Validation of an International Classification of Disease, 10th revision coding adaptation for the Charlson Comorbidity Index in United States healthcare claims data.

PURPOSE: An International Classification of Disease (ICD-10) Charlson Comorbidity Index (CCI) adaptation had not been previously developed and validated for United States (US) healthcare claims data. Many researchers use the Canadian adaption by Quan et al (2005), not validated in US data. We sought to evaluate the predictive validity of a US ICD-10 CCI adaptation in US claims and compare it with the Canadian standard. METHODS: Diverse patient cohorts (rheumatoid arthritis, hip/knee replacement, lumbar spine surgery, acute myocardial infarction [AMI], stroke, pneumonia) in the IBM® MarketScan® Research Databases were linked with the IBM MarketScan Mortality file. Predictive performance was measured using c-statistics for binary outcomes (1-year and postoperative mortality, in-hospital complications) and root mean square prediction error (RMSE) for continuous outcomes (1-year all-cause medical costs, index hospitalization costs, length of stay [LOS]), after adjusting for age and sex. C-statistics were compared by the method of DeLong and colleagues (1988); RMSEs, by resampling. RESULTS: C-statistics were generally high (≥ ~ 0.8) for mortality but lower for in-hospital complications (~0.6-0.7). RMSEs for costs and hospitalization LOS were relatively large and comparable to standard deviations. Results were similar overall between the US and Canadian adaptations, with relative differences typically <1%. CONCLUSIONS: This US-based coding adaptation and a previously published Canadian adaptation resulted in similar predictive ability for all outcomes evaluated but may have different construct validity (not evaluated in our study). We recommend using adaptations specific to the country of data origin based on good research practice.

Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States.

OBJECTIVE: Real-world data on patients with cancer developing secondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are lacking. This study assessed the incidence and impact of select DNA-damaging therapy exposure on risk of secondary MDS and AML in patients with ovarian cancer (OC) or breast cancer (BC). METHODS: Adults with a first observed OC or BC diagnosis (index date) between 1/1/2000 and 6/30/2014 were identified from MarketScan® Commercial and Medicare databases. Patients had ≥12 months of pre-index and ≥1 month of post-index continuous health plan enrollment. Incidence of MDS/AML was evaluated over a variable-length period following the index date for each cancer cohort. Risk factors for secondary MDS/AML, including duration of DNA-damaging therapy exposure, were assessed using Poisson regression. RESULTS: Study selection criteria identified 23,862 patients with OC and 281,473 patients with BC (mean [SD] follow-up: 35.8 [31.4] and 46.0 [37.2] months, respectively). Incidence of MDS/AML was 2.77 and 1.44 per 1000 person-years among patients with OC and BC, respectively. Within both cohorts, incidence of MDS and AML was higher among patients exposed than those not exposed to select DNA-damaging therapy (alkylating agents, antimetabolites, platinum-based antineoplastic agents, and topoisomerase inhibitors). Duration of exposure to DNA-damaging therapy was a significant risk factor for developing MDS/AML during follow-up. CONCLUSIONS: Data suggest that there is likely a background risk of secondary MDS/AML associated with use of DNA-damaging therapies in earlier lines of chemotherapy and it is elevated in subcohorts exposed to select DNA-damaging therapies.

Respiratory Syncytial Virus Hospitalizations among U.S. Preterm Infants Compared with Term Infants Before and After the 2014 American Academy of Pediatrics Guidance on Immunoprophylaxis: 2012-2016.

OBJECTIVE: The objective of this study was to compare risk for respiratory syncytial virus (RSV) hospitalizations (RSVH) for preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after 2014 guidance changes for immunoprophylaxis (IP), using data from the 2012 to 2016 RSV seasons. STUDY DESIGN: Using commercial and Medicaid claims databases, infants born between July 1, 2011 and June 30, 2016 were categorized as preterm or term. RSVH during the RSV season (November-March) were identified for infants aged <6 months and rate ratios (RRs) for hospitalization comparing preterm and term infants were calculated. Difference-in-difference models were fit to evaluate the changes in hospitalization risks in preterm versus term infants from 2012 to 2014 seasons to 2014 to 2016 seasons. RESULTS: In all seasons, preterm infants had higher RSVH rates than term infants. Seasonal RRs prior to the guidance change for preterm wGA categories versus term infants ranged from 1.6 to 3.4. After the guidance change, the seasonal RRs ranged from 2.6 to 5.6. In 2014 to 2016, the risk associated with prematurity of 29 to 34 wGA versus term was significantly higher than in 2012 to 2014 (P<0.0001 for commercial and Medicaid samples). CONCLUSION: In infants aged <6 months, the risk for RSVH for infants 29 to 34 wGA compared with term infants increased significantly after the RSV IP recommendations became more restrictive.

