Understanding healthcare providers' preferred attributes of pediatric pneumococcal conjugate vaccines in the United States.

As higher-valent pneumococcal conjugate vaccines (PCVs) become available for pediatric populations in the US, it is important to understand healthcare provider (HCP) preferences for and acceptability of PCVs. US HCPs (pediatricians, family medicine physicians and advanced practitioners) completed an online, cross-sectional survey between March and April 2023. HCPs were eligible if they recommended or prescribed vaccines to children age <24 months, spent ≥25% of their time in direct patient care, and had ≥2 y of experience in their profession. The survey included a discrete choice experiment (DCE) in which HCPs selected preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes. Relative attribute importance was quantified. Among 548 HCP respondents, the median age was 43.2 y, and the majority were male (57.9%) and practiced in urban areas (69.7%). DCE results showed that attributes with the greatest impact on HCP decision-making were 1) immune response for the shared serotypes covered by PCV13 (31.4%), 2) percent of invasive pneumococcal disease (IPD) covered by vaccine serotypes (21.3%), 3) acute otitis media (AOM) label indication (20.3%), 4) effectiveness against serotype 3 (17.6%), and 5) number of serotypes in the vaccine (9.5%). Among US HCPs, the most important attribute of PCVs was comparability of immune response for PCV13 shared serotypes, while the number of serotypes was least important. Findings suggest new PCVs eliciting high immune responses for serotypes that contribute substantially to IPD burden and maintaining immunogenicity against serotypes in existing PCVs are preferred by HCPs.

Patient Preferences for Benefits, Risks, and Administration Route of Hypomethylating Agents in Myelodysplastic Syndromes.

INTRODUCTION/BACKGROUND: Therapy with infused or injected hypomethylating agents (HMAs) may lead to higher treatment administration burden (ie, local reaction, visit frequency and duration) vs. oral HMAs.   OBJECTIVES: To reveal preferences of US and Canadian patients with myelodysplastic syndromes (MDS) for HMAs' benefits, risks, and administration burden through an online discrete-choice experiment (DCE). MATERIALS AND METHODS: Choice of DCE attributes and survey development were informed by literature review and interviews with clinicians, MDS patients, and caregivers serving as patient proxies, and patient advocacy groups (PAGs) representatives, including from AAMAC, AAMDS, and MDSF. DCE choice tasks were analyzed using random parameter logit models. Survey patients were recruited by the PAGs via their networks. To understand key preference drivers and how much patients were willing to trade between attributes, we calculated each attribute's relative attribute importance (RAI) and marginal rates of substitution. RESULTS: One hundred eighty-four respondents (including 158 patients; mean age, 67.2 years; male, 50.5%; White, 50.5%; US residents, 88%) completed the survey. MDS risk was low (34.8%), high (30.9%), or unknown (34.2%). RAI (in decreasing order) was as follows: risk of AML (40%), fatigue level (33%), number of visits (12%), mode of administration (6%), visit duration (5%), and administration frequency (4%). Assuming the same risk of AML transformation or level of fatigue, most respondents (76.6%) were predicted to switch to an oral pill if it were available to them. CONCLUSION: Given equivalent effectiveness across HMAs, patients' preferences for HMA administration method should be considered in treatment decision-making to minimize burden and facilitate adherence.

Cost Burden of Endothelial Keratoplasty in Fuchs Endothelial Dystrophy: Real-World Analysis of a Commercially Insured US Population (2014-2019).

