical trials compared with placebo. However, it is uncertain whether these findings can be applied to the broader T2D population because these trials specifically included high-risk patients with established CVD. To evaluate and compare cardiovascular outcomes among adults with T2D newly initiated on SGLT-2is, GLP-1 RAs, and other antidiabetic medications (oADMs) in a real-world setting. This retrospective new-user cohort study used administrative claims and electronic health record data from an integrated delivery network in Texas. Patients aged ≥18 years with T2D and ≥1 prescription claim for an SGLT-2i, a GLP-1 RA, or an oADM filled between April 2013 and December 2018 were included. Patients were divided into three 1:1 propensity-matched groups according to index medication identified. Primary outcomes were heart failure hospitalization and a composite end-point of myocardial infarction, stroke, unstable angina, or coronary revascularization. Cox proportional hazards regression was used to compare cumulative incidence of all outcome variables. Among 9,477 patients, 1,134 were initiated on SGLT-2is, 1,072 on GLP-1 RAs, and 7,271 on oADMs. Patients initiating SGLT-2is versus oADMs had significantly lower risk of the composite endpoint (HR = 0.64, 95% CI = 0.46-0.90), heart failure hospitalization (HR = 0.56, 95% CI = 0.39-0.81), and unstable angina requiring hospitalization (HR = 0.56, 95% CI = 0.39-0.81). Patients initiating GLP-1 RAs compared with oADMs had significantly lower risk of the composite endpoint (HR = 0.71, 95% CI = 0.52-0.98) and unstable angina requiring hospitalization (HR = 0.60, 95% CI = 0.41-0.86). No differences in cardiovascular outcomes were found between SGLT-2is and GLP-1 RAs. Both SGLT-2is and GLP-1 RAs showed significant reductions in the composite outcome and unstable angina requiring hospitalization versus oADMs. However, only SGLT-2is were associated with a lower risk for heart failure hospitalizations. Nevertheless, cardiovascular outcomes were similar between SGLT-2is and GLP-1 RAs. No outside funding supported this study. The authors have no conflicts of interest to report.

PSU15 INCIDENCE AND RISK FACTORS OF PROXIMAL JUNCTION FAILURE AFTER MULTI-LEVEL SPINAL FUSION IN AN INTEGRATED NETWORK DELIVERY CARE SETTING

Proximal junction failure (PJF) is a serious post-operative complication of multi-level spinal surgery. PJF can lead to additional complications such as pain and reoperations, making it a costly complication. Furthermore, there are few cohort studies that evaluate PJF in non-academic hospital settings. This study aims to describe the incidence and risk factors of PJF in an integrated delivery network (IDN) of community hospitals. Through data partnership with Mercy Technology Services, adult patients who underwent multi-level thoracic and/or lumbar spine fusion surgery were extracted from 2011-2018 Mercy electronic health records (EHR), which is one of the comprehensive real-world databases including preoperative and intraoperative information. Occurrence of PJF 24 months after fusion was collected from the EHR using natural language processing. Kaplan-Meier curves for overall cohort and by surgical anatomy, were generated. To evaluate risk factors for PJF, cox proportional hazard models were fitted with anatomy and patient characteristics as covariates. Of the 585 patients included for analysis, 45 (7.7%) experienced PJF within 24-months of the index fusion surgery. The incidence of PJF for “thoracic or lumbar” group was 5.5% (23/414) versus 12.9% for thoracolumbar group (22/171). Compared to patients without PJF (n=540, 92.3%), after covariate adjustment, significant risk factors for PJF were fusion surgeries spanning the thoracolumbar spine (adjusted Hazard Ratio (aHR), 2.35,95% Confidence Interval (CI),1.30-4.25; p-0.005) and older age (aHR,1.02,95% CI,0.998-1.05; p-0.068). No significant association between higher BMI (aHR,0.999,95% CI,0.991-1.01, p-0.86), and osteoporosis (aHR,1.29,95% CI,0.60-2.76, p-0.51) were observed with PJF. The observed 24-month incidence of PJF in an IDN setting is 7.7%. Spinal fusion surgeries spanning both the thoracic and lumbar regions were significantly associated with a higher incidence of PJF. Further investigations with a larger cohort size are needed to appropriately identify potential risk factors for PJF.

