Leveraging the holistic benefits of biosimilars in Europe - part 2: how payers can safeguard the future of a healthy biosimilar market environment.

INTRODUCTION: Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets. AREAS COVERED: An expert panel of eight diverse European stakeholders provided insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1). Directional recommendations are provided for payers. EXPERT OPINION: The panel's market maturity framework for biosimilars has three stages: 'Invest,' 'Expand' and 'Harvest.' Across market stages, re-thinking the benefits of biosimilars beyond cost-savings, considering earlier or expanded access/new indications, product innovations, and re-investment of biosimilar-generated cost-savings should be communicated to stakeholders to promote further engagement. During 'Expand' and 'Harvest' stages, development of efficient, forward-looking procurement systems and mechanisms that drive uptake and stabilize competition between manufacturers are key. Future biosimilars will target various therapy areas beyond those targeted by existing biosimilars. To ensure a healthy, accessible future market, stakeholders must align their objectives, communicate, collaborate, and coordinate via education, incentivization, and procurement, to maximize the totality of benefits.

The Growth Hormone Deficiency (GHD) Reversal Trial: effect on final height of discontinuation versus continuation of growth hormone treatment in pubertal children with isolated GHD-a non-inferiority Randomised Controlled Trial (RCT).

BACKGROUND: Growth hormone deficiency (GHD) is the commonest endocrine cause of short stature and may occur in isolation (I-GHD) or combined with other pituitary hormone deficiencies. Around 500 children are diagnosed with GHD every year in the UK, of whom 75% have I-GHD. Growth hormone (GH) therapy improves growth in children with GHD, with the goal of achieving a normal final height (FH). GH therapy is given as daily injections until adult FH is reached. However, in many children with I-GHD their condition reverses, with a normal peak GH detected in 64-82% when re-tested at FH. Therefore, at some point between diagnosis and FH, I-GHD must have reversed, possibly due to increase in sex hormones during puberty. Despite increasing evidence for frequent I-GHD reversal, daily GH injections are traditionally continued until FH is achieved. METHODS/DESIGN: Evidence suggests that I-GHD children who re-test normal in early puberty reach a FH comparable to that of children without GHD. The GHD Reversal study will include 138 children from routine endocrine clinics in twelve UK and five Austrian centres with I-GHD (original peak GH < 6.7 mcg/L) whose deficiency has reversed on early re-testing. Children will be randomised to either continue or discontinue GH therapy. This phase III, international, multicentre, open-label, randomised controlled, non-inferiority trial (including an internal pilot study) will assess whether children with early I-GHD reversal who stop GH therapy achieve non-inferior near FH SDS (primary outcome; inferiority margin 0.55 SD), target height (TH) minus near FH, HRQoL, bone health index and lipid profiles (secondary outcomes) than those continuing GH. In addition, the study will assess cost-effectiveness of GH discontinuation in the early retesting scenario. DISCUSSION: If this study shows that a significant proportion of children with presumed I-GHD reversal generate enough GH naturally in puberty to achieve a near FH within the target range, then this new care pathway would rapidly improve national/international practice. An assumed 50% reversal rate would provide potential UK health service cost savings of £1.8-4.6 million (€2.05-5.24 million)/year in drug costs alone. This new care pathway would also prevent children from having unnecessary daily GH injections and consequent exposure to potential adverse effects. TRIAL REGISTRATION: EudraCT number: 2020-001006-39.

Impact of pharmacist alternative therapy interventions in a pediatric Medicaid population.