Purpose: To assess the incremental burden of corneal transplant surgery for US commercially insured patients with Fuchs endothelial corneal dystrophy (FECD) treated with endothelial keratoplasty (EK) compared to controls. Methods: The study design was retrospective cohort using IBM® MarketScan® claims (January 2014-September 2019) and included EK-treated (N=1562) and control patients (N=23,485) having ≥12 months' enrollment before and after diagnosis, who were subsequently matched on select characteristics. The index date was the beginning of the pre-operative period (3 months before EK); synthetic EK index was assigned for controls. All-cause, eye-disease, and complication-related healthcare resource utilization (HCRU) and costs were compared up to 36 months post index. For a small subset of patients, patient data were linked to the Health and Productivity Management supplemental database, which integrates data on productivity loss and disability payments. Results: Matched cohorts included 804 EK-treated and 1453 controls with average age 65.7 years, 1383 (61%) female. Over 12 months of follow-up, all-cause ($41,199 vs $20,222, p<0.001) and eye-disease related costs ($22,951 vs $1389, p<0.001) were higher among EK-treated patients than controls. The cost differential increased additionally by $1000-$2000 per annum by 36 months of follow-up. While balanced at baseline, over follow-up EK-treated patients had higher prevalence of glaucoma, elevated intraocular pressure, cataract, cataract surgery, diagnosis of cornea transplant rejection, retinal edema. By 36 month of follow-up, EK-treated patients had 9 more short-term disability days, resulting in $2992 additional burden of disability payments. Conclusion: This study found a higher cost burden among FECD patients receiving EK treatment versus those who did not. With a shift in management of FECD, cost burden estimates generated in this study could serve as an important benchmark for future studies.

Injectable Hypomethylating Agents for Management of Myelodysplastic Syndromes: Patients' Perspectives on Treatment.

BACKGROUND: Until recently, patients with MDSs could receive HMAs via intravenous (IV) or subcutaneous (SC) administration. An oral HMA was recently approved as an alternative to IV/SC administration. This study assessed the impact of IV/SC HMA on MDS patients, and their experience of, challenges with, and views about oral MDS treatment. PATIENTS AND METHODS: We conducted an online cross-sectional survey among adult MDS patients (or caregivers as proxies) invited by 2 U.S. MDS patient advocacy groups. Patients were required to have received IV/SC HMA (ie, azacitidine or decitabine) within 6 months of the survey. RESULTS: The survey was completed by 141 participants (120 patients, 21 caregiver proxies). Median patient age was 63.0 years, 53.9% were women, and 19.8%, 62.4%, and 17.7% had lower-, higher-, or unknown risk scores, respectively. HMA treatments received included SC azacitidine (37%), IV azacitidine (36%), and IV decitabine (27%). Among 89 IV HMA recipients, 74.2% and 69.7% reported treatment-related interference with their social and daily activities, respectively, and 66.3% reported pain related to treatment administration. Following an injection, SC HMA recipients reported pain (94.2%) and interference with daily (86.5%) and social (80.8%) activities. Among the 49.6% of patients who were working, 61.4% felt less productive due to treatment. Most (69.5%) MDS patients indicated they would prefer oral MDS treatment to IV/SC therapies. CONCLUSION: Patients receiving IV/SC HMAs experienced pain/discomfort and interference with social and daily activities. The introduction of an oral HMA may alleviate some treatment challenges for MDS patients.

Cardiovascular Healthcare Cost Savings Associated with Increased Whole Grains Consumption among Adults in the United States.

Little is known about the potential health economic impact of increasing the proportion of total grains consumed as whole grains to align with Dietary Guidelines for Americans (DGA) recommendations. Health economic analysis estimating difference in costs developed using (1) relative risk (RR) estimates between whole grains consumption and outcomes of cardiovascular disease (CVD) and a selected component (coronary heart disease, CHD); (2) estimates of total and whole grains consumption among US adults; and (3) annual direct and indirect medical costs associated with CVD. Using reported RR estimates and assuming a linear relationship, risk reductions per serving of whole grains were calculated and cost savings were estimated from proportional reductions by health outcome. With a 4% reduction in CVD incidence per serving and a daily increase of 2.24 oz-eq of whole grains, one-year direct medical cost savings were estimated at US$21.9 billion (B) (range, US$5.5B to US$38.4B). With this same increase in whole grains and a 5% reduction in CHD incidence per serving, one-year direct medical cost savings were estimated at US$14.0B (US$8.4B to US$22.4B). A modest increase in whole grains of 0.25 oz-eq per day was associated with one-year CVD-related savings of $2.4B (US$0.6B to US$4.3B) and CHD-related savings of US$1.6B (US$0.9B to US$2.5B). Increasing whole grains consumption among US adults to align more closely with DGA recommendations has the potential for substantial healthcare cost savings.

Health Care Costs and Savings Associated with Increased Dairy Consumption among Adults in the United States.

