Falls, healthcare resources and costs in older adults with insomnia treated with zolpidem, trazodone, or benzodiazepines.

BACKGROUND: Falls are the leading cause of injury-related death among older Americans. While some research has found that insomnia heightens falls, health care resource utilization (HCRU) and costs, the impact of insomnia treatments on fall risk, mortality, HCRU and costs in the elderly population, which could be of substantial interest to payers, has not been fully elucidated. This study evaluated the risk of falls and related consequences among adults ≥ 65 years of age treated with common prescription medications for insomnia compared with non-sleep disordered controls. METHODS: This was a retrospective cohort analysis of deidentified Medicare claims from January 2011 through December 2017. Medicare beneficiaries treated for insomnia receiving zolpidem extended-release, zolpidem immediate-release, trazodone, or benzodiazepines were matched with non-sleep disordered controls. The main outcomes were falls, mortality, healthcare resource utilization (HCRU), and medical costs during the 12 months following the earliest fill date for the insomnia medication of interest. Generalized linear models controlled for several key covariates, including age, race, sex, geographic region and Charlson Comorbidity Index score. RESULTS: The study included 1,699,913 Medicare beneficiaries (59.9% female, mean age 75 years). Relative to controls, adjusted analyses showed that beneficiaries receiving insomnia medication experienced over twice as many falls (odds ratio [OR] = 2.34, 95% CI: 2.31-2.36). In adjusted analyses, patients receiving benzodiazepines or trazodone had the greatest risk. Crude all-cause mortality rates were 15-times as high for the insomnia-treated as controls. Compared with controls, beneficiaries receiving insomnia treatment demonstrated higher estimated adjusted mean number of inpatient, outpatient, and emergency department visits and longer length of inpatient stay. All-cause total adjusted mean costs were higher among insomnia treated patients ($967 vs $454). CONCLUSIONS: Individuals receiving insomnia treatment had an increased risk of falls and mortality and higher HCRU and costs compared with matched beneficiaries without sleep disorders. Trazodone and benzodiazepines were associated with the greatest risk of falls. This analysis suggests that significant risks are associated with common, older generation insomnia medication treatments in the elderly. Nonetheless, these results should be interpreted with caution as the use of these medications may be indicative of underlying morbidity with potential for residual confounding.

Real-world hospitalization risk in patients with epilepsy treated with perampanel.

AIM: The aim of this study was to evaluate the risk of hospitalization and emergency department admission following initiation of perampanel treatment in patients with epilepsy. METHODS: This study is a retrospective longitudinal cohort study (Optum® Clinformatics® Datamart). Patients 4 to 11 years of age with a diagnosis of partial onset seizures or ≥12 years of age with primary generalized tonic-clonic seizures who had ≥1 perampanel prescription between 1/1/2014 and 3/31/2018 were eligible for the study. Additionally, patients were required to have 12-months of continuous enrollment before (pre-) and after (post-) the date of the first perampanel prescription (index-date). One-year relative-risks of all-cause and epilepsy-related hospitalizations and emergency department (ED) visits were estimated following initiation of perampanel treatment. Outcomes were also evaluated among a subsets of patients who were adherent to perampanel treatment, defined as a Medication Possession Ratio (MPR) ≥80%. RESULTS: A total of 320 patients were included in the study, mean age 38.2 ±â€¯19 years, 56.6% female. In the overall population, the relative risks of hospitalizations or ED visits after perampanel initiation were not significantly different. Among the 145 patients who had an MPR ≥80%, initiation of perampanel treatment resulted in a significantly lower risk of epilepsy-related hospitalization (relative risk [RR] = 0.68, confidence interval [CI] [0.47, 0.98]), all-cause ED visits (RR = 0.80, CI [0.66, 0.98]), and epilepsy-related ED visits (RR = 0.74, CI [0.57, 0.95]) in the follow-up period. CONCLUSIONS: Adherence to perampanel treatment was associated with significant reductions in one-year hospitalizations and ED visit risk in real world settings.

Real-world impact of antiepileptic drug combinations with versus without perampanel on healthcare resource utilization in patients with epilepsy in the United States.