BACKGROUND: Ambulatory clinical pharmacists are viewed as the medication experts on the health care team and frequently assist with medication access concerns. However, medication access and insurance navigation are difficult because of wide variations in insurance formularies. Accountable care organizations (ACOs) incorporate pharmacists as members of their population health teams to assist with these efforts. These ACO pharmacists are uniquely positioned to assist pediatric ambulatory care pharmacists with medication access concerns. This collaboration has the potential to not only improve patient care but also provide cost savings. OBJECTIVE: To estimate cost savings to an ACO derived from alternative therapy interventions made by pharmacists embedded in pediatric ambulatory clinics, using resources created by ACO pharmacists, within a pediatric Medicaid population. The secondary objectives were to quantify the frequency of alternative therapy interventions provided by these pharmacists, evaluate the impact on medication access through the avoidance of prior authorizations (PAs), and assess the frequency and cost savings of alternative therapy interventions per treatment category. METHODS: This was a retrospective review of alternative therapy interventions provided by pediatric ambulatory care pharmacists within a health-system in central Ohio. Interventions were collected within an electronic health record from January 1, 2020, to December 31, 2020. Cost savings were calculated using average wholesale pricing, and PA avoidance was quantified. RESULTS: A total of 278 alternative therapy interventions were made with an estimated cost savings of $133,191.43. Primary care clinics (n = 181, 65%) had the most documented interventions. A total of 174 (63%) interventions resulted in the avoidance of a PA. The antiallergen (28%) treatment category had the most documented interventions. CONCLUSIONS: Alternative therapy interventions were provided by pediatric ambulatory care pharmacists in collaboration with pharmacists working for an ACO. The use of ACO prescribing resources can result in cost savings to an ACO and PA avoidance within a pediatric Medicaid population. DISCLOSURES: The statistical analysis of this work was supported by the National Center for Advancing Translational Sciences (CTSA Grant UL1TR002733). Dr Sebastian discloses her role as a pharmacy consultant for Molina Healthcare Pharmacy and Therapeutics Committee. All other authors declare no relevant conflicts of interest or financial relationships.

Wide Awake Trigger Finger Releases Performed in the United States: Trends in Volume, Operative Setting, and Reimbursement.

BACKGROUND: Trigger finger release (TFR) has traditionally been performed in outpatient operating rooms. More recently, TFR may be performed in the office setting to achieve greater efficiency and cost savings. METHODS: The 2010-2020 Q2 PearlDiver M91Ortho data set was analyzed for cases of TFR. Exclusion criteria were age less than 18 years, <30 days of postoperative records, concomitant hand surgery, monitored anesthesia use, and inpatient surgery. Age, sex, and Elixhauser comorbidity index were recorded. Operating room and office procedures were matched 4:1 based on patient characteristics. Total and physician reimbursement for the day of surgery, as well as 30-day narcotics prescriptions, emergency department (ED) visits, and surgical site infections (SSI) were determined. RESULTS: Before matching, TFRs were found to be increasingly performed in the office (from 7.9% in 2010 to 14.6% in 2020). Matched cohorts consisted of 63,951 operating room and 15,992 office procedures. Office procedures had lower mean total reimbursements ($435 vs $752, P < 0.001), slightly lower mean physician reimbursements ($420 vs $460, P < 0.001), and lower rates of narcotic prescriptions (30.5% vs 50.5%, P < 0.001) and 30-day ED visits (2.2% vs 2.9%, P < 0.05). There was no difference in 30-day SSI (0.5% vs 0.6%, P = 0.374). CONCLUSIONS: In-office TFR is becoming increasingly prevalent. After matching, in-office TFRs were associated with lesser costs to the system, lower narcotic prescriptions, and fewer postoperative ED visits, without increased SSI. Although it is important to perform procedures in the best location for the patient, physician, and system, the current study supports the increased value offered by in-office TFR.

Cost analysis of face-to-face visits, virtual visits, and a digital care pathway in the treatment of tonsillitis patients.

PURPOSE: The aim of this study was to compare the costs of two different telemedicine-assisted tonsillitis care pathways with traditional face-to-face visits at the Department of Otorhinolaryngology - Head and Neck Surgery (ORL-HNS) at Helsinki University Hospital. METHODS: We characterized and analyzed the patient flows and their individual episodes of all tonsillitis patients at the Department of ORL-HNS between September 2020 and August 2022. Records were collected by doctors at the clinic. We investigated costs and allocated resources in four categories: invoice from the Department of ORL-HNS to the public payer, expenses to the Department, patient fees, and doctor's resource. RESULTS: At least a third of the tonsillitis patients were eligible for telemedicine. The digital care pathway was 12.6 % less expensive for the public payer compared to the previous virtual visit model. For the Department, the expense of the digital care pathway was 58.8 % less per patient than the virtual visit model. Patient fees decreased 79.5 %. The digital care pathway reduced the doctor's resource from 30.28 min to 19.78 min, which accounts for a 34.7 % reduction. Patients finished the digital care pathway in a median of 62 min (SD = 60) compared to the 2-4 h which they would spend on an outpatient clinic visit. CONCLUSION: Our study demonstrates that tonsillitis patients are eligible for preoperative telemedicine. With at least a third of the tonsillitis patients being eligible for telemedicine, major cost savings can be achieved with efficient e-health-assisted solutions.

