Healthcare Utilization Among Infants Covered by Medicaid and Newly Diagnosed With Respiratory Syncytial Virus.

Background: Infants covered by Medicaid have higher respiratory syncytial virus (RSV) hospitalization rates than those with commercial insurance, but findings are limited to the inpatient setting. This birth cohort study describes healthcare encounters for RSV across all settings among infants covered by Medicaid and the Children's Health Insurance Program. Methods: Medicaid claims for infants born and residing in Arizona (AZ), California (CA), Florida (FL), Michigan (MI), North Carolina (NC), New York (NY), and Texas (TX) were analyzed for first diagnosis of RSV in 2016-2018 using International Classification of Diseases, Tenth Revision codes. Encounters on the day of first diagnosis were examined by setting in 7 states and by setting and race in CA, FL, and NC. Results: A total of 80 945 infants were diagnosed with RSV in 7 states in 2016-2018. The highest encounter rates for first RSV diagnosis were in the emergency department (ED) in 5 states (11.0-33.4 per 1000 in AZ, CA, FL, MI, and NY) and outpatient setting in 2 states (54.8 and 68.5 per 1000 in TX and NC). Significantly higher outpatient encounter rates were found in CA and NC for White infants compared to non-White infants. In NC, ED encounter rates were significantly higher for non-White infants than White infants, whereas in CA, the rates were comparable. In these 2 states, hospitalization rates were similar across groups. In FL, compared with White infants, non-White infants had significantly higher encounter rates in each setting on the day of first RSV diagnosis. Conclusions: This is the first study to describe the burden of RSV by setting and race. Medicaid infants who are newly diagnosed with RSV have the highest burden in ED and outpatient settings.

Catheter ablation for supraventricular tachycardia and health resource utilization and expenditures: A propensity-matched cohort study.

BACKGROUND: Few data are available regarding temporal patterns of health resource utilization (HRU) and expenditures among patients undergoing catheter ablation for paroxysmal supraventricular tachycardia (PSVT). This study aimed to describe expenditures and HRU in patients with PSVT who underwent catheter ablation compared to a matched cohort of patients on medical therapy alone. METHODS: Using a large US administrative database, we identified adult patients (age 18 to 65 years) with a new PSVT diagnosis between 2008 and 2016. Propensity-score matching was used to assemble a PSVT cohort treated with ablation or medical therapy alone (N = 2556). Longitudinal trends in HRU and expenditures in the 3-years preceding and following PSVT diagnosis were compared. RESULTS: There were no significant differences in expenditures between groups except within the first year after PSVT diagnosis: $48,004 ablation vs. $17,560 medical therapy (p < 0.001). This difference was driven by procedural expenditures, where the mean cost of catheter ablation was $32,057 ± SD 26,737. In Years 2 and 3 post-ablation, HRU and expenditures decreased to the levels associated with the medical therapy group, although fewer ablation patients required any prescription for beta-blockers, calcium channel blockers, or anti-arrhythmic drugs (32% ablation vs. 42% medical therapy group, p < 0.001). CONCLUSION: Catheter ablation reduces medication burden in PSVT, yet health resource use and expenditures were similar beyond 2 years post-ablation when compared to PSVT patients on medical therapy alone. Additional studies are required to better understand drivers of these sustained health expenditures, and barriers to achieving cost-savings for a potentially curative procedure.

Health care resource utilization and costs in patients with painful diabetic neuropathy treated with 10 kHz spinal cord stimulation therapy.

BACKGROUND: Diabetic peripheral neuropathy, a common comorbidity of diabetes, is a neurodegenerative disorder that targets sensory, autonomic, and motor nerves frequently associated with painful diabetic neuropathy (PDN). PDN carries an economic burden as the result of reduced work and productivity. A recent multicenter randomized controlled trial, SENZA-PDN (NCT03228420), assessed the impact of high-frequency (10 kHz) spinal cord stimulation (SCS) on pain relief. The effects of high-frequency SCS on health care resource utilization and medical costs are not known. OBJECTIVE: To evaluate the effect of high-frequency (10 kHz) SCS on health care resource utilization (HRU) and medical costs in patients with PDN using data from the SENZA-PDN trial. METHODS: Participants with PDN were randomly assigned 1:1 to receive either 10 kHz SCS plus conventional medical management (CMM) (SCS treatment group) or CMM alone (CMM treatment group). Patient outcomes and HRU up to the 6-month follow-up are reported here. Costs (2020 USD) for each service was estimated based on publicly available Medicare fee schedules, Medicare claims data, and literature. HRU metrics of inpatient and outpatient contacts and costs are reported as means and SDs. Univariate and bivariate analyses were used to compare SCS and CMM treatment groups at 6 months. RESULTS: At 6-month follow up, the SCS arm experienced approximately half the mean rate of hospitalizations per patient compared with the CMM treatment group (0.08 vs 0.15; P = 0.066). The CMM treatment group's total health care costs per patient were approximately 51% higher compared with the SCS treatment group (equivalent to mean annual cost per patient of $9,532 vs $6,300). CONCLUSIONS: Our analysis of the SENZA-PDN trial indicates that the addition of 10 kHz SCS therapy results in lower rates of hospitalization and consequently lower health care costs among patients with PDN compared with those receiving conventional management alone.