OBJECTIVES: Combination regimens of antiepileptic drugs (AEDs) with various mechanisms of action (MOA) are commonly used in patients with refractory epilepsy. However, outcomes related to combination AEDs with novel MOA, such as perampanel (PER), are not well described. This study compared healthcare resource utilization (HRU) among recipients of PER-based combinations versus recipients of other non-PER-based combinations. METHODS: This retrospective study used claims data from the Symphony Health's IDV® (Integrated Dataverse) database (August 2012 to July 2018). Patients were aged ≥12 years with epilepsy or non-febrile convulsions, were treated with AED combinations, and had ≥12 and ≥6 months pre- and post-index date, respectively (date of initiation of the second AED in the combination). AEDs were categorized based on MOA: selective non-competitive antagonist of AMPA receptors (i.e., PER), sodium channel blocker (SC), synaptic vesicle protein 2A binding (SV2), and gamma-aminobutyric acid analog (G). Patients were then classified into MOA-based cohorts: PER + SC, PER + SV2, PER + G, SC + SC, SC + SV2, SC + G, SV2 + G, and G + G. HRU outcomes were evaluated during follow-up and compared between PER-based cohorts and non-PER-based cohorts. RESULTS: On average, patients in the PER + SC (N = 3,592), PER + SV2 (N = 2,200), and PER + G (N = 1,313) cohorts were younger and had a lower Quan-Charlson comorbidity index than those in non-PER-based cohorts. PER + SC and PER + SV2 users had significantly fewer all-cause hospitalizations than non-PER-based users (adjusted RR range: 0.66-0.89, all P < 0.05), while PER + G recipients had fewer all-cause hospitalizations than recipients of SV2 + G and G + G (adjusted RR range: 0.92-0.94). Similar trends were observed for epilepsy-related hospitalizations. Across all comparisons, PER-based combinations were associated with significantly lower rates of all-cause clinic/office/outpatient visits relative to non-PER-based combinations (adjusted RR range: 0.69-0.86, all P < 0.05). SIGNIFICANCE: Results showed that patients treated with PER-based combinations had fewer all-cause and epilepsy-related hospitalizations, and fewer all-cause clinic/office/outpatient visits compared with patients treated with most other non-PER-based combinations.

Quantifying the burden of generalized tonic-clonic seizures in patients with drug-resistant epilepsy.

OBJECTIVE: Compared to other seizure types, generalized tonic-clonic (GTC) seizures may be disproportionately related to increased morbidity, and reducing seizure frequency could translate into improvements across measures of morbidity in medically treated patients with drug-resistant epilepsy (DRE). The primary objective of this analysis was to quantify the burden of patients with DRE who experience GTC seizures (GTC+) compared to patients with DRE who do not experience GTC seizures (GTC-). METHODS: Adult patients from the Cleveland Clinic Epilepsy Center-Neurological Institute from 2012-2016 with DRE with epilepsy for at least 1 year were eligible for inclusion and were divided into GTC ± groups based on whether the patient had experienced a GTC seizure in the year preceding the first visit. Epilepsy duration, comorbidities, antiepileptic drug use, patient-reported outcomes (PROs) and seizure type, frequency, and etiology were captured. Generalized linear models, negative binomial regression, logistic regression, and linear regression were used as appropriate for multivariate analyses. RESULTS: A total of 379 patients met inclusion criteria and had data at 1-year follow-up after their baseline visit (192 GTC+ and 187 GTC-). Although DRE patients experiencing GTC seizures had fewer seizures per day over the preceding 6 months than those not experiencing GTC seizures, seizure severity and levels of depression and anxiety were greater. GTC+ patients who reported five or more seizures in the preceding 4 weeks had 82% lower odds (1-0.18 = 0.82) of working than patients with no seizures. SIGNIFICANCE: Patients with DRE experience a significant burden and decreased quality of life. Multivariate analysis is necessary to understand the complex relationship between seizure type, frequency, and impact on health-related quality of life (HRQoL) and changes over time. Effective treatments to reduce the burden for DRE patients who experience GTC seizures continue to be needed.

Economic burden of comorbid insomnia in 5 common medical disease subgroups.