The Positive Impact of Establishing an Internal Transfer Center

Health systems are facing greater pressures than ever before, with factors ranging from mergers and acquisitions and changing reimbursement models to capacity challenges and staffing shortages. A transfer center, where with 1 simple call from a referring physician, a decision to accept a critically ill patient can be made, placing them at the most appropriate level of care, the first time. Baptist Health in Jacksonville, Florida, went from an outsourced to an in-house center in 3 months—in the first 28 days alone, patient transfers increased from 900 to 1,500, growing to an average of 1,583 transfers per month.

Projecting total costs and health consequences of increasing mt-sDNA utilization for colorectal cancer screening from the payer and integrated delivery network perspectives

Aims: To evaluate total costs and health consequences of a colorectal cancer (CRC) screening program with colonoscopy, fecal immunochemical tests (FIT), and expanded use of multitarget stool DNA (mt-sDNA) from the perspectives of Integrated Delivery Networks (IDNs) and payers in the United States.Materials and methods: We developed a budget impact and cost-consequence model that simulates CRC screening for eligible 50- to 75-year-old adults. A status quo scenario and an increased mt-sDNA scenario were modeled. The status quo includes the current screening mix of colonoscopy (83%), FIT (11%), and mt-sDNA (6%) modalities. The increased mt-sDNA scenario increases mt-sDNA utilization to 28% over 10 years. Costs for both the IDN and the payer perspectives incorporated diagnostic and surveillance colonoscopies, adverse events (AEs), and CRC treatment. The IDN perspective included screening program costs, composed of direct nonmedical (e.g. patient navigation) and indirect (e.g. administration) costs. It was assumed that IDNs do not incur the costs for stool-based screening tests or bowel preparation for colonoscopies.Results: In a population of one million covered lives, the 10-year incremental cost savings incurred by increasing mt-sDNA utilization was $19.6 M for the IDN and $4.4 M for the payer. The incremental savings per-person-per-month were $0.16 and $0.04 for the IDN and payer, respectively. For both perspectives, increased diagnostic colonoscopy costs were offset by reductions in screening colonoscopies, surveillance colonoscopies, and AEs. Extending screening eligibility to 45- to 75-year-olds slightly decreased the overall cost savings.Limitations: The natural history of CRC was not simulated; however, many of the utilized parameters were extracted from highly vetted natural history models or published literature. Direct nonmedical and indirect costs for CRC screening programs are applied on a per-person-per modality basis, whereas in reality some of these costs may be fixed.Conclusions: Increased mt-sDNA utilization leads to fewer colonoscopies, less AEs, and lower overall costs for both IDNs and payers, reducing overall screening program costs and increasing the number of cancers detected while maintaining screening adherence rates over 10 years.

The Effect of Intravenous Acetaminophen on Patient Outcomes within a Large Integrated Delivery Network.

To evaluate the impact of intravenous acetaminophen on patient outcomes. In this retrospective observational analysis, 54,742 patients were identified from 19 Catholic Health Initiatives hospitals during a 12-month period. Charges were used to identify patients who received intravenous acetaminophen during their encounter. The control group included patients who did not receive intravenous acetaminophen. Five outcomes were measured: total length of stay, intensive care unit (ICU) length of stay, total narcotic use (in morphine milligram equivalents [MME]), likelihood of receiving a narcotic prescription at discharge, and 30-day readmission rate. Patients undergoing five procedures were evaluated: total knee replacements, total hip replacements, cesarean section, coronary artery bypass graft (CABG), and gallbladder resection. These patients were also evaluated in a combined group. After matching, population imbalances for patient characteristics were addressed. Combined with the five outcomes, 25 populations had a sufficient number of matched pairs for analysis. Six of the 25 tests showed a significant difference favoring the control group. Total length of stay was shorter for the control group in the combined population (-0.18days [4hours], 95% confidence interval (CI) -0.26 to -0.11). Total narcotic use was lower for the control group in the caesarean section (-10 MME, 95% CI -16 to -5), CABG (-26 MME, 95% CI -41 to -12), and combined (-13 MME, 95% CI -16 to -11) populations. The control group was less likely to be discharged with a narcotic prescription for the caesarean section (odds ratio (OR) -1.39, 95% CI -1.00 to -1.92) and combined (OR -1.14, 95% CI -1.04 to -1.24) populations. Intravenous acetaminophen was not associated with improvement in the following patient outcomes: total length of stay, ICU length of stay, total narcotic use, likelihood of receiving a discharge narcotic prescription, and 30-day readmission rate. Based on these findings, clinicians may reconsider the routine use of intravenous acetaminophen.