Lung Function Monitoring After Lung Transplantation and Allogeneic Hematopoietic Stem Cell Transplantation.

PURPOSE: Bronchiolitis obliterans syndrome (BOS) is a major cause of morbidity and mortality in lung transplantation and allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Clinical guidelines recommend lung function monitoring to aid early identification of BOS, but real-world rates of pulmonary function testing (PFT) have not been studied. The purpose of this study was to quantify PFT rates in lung transplantation and allo-HSCT recipients. METHODS: This longitudinal retrospective study used US data from the IQVIA PharMetrics Plus commercial claims database (January 1, 2006-September 30, 2018) and the Medicare Limited Data Set (January 1, 2010-December 31, 2018). Study recipients had no evidence of transplantation 12 months before transplantation, which was identified by using diagnosis and procedure codes. PFTs were identified by using procedure codes. Outcomes were percentage of recipients who received ≥1 PFT in each follow-up year, including spirometry, lung diffusion capacity, lung function volume test, and plethysmography, including the average number of total and specific tests per recipient. FINDINGS: The study identified 367 commercially insured and 1776 Medicare recipients who underwent lung transplantation; 92% and 86% received ≥1 lung function test in the first year after transplantation, respectively. Among recipients observable 3 years after transplant, 85% and 83% received ≥1 PFT. Among 2187 commercially insured and 1864 Medicare recipients who underwent allo-HSCT, 44% and 36% received ≥1 lung function test in the first posttransplant year. In the third year after transplant, only 31% and 26% of observable allo-HSCT recipients underwent any PFT. IMPLICATIONS: Morbidity and mortality from BOS remain high in lung transplant and allo-HSCT recipients, but lung function testing in the first posttransplant year is not universal, with substantially lower rates among allo-HSCT recipients. Furthermore, testing rates in all cohorts declined over time. Increased and sustained monitoring could lead to earlier detection of BOS and earlier intervention and treatment.

The healthcare resource utilization and costs of chronic lung allograft dysfunction following lung transplantation in patients with commercial insurance in the United States.

AIMS: Chronic lung allograft dysfunction (CLAD), a common complication of lung transplantation, is the leading cause of death for lung transplant recipients. While data on lung transplant costs are available, the impact of CLAD on healthcare resource use (HRU) and cost is not well understood. The primary objective was to quantify the HRU and costs of CLAD in the US using real-world data. METHODS: A longitudinal retrospective analysis was performed of commercial claims data from the IQVIA PharMetrics Plus database for patients aged 18-64 who underwent lung transplantation between January 1, 2006 and September 30, 2018. Lung transplantation was identified using International Classification of Disease and Common Procedure Terminology procedure codes. Patients studied were observable for at least 12 months before and after transplantation. Patients who developed CLAD were identified using novel, diagnosis codes for incident lung disease at least one year following transplantation. Descriptive analyses were conducted to assess the study's outcomes prior to and following a CLAD diagnosis. All-cause HRU and costs, the study's primary outcomes, leading up to and following CLAD diagnosis were calculated. RESULTS: Among 129 transplant patients who developed CLAD, healthcare costs were substantially higher in the year following diagnosis ($198,113), compared to the year leading to diagnosis ($85,276). Inpatient admissions were responsible for most costs in years 1 and 2 following diagnosis ($99,372 and $83,348 respectively). Drug costs were higher in the 12 months post-index, compared to the 12 months pre-index ($3,600 vs $2,527). LIMITATIONS: Claims data do not include clinical data, have limits determining loss of follow-up, and do not provide granularity to determine disease severity. Also, there is no ICD-10-CM code specific to CLAD or BOS. CONCLUSIONS: CLAD after lung transplant is associated with substantial HRU and costs. Further work is needed to develop interventions that reduce this impact.

The economic burden of NIPC and BOS following allogeneic HSCT in patients with commercial insurance in the United States.