Prevented cases of neural tube defects and cost savings after folic acid fortification of flour in Brazil.

Anencephaly, encephalocele, and spina bifida are congenital neural tube defects and are the main causes of neonatal morbidity and mortality and impose a heavy economic burden on health systems. This study to estimates the direct costs of neural tube defects from the perspective of the Brazilian Ministry of Health, and the prevented cases and cost savings during the period in which mandatory folic acid fortification was in effect in the country (2010-2019). It is a top-down cost-of-illness oriented study based on the prevalence of the disorders in Brazil. Data were collected from the Brazilian Ministry of Health's outpatient and hospital information system databases. The direct cost was estimated from the total patient-years, allocated by age and type of disorder. Prevented cases and cost savings were determined by the difference in the prevalence of the disorders in the pre- and post-fortification periods based on the total number of births and the sum of outpatient and hospital costs during the period. The total cost of outpatient and hospital services for these disorders totaled R$ 92,530,810.63 (Int$ 40,565,896.81) in 10 years; spina bifida accounted for 84.92% of the total cost. Hospital costs were expressive of all three disorders in the first year of the patient's life. Between 2010 and 2019, mandatory folic acid fortification prevented 3,499 live births with neural tube defects and resulted in R$ 20,381,586.40 (Int$ 8,935,373.25) in hospital and outpatient cost savings. Flour fortification has proved to be a valuable strategy in preventing pregnancies with neural tube defects. Since its implementation, there has been a 30% decrease in the prevalence of neural tube defects and a 22.81% decrease associated in hospital and outpatient costs.

Estimated Indirect Cost Savings of Using Telehealth Among Nonelderly Patients With Cancer.

Importance: Patients with cancer typically have greater financial hardships and time costs than individuals without cancer. The COVID-19 pandemic has exacerbated this, while posing substantial challenges to delivering cancer care and resulting in important changes in care-delivery models, including the rapid adoption of telehealth. Objective: To estimate patient travel, time, and cost savings associated with telehealth for cancer care delivery. Design, Setting, and Participants: An economic evaluation of cost savings from completed telehealth visits from April 1, 2020, to June 30, 2021, in a single-institution National Cancer Institute-Designated Comprehensive Cancer Center. All patients aged 18 to 65 years who completed telehealth visits within the designated time frame and had a Florida mailing address documented in their electronic medical record were included in the study cohort. Data were analyzed from April 2020 to June 2021. Main Outcomes and Measures: The main outcome was estimated patient cost savings from telehealth, which included 2 components: costs of travel (defined as roundtrip distance saved from car travel) and potential loss of productivity due to the medical visit (defined as loss of income from roundtrip travel plus loss of income from in-person clinic visits). Two different models with a combination of 2 different mileage rates ($0.56 and $0.82 per mile) and census tract-level median hourly wages were used. Results: The study included 25 496 telehealth visits with 11 688 patients. There were 4525 (3795 patients) new or established visits and 20 971 (10 049 patients) follow-up visits. Median (IQR) age was 55.0 (46.0-61.0) years among the telehealth visits, with 15 663 visits (61.4%) by women and 18 360 visits (72.0%) by Hispanic non-White patients. According to cost models, the estimated mean (SD) total cost savings ranged from $147.4 ($120.1) at $0.56/mile to $186.1 ($156.9) at $0.82/mile. For new or established visits, the mean (SD) total cost savings per visit ranged from $176.6 ($136.3) at $0.56/mile to $222.8 ($177.4) at $0.82/mile, and for follow-up visits, the mean (SD) total cost savings per visit was $141.1 ($115.3) at $0.56/mile to $178.1 ($150.9) at $0.82/mile. Conclusions and Relevance: In this economic evaluation, telehealth was associated with savings in patients time and travel costs, which may reduce the financial toxicity of cancer care. Expansion of telehealth oncology services may be an effective strategy to reduce the financial burden among patients with cancer.

