Total cost of care of Medicare Advantage beneficiaries participating in an appointment-based model in a national pharmacy chain.

BACKGROUND: The appointment-based model (ABM) is a pharmacy service to improve medication-related health outcomes. ABM involves medication synchronization and medication review, plus other services such as medication reconciliation, medication therapy management, vaccine administration, and multimedication packaging. ABM can improve medication adherence, but the economic impact is unknown. OBJECTIVE: To assess the effect of a national pharmacy chain's ABM program for Medicare Advantage beneficiaries on total cost of care (TCOC). METHODS: This study analyzed administrative claims data from April 7, 2017, through February 29, 2020, for Medicare Advantage beneficiaries with Part D using a propensity score-matched cohort design. The national pharmacy chain provided a list of ABM participants. Eligibility criteria for the ABM and control (non-ABM) groups included age 65 years or older on the index date (initial participation, ABM; random fill date, control) and continuous enrollment from at least 6 months pre-index (baseline) date through at least 6 months post-index (follow-up) date. Medical inflation-adjusted (2020) TCOC was calculated as the sum of all health care spending from Medicare Advantage beneficiaries with Part D plan and patient paid amounts, standardized to per patient per month (PPPM), during the follow-up period. Secondary outcomes included medication adherence calculated across prevalent maintenance therapeutic classes using proportion of days covered (PDC). RESULTS: Each group contained 5,225 patients with balanced characteristics after matching: 64% female, 73% White, mean age 75 years, mean Quan-Charlson comorbidity index score 0.9, and hypertension and dyslipidemia, each >65%. Median baseline all-cause PPPM health care costs in the ABM and control groups, respectively, were $517 and $548 ($221 and $234 medical, $135 and $164 pharmacy). Baseline PDC of at least 80% was 83% in the ABM group and, similarly, 84% in the control group. The mean (SD) follow-up was 604 (155) days for the ABM group and 598 (151) days for the control group. During the follow-up period, the median PPPM TCOC for the ABM group was $656 and was $723 for the control group (P = 0.011). Median pharmacy costs were also significantly less in the ABM group ($161 vs $193, P < 0.001), whereas median medical costs were $328 in the ABM group and $358 among controls (P = 0.254). More patients in the ABM group were adherent during follow-up, with 84% achieving PDC of at least 80% vs 82% among controls (P = 0.009). CONCLUSIONS: The ABM program was associated with significantly lower follow-up median total costs (medical and pharmacy), driven primarily by pharmacy costs. More patients were adherent in the ABM program. Payers and pharmacies can use this evidence to assess ABM programs for their members.

Glycemic and Cost Outcomes among Hispanic/Latino People with Type 2 Diabetes in the USA Initiating Dulaglutide versus Basal Insulin: a Real-World Study.

INTRODUCTION: Optimal glycemic management after diabetes onset remains a challenge in Hispanic/Latino adults with type 2 diabetes (T2D), often resulting in poor health outcomes and higher rates of diabetes-related complications. The aim of this study was to examine and compare demographic and clinical characteristics, glycemic outcomes, health care resource utilization (HCRU), and costs among injection-naïve Hispanic/Latino adults with T2D initiating dulaglutide or basal insulin. METHODS: This retrospective, observational study used administrative claims data from the Optum Research Database. Hispanic/Latino adults with T2D were assigned to dulaglutide or basal insulin cohorts on the basis of pharmacy claims and were propensity-score matched on demographic and baseline characteristics. Measures of glycemic management included 12 month follow-up glycated hemoglobin (HbA1c) and change in HbA1c from baseline. Follow-up all-cause and diabetes-related HCRU and costs, including costs per 1% change in HbA1c, were compared between cohorts. RESULTS: The final propensity-score matched sample included 2872 patients: 1436 patients in each cohort. Mean (SD) reduction in HbA1c from baseline to 12 month follow-up was greater in the dulaglutide cohort compared with the basal insulin cohort [-1.40% (1.88) versus -0.92% (2.07); p < 0.001]. The dulaglutide cohort had significantly lower proportions of patients with ≥ 1 all-cause and diabetes-related outpatient visits, emergency room visits, and inpatient stays compared with the basal insulin cohort (p < 0.05). The dulaglutide cohort had significantly lower all-cause total costs per 1% HbA1c reduction than the basal insulin cohort ($13,768 versus $19,128; p < 0.001). Diabetes-related costs per 1% reduction were numerically lower for the dulaglutide cohort, but the difference was not statistically significant ($9737 versus $11,403; p = 0.081). CONCLUSIONS: Dulaglutide demonstrated better glycemic outcomes and lower all-cause costs per 1% HbA1c reduction among Hispanic/Latino adults compared with those initiating basal insulin. Our real-world findings in the Hispanic/Latino population were consistent with results obtained from the overall population and confirm the glycemic benefits of dulaglutide observed in clinical settings.