Noninfectious pulmonary complications (NIPC) after allogeneic hematopoietic stem cell transplantation (alloHSCT), including bronchiolitis obliterans syndrome (BOS), cause significant morbidity and mortality, but their impact on health care resource utilization (HRU) and costs is unknown. This longitudinal retrospective study quantified the economic burden of NIPC and BOS in alloHSCT patients using commercial claims data from the IQVIA PharMetrics Plus database. Study patients were aged 0 to 64 years and underwent alloHSCT between 1 January 2006 and 30 September 2018, and were observable 12 months before and up to 5 years after index alloHSCT. NIPC patients were identified using International Classification of Disease (ICD) diagnosis codes. Outcomes were mean per patient HRU (inpatient admissions, outpatient office, hospital visits, and prescription medications) and costs paid by insurers in each post-transplant year. Among 2162 alloHSCT patients, 254 developed NIPCs, and 155 were propensity score (PS)-matched to non-NIPC patients. The year following transplantation, NIPC patients had significantly higher inpatient admission rates (3.8 ± 3.2 vs non-NIPC: 2.6 ± 2.4; P < .001) and higher total costs ($567 870 vs $412 400; P = .07), reflecting higher costs for inpatient admissions ($452 475 vs $300 202; P = .06). Among those observable for more years, costs remained higher for NIPC patients, reflecting significantly higher inpatient admission rates in the first 3 years following transplant. Subanalysis of patients with diagnoses likely reflective of BOS were consistent with these findings. AlloHSCT patients who developed NIPC had higher health care resource utilization and incurred higher costs compared with alloHSCT patients who did not develop NIPC following transplant.

Prevalence and incidence of patients with paroxysmal supraventricular tachycardia in the United States.

BACKGROUND: Paroxysmal supraventricular tachycardia (PSVT) encompasses a range of heart rhythm disorders leading to rapid heart rates. By virtue of its episodic nature, diagnosing PSVT is difficult and estimating incidence and prevalence on a population level is challenging. The objective of this study was to estimate the incidence and prevalence of PSVT in the United States (US) in contemporary practice. METHODS AND RESULTS: An observational retrospective longitudinal study using claims, enrollment, and demographic data from the IBM MarketScan® Commercial Research database (age < 65) and the Medicare Limited Data Set (age ≥ 65) from 2008 to 2016. Patients with a PSVT diagnosis code (ICD-9: 427.0; ICD-10: I47.1) on ≥2 outpatient, ≥1 emergency room, or ≥1 inpatient visit were considered as having PSVT. Patients with atrial fibrillation/atrial flutter (AF/AFL) were excluded from the initial analysis given the potential for misclassification. Incidence was estimated by assessing diagnoses made during year 5 of continuous enrollment. Finally, a sensitivity analysis was performed by including patients with both PSVT and AF/AFL diagnoses. Period prevalence and incidence rate were estimated to be 332.9 (323.2-342.9) and 57.8 (52.8-63.3) per 100 000 individuals, respectively, when excluding patients with AF/AFL. Projected to the 2018 US Census, prevalence and incidence are 1.26 million (1.21-1.30 million) and 188,981 (172,891-206,943), respectively. Including patients with AF/AFL, the prevalence may increase to 479.7 (467.9-491.8) with an incidence of 93.4 (86.9-100.5) per 100 000 individuals or a prevalence of 2.06 million (2.01-2.12 million). CONCLUSIONS: Approximately 1 in 300 people in the US had PSVT with the highest rates in older and female patients.

Costs and health resource use in patients with X-linked myotubular myopathy: insights from US commercial claims.