Annual incidence rates of herpes zoster among an immunocompetent population in the United States.

BACKGROUND: Herpes zoster (HZ), also known as shingles, is a painful and commonly occurring condition in the United States. In spite of a universally recommended vaccine for use in immunocompetent adults aged 60 years and older, HZ continues to impact the American public, and a better understanding of its current incidence is needed. The objective of the current study is to estimate the overall and age- and gender-specific incidence rates (IRs) of HZ among an immunocompetent US population in 2011 following availability of a vaccine. METHODS: Claims data from the Truven Health MarketScan® Research databases between 01/01/2011 and 12/31/2011 were extracted. Immunocompetent adult patients, enrolled as of January 1, 2011 were analyzed. The denominator was defined as eligible subjects who were immunocompetent, had no evidence of zoster vaccination, and no diagnosis of HZ (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 053.xx) in the 90 days prior to January 1, 2011. Subjects contributed person-days to the denominator until the occurrence of one of the following events: end of continuous enrollment in the database, a claim for zoster vaccination, diagnosis of HZ or end of the observation period (December 31, 2011). The numerator was defined as enrollees within the denominator file exhibiting evidence of HZ. Annual IRs were calculated for the entire population in the database as well as by gender and age group; standardized IRs were also produced using the 2010 US Census data. RESULTS: The overall annual IR of HZ across all ages was 4.47 per 1000 person-years (95% confidence interval [CI]: 4.44-4.50) which monotonically increased with age from 0.86 (95% CI: 0.84-0.88) for those aged ≤ 19 to 12.78 (95% CI: 12.49-13.07) for patients ≥ 80 years. The IR was 8.46 (95% CI: 8.39-8.52) among adults ≥ 50 years and 10.46 (95% CI: 10.35-10.56) among those aged ≥ 60 years. Women compared to men had higher HZ incidence (5.25, 95% CI: 5.21-5.29 vs. 3.66, 95% CI: 3.62-3.69) and this was seen across all age groups. When adjusted for age and gender using 2010 US Census data, the annual IR was 4.63 per 1000 person-years (95% CI: 4.61-4.66). CONCLUSIONS: Despite the availability of a vaccine, HZ remains common among immunocompetent adults in the US with incidence rates of HZ observed to increase with age and be higher in women than men.

Medication utilization patterns among type 2 diabetes patients initiating Exenatide BID or insulin glargine: a retrospective database study.

BACKGROUND: Type 2 diabetes is a common and costly illness, associated with significant morbidity and mortality. Despite this, there is relatively little information on the 'real-world' medication utilization patterns for patients with type 2 diabetes initiating exenatide BID or glargine. The objective of this study was to evaluate the 'real-world' medication utilization patterns in patients with type 2 diabetes treated with exenatide BID (exenatide) versus insulin glargine (glargine). METHODS: Adult patients( ≥18 years of age) with type 2 diabetes who were new initiators of exenatide or glargine from October 1, 2006 through March 31, 2008 with continuous enrollment for the 12 months pre- and 18 months post-index period were selected from the MarketScan® Commercial and Medicare Databases. To control for selection bias, propensity score matching was used to complete a 1:1 match of glargine to exenatide patients. Key study outcomes (including the likelihood of overall treatment modification, discontinuation, switching, or intensification) were analyzed using survival analysis. RESULTS: A total of 9,197 exenatide- and 4,499 glargine-treated patients were selected. Propensity score matching resulted in 3,774 matched pairs with a mean age of 57 years and a mean Deyo Charlson Comorbidity Index score of 1.6; 54% of patients were males. The 18-month treatment intensification rates were 15.9% and 26.0% (p < 0.0001) and the discontinuation rates were 38.3% and 40.0% (p = 0.14) for exenatide and glargine, respectively. Alternatively, 14.9% of exenatide-treated patients switched therapies, compared to 10.0% of glargine-treated patients (p < 0.0001). Overall, glargine-treated patients were more likely to modify their treatment [hazard ratio (HR) = 1.33, p < 0.0001] with shorter mean time on treatment until modification (123 vs. 159 days, p < 0.0001). Compared to exenatide-treated patients, glargine-treated patients were more likely to discontinue [hazard ratio (HR) = 1.25, p < 0.0001] or intensify therapy (HR = 1.72, p < 0.0001) but less likely to switch (HR = 0.71, p < 0.0001) the index therapy. CONCLUSIONS: Patients treated for type 2 diabetes with exenatide BID or insulin glargine differ in their adherence to therapy. Exenatide-treated patients were less likely to discontinue or modify treatment but more likely to switch therapy compared to glargine-treated patients.