Impact of oral chemotherapy pharmacists on cost avoidance of oral oncolytics in an integrated health system.

BACKGROUND: While the impact of oncology pharmacist interventions on patient outcomes has been well-documented in previous studies, there is a scarcity of articles relating to oncology pharmacists' impact on cost avoidance of oral oncolytics within an integrated health care system. Cost savings and cost avoidance studies are needed to help promote the expansion of clinical services provided by the oncology pharmacy department. OBJECTIVE: The primary objective of this study was to analyze interventions made by oncology pharmacists in the Oral Chemotherapy Treatment Program (OCTP) at the Kaiser Permanente-San Diego Service Area and determine the direct cost avoidance effects over one year. A secondary objective was to evaluate oncologists' satisfaction with OCTP. METHODS: This was a retrospective, observational, single-arm study where the drug cost avoidance impact resulting from oncology pharmacists' interventions was calculated. A report containing all documented oncology pharmacist interventions made in OCTP from 1 January to 31 December 2021 were reviewed for study inclusion. A retrospective chart review was conducted to verify that the interventions were made by the oncology pharmacists. The average wholesale price of drugs listed on Lexicomp as of 1 November 2021 was used to calculate drug cost avoidance values. RESULTS: A total of 238 OCTP oncology pharmacist interventions associated with direct drug cost avoidance values were identified, amounting to a total cost avoidance of $2,521,844 and an annual return on investment of 440%.

Fracture liaison service utilising an emergency department information system to identify patients effectively reduce re-fracture rate is cost-effective and cost saving in Western Australia.

OBJECTIVES: To assess the benefits of the Emergency Department Information System (EDIS)-linked fracture liaison service (FLS). METHODS: Patients identified through EDIS were invited to attend an FLS at the intervention hospital, the Sir Charles Gairdner Hospital (SCGS-FLS). The intervention group was compared to usual care. Retrospective control (RC) at this hospital determined historical fracture risk (SCGH-RC). Prospective control (PC) was from a comparator, Fremantle Hospital (FH-PC). The main outcome measures were cost-effectiveness from a health system perspective and quality of life by EuroQOL (EQ-5D). Bottom-up cost of medical care, against the cost of managing recurrent fracture (weighted basket), was determined from the literature and 2013/14 Australian Refined Diagnosis Related Groups (AR-DRG) prices. Mean incremental cost-effectiveness ratios were simulated from 5000 bootstrap iterations. Cost-effectiveness acceptability curves were generated. RESULTS: The SCGH-FLS program reduced absolute re-fracture rates versus control cohorts (9.2-10.2%), producing an estimated cost saving of AUD$750,168-AUD$810,400 per 1000 patient-years in the first year. Between-groups QALYs differed with worse outcomes in both control groups (p < 0.001). The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $8721 (95% CI -$1218, $35,044) and $8974 (95% CI -$26,701, $69,929), respectively, per 1% reduction in 12-month recurrent fracture risk. The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $292 (95% CI -$3588, $3380) and -$261 (95% CI -$1521, $471) per EQ-5D QALY gained at 12 months respectively. With societal willingness to pay of $16,000, recurrent fracture is reduced by 1% in >80% of patients. CONCLUSIONS: This simple and easy model of identification and intervention demonstrated efficacy in reducing rates of recurrent fracture and was cost-effective and potentially cost saving.

Integrative Approaches to Pediatric Chronic Pain in an Urban Safety-Net Hospital: Cost Savings, Clinical Benefits, and Safety.