STUDY OBJECTIVES: Approximately 85% of insomnia co-occurs with other disorders. Whereas insomnia was once considered "secondary" to these disorders, it is now widely recognized as an independent condition warranting treatment. While it is clear that insomnia can affect the course of other medical conditions, there is scant literature on the economic impact of comorbid insomnia among patients with common medical conditions. The aim of this study was to determine the economic burden of comorbid insomnia in 5 medical diseases commonly associated with insomnia: type 2 diabetes mellitus (T2DM), cancer undergoing treatment, menopause undergoing hormone replacement therapy, osteoporosis, and Alzheimer's disease and related dementias (ADRDs). METHODS: This retrospective cohort study used claims data from the IBM MarketScan Commercial and Medicare Supplemental Databases from January 1, 2014, through December 31, 2019. Insomnia and comorbid disease groups were defined using physician-assigned International Classification of Diseases diagnostic codes. Insomnia medication treatment was defined based on ≥1 prescription fills for the most commonly prescribed insomnia medications (zolpidem, low-dose trazodone, and benzodiazepines [as a class]). For each comorbid disease subgroup, 4 cohorts were created: (1) patients with either treated or untreated insomnia, (2) non-sleep-disordered controls, (3) patients with untreated insomnia, and (4) patients with treated insomnia. RESULTS: Sample sizes for individuals with comorbid insomnia ranged from 23,168 (T2DM) to 3,015 (ADRDs). Within each disease subgroup and relative to non-sleep-disordered controls, patients with comorbid insomnia demonstrated greater adjusted health care resource utilization and costs across most points of service. Likewise, relative to individuals with untreated insomnia, those with treated insomnia generally demonstrated greater adjusted health care resource utilization and costs. CONCLUSIONS: In this national analysis, both untreated comorbid insomnia and comorbid insomnia treated with commonly prescribed insomnia medications were associated with increased health care resource utilization and costs across most points of service. CITATION: Wickwire EM, Juday TR, Kelkar M, Heo J, Margiotta C, Frech FH. Economic burden of comorbid insomnia in 5 common medical disease subgroups. J Clin Sleep Med. 2023;19(7):1293-1302.

Benzodiazepine Usage, Healthcare Resource Utilization, and Costs Among Older Adults Treated with Common Insomnia Medications: A Retrospective Cohort Study.

Background: Benzodiazepines are commonly prescribed for insomnia management but are often associated with negative safety outcomes such as falls and abuse, particularly among older adults. Objective: The purpose of this real-world study was to compare the impact of benzodiazepines, low-dose trazodone, and zolpidem immediate release (IR) on healthcare resource utilization (HCRU), and costs among older adults (age ≥ 65 years) with insomnia in the US. Methods: Using the IBM MarketScan Medicare Supplemental Database, older adults with >1 physician-assigned diagnosis of insomnia and treated with benzodiazepines were matched 1:1 on age, sex, and index-date to individuals treated with trazodone, and separately matched 1:1 on age and sex, to individuals treated with zolpidem immediate release (IR). Between-groups differences were analyzed using general linear models (GLMs) that controlled for multiple confounders. Results: Significant between-groups differences in HCRU and costs were observed such that relative to zolpidem IR and separately relative to low-dose trazodone, benzodiazepines were consistently associated with worsened outcomes. Conclusion: These findings build upon and extend prior knowledge on the negative impact of benzodiazepines and suggest directions for future research.

The age-specific comorbidity burden of mild cognitive impairment: a US claims database study.

BACKGROUND: Identifying individuals with mild cognitive impairment (MCI) who are likely to progress to Alzheimer's disease and related dementia disorders (ADRD) would facilitate the development of individualized prevention plans. We investigated the association between MCI and comorbidities of ADRD. We examined the predictive potential of these comorbidities for MCI risk determination using a machine learning algorithm. METHODS: Using a retrospective matched case-control design, 5185 MCI and 15,555 non-MCI individuals aged ≥50 years were identified from MarketScan databases. Predictive models included ADRD comorbidities, age, and sex. RESULTS: Associations between 25 ADRD comorbidities and MCI were significant but weakened with increasing age groups. The odds ratios (MCI vs non-MCI) in 50-64, 65-79, and ≥ 80 years, respectively, for depression (4.4, 3.1, 2.9) and stroke/transient ischemic attack (6.4, 3.0, 2.1). The predictive potential decreased with older age groups, with ROC-AUCs 0.75, 0.70, and 0.66 respectively. Certain comorbidities were age-specific predictors. CONCLUSIONS: The comorbidity burden of MCI relative to non-MCI is age-dependent. A model based on comorbidities alone predicted an MCI diagnosis with reasonable accuracy.