Glycemic and Economic Outcomes in Elderly Patients with Type 2 Diabetes Initiating Dulaglutide Versus Basal Insulin in a Real-World Setting in the United States: The DISPEL-Advance Study.

INTRODUCTION: Treatments like glucagon-like peptide-1 receptor agonists carry low hypoglycemia risk and are recommended for elderly patients with type 2 diabetes (T2D), while some routine treatments, like insulin, increase hypoglycemia risk. The DISPEL-Advance (Dulaglutide vs Basal InSulin in Injection Naïve Patients with Type 2 Diabetes: Effectiveness in ReaL World) study compared glycemic outcomes, healthcare resource utilization, and costs in elderly patients with T2D who initiated treatment with dulaglutide versus those initiating treatment with basal insulin. METHODS: This observational, retrospective cohort study used data from the Optum Research Database. Medicare Advantage patients (≥ 65 years) with T2D were assigned to dulaglutide or basal insulin cohorts based on pharmacy claims and propensity score matched on demographic and baseline characteristics. Change in HbA1c, 12-months follow-up HbA1c, and follow-up all-cause and diabetes-related healthcare resource utilization and costs were compared. RESULTS: Propensity score matching yielded well-balanced cohorts with 1891 patients each (mean age: dulaglutide, 72.09 years; basal insulin, 72.56 years). The dulaglutide cohort had significantly greater mean HbA1c reduction from baseline to follow-up than basal insulin cohort (- 0.95% vs - 0.69%; p < 0.001). The dulaglutide cohort had significantly lower mean all-cause and diabetes-related medical costs (all-cause: $8306 vs $12,176; diabetes-related: $4681 vs $7582 respectively; p < 0.001) and lower mean all-cause total costs ($18,646 vs $20,972, respectively; p = 0.007) than basal insulin cohort. The dulaglutide cohort had significantly lower all-cause and diabetes-related total costs per 1% change in HbA1c than basal insulin cohort (all-cause: $19,729 vs $30,334; diabetes-related: $12,842 vs $17,288, respectively; p < 0.001). CONCLUSIONS: Elderly patients with T2D initiating dulaglutide had greater HbA1c reduction, lower mean all-cause medical and total costs, lower diabetes-related medical costs, and lower total all-cause and diabetes-related costs per 1% change in HbA1c than patients initiating basal insulin. Future studies assessing medications that do not increase hypoglycemia risk could help inform therapeutic strategies in elderly patients.

Levothyroxine Treatment Adequacy and Formulation Changes in Patients with Hypothyroidism: A Retrospective Study of Real-World Data from the United States.

Background: The prevalence of hypothyroidism (HT) has increased over time. To assess the effectiveness of treatment, we (1) studied thyrotropin (TSH) levels among patients receiving levothyroxine (LT4) and (2) determined the percentages of patients switching among LT4 formulations. Methods: Data on patients with HT receiving LT4 from the Optum™ Clinical and Claims Database were analyzed from March 2013 through February 2020. Eligible adult patients had ≥1 medical claim with an HT diagnosis and all patients were observed for ≥12 months. Patients included in Objective 1 were indexed on a randomly selected TSH result and had ≥2 results for TSH 1-15 months apart. Patients included in Objective 2 were indexed on a randomly selected LT4 pharmacy claim and had ≥2 LT4 claims ≥1 month apart and ≥1 claim during follow-up. Outcomes were the proportion of patients with low, normal, or high (<0.45, 0.45-4.5, or >4.5 mIU/L, respectively) TSH levels and the proportion of patients switching LT4 formulations, respectively. Data were stratified by age group, sex, and insurance type. All data reported were analyzed using descriptive statistics. Results: Of patients who were in the indexed TSH group, 81.1% [confidence intervals: 80.4-81.8; n/N = 9130/11,259] achieved normal TSH values. When stratified by age group, sex, and insurance type, ≥70% of patients in each of these subgroups exhibited normal mean TSH values at follow-up. For Objective 2 (N = 25,076), 24.9% (N = 6238) of the LT4-indexed group had ≥1 formulation switch in 12 months, of which 67.3% only switched once, and 41.4% (N = 10,370) had ≥1 formulation switch in up to 24 months. A significantly higher proportion of Medicare vs. commercially insured patients had switched formulations (26.2% vs. 23.1%, p < 0.001). Conclusions: Most LT4-treated patients maintain normal TSH levels, which is an improvement vs. previous reports. Continued physician engagement and patient education are advised to further reduce the number of patients who maintain off-target TSH levels. Contrary to clinical recommendations, about 25% of patients receiving LT4 switched formulations within 1 year, with >40% switching within 2 years; among patients who switched, most only switched once.