BACKGROUND: In X-linked myotubular myopathy (XLMTM), mutations in the MTM1 gene result in absence or dysfunction of myotubularin, a protein required for normal development, maintenance, and function of skeletal muscle. Extreme muscle weakness results in severe respiratory failure that is fatal for approximately half of XLMTM-affected children by age 18 months. Most surviving patients require invasive mechanical ventilation, feeding tubes, and wheelchairs for mobility, due to profoundly impaired motor function. Little is known about the costs of care for this rare disease. Currently, there are no approved therapies for XLMTM. OBJECTIVE: To quantify the direct medical costs and health care resource utilization (HRU) incurred by XLMTM patients and paid by commercial insurers. METHODS: A retrospective, longitudinal study was conducted using the IQVIA PharMetrics Plus commercial database of adjudicated claims for more than 140 million individuals with commercial insurance coverage in the United States. An algorithm based on demographic information, diagnosis and procedure codes, and medications was used to identify XLMTM patients younger than aged 2 years during the study period from January 1, 2006, through September 30, 2018. All-cause direct medical costs and HRU during each month were calculated. Costs were grouped as inpatient hospital admissions (including the intensive care unit or neonatal intensive care unit [NICU]); emergency department visits; outpatient services (outpatient hospital visits, office visits, physician/provider office visits, ambulatory surgeries and procedures, laboratory tests, and imaging tests); and prescription medications. Monthly costs and HRU over time were stratified by age and use of mechanical ventilation. RESULTS: 49 patients met the study criteria. All had at least 1 inpatient hospital admission, and 36 (73%) had at least 1 NICU stay. All patients received ventilation at some time during the study period, including 40 (82%) treated with invasive ventilation. Mean monthly per patient direct medical costs were highest in the first year of life ($74,831), including costs for inpatient admissions ($69,025), outpatient services ($5,266), and prescription medication ($540). Mean monthly costs were lower in the second, third, and fourth years of life ($23,207, $13,044, and $9,440, respectively). When annualized, these all-cause monthly medical costs totaled $897,978 per patient in the first year of life and nearly $1.5 million total for patients who survived the first 4 years of life. Costs were consistently highest when patients were receiving invasive ventilation and lowest when they were not receiving ventilation (i.e., before they started on ventilator support). CONCLUSIONS: This direct health care cost and HRU analysis demonstrates the substantial economic burden associated with XLMTM. Costs are highest in the first year of life and are particularly significant for patients receiving invasive ventilation. DISCLOSURES: This study was funded by Audentes Therapeutics, an Astellas Company, and was conducted by PRECISIONheor with funding from Audentes Therapeutics, an Astellas Company. Slocomb is an employee of Audentes Therapeutics, an Astellas Company; James was an employee at the time of the study. Sacks, Healey, and Cyr are employees of PRECISIONheor. Graham participated in the medical/scientific advisory board for Audentes as part of a clinical trial design for XLMTM but declares no vested interest or holdings that would represent a conflict of interest. Beggs received consulting fees from Audentes Therapeutics, for work on this study, and has received grants from Alexion Pharmaceuticals, Audentes Therapeutics, Dynacure SAS, Pfizer Pharmaceuticals, along with personal fees from Asklepios Biopharmaceutical, Inc., Ballard Biologics, Biogen, F. Hoffmann-La Roche AG, GLG, Guidepoint Global, and Kate Therapeutics, unrelated to this study. In addition, Beggs has a patent (Patent number: 10736945) for systemic gene replacement therapy for treatment of X-linked myotubular myopathy (XLMTM) licensed to Audentes Therapeutics.

Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis.

OBJECTIVE: Clostridioides difficile infection and recurrent C. difficile infection result in substantial economic burden and healthcare resource use. Sepsis and bowel surgery are known to be serious complications of C. difficile infection. This study evaluated clinical complications in patients with C. difficile infection and recurrent C. difficile infection during a 12-month period following the primary C. difficile infection. METHODS: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database was conducted for patients aged 18-64 years with an index C. difficile infection episode requiring inpatient stay or an outpatient visit for C. difficile infection followed by a C. difficile infection treatment. Each C. difficile infection episode ended after a 14-day C. difficile infection-claim-free period was observed. Recurrent C. difficile infection was defined as a further C. difficile infection episode within an 8-week window following the claim-free period. Clinical complications were documented over 12 months of follow-up and stratified by the number of recurrent C. difficile infection episodes (0 rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI). RESULTS: In total, 46,571 patients with index C. difficile infection episode were included. During the 6-month pre-index, the mean (standard deviation) baseline Charlson comorbidity index score, by increasing the recurrent C. difficile infection group, was 1.2 (1.9), 1.5 (2.2), 1.8 (2.3), and 2.3 (2.5). During the 12-month follow-up, sepsis occurred in 16.5%, 27.3%, 33.1%, and 43.3% of patients, and subtotal colectomy or diverting loop ileostomy was performed in 4.6%, 7.3%, 8.9%, and 10.5% of patients, respectively, by increasing the recurrent C. difficile infection group. CONCLUSIONS: Reduction in recurrent C. difficile infection is an important step to reduce the burden of serious clinical complications, and new treatments are needed to reduce C. difficile infection recurrence.

Trends in health care resource use and expenditures in patients with newly diagnosed paroxysmal supraventricular tachycardia in the United States.