BACKGROUND: The purpose of this study is to estimate the impact on health care costs if United States (US) adults increased their dairy consumption to meet Dietary Guidelines for Americans (DGA) recommendations. METHODS: Risk estimates from recent meta-analyses quantifying the association between dairy consumption and health outcomes were combined with the increase in dairy consumption under two scenarios where population mean dairy intakes from the 2015-2016 What We Eat in America were increased to meet the DGA recommendations: (1) according to proportions by type as specified in US Department of Agriculture Food Intake Patterns and (2) assuming the consumption of a single dairy type. The resulting change in risk was combined with published data on annual health care costs to estimate impact on costs. Health care costs were adjusted to account for potential double counting due to overlapping comorbidities of the health outcomes included. RESULTS: Total dairy consumption among adults in the US was 1.49 cup-equivalents per day (c-eq/day), requiring an increase of 1.51 c-eq/day to meet the DGA recommendation. Annual cost savings of $12.5 billion (B) (range of $2.0B to $25.6B) were estimated based on total dairy consumption resulting from a reduction in stroke, hypertension, type 2 diabetes, and colorectal cancer and an increased risk of Parkinson's disease and prostate cancer. Similar annual cost savings were estimated for an increase in low-fat dairy consumption ($14.1B; range of $0.8B to $27.9B). Among dairy sub-types, an increase of approximately 0.5 c-eq/day of yogurt consumption alone to help meet the DGA recommendations resulted in the highest annual cost savings of $32.5B (range of $16.5B to $52.8B), mostly driven by a reduction in type 2 diabetes. CONCLUSIONS: Adoption of a dietary pattern with increased dairy consumption among adults in the US to meet DGA recommendations has the potential to provide billions of dollars in savings.

A Systematic Review of Cost-Effectiveness Analyses of Left Ventricular Assist Devices: Issues and Challenges.

BACKGROUND: Advanced heart failure (HF) can be treated conservatively or aggressively, with left ventricular assist devices (LVADs) and heart transplant (HT) being the most aggressive strategies. OBJECTIVE: The goal of this review was to identify, describe, critique and summarize published cost-effectiveness analyses on LVADs for adults with HF. METHODS: We conducted a literature search using PubMed and ProQuest DIALOG databases to identify English-language publications from 2006 to 2017 describing cost-effectiveness analyses of LVADs and reviewed them against inclusion criteria. Those that met criteria were obtained for full-text review and abstracted if they continued to meet study requirements. RESULTS: A total of 12 cost-effectiveness studies (13 articles) were identified, all of which described models; they were almost evenly split between those examining LVADs as destination therapy (DT) or as bridge to transplant (BTT). Studies were Markov or semi-Markov models with one- or three-month cycles that followed patients until death. Inputs came from a variety of sources, with the REMATCH trial and INTERMACS registry common clinical data sources, although some publications also used data from studies at their own institutions. Costs were derived from standard sources in many studies but from individual hospital data in some. Inputs for health utilities, which were used in 11 of 12 studies, were generally derived from two studies. None of the studies reported a societal perspective, that is, included non-medical costs such as caregiving. CONCLUSIONS: No study found LVADs to be cost effective for DT or BTT with base case assumptions, although incremental cost-effectiveness ratios met thresholds for cost effectiveness in some probabilistic analyses. With constant improvements in LVADs and expanding indications, understanding and re-evaluating the cost effectiveness of their use will be critical to making treatment decisions.

Health Economic Evaluation Modeling Shows Potential Health Care Cost Savings with Increased Conformance with Healthy Dietary Patterns among Adults in the United States.