Burden of illness among patients with dementia-related psychosis.

BACKGROUND: More than 5.6 million Americans suffer from dementia, and that number is expected to double by 2060. This comes at a considerable burden to the health care system with costs estimated at $157-$215 billion in 2010. Depending on dementia type and disease progression, approximately 20%-70% of patients experience dementia-related psychosis (DRP), characterized by hallucinations and/or delusions resulting in worse clinical outcomes and greater caregiver burden compared with patients without DRP. OBJECTIVE: To compare real-world clinical events, health care resource utilization (HCRU), and health care costs among matched cohorts of DRP versus dementia-only patients. METHODS: This retrospective database analysis examined commercial and Medicare Advantage with Part D enrollees aged ≥ 40 years with evidence of DRP and dementia from January 1, 2010, through March 31, 2017. The first observed indicator of psychosis (≥ 2 diagnoses and/or antipsychotic pharmacy fills) co-occurring with or following evidence of dementia (≥ 2 diagnoses and/or dementia medication pharmacy fills) was the index date among patients with DRP. DRP patients were propensity score matched 1:1 to patients with dementia only based on demographics, comorbidities, dementia type, dementia severity, and pre-index all-cause HCRU. Continuous health plan enrollment ≥ 12 months before evidence of dementia through the index date and ≥ 12 months following the index date was required. Outcomes included clinical events, HCRU, and health care costs. RESULTS: A significantly higher percentage of DRP patients had ≥1 diagnosis for behavioral health conditions in the pre-index period compared with dementia-only patients (depression: 32.4% vs. 22.8%; anxiety: 19.1% vs. 11.5%; and insomnia: 9.0% vs. 6.3%; P < 0.001 for all comparisons). Diagnoses of post-index clinical events were significantly more likely among DRP patients compared with dementia-only patients including falls/fractures (28.3% vs. 14.1%), neurologic effects (17.7% vs. 12.9%), sedation (15.0% vs. 2.4%), cardiovascular effects (7.0% vs. 4.1%), and extrapyramidal reactions (3.2% vs. 1.7%; P < 0.001 for all comparisons). Higher percentages of DRP patients had an all-cause outpatient visit (80.2% vs. 68.9%), emergency visit (65.0% vs. 36.6%), or inpatient stay (47.2% vs. 20.0%) during the post-index period (P < 0.001 for all comparisons). The proportions of DRP patients with a post-index dementia-related office visit, outpatient visit, emergency visit, or inpatient stay was 48%, 147%, 339%, and 286% higher, respectively, compared with patients with dementia only. Compared with patients with dementia only, patients with DRP had significantly higher mean total post-index all-cause costs ($21,657 vs. $12,026; P < 0.001) and dementia-related costs ($11,852 vs. $3,013; P < 0.001). CONCLUSIONS: Patients with DRP were more likely to have diagnoses for behavioral health conditions, experience clinical events, and have higher mean all-cause and dementia-related HCRU and costs compared with patients with dementia only. These results reflect the unmet need of patients with DRP and an urgency for new treatment options to reduce substantial clinical and economic burden in this population. DISCLOSURES: This study was funded by Acadia Pharmaceuticals, which participated in the study design, interpretation of study results, and critical review of the manuscript. Abler, Skoog, and Rashid were employees of Acadia Pharmaceuticals at the time this study was conducted. Frazer and Halpern were employees of Optum at the time this study was conducted and were funded by Acadia Pharmaceuticals to conduct the study.

Real-world cost of treatment for multiple sclerosis patients initiating and receiving infused disease-modifying therapies per recommended label in the United States.