Are You In or Are You Out? Provider Note Sharing in Pediatrics.

The OpenNotes initiative launched an international movement aimed at making health care more transparent by improving communication with, and access to, information for patients through provider note sharing. Little has been written either on provider note sharing in pediatric and adolescent populations or on the impact of system default settings versus voluntary provider note sharing. We describe our journey as a pediatric integrated delivery network to default share notes in ambulatory specialty practices not only with parent proxies but also with teens and discuss the methods that led to a successful implementation. Retrospective analysis of every ambulatory shareable medical provider note written in pediatric subspecialty clinics within an integrated pediatric delivery network from April 2017 through March 2019. From April 2017 to February 2018, a total of 221,655 notes were shareable based on organizational policies, yet only 224 (0.1%) were actually shared with patients and families. After implementing a system of default release of notes from March 2018 to January 2019, a total of 224,960 notes were shareable, of which 191,379 (85%) were shared. Requiring providers to take an action to share notes (opt-in) results in few notes being shared while requiring providers to take an action to not share notes (opt-out) results in high levels of note sharing. We demonstrate that default release of notes in pediatric organizations to both proxies and teens is not only achievable but also likely to lead to increased provider note sharing with patients without obvious negative impact on providers or the organization.

Successful Transition from Bortezomib Subcutaneous (SubQ) to Generic Intravenous (IV) Bortezomib: Cost Savings Initiative with Global Economic Impact

Background: It is estimated that the U.S. will spend $370 billion in 2019 on pharmaceuticals and by 2020 the cost of cancer care will be approximately 158 billion. Cost containment strategies for high cost drugs are needed. In 2019 global sales from subcutaneous (SubQ) bortezomib manufactured by Takeda® will exceed $1 billion. There exists an opportunity to decrease overall cost related to bortezomib by $300-400 million across the globe by switching patients to bortezomib intravenous (IV) (manufactured by Fresenius Kabi®). Generic bortezomib was first approved by the FDA in January 2018 but it can only be administered intravenously. A phase 3 randomized controlled trial of twice weekly SubQ vs IV bortezomib showed no difference in time to progression or 1 year overall survival, however rate of Grade 3 peripheral neuropathy doubled in the IV arm compared to SubQ (Moreau et al, 2011). Although twice weekly bortezomib has fallen out of favor and there are retrospective data suggesting that neuropathy from weekly subQ and weekly IV bortezomib may be similar, there exist no prospective data to date to confirm this. Bortezomib induced peripheral neuropathy (BIPN) typically occurs by cycle 4 of twice weekly therapy, and the majority of cases are partially reversible (Dimopolous et al, 2011). We hypothesized that patients who have not developed neuropathy after or during 4 cycles of subcutaneous bortezomib could be switched to IV bortezomib without greatly increasing neuropathy. Methods: Boston Medical Center Health System is a 500 plus bed integrated delivery network which not only functions as payer but also as a provider. A protocol was implemented to switch patients from SubQ to IV bortezomib. Patients had to complete 4 cycles of SubQ bortezomib and have either Grade 1 or no BIPN to qualify to switch to IV bortezomib generic formulation. Patients were eligible to be switched regardless of indication or dose, if other criteria were met. After approval from the hematology/oncology providers and nursing department, this protocol was implemented to start accrual in November 2018. Patients eligible for the switch were identified primarily by pharmacists. After provider approval, pharmacists would update the treatment plan orders and also notify nursing and patients of the change. Nursing and patient satisfaction surveys were also administered to obtain input from all stakeholders. Results: Eleven patients have received at least 1 cycle of IV generic bortezomib for various indications from Nov 2018 to June 2019, with minimum of 2 doses and maximum of 16 doses. The diseases for which bortezomib was being used included multiple myeloma (n= 6) and AL amyloidosis (n= 2), renal transplant rejection and thrombotic thrombocytopenic purpura (TTP). One of the 11 patients had Grade 1 BIPN prior to switching, while all others reported no neuropathy prior to the switch. None of the patients have developed new neuropathy after making the switch from subQ to IV bortezomib. Results of the nursing and patient satisfaction surveys are being collected and will be presented. Conclusion: We describe a method to switch from subcutaneous bortezomib to generic IV bortezomib instituted at a large academic medical center as a cost containment strategy. This has resulted in no new cases of neuropathy in our growing data set. Global adoption of this protocol has the potential to substantially reduce drug costs related to multiple myeloma. Disclosures Sanchorawala: Celgene: Research Funding; Takeda: Research Funding; Proclara: Consultancy, Honoraria; Caelum: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Research Funding; Prothena: Research Funding. Sloan:Merck: Other: endpoint review commitee; Abbvie: Other: Endpoint Review Committee; Stemline: Consultancy. Sarosiek:Acrotech: Research Funding. Shah:Rigel Pharmaceutical: Consultancy, Speakers Bureau.