BACKGROUND: Many American adults have one or more chronic diseases related to a poor diet, resulting in significant direct and indirect economic impacts. The 2015-2020 Dietary Guidelines for Americans (DGA) recognized that dietary patterns may be more relevant for predicting health outcomes compared with individual diet elements and recommended three healthy patterns based on evidence of favorable associations with many chronic disease risk factors and outcomes. Health economic assessments provide a model to estimate the potential influence on costs associated with changes in chronic disease risk resulting from improved diet quality in the US adult population. OBJECTIVE: To estimate the impact on health care costs associated with increased conformance with the three healthy patterns recommended in the 2015-2020 DGA, including the Healthy US-Style, the Healthy Mediterranean-Style, and the Healthy Vegetarian eating patterns. METHODS: Recent moderate- to high-quality meta-analyses of health outcomes associated with increased conformance with the Healthy US-Style eating pattern as measured by the Healthy Eating Index (HEI) or the Healthy Mediterranean-Style eating pattern measured by a Mediterranean diet score (MED) were identified. Given the lack of quantification of the association between an increased conformance with a vegetarian pattern and health outcomes, the analysis was limited to studies that evaluated Healthy US-style and Healthy Mediterranean-style eating patterns. The 2013-2014 What We Eat in America data provided estimates of conformance with these two eating patterns using the HEI-2015 and the 9-point MED among the US adult population. Risk estimates quantifying the association between eating patterns and health outcomes were combined with the eating pattern score increase under two conformance scenarios: increasing the average HEI-2015 and MED by 20% and increasing the average HEI-2015 and MED to achieve 80% of complete conformance. The resulting change in risk was combined with published data on annual health care and indirect costs, inflated to 2017 US dollars to estimate cost. To address double counting, costs were adjusted to minimize potential overlap of comorbidities. RESULTS: Overall modeled cost savings were $16.7 billion (range=$6.7 billion to $25.4 billion) to $31.5 billion (range=$23.9 billion to $38.9 billion) based on a 20% increase in the MED and HEI-2015, respectively, resulting from reductions in cardiovascular disease, cancer, and type 2 diabetes for both patterns and including Alzheimer's disease and hip fractures for the MED. In the case that diet quality of US adults were to improve to achieve 80% of the maximum MED and HEI-2015, cost savings were estimated at $88.2 billion (range=$35.7 billion to $133 billion) and $55.1 billion (range=$41.8 billion to $68.2 billion), respectively. CONCLUSIONS: This is the first study quantifying savings from all health outcomes identified to be associated with the HEI and the MED to assess conformance with two eating patterns recommended as part of the 2015-2020 DGA. Findings from this study suggest that increasing conformance with healthy eating patterns among US adults could reduce costs, with billions of dollars in potential savings.

Effect of battery longevity on costs and health outcomes associated with cardiac implantable electronic devices: a Markov model-based Monte Carlo simulation.

INTRODUCTION: The effects of device and patient characteristics on health and economic outcomes in patients with cardiac implantable electronic devices (CIEDs) are unclear. Modeling can estimate costs and outcomes for patients with CIEDs under a variety of scenarios, varying battery longevity, comorbidities, and care settings. The objective of this analysis was to compare changes in patient outcomes and payer costs attributable to increases in battery life of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). METHODS AND RESULTS: We developed a Monte Carlo Markov model simulation to follow patients through primary implant, postoperative maintenance, generator replacement, and revision states. Patients were simulated in 3-month increments for 15 years or until death. Key variables included Charlson Comorbidity Index, CIED type, legacy versus extended battery longevity, mortality rates (procedure and all-cause), infection and non-infectious complication rates, and care settings. Costs included procedure-related (facility and professional), maintenance, and infections and non-infectious complications, all derived from Medicare data (2004-2014, 5% sample). Outcomes included counts of battery replacements, revisions, infections and non-infectious complications, and discounted (3%) costs and life years. An increase in battery longevity in ICDs yielded reductions in numbers of revisions (by 23%), battery changes (by 44%), infections (by 23%), non-infectious complications (by 10%), and total costs per patient (by 9%). Analogous reductions for CRT-Ds were 23% (revisions), 32% (battery changes), 22% (infections), 8% (complications), and 10% (costs). CONCLUSION: Based on modeling results, as battery longevity increases, patients experience fewer adverse outcomes and healthcare costs are reduced. Understanding the magnitude of the cost benefit of extended battery life can inform budgeting and planning decisions by healthcare providers and insurers.

Costs of Providing Infusion Therapy for Rheumatoid Arthritis in a Hospital-based Infusion Center Setting.

