ClinicoEconomics and Outcomes Research最新文献

Objective: Reoperations for spinopelvic failure after adult spinal deformity (ASD) surgery are common. We sought to determine the added costs of ASD surgery attributable to reoperations for spinopelvic construct failures.

Methods: We constructed a Markov process model to calculate the expected discounted 5-year costs of spinopelvic construct failures after ASD surgery. The Nationwide Inpatient Sample (NIS) was queried to estimate the number of ASD surgeries. Model inputs were based on literature review and expert opinion. ASD surgery was defined as thoracolumbar fusion of 4 or more levels with pelvic fixation. The following pelvic fixation failures were included: 1) rod fracture or pseudarthrosis from L4-S1, 2) iliac screw failure or set plug dislodgment, 3) iliac screw prominence, and 4) sacroiliac (SI) joint pain. The number of patients undergoing ASD surgery annually in the US was determined using a commercial claims database.

Results: The net present value 5-year cost per patient for spinopelvic complications was $35,265, equal to 29% of index surgery costs. Given an estimated 27,580 cases annually in the US, the additional cost to address spinopelvic complications reach nearly $1 billion over 5-years. A sensitivity analysis showed that these costs were most sensitive to the rate of rod fracture/pseudarthrosis, iliac screw prominence, and reoperation.

Conclusion: A conservative estimate of the cost of spinopelvic failures after ASD surgery is substantial, nearly $1 billion over 5-years. We propose a method of capturing spinopelvic fixation failures for use in future clinical studies and cost analyses.

Objective: To measure the economic impact of conditionally essential amino acids (CEAA) among patients with operative treatment for fractures.

Methods: A decision tree model was created to estimate changes in annual health care costs and quality of life impact due to complications after patients underwent operative treatment to address a traumatic fracture. The intervention of interest was the use of CEAA alongside standard of care as compared to standard of care alone. Patients were required to be aged ≥18 and receive the surgery in a US Level 1 trauma center. The primary outcomes were rates of post-surgical complications, changes in patient quality adjusted life years (QALYs), and changes in cost. Cost savings were modeled as the incremental costs (in 2022 USD) of treating complications due to changes in complication rates.

Results: The per-patient cost of complications under CEAA use was $12,215 compared to $17,118 under standard of care without CEAA. The net incremental cost savings per patient with CEAA use was $4902, accounting for a two-week supply cost of CEAA. The differences in quality-adjusted life years (QALYs) under CEAA use and no CEAA use was 0.013 per person (0.739 vs 0.726). Modeled to the US population of patients requiring fracture fixations in trauma centers, the total value of CEAA use compared to no CEAA use was $316 million with an increase of 813 QALYs per year. With a gain of 0.013 QALYs per person, valued at $150,000, and the incremental cost savings of $4902 resulted in net monetary benefit of $6852 per patient. The incremental cost-effectiveness ratio showed that the use of CEAA dominated standard of care.

Conclusion: CEAA use after fracture fixation surgery is cost saving. Level of Evidence: Level 1 Economic Study.

Introduction: Sarcoidosis is a multisystem, inflammatory, systemic granulomatous disease with unknown etiology. Despite the current standard of care (SoC), there is an unmet need for the treatment of advanced symptomatic sarcoidosis. This study assessed the cost-effectiveness of Acthar^® Gel (repository corticotropin injection) versus SoC in patients with advanced symptomatic sarcoidosis from the United States (US) payer and societal perspectives over 2 and 3 years.

Methods: A probabilistic cohort-level state-transition approach was used for this cost-effectiveness analysis. Patients were monitored at the end of a 3-month cycle for the attainment of partial or complete response. Patients in the partial, complete, or no-response state were allowed to transition in each of these states at each 3-month cycle. Following the attainment of response, patients could have a durable response or relapse to a no-response state. Patients in a no-response state received treatment and could transition into a response or no-response state based on the probability of treatment success with the respective treatment. Clinical parameters and health utility data were sourced from the Acthar Gel in Participants with Pulmonary Sarcoidosis (PULSAR) trial (NCT03320070) and healthcare utilization, costs, and disutilities were sourced from the published literature. Base case analysis considered a payer perspective over 2 years.

Results: From a payer perspective, Acthar Gel versus SoC results in an incremental cost-effectiveness ratio (ICER) of $134,796 per quality-adjusted life-year (QALY) and $39,179 per QALY over 2 and 3 years, respectively. From a societal perspective, Acthar Gel versus SoC results in an ICER of $117,622 per QALY and $21,967 per QALY over 2 and 3 years, respectively. Sensitivity analysis findings were consistent with the base case.

Conclusion: The results from this cost-effectiveness analysis indicate that Acthar Gel is a cost-effective, value-based treatment option for advanced symptomatic sarcoidosis compared to the SoC from the US payer and societal perspectives.