Impact of Pain Severity and Opioid Use on Health Care Resource Utilization and Costs Among Patients with Knee and Hip Osteoarthritis.

Osteoarthritis (OA) is the most common form of arthritis. The primary symptom of OA-pain-increases the disease burden by negatively affecting daily activities and quality of life. Opioids are often prescribed for treating pain in patients with OA but have questionable benefit-risk profiles. There is limited evidence on the economic impact of pain severity and opioid use among patients with OA. To (a) evaluate the association of pain severity with health care resource utilization (HRU) and costs among patients with knee/hip OA and (b) characterize the association of opioid use with HRU and costs while controlling for pain severity. Using deterministically linked health care claims data and electronic health records from the Optum Research Database, this retrospective cohort study included commercial and Medicare Advantage Part D enrollees who were diagnosed with knee/hip OA during the January 1, 2010-December 31, 2016 time period and had ≥ 1 pain score (11-point Likert scale: 0 = no pain, 10 = worst possible pain) between the first OA diagnosis date and October 2016. The index date was the date of the evaluated pain score; HRU and costs were observed over the 3-month postindex period. For patients with multiple pain scores, each episode required a 3-month post-index follow-up period. Generalized estimating equation models, adjusted for multiple observation panels per patient and baseline variables that may contribute to HRU and costs (age, sex, race/ethnicity, region, insurance type, integrated delivery network, body mass index, pain medication use, provider specialty, Charlson Comorbidity Index score, and other select comorbid conditions), were used to estimate all-cause and OA-related costs expressed as per patient per month (PPPM). Comparisons were performed for moderate (score 4-6) and severe (score 7-10) pain episodes versus no/mild pain episodes (score 0-3) and those with baseline opioid use versus those without. Included were 35,861 patients with knee/hip OA (mean age 66.5 years; 64.7% women) who had 70,716 pain episodes (58% mild, 23% moderate, 19% severe, and 37.0% with baseline opioid use). When controlling for other potential confounding factors, moderate/severe pain episodes were associated with higher all-cause and OA-related HRU than mild pain episodes. Relative to mild pain episodes, moderate/severe pain episodes were also associated with significantly higher adjusted average all-cause PPPM costs ($1,876/$1,840 vs. $1,602), and OA-related PPPM costs ($550/$577 vs. $394; all P < 0.05). Baseline opioid use was associated with significantly higher all-cause PPPM costs versus no opioid use (mild, $1,735 vs. $1,492; moderate, $2,034 vs. $1,755; severe, $2,100 vs. $1,643, all P < 0.001), and a higher likelihood of incurring OA-related costs relative to those without (P < 0.001). These results provide evidence of the economic impact of opioid use and inadequate pain control by demonstrating that increased pain severity and opioid use in patients with OA were independently associated with higher HRU and costs. Additional studies should confirm causality between opioid use and HRU and costs, taking into consideration underlying OA characteristics. Funding for this study was contributed by Regeneron Pharmaceuticals and Teva Pharmaceutical Industries. Wei is an employee at Regeneron Pharmaceuticals, with stock ownership. Gandhi was an employee at Teva Pharmaceutical Industries, with stock ownership, at the time of this study. Blauer-Peterson and Johnson are employees of Optum, which was contracted to conduct the research for this study.

Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to Evaluate Patterns of Care.

As clinical trials test efficacy rather than effectiveness of medications, real-world effectiveness data often vary from clinical trial data. Given the recent market entry of multiple biologics and biosimilars, a dedicated assessment of these diverse agents is needed to build the evidence base regarding efficacy and safety of innovator biologics and biosimilars. The Academy of Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was convened to address the lack of real-world, postmarket outcome evidence generation for innovator biologics and corresponding biosimilars. The BBCIC is a multistakeholder scientific research consortium whose participants prioritize topics and collaboratively conduct research studies. The BBCIC conducts a wide range of analyses, including population characterization, epidemiologic studies, and active observational studies, and develops best practices for conducting large-scale studies to provide real-world evidence. Over the past 3 years, we undertook multiple descriptive analyses with the goal of characterizing data availability and demonstrating the feasibility and efficacy of using the BBCIC distributed research network (DRN), which includes commercial claims data from 2008-2018 covering approximately 100 million lives, with approximately 20 million active members in 2017 from 2 major U.S. health plans and 3 regional integrated delivery networks. We analyzed 4 medication classes of particular interest to biologics and biosimilars development: insulins, granulocyte colony-stimulating factors, erythropoietic-stimulating agents, and anti-inflammatories. We were able to identify exposures and user characteristics in all 4 categories. Herein we describe the successes and challenges of conducting some of our analyses, specifically among insulin users with type 1 diabetes mellitus. Our results demonstrate the BBCIC DRN's ability to identify and characterize exposures, cohorts, and outcomes that can contribute to more sophisticated comparative surveillance of biosimilars and innovator biologics in the future. Additional linkages to laboratory data and a wider range of insurance carriers will further strengthen the BBCIC DRN. This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC; Eichelberger was employed by the BBCIC at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. This work was presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.

US Integrated Delivery Networks Perspective on Economic Burden of Patients with Treatment-Resistant Depression: A Retrospective Matched-Cohort Study.

ObjectiveOur objective was to assess healthcare resource utilization (HRU) and costs among patients with major depressive disorder (MDD) with and without treatment-resistant depression (TRD) and those without MDD in US Integrated Delivery Networks (IDNs).MethodsThis was a retrospective matched-cohort study. The Optum© Integrated Claims Electronic Health Record de-identified database was used to identify adult patients with TRD (January 2011–June 2017) across US IDNs. TRD patients were propensity score matched 1:1 with non-TRD MDD and non-MDD patients on demographics. Rates of HRU and costs were compared up to 2 years following the first antidepressant pharmacy claim (or randomly imputed date for non-MDD patients) using negative binomial and ordinary least squares regressions, respectively, with 95% confidence intervals (CIs) from nonparametric bootstraps (costs only) adjusted for baseline comorbidity index and costs.ResultsAll 1582 TRD patients were matched to non-TRD MDD and non-MDD patients and evaluated. TRD patients were on average 46 years old, and 67% were female. Mean duration of observation was 20.1, 19.6, and 17.9 months in the TRD, non-TRD MDD, and non-MDD cohorts, respectively. Patients with TRD had significantly higher rates of HRU than did non-TRD MDD patients (inpatient visits 0.35 vs. 0.16 per patient per year [PPPY]; adjusted incidence rate ratio [IRR] 2.04 [95% CI 1.74–2.39]) and non-MDD patients (0.35 vs. 0.09 PPPY, adjusted IRR 3.05 [95% CI 2.54–3.66]). TRD patients incurred significantly higher costs PPPY than did non-TRD MDD patients ($US25,807 vs. 13,701, adjusted cost difference $US9479 [95% CI 7071–11,621]) and non-MDD patients ($US25,807 vs. 8500, adjusted cost difference $US11,433 [95% CI 8668–13,876]).ConclusionsHRU and costs associated with TRD are significant in US IDNs.Electronic supplementary materialThe online version of this article (10.1007/s41669-019-0154-z) contains supplementary material, which is available to authorized users.