Purpose: Chronic pain experienced by children and adolescents represents a significant burden in terms of health, quality of life, and economic costs to U.S. families. In 2015, the Boston Medical Center (BMC) Interdisciplinary Pain Clinic initiated an Integrative Medicine (IM) team model to address chronic pain in children. Team members included a pediatrician, child psychologist, physical therapist, acupuncturist, and massage therapist. Children were referred to the pain clinic from primary care and specialty services within BMC, the largest safety-net hospital in the northeastern United States. For this observational assessment, consent and assent were obtained from parents and pediatric patients. Individualized treatment plans were recommended by the IM team. Methods: Self-reported survey and electronic medical record data were collected about socioeconomic demographics, pain, use of medical and IM services, and quality of life. The authors compared health and quality of life indicators and costs of care for each participant from the year before entering the project with these same indicators for the subsequent year. Results: Eighty-three participants were enrolled. Participants ranged in age from 4 to 22 years (mean 14.7 years). Eighty percent of the group were females. Forty-two percent of the sample were white, 30% were Hispanic/Latinx, and 28% were African American. Primary types of pain were abdominal (52%), headache (23%), musculoskeletal (18%), and other (7%). Quality of life indicators improved (p = 0.049) and pain interference decreased (Wilcoxon p = 0.040). Major economic drivers of cost were emergency department (ED) visits, inpatient hospitalizations, and consultations with medical specialists. For the 46 participants who completed the project, the following total cost savings were noted: $27,819 (surgeries), $17,638 (ED visits), $25,033 (hospitalizations), and $42,843 (specialist consults). No adverse events were reported. Conclusion: The authors' experience demonstrated that the use of IM approaches in an interdisciplinary team approach is safe, feasible, and acceptable to families. Considerable cost savings were observed in the area of surgical procedures, hospitalizations, and consultations with specialists.

Do we care about high-cost patients? Estimating the savings on health spending by integrated care.

A recent integrated health care initiative in Belgium supports 12 regional pilot projects scattered across the country and representing 21% of the population. As in shared savings programs, part of the estimated savings in health spending are paid out to the projects to reinvest in new actions. Short-term savings are expected in particular from cost reductions among high-cost patients. We estimate the effect of the projects on spending using a difference-in-difference model. The sensitivity of the results to the right-skewness of spending is commonly addressed by removing or top-coding high-cost cases. However, this leads to an underestimation of realized savings at the top end of the distribution, therefore, lowering incentives for cost reduction. We show that this trade-off can be weakened by an alternative approach in which cost categories that fall out of the scope of the projects' interventions are excluded from the dependent variable. We find that this approach leads to improvements in precision and model fit that are of the same magnitude as excluding high-cost cases altogether. At the same time, it sharpens the incentives for cost reduction because the model better reflects the costs that projects can affect.

Analysis of an Alternative Model of Definitive Care For Low-Acuity Emergency Calls: A Natural Experiment.

BACKGROUND: Emergency medical services (EMS) diversion strategies attempt to limit the impact of low-acuity care on emergency department (ED) crowding, but evidence supporting these strategies is scarce. OBJECTIVE: This study aims to measure the effect of a treat-in-place and alternative destination program on ED transports and EMS utilization. METHODS: We used a natural experiment study design to measure effects of a pilot prehospital diversion program on ED transport, number of EMS vehicles dispatched, and EMS time on task for low-acuity emergency calls in a midsized urban setting characterized by a high prevalence of health disparities, concentrated poverty, and limited access to primary care between October 2018 and January 2020. We also used direct variable cost to estimate the return on investment attributable to avoided ED visits. RESULTS: Of 3725 calls that met eligibility criteria, the program responded to 1084 (29.1%), with 56.7% of those resulting in an ED visit, compared with 64.6% of the 492 control calls that were eligible but were dispatched when program services were unavailable. Of 1084 calls receiving response, 213 (19.6%) were enrolled in the program, and 8.5% of those were transported by EMS to the ED. Adjusted results show EMS time on task was 23.4 min less for enrolled calls vs. controls. The program can achieve a positive return on investment by enrolling 2.9 patients/day. CONCLUSIONS: A prehospital diversion program reduced ED visits and EMS transport times. Improved targeting of patients for enrollment would further increase the intervention's efficacy and cost savings.