Background: A randomized clinical trial (HiFlo-COVID-19 Trial) showed that among patients with severe COVID-19, treatment with high-flow oxygen therapy (HFOT) significantly reduced the need for invasive mechanical ventilation support and time for clinical recovery compared with conventional oxygen therapy (COT). However, the cost of this strategy is unknown.

Objective: We examined total cost of HFOT treatment compared with COT in real-world setting.

Methods: We conducted a post-trial-based cost analysis from the perspective of a managed competition healthcare system, using actual records of billed costs. Cost categories include general ward, intensive care unit, procedures, imaging, laboratories, medications, supplies, and others.

Results: A total of 188 participants (mean age 60, 33% female) were included. Average costs (and standard deviation) in the HFOT group were USD $7992 (7394) and in the COT group USD $ 10,190 (9402). Differences, however, did not reach statistical significance (P=0.093). However, resource use was always less costly for the HNFO group, with an overall percentage decrease of 27%. Two categories make up 72% of all savings: medications (41%) and intensive care unit (31%).

Conclusion: For patients in ICU with severe COVID-19 the cost of treatment with HFOT as compared to COT is likely to be cost-saving due to less use of medications and length of stay in ICU.

Background: Two-thirds of the 1 million annual US CHF hospitalizations are for diuresis only; some may be avoidable. We describe a population of low-severity short-stay (

Methods: We conducted a retrospective cohort study within the Premier Healthcare Database, 2016-2021. CHF was defined via an administrative code algorithm. High severity (CHF-H) was marked by cardiogenic shock, the need for respiratory or circulatory support, and/or a Charlson comorbidity index >2. We compared baseline characteristics, processes of care, and outcomes in low-severity (CHF-L) to CHF-H.

Results: Among 301,672 short-stay CHF patients, 135,304 (44.8%) were CHF-L. Compared to CHF-H, CHF-L was younger (70.5 ± 14.1 vs 72.1 ± 13.6 years, p < 0.001), more commonly female (48.6% vs 45.8%, p < 0.001), and more likely to receive IV ACE-I/ARB agents (0.5% vs 0.4%, p = 0.003). Most other IV medications were more common in CHF-H, and anticoagulation was the most prevalent non-diuretic IV therapy in both groups (23.8% vs 33.3%, p < 0.001). Hospital mortality (0.2% vs 1.5%, p < 0.001) and CHF-related 30-day readmissions (8.1% vs 10.5%, p < 0.001) were lower in CHF-L than CHF-H.

Conclusion: Among short-stay CHF patients, nearly ½ meet criteria for CHF-L, and are mainly admitted for fluid management. Avoiding these admissions could result in substantial savings.

Purpose: To characterize medical and surgical patient characteristics, as well as clinical and economic outcomes, associated with unplanned intensive care unit (ICU) admissions.

Patients and methods: This was a retrospective matched cohort analysis that utilized the PINC AI^TM Healthcare Database, which collects deidentified data from 25% of United States (US) hospital admissions. Discharge records were assessed for medical and surgical admissions in 2021. An unplanned ICU admission was defined as direct transfer from a medical, surgical, or telemetry unit to the ICU. Patients with and without an unplanned ICU admission were 1:1 propensity score matched. Differences between patients with and without unplanned ICU admissions were assessed using two-sample t-tests for continuous measures and Chi-square tests for categorical measures.

Results: A total of 3,807,124 qualifying admissions were identified. Medical admissions with unplanned ICU transfers were more likely to be urgent/emergent (odds ratio [OR] 2.9, 95% confidence interval [CI 2.7-3.0], p<0.0001), with patient characteristics including male sex (1.4, [1.4-1.4], p<0.0001), obesity (1.7, [1.6-1.7], p<0.0001), and increased Charlson Comorbidity Index (CCI=1: 1.8, [1.8-1.9], p<0.0001; CCI≥5: 3.2, [3.1-3.3], p<0.0001). Surgical admissions with unplanned ICU transfers were more likely to be urgent/emergent (3.1, [2.9-3.2], p<0.0001) and with patients of higher CCI (2.5, [2.3-2.6], p<0.0001 to a CCI of≥5 (7.9, [7.4-8.4], p<0.0001). Between matched medical patients, mean differences in length of stay, cost, and mortality were 4.1 days (p<0.0001), $13,424 (p<0.0001), and 21% (p<0.0001), respectively. Between matched surgical patients, mean differences in these outcomes were 6.4 days (p<0.0001), $21,448 (p<0.0001), and 14% (p<0.0001), respectively.

Conclusion: Emergency care in patients with a higher co-morbid burden is more likely to lead to unplanned ICU admission, putting patients at a significantly increased chance of mortality, longer length of stay, and increased costs. Improving care and monitoring of patients outside the ICU may help detect early changes in pathophysiology and enable early intervention.