Trends in dual-energy X-ray absorptiometry in the United States, 2000-2009.

After a decade of policies encouraging dual-energy X-ray absorptiometry (DXA) use, Medicare incrementally decreased reimbursement for non-facility-based DXAs, effective 2007. This study quantifies trends in central DXA use before and after the reimbursement change. Using 2000-2009 claims data, we selected subjects aged 50+yr with Medicare supplemental or commercial insurance. The central site DXA test (using CPT codes) rate was calculated within each calendar quarter as the number of patients with a DXA test divided by the total number of patients. Piecewise linear regression was used to quantify change in DXA rates coincident with the 2007 reimbursement reductions. During 2000-2009, slightly over 5 million DXA tests were conducted. Annual rates for females with Medicare steadily increased until 2007, when they leveled off; a similar pattern was observed for the commercially insured. Regression modeling showed that pre-2007 rates increased annually by 0.76% (0.72-0.80) and 0.76% (0.70-0.82) among those with Medicare supplemental and commercial insurance, respectively, and over 2007-2009, rates changed annually by +0.07% (-0.05% to 0.19%) and -0.12% (-0.29% to 0.04%), respectively. During 2007-2009, there were 3.1 (2.4-3.8) and 4.0 (3.1-4.9) fewer tests per 100 person years for females with Medicare supplemental and commercial insurance, respectively, than would have been expected based on the pre-2007 trend. The post-2007 DXA rate was lower than what would have been expected had the observed trend of increasing annual DXA rates from 2000 to 2007 continued unabated beyond the Medicare reimbursement change in 2007. Continuing to provide access to DXA testing for women at increased risk of osteoporosis is important to providing high-quality care for metabolic bone disease in the United States.

Absenteeism and Indirect Economic Burden Associated With Primary and Secondary Hypogonadism: A Retrospective Matched Cohort Analysis of Employed, Commercially Insured Patients in the U.S.

OBJECTIVE: The aim of this study was to evaluate the indirect economic burden incurred by patients with primary and secondary hypogonadism (HG) compared with non-HG controls using real-world data. METHODS: In this retrospective cohort study using a large US administrative claims database, adult males with primary or secondary HG were selected from 2010 to 2014. Non-HG controls had no evidence of HG from 2009 to 2014 and were matched on age, insurance type, and geographic region to HG patients. Outcomes included absenteeism and associated costs. RESULTS: HG (vs non-HG) patients had a significant 15% increase in nonrecreational absenteeism hours (adjusted odds ratio 1.15, P = 0.002) and associated costs ($2152 vs $1172, P < 0.001) post-index after adjusting for pre-period differences. CONCLUSION: The indirect economic burden of HG is significant. Further research is needed to test whether treatment with testosterone can help alleviate the indirect burden associated with HG.

Return on Investment for a Payer-Provider Partnership to Improve Care Management of Employees and Early Retirees.