PURPOSE: Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA. METHODS: A spreadsheet-based model was developed. Inputs included hourly wages, time spent providing care, supply/overhead costs, laboratory testing, infusion center size, and practice pattern information. Base-case values were derived from data from surveys, published studies, standard cost sources, and expert opinion. Costs are presented in year-2017 US dollars. The base case modeled a hospital infusion center serving patients with RA treated with abatacept, tocilizumab, infliximab, or rituximab. FINDINGS: Estimated overall costs of infusions per patient per year were $36,663 (rituximab), $36,821 (tocilizumab), $44,973 (infliximab), and $46,532 (abatacept). Of all therapies, the biologic agents represented the greatest share of overall costs, ranging from 87% to $91% of overall costs per year. Excluding infusion drug costs, labor accounted for 53% to 57% of infusion costs. IMPLICATIONS: Biologic agents represented the highest single cost associated with RA infusion care; however, personnel, supplies, and overhead costs also contributed substantially to overall costs (8%-16%). This model may provide a helpful and adaptable framework for use by hospitals in informing decision making about services offered and their associated financial implications.

Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System.

Heart failure (HF) is a leading cause of cardiovascular mortality in the United States and presents a substantial economic burden. A recently approved implantable wireless pulmonary artery pressure remote monitor, the CardioMEMS HF System, has been shown to be effective in reducing hospitalizations among New York Heart Association (NYHA) class III HF patients. The objective of this study was to estimate the cost-effectiveness of this remote monitoring technology compared to standard of care treatment for HF. A Markov cohort model relying on the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) clinical trial for mortality and hospitalization data, published sources for cost data, and a mix of CHAMPION data and published sources for utility data, was developed. The model compares outcomes over 5 years for implanted vs standard of care patients, allowing patients to accrue costs and utilities while they remain alive. Sensitivity analyses explored uncertainty in input parameters. The CardioMEMS HF System was found to be cost-effective, with an incremental cost-effectiveness ratio of $44,832 per quality-adjusted life year (QALY). Sensitivity analysis found the model was sensitive to the device cost and to whether mortality benefits were sustained, although there were no scenarios in which the cost/QALY exceeded $100,000. Compared with standard of care, the CardioMEMS HF System was cost-effective when leveraging trial data to populate the model.

An updated estimate of costs of endophthalmitis following cataract surgery among Medicare patients: 2010-2014.

BACKGROUND: Endophthalmitis, which can occur after ophthalmic surgery, is an inflammation of the intraocular cavity and causes temporary or permanent vision impairment. However, little is known about the cost of treatment. The objective of this analysis was to update and expand upon the results of a previously published report that estimated the direct medical cost of treatment for endophthalmitis. METHODS: Retrospective data analysis using 2010 through 2014 United States Medicare Limited Data Sets. Procedure codes were used to identify beneficiaries who underwent cataract surgery; demographic and clinical characteristics at the time of diagnosis were determined. Patients were stratified into cases (those who developed endophthalmitis) and controls (those who did not develop endophthalmitis) in the 3 months following surgery. Claims (ie, charges) and reimbursements (ie, costs) for cases and controls in the 6 months following cataract surgery were identified and compared. Results are presented in 2015 US dollars. RESULTS: Of a total of 153,860 cataract surgery patients, 181 were diagnosed with endophthalmitis following cataract surgery, at a rate of 1.2 per 1,000. Cases were more likely to be male and less likely to be white than controls; age was similar. Total medical claims and reimbursements as well as ophthalmic claims and reimbursements were significantly higher for cases compared with controls. Total reimbursements, adjusted for age, sex, and region, were $4,893 higher (83% greater) and adjusted ophthalmic reimbursements were $3,002 higher (156% greater) for cases than for controls. Claims and reimbursements were significantly higher across all types of Medicare cost components. CONCLUSION: Postcataract surgery endophthalmitis is associated with a substantial cost. Successful prophylaxis with antibiotic agents would reduce the significant costs associated with treating endophthalmitis.

A novel cost-effectiveness model of prescription eicosapentaenoic acid extrapolated to secondary prevention of cardiovascular diseases in the United States.