BACKGROUND: Few data are available on the temporal patterns of health resource utilization (HRU) and expenditures around paroxysmal supraventricular tachycardia (PSVT) diagnosis. This study assessed the longitudinal trends in HRU and expenditures in the 3 years preceding and subsequent to PSVT diagnosis. METHODS: Adult patients (age 18-65 years) with newly diagnosed PSVT were identified using administrative claims from the IBM MarketScan Research Database between January 1, 2008 and December 31, 2016 and propensity-score matched (1:1) with non-PSVT controls. RESULTS: Among the 12,305 PSVT patients compared with matched controls, PSVT was associated with statistically significant higher annual rates of emergency department visits, physician office visits, inpatient hospitalizations, and diagnostic testing. HRU increased in the years preceding PSVT diagnosis, reaching its peak in the year following PSVT diagnosis. Over the 6-year follow-up period, PSVT was associated with higher mean annual per patient expenditures ($12,665) compared to matched controls ($6,004; P < .001). Upon diagnosis of PSVT, the mean expenditures per PSVT patient doubled from $11,714 in the year immediately preceding index diagnosis to $23,335 in the first postdiagnosis year. Inpatient services, diagnostic testing, and ablation procedures were the principle drivers of higher mean expenditures in the first year post-PSVT diagnosis versus the year prior to PSVT diagnosis. CONCLUSIONS: PSVT presents a substantial economic burden to health care systems. The annual expenditure per PSVT patient is within the range previously reported for atrial fibrillation. The increased HRU and expenditures in the year following diagnosis, which do not return to baseline, suggest a potential gap in non-interventional, long-term PSVT management.

Disparities in the Management of Newly Diagnosed Paroxysmal Supraventricular Tachycardia for Women Versus Men in the United States.

Background Information on differences in paroxysmal supraventricular tachycardia (PSVT) diagnosis, healthcare resource use, expenditures, and treatment among women versus men is limited. Methods and Results Study participants identified in the IBM MarketScan Commercial Research Databases were aged 18 to 40 years with newly diagnosed PSVT (International Classification of Diseases, Ninth Revision [ICD-9]: 427.0; International Classification of Diseases, Tenth Revision [ICD-10]: I47.1) from October 1, 2012, through September 30, 2016, observable 1 year preindex and postindex diagnosis. Study outcomes were mean annual per-patient healthcare resource use and expenditures before and after diagnosis. Among 5466 patients newly diagnosed with PSVT, most (66.9%) were women. Compared with men, women with PSVT tended to have higher rates of anxiety (13.9% versus 10.9%; P<0.01) and chronic pulmonary disease (10.9% versus 8.3%; P<0.01). Following diagnosis, mean annual per-patient expenditures increased for all patients, but were significantly lower for women ($26 922 versus $33 112; P<0.05), reflecting lower spending for services billed as a result of a PSVT diagnosis ($8471 versus $11 405; P<0.05). After diagnosis, nearly half of all patients had at least 1 emergency department visit (women versus men, 49.6% versus 44.5%; P<0.01) and more had hospital admissions (women versus men, 24.7% versus 20.0%; P<0.01). Fewer women were treated with cardiac ablation (12.6% versus 15.3%; P<0.01), and more were treated with medical therapy, including ß blockers or calcium channel blockers (odds ratio, 1.15; 95% CI, 1.02-1.31). Conclusions Among patients aged 18 to 40 years, ≈2 of 3 patients diagnosed with PSVT were women. After diagnosis, spending was significantly lower for women, reflecting lower ablation rates and less spending on services with a PSVT diagnosis.

Healthcare Resource Use and Expenditures in Patients Newly Diagnosed With Paroxysmal Supraventricular Tachycardia.

Information on paroxysmal supraventricular tachycardia (PSVT) patient characteristics and the associated economic burden of the disease is limited. Therefore, we sought to characterize newly diagnosed PSVT patients and quantify their healthcare resource use and expenditures. We used enrollment, demographic, and claims data from IBM MarketScan Research Database and Medicare Limited Data Set (LDS) to identify patients newly diagnosed with PSVT (ICD-9: 427.0; ICD-10: I47.1) from 10/1/2012 to 9/30/2016. Patients were required to be observable 1-year before and after index diagnosis. Patients were stratified by age (<65 years and ≥65 years), and propensity-matched to patients without PSVT. Expenditures and healthcare resource use were analyzed 1 year before and 1-year following index diagnosis. Among 49,316 patients <65 years and 23,954 patients ≥65 years, most were female (64% and 63%, respectively). Compared with matched controls, all PSVT patients had significantly more emergency department visits pre- and postdiagnosis, and more hospitalizations following diagnosis. Mean annual per patient expenditures paid by insurers were significantly higher in the year post-PSVT diagnosis, tripling for patients <65 years ($9,028 to $29,867) and nearly doubling for patients ≥65 years ($10,867 to $20,143). Spending for PSVT services accounted for 43% and 33% of the increase in expenditures in these patient-groups, respectively. Few patients had an ablation within 1 year of diagnosis, although ablations were more frequent in patients age <65 years (13% vs 3%). In conclusion, PSVT imposes a substantial economic burden, with increases in expenditures following initial diagnosis in both younger (<65 years) and older (≥65 years) patients who are not accounted for by cardiac ablation spending alone.

Real-world comparison of the effectiveness and safety of different bowel preparation agents.