Incremental health care resource use and costs among adult patients with depression and treated for insomnia with zolpidem, trazodone, or benzodiazepines.

OBJECTIVE: To quantify health care resource utilization (HCRU) and costs associated with insomnia treated with commonly prescribed insomnia medications among patients with depression. METHODS: A retrospective cohort study was conducted using IBM MarketScan Commercial and Medicare Supplemental Databases to identify adults with: (1) ≥1 ICD-9/ICD-10 code for depression; (2) ≥1 commonly prescribed medication for insomnia (zolpidem immediate release [IR], zolpidem extended release [ER], trazodone, or benzodiazepines); and (3) ≥12 months of eligibility before and after initiating insomnia medication. A 1:1 age- and sex-matched control cohort with depression but without sleep-related disorders was identified. Adjusted HCRU and costs were compared using generalized linear models. RESULTS: A total of 21,027 patients (mean age = 48.3 years, 69.5% female) with depression and treated insomnia (D + TI; 1.9% zolpidem ER, 32.0% zolpidem IR, 50.0% trazodone, 16.1% benzodiazepines) were matched to controls. Although mean number of inpatient visits were similar (0.1 for both), relative to controls, D + TI had a higher mean number of ED (0.2 vs 0.1, p < .001) and outpatient visits (2.2 vs 1.3, p < .001). Adjusted total costs per patient per month were higher among D + TI patients ($2450 vs $1095, p < .001). Inpatient and ED costs were higher among patients prescribed zolpidem IR, trazodone, or benzodiazepines, but not zolpidem ER. CONCLUSIONS: Relative to controls with depression but without sleep disorders, overall, health care costs for adults with D + TI were 2.2-fold higher; costs and HCRU varied by insomnia medication. Further study of the impact of newer insomnia treatments on patient outcomes in depression and comorbid insomnia is warranted.

Cardiac events and economic burden among patients with hypertension and treated insomnia in the USA.

Background: Cardiovascular (CV) event risk, healthcare resource utilization (HCRU) and costs have not been elucidated among hypertension patients with treated insomnia (H + TI). Materials & methods: Adult patients with H + TI were identified in IBM MarketScan databases. H + TI patients were matched 1:1 on age and sex to controls with hypertension but without sleep disorders. Multivariable models were used to estimate associations between treated insomnia and CV event risk, HCRU and costs. Results: In total, 81,502 H + TI patients (mean age = 62 years, 53% female) were matched. Relative to controls, H + TI patients were 2.4 times as likely to have CV events. H + TI patients incurred higher costs per patient per month (US$2343 vs US$1013). Conclusion: Treated insomnia was associated with higher costs and HRCU in hypertension patients.

Patient-Reported Outcome Measures in Adult Patients Diagnosed with Epilepsy Being Treated with Perampanel.

BACKGROUND: Epilepsy is a complex disorder that can affect patients' medical, psychological, and social well-being. The purpose of this study was to evaluate the patient-reported outcome (PRO) measures of health-related quality of life (HRQoL), satisfaction, and adherence in adult patients diagnosed with epilepsy treated with perampanel in the United States (US). METHODS: A US-based, multicenter, observational cross-sectional survey was completed by 61 patients taking perampanel with or without other antiseizure medications (ASMs). Respondents were ≥18 years old, had a physician-confirmed diagnosis of epilepsy, used perampanel for ≥4 months, and provided informed consent. Patients responded to questions concerning their demographic characteristics, treatment history, experiences before perampanel, experiences while taking perampanel, HRQoL, treatment satisfaction, and medication adherence. RESULTS: Patients (N=61) were 42.8 years old on average; majority were female (63.9%) and white (75.4%). Mean time on perampanel was 2.5 years, with sodium channel blockers often (55.7%) used concomitantly with perampanel. Patients reported, on average, 5.5 (standard deviation [SD]=13.2) seizures/month after initiating perampanel, whereas these same patients reported experiencing 20.4 (SD=60.0) seizures/month prior to perampanel. When comparing their experience on perampanel with their experience with previous ASMs, more patients "strongly agreed" that perampanel allowed them to live a more normal life (36.1% vs 27.5%) and worked as intended if they missed taking a dose (16.4% vs 7.8%). Average satisfaction scores were high, with ratings of 71.8 for effectiveness, 84.0 for convenience, and 71.9 for global satisfaction (0-100 scores). Perampanel use was associated with improvements in HRQoL and fewer symptoms of depression and anxiety. The majority of patients were adherent (62.3%) to perampanel. DISCUSSION: Perampanel use was associated with reductions in number of seizures, better HRQoL, and high adherence rates. These results provide initial evidence that perampanel can be an effective, tolerable, and valid option for patients with epilepsy in the real world.