OBJECTIVE: A large employer partnered with local health care providers to pilot test an intensive nurse care manager program for employees and retirees. We evaluated its impact on health care utilization and costs. METHODS: A database was developed containing 2011 to 2015 health care enrollment and claims data for 2914 patients linked to their nurse care manager data. We used a difference-in-difference design to compare health care costs and utilization of members recruited for the pilot program and a propensity-score-matched comparison group. RESULTS: We found statistically significant reductions in doctors' office visits and prescription drug costs. A return-on-investment analysis determined that the program saved $0.83 for every dollar spent over the 2-year pilot study period. CONCLUSIONS: Employer-driven care management programs can succeed at reducing utilization, although they may not achieve cost neutrality in the short run.

Treatment Patterns and Associated Health Care Costs Before and After Treatment Initiation Among Pulmonary Arterial Hypertension Patients in the United States.

BACKGROUND: Despite multiple treatment options, the prognosis of pulmonary arterial hypertension (PAH) remains poor. PAH patients experience a high economic burden due to comorbidities, hospitalizations, and medication costs. Although combination therapy has been shown to reduce hospitalizations, the relationship between treatment, health care utilization, and costs remains unclear. OBJECTIVE: To provide a characterization of health care utilization and costs in real-world settings by comparing periods before and after initiating PAH-specific treatment. METHODS: This retrospective study identified PAH patients in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2010 and 2014 who initiated treatment with endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE-5Is), or soluble guanylate cyclase (sGC) stimulators. The index date was the date of the first PAH pharmacy claim. We included patients with ≥ 2 medical claims with diagnoses for PAH (ICD-9-CM: 416.0, 416.8) or PAH-related conditions and continuous enrollment in medical and pharmacy benefits for the 6 months before and after the index date. Treatment patterns were assessed at the drug class level (ERAs, PDE-5Is, sGC stimulators, and prostacyclins) from outpatient pharmacy claims during the 6-month post-index period. All-cause and PAH-related utilization and costs were measured. McNemar's and paired t-tests were used to compare patients' health care resource utilization and costs in the 6-month pre- and posttreatment periods. RESULTS: A total of 3,908 patients met the selection criteria. The study sample was 63% female with a mean age of 63 ± 15 years. Only 5% of patients began initial combination therapy for PAH, defined as claims for ≥ 2 medication classes within the first 30 days of treatment. Treatment interruption (≥ 30-day gap in days supply) of any PAH-specific medication was observed in 38% of patients. Compared with the 6-month pre-index period, the proportion of patients in the 6-month post-index period with any inpatient admission decreased, 42% versus 30% (P < 0.001). In addition, PAH-related inpatient admissions decreased in the 6-month post-index period from 7% to 3% (P < 0.001). After treatment initiation, patients' nonpharmacy medical costs decreased from $48,200 (SD = $117,686) to $33,962 (SD = $90,294; P < 0.001), mainly attributable to reduced inpatient costs. However, total average medical costs including pharmacy costs remained comparable after treatment initiation (pre-index period = $51,455 vs. post-index period = $53,923; P = 0.213). CONCLUSIONS: This study found that while patients' PAH-related pharmacy costs increased after treatment initiation, the increase was offset by reduced inpatient utilization; therefore, total health care costs remained constant. While the majority of patients in this study were treated with monotherapy, the recently completed AMBITION study indicated that initial combination therapy with ambrisentan plus tadalafil reduced PAH-related hospitalizations compared with initial monotherapy with either of these agents. Future cost analyses of patients treated with combination therapy will be required to determine the economic effect of initial combination therapy. DISCLOSURES: This study was sponsored and funded by Gilead Sciences. Ozbay is an employee of Gilead Sciences. At the time that this project and manuscript were developed, Lazarus was an employee of Gilead Sciences and may own stock/stock options. Riehle, Montejano, and Lenhart are employees of Truven Health Analytics, an IBM company, which received funding from Gilead Sciences to conduct this study. Burger and White do research with, and are paid consultants for, Gilead Sciences; they do not own equity and received no personal compensation for the work here. Burger also reports consultancy and advisory board work for Actelion Pharmaceuticals and grants from Gilead Sciences, Actelion Pharmaceuticals, Bayer, and United Therapeutics.

Association Between Glucocorticoid Exposure and Healthcare Expenditures for Potential Glucocorticoid-related Adverse Events in Patients with Rheumatoid Arthritis.