OBJECTIVE: Given the substantial economic and health burden of cardiovascular disease and the residual cardiovascular risk that remains despite statin therapy, adjunctive therapies are needed. The purpose of this model was to estimate the cost-effectiveness of high-purity prescription eicosapentaenoic acid (EPA) omega-3 fatty acid intervention in secondary prevention of cardiovascular diseases in statin-treated patient populations extrapolated to the US. METHODS: The deterministic model utilized inputs for cardiovascular events, costs, and utilities from published sources. Expert opinion was used when assumptions were required. The model takes the perspective of a US commercial, third-party payer with costs presented in 2014 US dollars. The model extends to 5 years and applies a 3% discount rate to costs and benefits. Sensitivity analyses were conducted to explore the influence of various input parameters on costs and outcomes. RESULTS: Using base case parameters, EPA-plus-statin therapy compared with statin monotherapy resulted in cost savings (total 5-year costs $29,393 vs $30,587 per person, respectively) and improved utilities (average 3.627 vs 3.575, respectively). The results were not sensitive to multiple variations in model inputs and consistently identified EPA-plus-statin therapy to be the economically dominant strategy, with both lower costs and better patient utilities over the modeled 5-year period. LIMITATIONS: The model is only an approximation of reality and does not capture all complexities of a real-world scenario without further inputs from ongoing trials. The model may under-estimate the cost-effectiveness of EPA-plus-statin therapy because it allows only a single event per patient. CONCLUSION: This novel model suggests that combining EPA with statin therapy for secondary prevention of cardiovascular disease in the US may be a cost-saving and more compelling intervention than statin monotherapy.

Estimated hospital costs associated with preventable health care-associated infections if health care antiseptic products were unavailable.

OBJECTIVES: Health care-associated infections (HAIs) pose a significant health care and cost burden. This study estimates annual HAI hospital costs in the US avoided through use of health care antiseptics (health care personnel hand washes and rubs; surgical hand scrubs and rubs; patient preoperative and preinjection skin preparations). METHODS: A spreadsheet model was developed with base case inputs derived from the published literature, supplemented with assumptions when data were insufficient. Five HAIs of interest were identified: catheter-associated urinary tract infections, central line-associated bloodstream infections, gastrointestinal infections caused by Clostridium difficile, hospital- or ventilator-associated pneumonia, and surgical site infections. A national estimate of the annual potential lost benefits from elimination of these products is calculated based on the number of HAIs, the proportion of HAIs that are preventable, the proportion of preventable HAIs associated with health care antiseptics, and HAI hospital costs. The model is designed to be user friendly and to allow assumptions about prevention across all infections to vary or stay the same. Sensitivity analyses provide low- and high-end estimates of costs avoided. RESULTS: Low- and high-end estimates of national, annual HAIs in hospitals avoided through use of health care antiseptics are 12,100 and 223,000, respectively, with associated hospital costs avoided of US$142 million and US$4.25 billion, respectively. CONCLUSION: The model presents a novel approach to estimating the economic impact of health care antiseptic use for HAI avoidance, with the ability to vary model parameters to reflect specific scenarios. While not all HAIs are avoidable, removing or limiting access to an effective preventive tool would have a substantial impact on patient well-being and infection costs. HAI avoidance through use of health care antiseptics has a demonstrable and substantial impact on health care expenditures; the costs here are exclusive of administrative penalties or long-term outcomes for patients and caregivers such as lost productivity or indirect costs.

Treatment costs of cystoid macular edema among patients following cataract surgery.

PURPOSE: The current costs of treating cystoid macular edema (CME), a complication that can follow cataract surgery, are largely unknown. This analysis estimates the treatment costs for CME based on the recently released US Medicare data. SETTING: Nationally representative database. DESIGN: Retrospective analysis of the 2011 through 2013 Medicare 5% Beneficiary Encrypted Files. METHODS: Beneficiaries who underwent cataract surgery were identified and stratified by diagnosis of CME (cases) or no diagnosis of CME (controls) within 6 months following surgery. Claims and reimbursements for ophthalmic care were identified. Subgroup analyses explored the rates of CME in beneficiaries based on the presence of selected comorbidities and by the type of procedure (standard vs complex). Total Medicare and ophthalmic costs for cases and controls are presented. The analysis explored the effect of considering diabetic macular edema (DME) and macular edema (ME) as exclusion criteria. RESULTS: Of 78,949 beneficiaries with cataract surgery, 2.54% (n=2,003) were diagnosed with CME. One-third of beneficiaries had one or more conditions affecting retinal health (including diabetes), 4.5% of whom developed CME. The rate of CME, at 22.5%, was much higher for those patients with preoperative DME or ME. Ophthalmic charges were almost twice as high for cases compared with controls (US$10,410 vs $5,950); payments averaged 85% higher ($2,720 vs $1,470) (both P<0.0001). CONCLUSION: Substantial costs can be associated with CME; beneficiaries whose retinas are already compromised before cataract surgery face higher risk. Cost savings could be realized with the use of therapies that reduce the risk of developing CME. Future analyses could identify whether and to what extent comorbidities influence costs.