Fall Risk, Healthcare Resource Use, and Costs Among Adult Patients in the United States Treated for Insomnia with Zolpidem, Trazodone, or Benzodiazepines: A Retrospective Cohort Study.

INTRODUCTION: Falls are a common cause for morbidity and mortality among patients taking prescription insomnia medication. The objective of this study is to compare the risk of falls, all-cause healthcare resource utilization (HCRU), and costs among patients treated with commonly used, older generation insomnia medications and non-sleep-disordered controls. METHODS: This retrospective cohort study used the IBM® MarketScan® Commercial and Medicare Supplemental Databases to identify patients aged at least 18 years treated with commonly prescribed medications for insomnia (zolpidem, trazodone, benzodiazepines) between 1 January 2012 and 30 September 2017. The insomnia-treated cohort were age- and sex-matched (1:1) to non-sleep-disordered controls. Odds ratios (ORs) compared risk of falls in each cohort, adjusting for covariates. Costs were adjusted to 2018 dollars, the most recent year for the study data. RESULTS: Relative to matched controls (n = 313,086), the insomnia-treated cohort had a higher rate of falls (3.34% vs. 1.33%), and higher risk of falls [OR = 2.36 (95% confidence interval 2.27-2.44)]. Relative to other index treatments, patients treated with trazodone had the greatest risk of falls. Compared with matched controls, the estimated mean number of inpatient visits, emergency department visits, outpatient visits, and mean length of inpatient stay were all significantly higher among patients treated for insomnia. Such patients incurred greater total costs per patient per month than matched controls ($2100 versus $888; estimated mean ratio, 2.36; 95% CI 2.35-2.38; p < 0.0001). CONCLUSIONS: Relative to matched controls, the insomnia-treated cohort showed higher risk of falls with greater HCRU and costs. Each outcome measured was highest among patients treated with trazodone, relative to other index treatments. Findings suggest the need for new treatment options to optimize quality of care for patients with insomnia.

Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed.

Objective: To describe lemborexant for the treatment of insomnia (DSM-5) in adults using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).Methods: Lemborexant data were obtained from two Phase 3 trials conducted 2016-2018. Efficacy was assessed using different categorical definitions for response, and tolerability was assessed by evaluating rates of adverse events (AEs). Direct comparisons were made with zolpidem extended release (ER), and indirect comparisons were made with other hypnotic agents, including suvorexant, doxepin, ramelteon, zolpidem immediate release, eszopiclone, zaleplon, and selected benzodiazepines, using data from published reports and regulatory documents.Results: Lemborexant had a clinically relevant magnitude of therapeutic effect, as evidenced by NNT values versus placebo as robust as 3 (95% CI, 2-3). In general, NNH values for lemborexant versus placebo were ≥ 10, suggesting that lemborexant is relatively tolerable. Somnolence was the most common AE, with NNH estimates of 28 (95% CI, 18-61) and 15 (95% CI, 11-22) for lemborexant 5 mg and 10 mg, respectively. Rates of discontinuation of lemborexant because of an AE were low, and for lemborexant 5 mg the rate was lower than that for placebo. LHH contrasting the statistically significant endpoint efficacy measures versus discontinuation because of an AE ranged from 13 to 54. NNT values for lemborexant were generally more robust than for zolpidem ER for the polysomnography and sleep diary outcomes. In indirect comparisons, NNT data for the other hypnotics demonstrated effect sizes that were generally similar to those for lemborexant.Conclusions: In Phase 3 trials, the benefit-risk ratio for lemborexant is favorable as measured by NNT, NNH, and LHH.Trial Registration: ClinicalTrials.gov identifiers: NCT02783729, NCT02952820.

The development of the Herpes Symptom Checklist and the Herpes Outbreak Impact Questionnaire.