Aims: The study evaluated the real-world cost of treatment in multiple sclerosis (MS) patients initiating infused disease-modifying-therapies (DMT) in the United States.Materials and Methods: This retrospective cohort study using administrative claims data included adult patients with MS initiating index infusion DMT (ocrelizumab (OCR), natalizumab (NTZ) or alemtuzumab (ATZ)) from April 2017-September 2018 with 6-months pre/12-months post-index continuous enrollment. The primary cohort included patients who had prescribed annual dosing visits indicated by the approved product label (PL): 3 OCR, 5 ATZ, and 12-13 NTZ infusion visits within the first year of initiation. Annual treatment cost was the sum of all costs on index DMT infusion visit dates. Costs were summarized for a primary and secondary cohort of patients receiving additional doses than prescribed in PL (>3 OCR, >5 ATZ, and >13 NTZ infusion visits); and an overall cohort of patients who met minimum required annual dose (≥3 OCR, ≥5 ATZ, and ≥12 NTZ), further stratified by insurance type.Results: For patients in the primary cohort (123 OCR, 18 ATZ, and 48 NTZ), mean (standard-deviation) annual cost of treatment with OCR, ATZ, and NTZ cohorts was $72,066 ($34,480), $121,053 ($51,097) and $93,777 ($38,815), respectively. Among patients initiating OCR and NTZ, 15 and 6% respectively, had additional infusion visits leading to greater costs. Mean annual costs of index infusion DMT treatment in the overall cohort (162 patients treated with OCR, 18 with ATZ, 56 with NTZ) were $80,582, $121,053, and $93,807, respectively. The mean costs for commercial enrollees were higher than those for MAPD enrollees.Limitations: Small sample size, limited population generalizability, and cost-reduction for ATZ beyond the second year need to be accounted for.Conclusions: Real-world infusion DMT treatment costs for commercially insured patients were higher than perceived expenditures based on wholesale acquisition cost and administration costs via a physician-fee schedule. Consideration of real-world costs in cost-effectiveness and treatment/coverage decisions is needed.

Hospitalization risk in bipolar disorder patients treated with lurasidone versus other atypical antipsychotics.

OBJECTIVE: This observational study compared the risk of hospitalization for patients with bipolar disorder when treated with lurasidone versus other oral atypical antipsychotics. METHODS: This US commercial claims analysis (4 April 2010 through 24 September 2014) used the Optum Research Database to identify adult patients with bipolar disorder treated with oral atypical antipsychotics (N = 11,132). The first claim for an atypical antipsychotic defined the index date, with pre-index and post-index periods of 180 and 360 days, respectively. Every month of the post-index period was categorized as monotherapy treatment with lurasidone, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, no/minimal treatment or other. Starting with the initial month of treatment, the risk of psychiatric or all-cause hospitalization in the subsequent month was examined based on treatment in the current month and pre-index covariates (age, gender, hospitalizations, emergency room visits, diagnoses for anxiety, alcohol abuse, substance abuse, hypertension, type 2 diabetes and obesity) and time-varying versions of the pre-index covariates using a marginal structural model. RESULTS: After controlling for covariates, relative to lurasidone, the odds of psychiatric and all-cause hospitalization, respectively, were 2-3 times higher for olanzapine (odds ratio [OR] = 2.78, CI 1.09, 7.08, p = .032; OR = 3.20, CI 1.24, 8.26, p = .016), quetiapine (OR = 2.80, CI 1.13, 6.95, p = .026; OR = 3.23, CI 1.29, 8.11, p = .013), risperidone (OR = 2.50, CI 1.01, 6.21, p = .048; OR = 2.79, CI 1.11, 7.02, p = .029), aripiprazole (OR = 2.13, CI 0.87, 5.20, p = .097; OR = 2.57, CI 1.04, 6.37, p = .041) and ziprasidone (OR =2.31, CI 0.91, 5.85, p = .079; OR = 2.49, CI 0.97, 6.40, p = .058). CONCLUSIONS: In this claims database analysis, lurasidone-treated patients with bipolar disorder had a significantly lower risk of psychiatric hospitalization compared to quetiapine, olanzapine and risperidone, but not aripiprazole or ziprasidone. Lurasidone-treated patients had a significantly lower risk of all-cause hospitalization compared to quetiapine, olanzapine, risperidone and aripiprazole, but not ziprasidone.