OBJECTIVE: Oral glucocorticoid (OGC) use for rheumatoid arthritis (RA) is debated because of the adverse event (AE) profile of OGC. We evaluated the associations between cumulative doses of OGC and potential OGC-related AE, and quantified the associated healthcare expenditures. METHODS: Using the MarketScan databases, patients ≥ 18 years old who have RA with continuous enrollment from January 1 to December 31, 2012 (baseline), and from January 1 to December 31, 2013 (evaluation period), were identified. Cumulative OGC dose was measured using prescription claims during the baseline period. Potential OGC-related AE (osteoporosis, fracture, aseptic necrosis of the bone, type 2 diabetes, ulcer/gastrointestinal bleeding, cataract, hospitalization for opportunistic infection, myocardial infarction, or stroke) and AE-related expenditures (2013 US$) were gathered during the evaluation period. Multivariable regression models were fitted to estimate OR of AE and incremental costs for patients with AE. RESULTS: There were 84,357 patients analyzed, of whom 48% used OGC during the baseline period and 26% had an AE during the evaluation period. A cumulative OGC dose > 1800 mg was associated with an increased risk of any AE compared with no OGC exposure (OR 1.19, 99.65% CI 1.09-1.30). Incremental costs per patient with any AE were significantly greater for cumulative OGC dose > 1800 mg compared with no OGC exposure (incremental cost = $3528, 99.65% CI $2402-$4793). CONCLUSION: Chronic exposure to low to medium doses of OGC was associated with significantly increased risk of potential OGC-related AE in patients with RA, and greater cumulative OGC dose was associated with substantially higher AE-related healthcare expenditures among patients with AE.

Cost effectiveness of imatinib mesylate in the treatment of advanced gastrointestinal stromal tumours.

BACKGROUND AND OBJECTIVE: Imatinib mesylate is the first effective therapy for advanced unresectable gastrointestinal stromal tumours (GIST). Adoption of this therapy in clinical practice is partly dependent on reimbursement by third-party payers in many countries. The objective of this study was to estimate the cost effectiveness of imatinib mesylate in the treatment of GIST. METHODS: A cost-effectiveness model of GIST treatment was developed. Long- term survival and duration of imatinib mesylate benefit were projected by fitting curves to 52-month follow-up data from a phase II clinical trial of imatinib and projecting weekly probabilities of survival and continued treatment over 10 years. Weekly cost estimates in 2005 US dollars included cost of imatinib mesylate 400 mg/day ($US685), other medical services for imatinib mesylate-treated patients ($US359) and palliative care for patients in the end stage of GIST ($US2575). Utility associated with successful treatment was estimated at 0.935 and that of treatment failure and progressive disease at 0.875. Costs, life-years and quality- adjusted life-years (QALYs) were calculated over the 10-year time horizon and discounted to treatment initiation at an annual rate of 3%. RESULTS: Imatinib mesylate therapy for unresectable GIST was projected to increase life expectancy to 5.8 years, an increase of 2.7 years over the control group. This translated into an increase of 1.9 QALYs at a marginal cost of $US74 369, yielding a cost-effectiveness ratio of $US38 723 per QALY. Cost effectiveness was not very sensitive to model parameters other than the cost of imatinib mesylate itself. CONCLUSION: The cost effectiveness of imatinib mesylate in the treatment of GIST is within the commonly accepted range for life-saving interventions, based on US data.

Patterns of initial pharmacotherapy for Parkinson's disease in the United States.

Data from a mix of employer- and government-funded health plans were used to investigate actual treatment patterns for patients initiating pharmacotherapy for Parkinson's disease in the United States. Treatment patterns evaluated included type of initial therapy and rates and types of adjunctive and substitute therapies. The study confirms that levodopa remains the most often prescribed initial treatment for Parkinson's disease regardless of age or drug benefit coverage. The widespread use of levodopa in young Parkinson's patients (<65 years) with private insurance may indicate that physicians are not overly concerned about or are not fully aware of the association of levodopa with long-term motor complications. It may also indicate that currently available alternatives to levodopa are not sufficiently effective or well tolerated.

The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis.