Cost-Effectiveness Models in Age-Related Macular Degeneration: Issues and Challenges.

Age-related macular degeneration (AMD) is a common ophthalmic condition that can have few symptoms in its early stage but can progress to major visual impairment. While there are no treatments for early-stage AMD, there are multiple modalities of treatment for advanced disease. Given the increasing prevalence of the disease, there are dozens of analyses of cost effectiveness of AMD treatments, but methods and approaches vary broadly. The goal of this review was to identify, characterize, and critique published models in AMD and provide guidance for their interpretation. After a literature review was performed to identify studies, and exclusion criteria applied to limit the review to studies comparing treatments for AMD, we compared methods across the 36 studies meeting the review criteria. To some extent, variation was related to targeting different audiences or acknowledging the most appropriate population for a given treatment. However, the review identified potential areas of uncertainty and difficulty in interpretation, particularly regarding duration of observation periods and the importance of visual acuity as an endpoint or a proxy for patient-reported utilities. We urge thoughtful consideration of these study characteristics when comparing results.

Adjunctive therapy patterns in glaucoma patients using prostaglandin analogs.

PURPOSE: To analyze patterns of use of adjunctive therapies among new initiators of topical prostaglandin analogs (PGAs) in a managed care population. METHODS: The study cohort included patients in a claims database who initiated PGA therapy between June 2007 and April 2011. Patients who had one or more adjunctive therapy prescriptions during 24 months of follow-up were included. Patterns of adjunctive therapy use were identified and compared between patients who had one or two fills of the initial adjunctive therapy and those who had three or more. RESULTS: There were 16,486 eligible beneficiaries. Of these, 5,933 (36%) had one or more adjunctive therapies within 24 months from the start of the PGA, 82% of whom started adjunctive therapy within 12 months. About 28% of patients started adjunctive therapy with a fixed-combination product; 45% of these patients started within the first 30 days. Overall, a large number of patients (42%) required adjunctive therapy within 30 days. Twenty-five percent of patients had only one or two prescriptions of their initial adjunctive therapy; of these patients, 74% discontinued adjunctive therapy altogether. CONCLUSION: Approximately 30% of patients starting glaucoma therapy will require adjunctive therapy within 1 year, and many receive a fixed-combination product as initial adjunctive therapy shortly after starting glaucoma therapy. This suggests a prescribing trend toward earlier, more aggressive drug therapy to control pressure and minimize disease progression. We found that compliance with adjunctive therapy continues to be a problem for patients, which could be attributed to a number of treatment burden and economic factors.

Perioperative outcomes, complications, and costs associated with lumbar spinal fusion in older patients with spinal stenosis and spondylolisthesis.

OBJECT: The purpose of this study was to quantify the perioperative outcomes, complications, and costs associated with posterolateral spinal fusion (PSF) among Medicare enrollees with lumbar spinal stenosis (LSS) and/or spondylolisthesis by using a national Medicare claims database. METHODS: A 5% systematic sample of Medicare claims data (2005-2009) was used to identify outcomes in patients who had undergone PSF for a diagnosis of LSS and/or spondylolisthesis. Patients eligible for study inclusion also required a minimum of 2 years of follow-up and a claim history of at least 12 months prior to surgery. RESULTS: A final cohort of 1672 patients was eligible for analysis. Approximately half (50.7%) had LSS only, 10.2% had spondylolisthesis only, and 39.1% had both LSS and spondylolisthesis. The average age was 71.4 years, and the average length of stay was 4.6 days. At 3 months and 1 and 2 years postoperatively, the incidence of spine reoperation was 10.9%, 13.3%, and 16.9%, respectively, whereas readmissions for complications occurred in 11.1%, 17.5%, and 24.9% of cases, respectively. At 2 years postoperatively, 36.2% of patients had either undergone spine reoperation and/or received an epidural injection. The average Medicare payment was $36,230 ± $17,020, $46,840 ± $31,350, and $61,610 ± $46,580 at 3 months, 1 year, and 2 years after surgery, respectively. CONCLUSIONS: The data showed that 1 in 6 elderly patients treated with PSF for LSS or spondylolisthesis underwent reoperation on the spine within 2 years of surgery, and nearly 1 in 4 patients was readmitted for a surgery-related complication. These data highlight several potential areas in which improvements may be made in the effective delivery and cost of surgical care for patients with spinal stenosis and spondylolisthesis.