BACKGROUND AND AIMS: Proper bowel cleansing is necessary prior to colonoscopy, but poor tolerability to bowel preparation agents may increase the odds of poor cleansing and incomplete screenings. The aim of this study was to evaluate the real-world effectiveness and safety of bowel preparation agents. METHODS: Claims data were extracted for individuals who had a screening colonoscopy from July 1, 2012, to June 30, 2015, were ≥18 years of age, and who could be observed ≥6 months before and ≥3 months after the screening. Data were stratified by agent class, including over-the-counter (OTC), low-volume (LV), and high-volume (HV) agents. Rates of incomplete screenings, repeat screenings, and hospitalizations were reported. Multivariate logistic regression was conducted to compare outcomes for sodium picosulfate, magnesium oxide, and citric acid (P/MC) vs other agents. RESULTS: Of 2.8 million individuals, 71.5% were average risk and 28.5% were high risk for colorectal cancer. Rates of use were 2.8% for P/MC, 30.1% for other LV agents, 9.4% for HV agents, and 56.6% for OTC agents. All individuals who used P/MC had significantly lower odds of incomplete screenings compared to those who used other LV agents or HV agents (P<0.05). In average-risk patients, rates of 30- and 90-day repeat screenings were highest for the P/MC group (16.7% and 23.0%, respectively) compared to other agents. Across all patient analysis groups, the rates of hospitalizations for hyponatremia or dehydration were much higher for those who used an OTC bowel preparation agent compared to those who used LV or HV agents, or P/MC. CONCLUSION: P/MC was associated with lower rates of incomplete colonoscopy and higher rates of repeat screenings, suggesting it was better tolerated than other agents. OTC agents were associated with higher rates of hospitalizations.

Burden of Acute Myeloid Leukemia Among Older, Newly Diagnosed Patients: Retrospective Analysis of Data From the 2010-2012 Medicare Limited Data Set.

PURPOSE: Acute myeloid leukemia (AML) disproportionately affects older adults; the prognosis in this subpopulation is generally poor, with variable use of inpatient chemotherapy. This study characterizes treatment patterns, hospitalizations, and outcomes among older patients with AML. METHODS: Using the Centers for Medicare & Medicaid Services' 2010-2012 100% Limited Data Set (LDS), data from all hospital claims from fee-for-service Medicare beneficiaries between 60 and 75 years of age with newly diagnosed AML and ≥1 hospitalization were analyzed. FINDINGS: Among 3700 identified patients with AML, 1979 (53.5%) received chemotherapy. Hospitalization rates were highest initially and then declined over time, irrespective of chemotherapy use. The mean length of initial hospital stay was longer in patients receiving chemotherapy. Intensive care unit admissions occurred in 33% of initial hospitalizations. Factors associated with receiving chemotherapy included younger age, fewer comorbidities, and the absence of prior hematologic disorders. Chemotherapy was associated with significantly increased survival compared with no chemotherapy (P < 0.0001). IMPLICATIONS: AML in older patients is associated with frequent hospitalizations and intensive care unit admissions. New treatment options with more favorable risk-to-benefit profiles are needed in this population.

Budget Impact Analysis of Using Daunorubicin-Cytarabine Liposome in Patients with Newly Diagnosed Therapy-Related AML or AML and Myelodysplasia-Related Changes.

BACKGROUND: Current national estimates for acute myelogenous leukemia (AML) indicate this disease accounts for 1.1% of new cancer diagnoses and 1.8% of cancer deaths in the United States. The 5-year overall survival rate for patients with AML was 27.4% between 2008 and 2014. The standard induction for patients with AML includes cytarabine, infused for 7 days, with 3 once-daily injections of an anthracycline, such as daunorubicin, known as the 7+3 regimen. Daunorubicin plus cytarabine liposomal encapsulation for injection was approved in the United States in 2017 for adults with newly diagnosed therapy-related AML (tAML) or AML with myelodysplasia-related changes (AML-MRC). OBJECTIVE: To estimate the annual budget impact of introducing daunorubicin-cytarabine liposome as induction treatment for patients with tAML or AML-MRC in the United States over a 3-year period. METHODS: The model consisted of a simple decision analytic framework for a 1- to 3-year period. We used an incidence-based approach to estimate the annual number of patients newly diagnosed with tAML or AML-MRC in a hypothetical 1-million-member plan. Patients were allocated to 2 groups based on when daunorubicin-cytarabine liposome became available, with the base-case group allocated to the 7+3 regimen, and another group allocated to daunorubicin-cytarabine liposome treatment. The incidence of AML was estimated as 4.3 per 100,000 people. Efficacy measures included the proportion of complete responders, proportion of patients who had undergone transplantation, and survival at 180 and 365 days. Inpatient drug and hospitalization costs were based on diagnosis-related group rates, and outpatient drug costs on wholesale acquisition costs. RESULTS: Based on this hypothetical 1-million-member health plan, 15.1 members would receive intensive induction for newly diagnosed tAML or AML-MRC annually. Increasing the use of daunorubicin-cytarabine liposome (assumption of year 1, 20%; year 2, 50%; year 3, 80%) resulted in a 3-year incremental cumulative budget impact of $72,041 (1.7% increase for patients with tAML or AML-MRC), with a per-member per-month cost of $0.0032 at year 3. Over a 3-year period, the use of daunorubicin-cytarabine liposome would result in an estimated increase in the number of patients with a complete response to therapy by 2.72 (23.1%), which would lead to an incremental cost decrease of $179,956 per responding patient compared with the use of the 7+3 regimen in the base-case group. CONCLUSIONS: Based on these results, induction treatment with daunorubicin-cytarabine liposome for patients with tAML or AML-MRC instead of the 7+3 regimen may have a limited economic impact on the budget of commercial health plans and may result in cost offsets, particularly in patients who respond to therapy.