OBJECTIVE: To develop measures of the day-to-day symptomatic and functional impact of recurrent genital herpes (RGH) outbreaks. The Herpes Outbreak Impact Questionnaire (HOIQ) and the Herpes Symptom Checklist (HSC) were designed to be acceptable to clinical professionals and to reflect patients' experience. METHODS: Scale content was derived via literature review and interviews with RGH patients and physicians. Questionnaires were assessed for face/content validity in the UK and the language checked for acceptability in the United States. The US measures were assessed for face/content validity with patients. Scaling/psychometric properties were determined via web survey. Participants completed the questionnaires twice during an outbreak, with 24 to 72 hours between administrations. RESULTS: Respondents found the questionnaires relevant and easy to understand and complete. Application of Rasch analysis resulted in the removal of two HOIQ items. Both scales were found to be unidimensional. Item stability testing for the HOIQ indicated that the measure is reproducible. Internal consistency was good (alpha: time 1 = 0.87, time 2 = 0.91). Discriminative validity was demonstrated by the measure's ability to distinguish between individuals who differed by self-reported severity of outbreak. The HOIQ and HSC were both responsive to change over time. CONCLUSIONS: The HSC and the HOIQ can determine the impact of a herpes outbreak effectively. They are designed to be used daily during such outbreaks and to determine the effectiveness of RGH treatment.

Budgetary Impact of Telotristat Ethyl, a Novel Treatment for Patients with Carcinoid Syndrome Diarrhea: A US Health Plan Perspective.

PURPOSE: Telotristat ethyl (TE) was recently approved for carcinoid syndrome diarrhea (CSD) in patients not adequately controlled with somatostatin analog long-acting release (SSA LAR) therapy alone. A budget impact model was developed to determine the short-term affordability of reimbursing TE in a US health plan. METHODS: A budget impact model compared health care costs when CSD is managed per current treatment patterns (SSA LAR, reference drug scenario) versus when TE is incorporated in the treatment algorithm (SSA LAR + TE, new drug scenario). Prevalence of CSD, proportion of patients not adequately controlled on SSA LAR, monthly treatment costs (pharmacy and medical), and treatment efficacy were derived from the literature. In the reference drug scenario, an escalated monthly dose of SSA LAR therapy of 40 mg was assumed to treat patients with CSD not adequately controlled on the labeled dose of SSA LAR. In the new drug scenario, TE was added to the maximum labeled monthly dose of SSA LAR therapy of 30 mg. The incremental budget impact was calculated based on an assumed TE market uptake of 28%, 42%, and 55% during Years 1, 2, and 3, respectively. One-way sensitivity analyses were conducted to test model assumptions. FINDINGS: A hypothetical health plan of 1 million members was estimated to have 42 prevalent CSD patients of whom 17 would be inadequately controlled on SSA LAR therapy. The monthly medical cost per patient not adequately controlled on SSA LAR in addition to pharmacotherapy was estimated to be $3946 based on the literature. Based on the observed treatment response in a clinical trial of 20% and 44% for the base case reference and new drug scenarios, total per patient per month costs were estimated to be $7563 and $11,205, respectively. Total annual costs in the new drug scenario were estimated to be $2.3 to $2.5 million during the first 3 years. The overall incremental annual costs were estimated to be $154,000 in Year 1, $231,000 in Year 2, and $302,000 in Year 3. This translated to an incremental per patient per month cost of $0.013, $0.019, and $0.025 for Years 1, 2, and 3. These results remained robust in 1-way sensitivity analyses. IMPLICATIONS: The availability of TE for patients not adequately controlled on SSA LAR therapy provides a novel treatment option for CSD. This model showed that providing access to this first-in-class oral agent would have a minimal budget impact to a US health plan.

Health Care Utilization and Costs Associated with Nausea and Vomiting in Patients Receiving Oral Immediate-Release Opioids for Outpatient Acute Pain Management.