BACKGROUND: Consensus United States cervical cancer screening guidelines recommend use of combination Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years. An HPV test was approved by the Food and Drug Administration in 2014 for primary cervical cancer screening in women age 25 years and older. Here, we present the results of clinical-economic comparisons of Pap plus HPV mRNA testing including genotyping for HPV 16/18 (co-testing) versus DNA-based primary HPV testing with HPV 16/18 genotyping and reflex cytology (HPV primary) for cervical cancer screening. METHODS: A health state transition (Markov) model with 1-year cycling was developed using epidemiologic, clinical, and economic data from healthcare databases and published literature. A hypothetical cohort of one million women receiving triennial cervical cancer screening was simulated from ages 30 to 70 years. Screening strategies compared HPV primary to co-testing. Outcomes included total and incremental differences in costs, invasive cervical cancer (ICC) cases, ICC deaths, number of colposcopies, and quality-adjusted life years for cost-effectiveness calculations. Comprehensive sensitivity analyses were performed. RESULTS: In a simulation cohort of one million 30-year-old women modeled up to age 70 years, the model predicted that screening with HPV primary testing instead of co-testing could lead to as many as 2,141 more ICC cases and 2,041 more ICC deaths. In the simulation, co-testing demonstrated a greater number of lifetime quality-adjusted life years (22,334) and yielded $39.0 million in savings compared with HPV primary, thereby conferring greater effectiveness at lower cost. CONCLUSIONS: Model results demonstrate that co-testing has the potential to provide improved clinical and economic outcomes when compared with HPV primary. While actual cost and outcome data are evaluated, these findings are relevant to U.S. healthcare payers and women's health policy advocates seeking cost-effective cervical cancer screening technologies.

Development and Validation of an Algorithm to Identify Patients with Multiple Myeloma Using Administrative Claims Data.

PURPOSE: The objective was to expand on prior work by developing and validating a new algorithm to identify multiple myeloma (MM) patients in administrative claims. METHODS: Two files were constructed to select MM cases from MarketScan Oncology Electronic Medical Records (EMR) and controls from the MarketScan Primary Care EMR during January 1, 2000-March 31, 2014. Patients were linked to MarketScan claims databases, and files were merged. Eligible cases were age ≥18, had a diagnosis and visit for MM in the Oncology EMR, and were continuously enrolled in claims for ≥90 days preceding and ≥30 days after diagnosis. Controls were age ≥18, had ≥12 months of overlap in claims enrollment (observation period) in the Primary Care EMR and ≥1 claim with an ICD-9-CM diagnosis code of MM (203.0×) during that time. Controls were excluded if they had chemotherapy; stem cell transplant; or text documentation of MM in the EMR during the observation period. A split sample was used to develop and validate algorithms. A maximum of 180 days prior to and following each MM diagnosis was used to identify events in the diagnostic process. Of 20 algorithms explored, the baseline algorithm of 2 MM diagnoses and the 3 best performing were validated. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated. CONCLUSION: Three claims-based algorithms were validated with ~10% improvement in PPV (87-94%) over prior work (81%) and the baseline algorithm (76%) and can be considered for future research. Consistent with prior work, it was found that MM diagnoses before and after tests were needed.

Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden.

OBJECTIVE: The objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective. METHODS: An economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers - Boston Scientific Corporation, St. Jude Medical, and Medtronic - over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum. RESULTS: Base-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year's cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life. CONCLUSION: Extended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden.

Healthcare resource utilization and costs associated with herpes zoster in the US.

OBJECTIVES: To evaluate the economic burden of herpes zoster (HZ) on the US healthcare system among an immunocompetent population. METHODS: Claims data from the MarketScan Research databases for 2008-2011 were extracted to determine the incremental healthcare resource utilization (RU) and direct medical costs associated with HZ. Immunocompetent HZ-patients were identified and directly matched 1:1 with immunocompetent non-HZ controls using demographic and clinical variables. Analysis was limited to claims 21 days prior to through the first year following HZ diagnosis. Cases with post-herpetic neuralgia (PHN) were analyzed separately. RESULTS: A total of 98,916 HZ-patients were matched to controls. HZ-patients had a mean age of 50.4 (SD = 18.8) years and 56.6% were females. HZ-cases had significantly higher RU (0.016 inpatient visits, 0.153 ER visits, 2.116 outpatient office visits, and 3.730 other outpatient services) compared to controls (p < 0.001). Differences increased substantially in the presence of PHN. Total mean incremental healthcare costs for HZ-cases were $1308 and quadrupled to $5463 in those with PHN (both p < 0.001). Overall, primary cost drivers were outpatient prescriptions and other outpatient services. For those with PHN, inpatient services also played a significant role. LIMITATIONS: This study was limited to only those individuals with US commercial health coverage or private Medicare supplemental coverage; therefore, results of this analysis may not be generalizable to HZ patients outside of the US, with other health insurance or without coverage. CONCLUSIONS: HZ presents a significant economic and resource burden on the US healthcare system among immunocompetent patients of nearly all ages, particularly when complicated by PHN.