Comparison of claims data on hospitalization rates and repeat procedures in patients receiving a bowel preparation prior to colonoscopy.

OBJECTIVES: To evaluate outcomes of colorectal screening using sodium picosulfate and magnesium citrate compared with other prescription bowel-preparation agents. Primary endpoints were rates of procedure-associated hospitalizations, diagnosis at hospitalization, and rates of early repeat screenings. METHODS: This retrospective cohort study identified patients using the Truven Health Analytics MarketScan databases, which contain fully adjudicated, de-identified, medical- and prescription-drug claims, as well as demographic and enrollment information for individuals with commercial, Medicaid, and Medicare supplemental insurance coverage. Patients who had a colonoscopy or sigmoidoscopy over a 3-year period were identified using International Classification of Diseases Clinical Modification procedure codes, recorded on claims from physicians and facilities. First, screening colonoscopy was identified for each patient, and the study was limited to those patients who could be observed for ≥6 months before and 3 months after the screening procedure. Total number of hospitalizations and rates of early repeat screenings were evaluated for all patients who received sodium picosulfate and magnesium citrate and compared with those who received other bowel-preparation agents. Individual prescription medications that could affect the outcome of the cleansing agent were identified; further evaluations were made to establish whether patients had comorbid conditions, such as chronic kidney disease, cardiovascular disease, or psychiatric illness. Statistical methods included descriptive statistics, two-tailed t-tests, and multivariate logistic regression. RESULTS: A total of 566,628 procedures were identified in the MarketScan databases and included in the study. Sodium picosulfate and magnesium citrate performed well in terms of safety outcomes, with no hospitalizations due to diagnosis of hyponatremia, dehydration, or other fluid disorders in the 10 days after procedure. Early repeat rates among sodium picosulfate and magnesium citrate patients were comparable with rates observed for all other cleansing agents. CONCLUSION: Outcomes of colorectal screening using sodium picosulfate and magnesium citrate were not significantly different compared with other prescription bowel-preparation agents.

Myopic and Forward Looking Behavior in Branded Oral Anti-Diabetic Medication Consumption: An Example from Medicare Part D.

We evaluate consumption responses to the non-linear Medicare Part D prescription drug benefit. We compare propensity-matched older patients with diabetes and Part D Standard or low-income-subsidy (LIS) coverage. We evaluate monthly adherence to branded oral anti-diabetics, with high end-of-year donut hole prices (>$200) for Standard patients and consistent, low (≤$6) prices for LIS. As an additional control, we examine adherence to generic anti-diabetics, with relatively low, consistent prices for Standard patients. If Standard patients are forward looking, they will reduce branded adherence in January, and LIS-Standard differences will be constant through the year. Contrary to this expectation, branded adherence is lower for Standard patients in January and diverges from LIS as the coverage year progresses. Standard-LIS generic adherence differences are minimal. Our findings suggest that seniors with chronic conditions respond myopically to the nonlinear Part D benefit, reducing consumption in response to high deductible, initial coverage and gap prices. Thus, when the gap is fully phased out in 2020, cost-related nonadherence will likely remain in the face of higher spot prices for more costly branded medications. These results contribute to studies of Part D plan choice and medication adherence that suggest that seniors may not make optimal healthcare decisions. Copyright © 2016 John Wiley & Sons, Ltd.

Trends in acute myocardial infarction hospitalizations: Are we seeing the whole picture?