INTRODUCTION: Nausea and vomiting (NV) are common side effects of opioid use and limiting factors in pain management. This study sought to quantify the frequency of antiemetic prescribing and the impact of NV on health care resource utilization and costs in outpatients prescribed opioids for acute pain. The perspective was that of a commercial health plan. METHODS: Medical and pharmacy claims from IMS PharMetrics Plus were used to identify patients initiating opioid therapy with a prescription for an oxycodone-, hydrocodone- or codeine-containing immediate-release product for acute use (≤15-day supply) between October 1, 2013 and September 30, 2014. Patients with a medical claim for NV (International Classification of Diseases, Ninth Revision, Clinical Modification codes 787.0x), with or without an antiemetic prescription fill, were compared with patients with no NV claim or antiemetic prescription fill to assess differences in all-cause health care utilization and costs over 1 month. Propensity score matching (PSM) was used to adjust for between-group differences in baseline patient characteristics. RESULTS: The co-prescribing of opioids with antiemetic agents was 10.2%. After PSM (n = 45,790 per group), patients with NV claims had significantly more hospitalizations (11.5% vs 4.2%), emergency department visits (65.0% vs 12.1%), and physician office visits (85.2% vs 64.5%) compared with patients with no NV claims (all P < 0.0001). Mean total health care costs were higher among patients with a NV claim versus those without evidence of the side effect ($6290 vs $2309; P < 0.0001). Among patients with a recent hospitalization, patients with NV claims had higher rates of 30-day rehospitalization than those with no NV claims (24.4% vs 3.0%; P < 0.0001). CONCLUSIONS: Among outpatients prescribed opioids for management of acute pain, co-prescribing with antiemetics was low, and the economic burden associated with NV was high. Efforts to prevent NV in patients receiving opioid therapy may improve patient outcomes and provide cost savings to the health care system. FUNDING: Daiichi Sankyo, Inc.

Use of valsartan for the treatment of heart-failure patients not receiving ACE inhibitors: a budget impact analysis.

BACKGROUND: Heart failure is a widespread and costly malady. It represents the leading single diagnosis for hospitalized patients. For many heart failure patients, angiotensin-converting enzyme (ACE) inhibitors are either not tolerated or contraindicated, but angiotensin receptor blockers such as valsartan may be a therapeutic option for them. OBJECTIVE: The aim of this study was to prepare a budget impact analysis to assist health plans in evaluating the financial impact of adding valsartan therapy to usual care for heart failure patients not receiving ACE inhibitors. METHODS: A budget impact analysis was developed for a hypothetical US health plan. Model inputs included demographic data, estimates of the prevalence of heart failure and proportion of heart-failure patients not on ACE inhibitors, prevalence of heart failure-related hospitalization, cost data, and resultant health care utilization from the Valsartan Heart Failure Trial (Val-HeFT). Costs and cost savings were reported as year-2001 US dollars. RESULTS: An estimated 1207 of hypothetical 250,000 enrollees were projected to have heart-failure diagnoses, with 603 (50.0%) not receiving ACE inhibitors, and 160 (26.5%) of such patients being hospitalized each year. For valsartan-treated patients, savings due to reduced hospitalizations and shorter length of hospital stay were 1,083,938 US dollars and 221,364 US dollars, respectively. Subtracting the cost of valsartan treatment (629,472 US dollars) from savings yielded projected net savings of 675,830 US dollars per year. Varying patient, treatment, and payer-mix characteristics resulted in projected net savings of $409,598 to 1,350,617 US dollars per year. CONCLUSIONS: Addition of valsartan therapy to usual care in this model analysis resulted in net cost savings among hypothetical heart-failure patients not receiving ACE inhibitors. Substantial cost savings were realized, regardless of variation in model parameters.

The need for improved medical management of patients with concomitant hypertension and type 2 diabetes mellitus.

OBJECTIVES: To determine level of blood pressure (BP) control and to evaluate hypertension management strategies in patients with hypertension and type 2 diabetes mellitus. STUDY DESIGN: Retrospective review of 2 consecutive years of pharmacy and medical insurance claims data and medical charts from patients participating in 10 health plans in 9 states. PATIENTS AND METHODS: Patients 18 years and older with a medical or pharmacy claim related to hypertension were identified and assessed for inclusion in the database. A random sample of medical charts was reviewed to confirm the diagnoses of hypertension and diabetes mellitus and degree of BP control and to assess the prevalence of other cardiovascular disease risk factors and current antihypertensive treatment. RESULTS: Type 2 diabetes mellitus was documented in 977 patients. The mean age was 64.3 years, and 55.1% were women. A BP goal of less than 130/85 mm Hg was achieved in 192 patients (19.7%), and a BP goal of less than 130/80 mm Hg was achieved in 135 patients (13.8%). Fifty-two percent of patients had dyslipidemia, and 87.6% were overweight, obese, or morbidly obese; tobacco use was documented in 19.5%. CONCLUSIONS: Hypertensive diabetic patients are frequently not treated to their goal BP, which requires the use of 2 or more agents in most patients. Quality improvement programs should emphasize the importance of treating hypertensive diabetic patients to their goal BP, as well as controlling other major cardiovascular disease risk factors, such as smoking, dyslipidemia, and overweight or obesity, that are prevalent among these high-risk patients.