Purpose: Hyperkalemia, defined as abnormally high serum potassium levels of ≥5.1 mmol/L, is associated with increased medical costs. This real-world study evaluated the impact of long-term sodium zirconium cyclosilicate (SZC) therapy on medical costs in patients with hyperkalemia.

Patients and methods: This retrospective, comparative study used claims data from IQVIA PharMetrics^® Plus. Patients aged ≥18 years with hyperkalemia who had outpatient SZC fills (>3-month supply over 6 months) between July 2019 and December 2021 and continuous insurance coverage 6 months before and 6 months after the first SZC fill were included. These patients (SZC cohort) were 1:1 exact- and propensity score-matched on baseline variables with patients with hyperkalemia who did not receive SZC (non-SZC cohort). The primary endpoint was hyperkalemia-related medical costs to payers over 6 months.

Results: Each cohort included 661 matched patients. Mean per-patient hyperkalemia-related medical costs were reduced by 49.5% ($3728.47) for the SZC versus non-SZC cohort ($3798.04 vs $7526.51; P<0.001), whereas mean all-cause medical costs were reduced by 21.0% ($5492.20; $20,722.23 vs $26,214.43; P<0.01). A 39.8% ($3621.03) increase in all-cause pharmacy costs ($12,727.20 vs $9106.17; P<0.01) was offset by the medical cost savings.

Conclusion: This study demonstrated that long-term (>3 months) outpatient treatment with SZC was associated with medical cost savings compared with no SZC therapy.

Introduction: People living with bipolar I disorder (BD-I) have an increased risk for obesity compared with the general population that may be related to genetic, lifestyle, and treatment factors. Few studies have examined possible effects of obesity on those living with BD-I. This study examined relationships between obesity and clinical, humanistic, and economic outcomes among adults with BD-I.

Methods: This retrospective, cross-sectional study analyzed survey responses from a nationally representative sample of US adults participating in the 2016 or 2020 National Health and Wellness Survey. Respondents (18-64 years) with a self-reported physician diagnosis of BD-I were included and categorized by body mass index: underweight/normal weight (<25 kg/m²), overweight (25 to <30 kg/m²), or obese (≥30 kg/m²). Adjusted analyses assessed comorbidities, health-related quality of life (HRQoL), work productivity, health care resource utilization (HCRU), and economic outcomes.

Results: In total, responses from 1,853 participants were analyzed; most were female (65%) and white (62%). Respondents with obesity had the highest prevalence of medical comorbidities, including high blood pressure (52%), sleep apnea (37%), hypercholesterolemia (34%), and type 2 diabetes (12%). Obesity was generally associated with the lowest scores of physical health and HRQoL. Activity impairment scores were highest among respondents with obesity, as were numbers of hospitalizations and emergency department visits in the previous 6 months. Respondents with obesity incurred higher annual indirect and direct medical costs ($28,178 and $37,771, respectively) when compared with the underweight/normal weight ($23,823 and $32,227, respectively) and overweight ($24,312 and $35,231, respectively) groups.

Conclusion: In this nationally representative sample, obesity was associated with several outcomes that may negatively affect people living with BD-I, including medical comorbidities, higher HCRU, HRQoL impairments, and greater indirect and direct medical costs. These findings highlight the importance of considering the presence of or risk for obesity and associated medical comorbidities when treating BD-I.

Purpose: Patients with diagnosed with systemic light chain (AL) amyloidosis at advanced Mayo stages have greater morbidity and mortality than those diagnosed at non-advanced stages. Estimating service use by severity is difficult because Mayo stage is not available in many secondary databases. We used an expert panel to estimate healthcare utilization among advanced and non-advanced AL amyloidosis patients.

Patients and methods: Using the RAND/UCLA modified Delphi method, expert panelists completed 180 healthcare utilization estimates, consisting of inpatient and outpatient visits, testing, chemotherapy, and procedures by disease severity and organ involvement during two treatment phases (the 1 year after starting first line [1L] therapy and 1 year following treatment [post-1L]). Estimates were also provided for post-1L by hematologic treatment response (complete or very good partial response [CR/VGPR], partial, no response or relapse [PR/NR/R]). Areas of disagreement were discussed during a meeting, after which ratings were completed a second time.

Results: During 1L therapy, 55% of advanced patients had ≥1 hospitalization and 38% had ≥2 admissions. Rates of hematopoietic stem cell transplant (HSCT) in advanced patients were 5%, while pacemaker or implantable cardioverter defibrillator (ICD) placement were 15%. During post-1L therapy, rates of hospitalization in advanced patients remained high (≥1 hospitalization: 20-43%, ≥2 hospitalizations: 10-20%), and up to 10% of advanced patients had a HSCT. Ten percent of these patients underwent pacemaker/ICD placement.

Conclusion: Experts estimated advanced patients, who would not be good candidates for HSCT, would have high rates of hospitalization (traditionally the most expensive type of healthcare utilization) and other health service use. The development of new treatment options that can facilitate organ recovery and improve function may lead to decreased utilization.