BACKGROUND: Payers and policy makers rely on studies of trends in acute myocardial infarction (AMI) hospitalizations and spending that count only hospitalizations where the AMI is the principal discharge diagnosis. Hospitalizations with AMI coded as a secondary diagnosis are ignored. The effects of excluding these hospitalizations on estimates of trends are unknown. METHODS: Observational study of all AMI hospitalizations in Fee-for-Service Medicare beneficiaries 65 years and older, from 2002 through 2011. RESULTS: We studied 3,663,137 hospitalizations with any AMI discharge diagnosis over 288,873,509 beneficiary-years. Of these, 66% had AMI coded as principal (versus secondary). From 2002 to 2011, AMI hospitalization rates declined 24.5% (from 1,485 per 100,000 beneficiary-years in 2002 to 1,122 in 2011). Meanwhile, the proportion of these hospitalizations with a secondary AMI diagnosis increased from 28% to 40%; by 2011 these secondary AMI hospitalizations accounted for 43% of all expenditures for hospitalizations with AMI, or $2.8 billion. Major changes in comorbidities, principal diagnoses and mean costs for hospitalizations with a non-principal AMI diagnosis occurred in the 2006-2008 timeframe. CONCLUSIONS: Current estimates of the burden of AMI ignore an increasingly large proportion of overall AMI hospitalizations and spending. Changes in the characteristics of hospitalizations that coincided with major payment and policy changes suggest that non-clinical factors affect AMI coding. Failing to consider all AMIs could inflate estimates of population health improvements, overestimate the value of AMI prevention and treatment and underestimate current and future AMI burden and expenditures.

The Effects of Cost Sharing on Adherence to Medications Prescribed for Concurrent Use: Do Definitions Matter?

BACKGROUND: Accurate estimates of the effects of cost sharing on adherence to medications prescribed for use together, also called concurrent adherence, are important for researchers, payers, and policymakers who want to reduce barriers to adherence for chronic condition patients prescribed multiple medications concurrently. But measure definition consensus is lacking, and the effects of different definitions on estimates of cost-related nonadherence are unevaluated. OBJECTIVES: To (a) compare estimates of cost-related nonadherence using different measure definitions and (b) provide guidance for analyses of the effects of cost sharing on concurrent adherence. METHODS: This is a retrospective cohort study of Medicare Part D beneficiaries aged 65 years and older who used multiple oral antidiabetics concurrently in 2008 and 2009. We compared patients with standard coverage, which contains cost-sharing requirements in deductible (100%), initial (25%), and coverage gap (100%) phases, to patients with a low-income subsidy (LIS) and minimal cost-sharing requirements. Data source was the IMS Health Longitudinal Prescription Database. Patients with standard coverage were propensity matched to controls with LIS coverage. Propensity score was developed using logistic regression to model likelihood of Part D standard enrollment, controlling for sociodemographic and health status characteristics. For analysis, 3 definitions were used for unadjusted and adjusted estimates of adherence: (1) patients adherent to All medications; (2) patients adherent on Average; and (3) patients adherent to Any medication. Analyses were conducted using the full study sample and then repeated in analytic subgroups where patients used (a) 1 or more costly branded oral antidiabetics or (b) inexpensive generics only. RESULTS: We identified 12,771 propensity matched patients with Medicare Part D standard (N = 6,298) or LIS (N = 6,473) coverage who used oral antidiabetics in 2 or more of the same classes in 2008 and 2009. In this sample, estimates of the effects of cost sharing on concurrent adherence varied by measure definition, coverage type, and proportion of patients using more costly branded drugs. Adherence rates ranged from 37% (All: standard patients using 1+ branded) to 97% (Any: LIS using generics only). In adjusted estimates, standard patients using branded drugs had 0.63 (95% CI = 0.57-0.70) and 0.70 (95% CI = 0.63-0.77) times the odds of concurrent adherence using All and Average definitions, respectively. The Any subgroup was not significant (OR = 0.89, 95% CI = 0.87-1.17). Estimates also varied in the full-study sample (All: OR = 0.79, 95% CI = 0.74-0.85; Average: OR = 0.83, 95% CI = 0.77-0.89) and generics-only subgroup, although cost-sharing effects were smaller. The Any subgroup generated no significant estimates. CONCLUSIONS: Different concurrent adherence measure definitions lead to markedly different findings of the effects of cost sharing on concurrent adherence, with All and Average subgroups sensitive to these effects. However, when more study patients use inexpensive generics, estimates of these effects on adherence to branded medications with higher cost-sharing requirements may be diluted. When selecting a measure definition, researchers, payers, and policy analysts should consider the range of medication prices patients face, use a measure sensitive to the effects of cost sharing on adherence, and perform subgroup analyses for patients prescribed more medications for which they must pay more, since these patients are most vulnerable to cost-related nonadherence.