Intermediate Services After Behavioral Health Hospitalization: Effect on Rehospitalization and Emergency Department Visits.

OBJECTIVE: This study examined the effect of intermediate service use on behavioral health inpatient readmissions and subsequent emergency department (ED) visits among Medicaid enrollees. METHODS: Data were from fee-for-service inpatient admissions from the 2008 Medicaid Analytic eXtract files for adults with a primary diagnosis of a mental or substance use disorder. A multivariate survival analysis estimated the association between posthospital services-particularly intermediate services (residential, partial hospital, intensive outpatient, and other rehabilitative services)-and time to readmission or ED visit. A propensity score-matched sample was used to examine the relationship between time to readmission and ED visit in the nondisabled and disabled populations more closely. RESULTS: The sample included 32,037 adults (nondisabled, 27.6%; disabled, 72.4%). Only 2.5% of nondisabled adults and 5.4% of disabled adults used intermediate services within seven days of hospital discharge. In the multivariate analysis, significant associations were found between intermediate service use and readmissions and ED visits in the nondisabled population (hazard ratio [HR]=.71, p=.04, and HR=.68, p<.01, respectively), but not in the disabled population. Significant associations were also found between use of other health care in the seven-day posthospitalization period and decreased time to readmission and ED visits in the nondisabled population and increased time to readmission and ED visits in the disabled population. In the propensity score--matched analysis, use of intermediate services was not significant in either population. CONCLUSIONS: The low use of intermediate services may reflect limited availability as well as Medicaid coverage limits. Research is needed to determine the optimal number and type of intermediate services for this population to minimize the need for additional hospital services.

Cost-effectiveness of edoxaban versus rivaroxaban for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the US.

BACKGROUND: Understanding the value of new anticoagulation therapies compared with existing therapies is of paramount importance in today's cost-conscious and efficiency-driven health care environment. Edoxaban and rivaroxaban for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients with CHADS2 scores ≥2 have been evaluated in pivotal trials versus warfarin. The relative value of edoxaban versus rivaroxaban would be of interest to health care stakeholders and patients who prefer a once-daily treatment option for long-term stroke prevention in NVAF. OBJECTIVE: To evaluate the relative cost-effectiveness of two once-daily regimens of novel oral anticoagulation therapy - edoxaban (60 mg/30 mg dose-reduced) versus rivaroxaban (20 mg/15 mg dose-reduced) - for stroke prevention in NVAF patients from a US health-plan perspective. MATERIALS AND METHODS: A Markov model simulated lifetime risk and treatment of stroke, systemic embolism, major bleeding, clinically relevant nonmajor bleeding, myocardial infarction, and death in NVAF patients treated with edoxaban or rivaroxaban. Efficacy and safety data were derived from a network meta-analysis that utilized data from patients enrolled in ENGAGE AF-TIMI 48 and ROCKET-AF. Health care cost and utility data were obtained from published sources. Incremental cost-effectiveness ratios of $150,000 per quality-adjusted life year (QALY) gained were used as thresholds for "highly cost-effective", "cost-effective", and "not cost-effective" treatment options, respectively, as per American Heart Association/American College of Cardiology guidelines. RESULTS: Edoxaban was dominant relative to rivaroxaban, such that it was associated with lower total health care costs and better effectiveness in terms of QALYs in the base-case analysis. Results were supported by probabilistic sensitivity analyses that showed edoxaban as either dominant or a highly cost-effective alternative (incremental cost-effectiveness ratio <$50,000) to rivaroxaban in 88.4% of 10,000 simulations. CONCLUSION: Results of this study showed that the once-daily edoxaban (60 mg/30 mg dose-reduced) regimen is a cost-saving or highly cost-effective treatment relative to rivaroxaban (20 mg/15 mg dose-reduced) for stroke prevention in NVAF patients with CHADS2 ≥2.