Implementation of Evidence-Based Presurgical Testing Guidelines in Patients Undergoing Ambulatory Surgery for Endometrial Cancer.

PURPOSE: The aim of this quality improvement intervention was to evaluate the safety and cost savings of presurgical testing (PST) guidelines for patients undergoing hysterectomy for endometrial pathology in the ambulatory setting. METHODS: Evidence-based presurgical testing (PST) guidelines were developed by a multidisciplinary team. These guidelines were implemented on the gynecologic surgery service of a comprehensive cancer center in January 2016. All patients with a diagnosis of endometrial pathology who underwent ambulatory surgery during the specified time periods were included in this analysis. A pre-post analysis was performed (preperiod, July 2014-December 2015; postperiod, July 2016-December 2017). Rates of completed presurgical tests and perioperative adverse events were compared between time periods. Cost savings related to the reduction in PST were calculated using the direct cost of testing and reported in percentage cost reduction. RESULTS: A total of 749 hysterectomies were completed in the preperiod and 775 in the postperiod. After implementation of PST guidelines, complete blood counts, coagulation testing, comprehensive metabolic panels, chest x-rays, and electrocardiograms were reduced by 13.4%, 78.1%, 36.8%, 39.0%, and 15.5%, respectively (all P < .001). Rates of perioperative cardiopulmonary adverse events (0% v 0%) and hematologic adverse events (3.3% v 2.0%; P = .10) were stable between time periods. There were no deaths within 90 days of surgery. There was a 41.4% reduction in direct costs related to PST in the postperiod. CONCLUSION: The use of evidence-based PST guidelines for patients with endometrial pathology undergoing hysterectomy in the ambulatory setting is safe and cost-effective. A multidisciplinary approach is essential for successful development and implementation.

Organizational Characteristics Associated with High Performance in Medicare's Comprehensive End-Stage Renal Disease Care Initiative.

BACKGROUND AND OBJECTIVES: Medicare plans to extend financial structures tested through the Comprehensive End-Stage Renal Disease Care (CEC) Initiative-an alternative payment model for maintenance dialysis providers-to promote high-value care for beneficiaries with kidney failure. The End-Stage Renal Disease Seamless Care Organizations (ESCOs) that formed under the CEC Initiative varied greatly in their ability to generate cost savings and improve patient health outcomes. This study examined whether organizational or community characteristics were associated with ESCOs' performance. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a retrospective pooled cross-sectional analysis of all 37 ESCOs participating in the CEC Initiative during 2015-2018 (n=87 ESCO-years). Key exposures included ESCO characteristics: number of dialysis facilities, number and types of physicians, and years of CEC Initiative experience. Outcomes of interest included were above versus below median gross financial savings (2.4%) and standardized mortality ratio (0.93). We analyzed unadjusted differences between high- and low-performing ESCOs and then used multivariable logistic regression to construct average marginal effect estimates for parameters of interest. RESULTS: Above-median gross savings were obtained by 23 (52%) ESCOs with no program experience, 14 (32%) organizations with 1 year of experience, and seven (16%) organizations with 2 years of experience. The adjusted likelihoods of achieving above-median gross savings were 23 (95% confidence interval, 8 to 37) and 48 (95% confidence interval, 24 to 68) percentage points higher for ESCOs with 1 or 2 years of program experience, respectively (versus none). The adjusted likelihood of achieving above-median gross savings was 1.7 (95% confidence interval, -3 to -1) percentage points lower with each additional affiliated dialysis facility. Adjusted mortality rates were lower for ESCOs located in areas with higher socioeconomic status. CONCLUSIONS: Smaller ESCOs, organizations with more experience in the CEC Initiative, and those located in more affluent areas performed better under the CEC Initiative.

Expedited and Comprehensive Management of Low-Risk TIA Patients in the Emergency Department is Safe and Less Costly.