Impairment in work productivity and health-related quality of life in patients with IBS.

Irritable bowel syndrome (IBS) is a long-term and episodic medical disorder shown to have an impact on work productivity and health-related quality of life (QOL). The objective of this study was to assess the impact of IBS on work productivity and on health-related QOL in an employed population in the United States and to quantify the cost of these factors to the employer. A 2-phase survey was sent to the workforce of a large US bank to assess the presence of IBS among employees and to measure their work productivity (absenteeism [time lost from work] and presenteeism [reduced productivity at work]) and health-related QOL. Forty-one percent of the 1776 employees responding to both phases of the survey met the Rome II criteria for IBS. Employees with IBS reported a 15% greater loss in work productivity because of gastrointestinal symptoms than employees without IBS and had significantly lower Medical Outcomes Study Short Form 36 (SF-36) scores than those without IBS. IBS was associated with a 21% reduction in work productivity, equivalent to working less than 4 days in a 5-day workweek. Employees with IBS also had significantly lower scores on all domains of the SF-36, indicating poorer functional outcomes. Reduced work productivity and diminished QOL of these magnitudes may have substantial financial impact on employers.

The economic consequences of irritable bowel syndrome: a US employer perspective.

BACKGROUND: The objective of this study was to measure the direct costs of treating irritable bowel syndrome (IBS) and the indirect costs in the workplace. This was accomplished through retrospective analysis of administrative claims data from a national Fortune 100 manufacturer, which includes all medical, pharmaceutical, and disability claims for the company's employees, spouses/dependents, and retirees. METHODS: Patients with IBS were identified as individuals, aged 18 to 64 years, who received a primary code for IBS or a secondary code for IBS and a primary code for constipation or abdominal pain between January 1, 1996, and December 31, 1998. Of these patients with IBS, 93.7% were matched based on age, sex, employment status, and ZIP code to a control population of beneficiaries. Direct and indirect costs for patients with IBS were compared with those of matched controls. RESULTS: The average total cost (direct plus indirect) per patient with IBS was 4527 dollars in 1998 compared with 3276 dollars for a control beneficiary (P<.001). The average physician visit costs were 524 dollars and 345 dollars for patients with IBS and controls, respectively (P<.001). The average outpatient care costs to the employer were 1258 dollars and 742 dollars for patients with IBS and controls, respectively (P<.001). Medically related work absenteeism cost the employer 901 dollars on average per employee treated for IBS compared with 528 dollars on average per employee without IBS (P<.001). CONCLUSION: Irritable bowel syndrome is a significant financial burden on the employer that arises from an increase in direct and indirect costs compared with the control group.

Health-related quality of life in patients treated for hypertension: a review of the literature from 1990 to 2000.

BACKGROUND: The goals of antihypertensive therapy are to achieve and maintain blood pressure control by the least intrusive means possible to prevent future cardiovascular and renal events. To achieve these goals, pharmacologic agents must be chosen so as to minimize drug-related adverse events, increase patient adherence to treatment regimens, and minimize the negative impact on health-related quality of life (HRQL). Although the effects of antihypertensive therapy on HRQL have been extensively investigated, there is little synthesis of the research findings. OBJECTIVE: This review was undertaken to provide a synthesis of the available data on the impact of antihypertensive therapy on HRQL and to provide recommendations for future research. METHODS: A MEDLINE literature search was conducted to identify English-language articles published from 1990 to 2000 that included random assignment to antihypertensive treatment and HRQL as an outcome. In addition, reference lists of published reviews and other trials were reviewed to identify other studies of HRQL and antihypertensive therapy. RESULTS: A total of 48 articles were included in the review. Results among studies were frequently inconsistent, which is likely due to the wide variety of dimensions studied and instruments used as well as a number of methodological weaknesses, including small sample sizes, short-term assessments, and failure to account for missing data. CONCLUSION: A standardized approach to the assessment of HRQL in hypertensive patients is needed so that research in this area can be of value to clinical practice and to hypertensive patients and their families.