Comparison of direct and indirect costs of abnormal uterine bleeding treatment with global endometrial ablation and hysterectomy.

AIM: The objective was to compare abnormal uterine bleeding (AUB) direct healthcare costs and indirect work absence or short-term disability costs associated with treatment with second-generation global endometrial ablation (GEA) or hysterectomy. METHODS: Women aged 30-55 years with AUB who underwent GEA or hysterectomy during 2006-2010 were identified in the Truven Health MarketScan(®) Commercial and Health and Productivity Management databases. RESULTS & CONCLUSION: Two-thirds (66.3%) of the 61,602 study patients underwent GEA compared with hysterectomy (33.7%). Hysterectomy patients had higher treatment costs (US$12,147 vs 5837; p < 0.001), higher annual absenteeism costs (US$7543 vs 5621; p < 0.001), were four-times more likely to have a short-term disability claim (84 vs 21%; p < 0.001) and had higher per-patient short-term disability costs (US$5744 vs 1361; p < 0.001). Overall hysterectomy costs were approximately twice those of GEA.

Economic burden associated with adverse events in patients with metastatic melanoma.

BACKGROUND: There are currently many approved agents for the treatment of metastatic melanoma (MM), the most aggressive form of skin cancer. Treatments may include systemic therapies such as ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, interferon α, dacarbazine- or temozolomide-based combination chemotherapy/biochemotherapy, paclitaxel, paclitaxel/cisplatin, and paclitaxel/carboplatin, as well as the targeted therapies vemurafenib, dabrafenib, and trametinib for patients with BRAF V600 mutation. However, all treatment options are associated with different adverse events (AEs) and, in some instances, considerable toxicity. The occurrence of such treatment-related AEs can lead to higher health care resource utilization and increasing treatment and patient management costs. An understanding of the economic burden of these AEs will therefore enable better management of health care expenditures, not just for existing therapies, but also for new and novel treatments in development. OBJECTIVE: To estimate the incremental health care costs of specific AEs among patients with MM treated with paclitaxel, vemurafenib, ipilimumab, dacarbazine, temozolomide, high-dose interleukin 2, or interferon α, along with AEs known to be associated with dabrafenib and trametinib. METHODS: This cohort study employed a retrospective administrative claims-based analysis of MarketScan commercial and Medicare supplemental databases from July 1, 2004, to April 30, 2012. Patients included those aged ≥ 18 years who had diagnosed melanoma (ICD-9-CM code 172.xx)with ≥ 1 diagnosis of metastasis and ≥ 1 claim for any of the 7 study treatments. Health care encounters for AEs of interest were based on ICD-9-CM diagnosis/procedure codes. Incremental cost per AE was determined by comparing the 30-day expenditures in patients with the event to patients without the event based on a shadow event date. Multivariate generalized linear models (GLMs) with a log-link function and gamma distribution were utilized to control for baseline differences between groups. RESULTS: A total of 2,621 patients with MM were included. Mean age was 56.0 years (SD ± 13.0); 64% were male; and 24% had a diagnosis of primary or secondary brain cancer at the time of MM diagnosis. GLM-based estimate of 30-day incremental costs by AE category were metabolic, $9,135 (95% CI = $6,404-$12,392); hematologic/lymphatic, $8,450 (95% CI = $6,528-$10,633); cardiovascular, $6,476 (95% CI = $4,667-$8,541); gastrointestinal, $6,338 (95% CI = $4,740-$8,122); skin/subcutaneous, -$900 (95% CI = -$1,899-$237); central nervous system/psychiatric, $5,903 (95% CI = $3,842-$8,313); and pain, $5,078 (95% CI = $3,392-$7,012). CONCLUSIONS: Incremental costs associated with many MM treatment-related AEs are substantial. New approaches to prevent and/or better manage these events may reduce overall health care costs.