OBJECTIVES: Transient ischemic attack (TIA) can be a warning sign of an impending stroke. The objective of our study is to assess the feasibility, safety, and cost savings of a comprehensive TIA protocol in the emergency room for low-risk TIA patients. MATERIALS AND METHODS: This is a retrospective, single-center cohort study performed at an academic comprehensive stroke center. We implemented an emergency department-based TIA protocol pathway for low-risk TIA patients (defined as ABCD2 score < 4 and without significant vessel stenosis) who were able to undergo vascular imaging and a brain MRI in the emergency room. Patients were set up with rapid outpatient follow-up in our stroke clinic and scheduled for an outpatient echocardiogram, if indicated. We compared this cohort to TIA patients admitted prior to the implementation of the TIA protocol who would have qualified. Outcomes of interest included length of stay, hospital cost, radiographic and echocardiogram findings, recurrent neurovascular events within 30 days, and final diagnosis. RESULTS: A total of 138 patients were assessed (65 patients in the pre-pathway cohort, 73 in the expedited, post-TIA pathway implementation cohort). Average time from MRI order to MRI end was 6.4 h compared to 2.3 h in the pre- and post-pathway cohorts, respectively (p < 0.0001). The average length of stay for the pre-pathway group was 28.8 h in the pre-pathway cohort compared to 7.7 h in the post-pathway cohort (p < 0.0001). There were no differences in neuroimaging or echocardiographic findings. There were no differences in the 30 days re-presentation for stroke or TIA or mortality between the two groups. The direct cost per TIA admission was $2,944.50 compared to $1,610.50 for TIA patients triaged through the pathway at our institution. CONCLUSIONS: This study demonstrates the feasibility, safety, and cost-savings of a comprehensive, emergency department-based TIA protocol. Further study is needed to confirm overall benefit of an expedited approach to TIA patient management and guide clinical practice recommendations.

Does Cost-Effectiveness Analysis Overvalue Potential Cures? Exploring Alternative Methods for Applying a "Shared Savings" Approach to Cost Offsets.

OBJECTIVES: To evaluate alternative methods to calculate and/or attribute economic surplus in the cost-effectiveness analysis of single or short-term therapies. METHODS: We performed a systematic literature review of articles describing alternative methods for cost-effectiveness analysis of potentially curative therapies whose assessment using traditional methods may suggest unaffordable valuations owing to the magnitude of estimated long-term quality-adjusted life-year (QALY) gains or cost offsets. Through internal deliberation and discussion with staff at the Health Technology Assessment bodies in England and Canada, we developed the following 3 alternative methods for further evaluation: (1) capping annual costs in the comparator arm at $150 000 per year; (2) "sharing" the economic surplus with the health sector by apportioning only 50% of cost offsets or 50% of cost offsets and QALY gains to the value of the therapy; and (3) crediting the therapy with only 12 years of the average annual cost offsets or cost offsets and QALY gains over the lifetime horizon. The impact of each alternative method was evaluated by applying it in an economic model of 3 hypothetical condition-treatment scenarios meant to reflect a diversity of chronicity and background healthcare costs. RESULTS: The alternative with greatest impact on threshold price for the fatal pediatric condition spinal muscular atrophy type 1 was the 12-year cutoff scenario. For a hypothetical one-time treatment for hemophilia A, capping cost offsets at $150 000 per year had the greatest impact. For chimeric antigen receptor T-cell treatment of non-Hodgkin's lymphoma, capping cost offsets or using 12-year threshold had little impact, whereas 50% sharing of surplus including QALY gains and cost offsets greatly reduced threshold pricing. CONCLUSIONS: Health Technology Assessment bodies and policy makers will wrestle with how to evaluate single or short-term potentially curative therapies and establish pricing and payment mechanisms to ensure sustainability. Scenario analyses using alternative methods for calculating and apportioning economic surplus can provide starkly different assessment results. These methods may stimulate important societal dialogue on fair pricing for these novel treatments.

Health and economic impact of the correct diagnosis of transthyretin cardiac amyloidosis in Spain.