Cost savings of reduced constipation rates attributed to increased dietary fiber intakes: a decision-analytic model.

BACKGROUND: Nearly five percent of Americans suffer from functional constipation, many of whom may benefit from increasing dietary fiber consumption. The annual constipation-related healthcare cost savings associated with increasing intakes may be considerable but have not been examined previously. The objective of the present study was to estimate the economic impact of increased dietary fiber consumption on direct medical costs associated with constipation. METHODS: Literature searches were conducted to identify nationally representative input parameters for the U.S. population, which included prevalence of functional constipation; current dietary fiber intakes; proportion of the population meeting recommended intakes; and the percentage that would be expected to respond, in terms of alleviation of constipation, to a change in dietary fiber consumption. A dose-response analysis of published data was conducted to estimate the percent reduction in constipation prevalence per 1 g/day increase in dietary fiber intake. Annual direct medical costs for constipation were derived from the literature and updated to U.S. $ 2012. Sensitivity analyses explored the impact on adult vs. pediatric populations and the robustness of the model to each input parameter. RESULTS: The base case direct medical cost-savings was $12.7 billion annually among adults. The base case assumed that 3% of men and 6% of women currently met recommended dietary fiber intakes; each 1 g/day increase in dietary fiber intake would lead to a reduction of 1.9% in constipation prevalence; and all adults would increase their dietary fiber intake to recommended levels (mean increase of 9 g/day). Sensitivity analyses, which explored numerous alternatives, found that even if only 50% of the adult population increased dietary fiber intake by 3 g/day, annual medical costs savings exceeded $2 billion. All plausible scenarios resulted in cost savings of at least $1 billion. CONCLUSIONS: Increasing dietary fiber consumption is associated with considerable cost savings, potentially exceeding $12 billion, which is a conservative estimate given the exclusion of lost productivity costs in the model. The finding that $12.7 billion in direct medical costs of constipation could be averted through simple, realistic changes in dietary practices is promising and highlights the need for strategies to increase dietary fiber intakes.

Comparative cost effectiveness of Coflex® interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis.

INTRODUCTION: Symptomatic chronic low back and leg pain resulting from lumbar spinal stenosis is expensive to treat and manage. A randomized, controlled, multicenter US Food and Drug Administration Investigational Device Exemption clinical trial assessed treatment-related patient outcomes comparing the Coflex® Interlaminar Stabilization Device, an interlaminar stabilization implant inserted following decompressive surgical laminotomy in the lumbar spine, to instrumented posterolateral fusion among patients with moderate to severe spinal stenosis. This study uses patient-reported outcomes and clinical events from the trial along with costs and expected resource utilization to determine cost effectiveness. METHODS: A decision-analytic model compared outcomes over 5 years. Clinical input parameters were derived from the trial. Oswestry Disability Index scores were converted to utilities. Treatment patterns over 5 years were estimated based on claims analyses and expert opinion. A third-party payer perspective was used; costs (in $US 2013) and outcomes were discounted at 3% annually. Sensitivity analyses examined the influence of key parameters. Analyses were conducted using Medicare payment rates and typical commercial reimbursements. RESULTS: Five-year costs were lower for patients implanted with Coflex compared to those undergoing fusion. Average Medicare payments over 5 years were estimated at $15,182 for Coflex compared to $26,863 for the fusion control, a difference of $11,681. Mean quality-adjusted life years were higher for Coflex patients compared to controls (3.02 vs 2.97). Results indicate that patients implanted with the Coflex device derive more utility, on average, than those treated with fusion, but at substantially lower costs. The cost advantage was greater when evaluating commercial insurance payments. Subgroup analyses found that the cost advantage for Coflex relative to fusion was even larger for two-level procedures compared to one-level procedures. CONCLUSION: The Coflex Interlaminar Stabilization Device was found to be cost effective compared to instrumented posterolateral fusion for treatment of lumbar spinal stenosis. It provided higher utility at substantially lower cost.