Objective: To estimate the health and economic impact of the reduction in mortality and cardiovascular hospitalizations, associated with correct diagnosis of cardiac transthyretin amyloidosis (ATTR-CM), from the Spanish National Health System (NHS) perspective.Methods: A costs and effects analysis were performed (probabilistic Markov model) with time horizons between 1 and 15 years, comparing the correct diagnosis of ATTR-CM versus the non-diagnosis. Transition probabilities were obtained from the ATTR-ACT study (placebo arm) and from the literature. Costs and healthcare resources were obtained from Spanish sources (€ 2019) and from a panel of Spanish clinical experts.Results: After 1, 5, 10 and 15 years, the diagnosis of ATTR-CM would generate a gain of 0.031 (95%CI 0.025; 0.038); 0.387 (95%CI 0.329; 0.435); 0.754 (95%CI 0.678; 0.781) and 0.944 (95%CI 0.905; 0.983) life years per patient, respectively, with savings of € 212 (95%CI € -632; 633), € 2,289 (95%CI € 2,250; 2,517), € 2,859 (95%CI € 2,584; 3,149) and € 2,906 (95%CI € 2,669; 3,450) per patient, respectively, versus the non-diagnosis.Conclusions: Just by correctly diagnosing ATTR-CM, years of life would be gained, cardiovascular hospitalizations would be avoided, and savings would be generated for the NHS, compared to the non-diagnosis of the disease.

Clinical and Financial Implications of Second-Opinion Surgical Pathology Review.

OBJECTIVES: Second-opinion pathology review identifies clinically significant diagnostic discrepancies for some patients. Discrepancy rates and laboratory-specific costs in a single health care system for patients referred from regional affiliates to a comprehensive cancer center ("main campus") have not been reported. METHODS: Main campus second-opinion pathology cases for 740 patients from eight affiliated hospitals during 2016 to 2018 were reviewed. Chart review was performed to identify changes in care due to pathology review. To assess costs of pathology interpretation, reimbursement rates for consultation Current Procedural Terminology billing codes were compared with codes that would have been used had the cases originated at the main campus. RESULTS: Diagnostic discrepancies were identified in 104 (14.1%) patients, 30 (4.1%) of which resulted in a change in care. In aggregate, reimbursement for affiliate cases was 65.6% of the reimbursement for the same cases had they originated at the main campus. High-volume organ systems with low relative consultation reimbursement included gynecologic, breast, and thoracic. CONCLUSIONS: Preventable diagnostic errors are reduced by pathology review for patients referred within a single health care system. Although the resulting changes in care potentially lead to overall cost savings, the financial value of referral pathology review could be improved.

Effect of clinical pharmacist interventions on cost in an integrated health system specialty pharmacy.

BACKGROUND: Patients who are prescribed specialty medications require close monitoring, including assessment of laboratory parameters, toxicities, and adherence. Specialty pharmacies integrated within a health system are able to access records, assess therapy, and efficiently communicate with prescribers. OBJECTIVE: To analyze interventions made by clinical pharmacists within the Cleveland Clinic Specialty Pharmacy (CCSP) regarding cost avoidance for the health care system and improvements in patient safety. METHODS: This was a retrospective, observational study that analyzed pharmacist interventions regarding specialty hematology/oncology medications. Interventions were measured with pharmacist documentation within the electronic health record (EHR). The primary endpoint was the cost-avoidance effect of clinical pharmacist interventions resulting from pharmacist access to the EHR. Secondary endpoints included pharmacist interventions that led to additional ancillary or supportive care, time taken to perform interventions, total interventions according to new or refill status, and total interventions performed according to insurance subtype. RESULTS: 547 interventions were identified during the study period, with a total cost avoidance of $1,508,131. The intervention with the highest overall cost savings was discontinuation of therapy ($290,091). The highest cost savings, based on intervention type, was lack of follow-up ($30,892). The medication with the highest overall cost savings was abiraterone ($273,160). Gilteritinib was associated with the highest cost saving per intervention ($28,350). The indication with the highest overall cost savings was prostate cancer ($402,601), while cutaneous T-cell lymphoma had the highest cost savings per intervention ($25,424). CONCLUSIONS: CCSP pharmacist interventions led to significant overall cost savings to the health care system. Although not measured in this study, it is reasonable to expect that decreased medication use may also translate into less financial burden for patients, as well as for pharmacy benefit managers. Access to the EHR and integration within the health care system may have facilitated the cost savings. DISCLOSURES: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no conflicts of interest to disclose.