Using electronic health records to estimate the prevalence of agitation in Alzheimer disease/dementia.

BACKGROUND: Agitation is a common neuropsychiatric symptom of Alzheimer disease (AD). Data are scarce regarding agitation prevalence among community-dwelling patients with AD. OBJECTIVE: To estimate agitation prevalence in a sample of US patients with AD/dementia overall and by AD/dementia disease severity, using data from electronic health records (EHR). METHODS: This retrospective database study examined community-dwelling patients with ≥1 EHR record indicating AD/dementia from January 2008 to June 2015 and no evidence of non-Alzheimer dementia during the 12-month preindex and postindex periods. Agitation was identified using diagnosis codes for dementia with behavioral disturbance and EHR abstracted notes records indicating agitation symptoms compiled from the International Psychogeriatric Association provisional consensus definition. RESULTS: Of 320 886 eligible patients (mean age, 76.4 y, 64.7% female), 143 160 (44.6%) had evidence of agitation during the observation period. Less than 5% of patients with agitation had a diagnosis code for behavioral disturbance. The most prevalent symptom categories among patients with agitation, preindex and postindex, were agitation (31.4% and 41.3%), falling (22.6% and 21.7%), and restlessness (18.3% and 23.3%). Among the 78 827 patients (24.6%) with known AD/dementia severity, agitation prevalence was 61.3%. Agitation during the observation period was most prevalent for moderate-to-severe and severe AD/dementia (74.6% and 68.3%, respectively) and lowest for mild AD/dementia (56.4%). CONCLUSIONS: Agitation prevalence was 44.6% overall and 61.3% among patients with staged AD/dementia. Behavioral disturbance appeared to be underdiagnosed. While agitation has previously been shown to be highly prevalent in the long-term care setting, this study indicates that it is also common among community-dwelling patients.

Sacroiliac joint fusion health care cost comparison prior to and following surgery: an administrative claims analysis.

PURPOSE: To assess real-world expenditures on surgical and non-surgical treatment for sacroiliac joint (SIJ) pain by comparing direct health care costs before and after surgery in patients who underwent an SIJ fusion (SIJF) procedure. MATERIALS AND METHODS: This retrospective observational study examined administrative claims data (January 1, 2010 to February 28, 2017) for adult commercial health plan members with a medical claim for SIJF. Identified patients were included if they had continuous enrollment in the health plan for 12 months pre-SIJF (baseline period) and 12 months post-SIJF (follow-up period). The outcomes of interest were low back pain-related health care costs in the first three quarters of the baseline period (pre-surgery period; excludes the quarter immediately preceding surgery) and last three quarters of the follow-up period (post-surgery period; excludes the quarter in which SIJF was performed). RESULTS: Some 302 patients met inclusion criteria: 159 patients had the index SIJF in an inpatient hospital setting, 122 in an outpatient hospital setting, 18 in a surgery center, and three in other settings. Mean and median costs in the pre-surgery period were US$16,803 and US$5,849, respectively, and US$13,297 and US$2,269 in the post-surgery period. Median costs were significantly different in the pre- and post-surgery periods (P<0.001), while mean costs were not. Median health care costs in the pre-surgery and post-surgery periods were lower than the corresponding means due to the highly skewed nature of the cost data. CONCLUSION: This health care claims data analysis shows the potential for lower post-operative health care costs compared to pre-operative costs in patients undergoing SIJF. Median low back pain-related costs in the post-surgery period were approximately US$400 per quarter overall and US$250 per quarter for those undergoing SIJF in the non-inpatient setting. Future studies with larger sample sizes and longer follow-up will improve the precision of the cost data.

The challenges of assessing effectiveness of lacosamide using electronic medical record databases.

PURPOSE: Electronic health record (EHR) databases are a potential source for conducting research to generate real world evidence on patient outcomes. The objective of the study was to evaluate the feasibility of using EHR data to assess seizure outcomes in patients treated with lacosamide (LCM) monotherapy. METHODS: This was a retrospective cohort study conducted using the Optum clinical EHR database. The study sample comprised patients ≥17 years of age with epilepsy or seizures and treated with LCM monotherapy between 1 January 2009 and 31 December 2013. Structured and unstructured data from prescribed medication and abstracted physician note records were used to identify patients with epilepsy treated with LCM monotherapy and measure seizure frequency outcomes. The index date was the first date of LCM monotherapy, with a 6-month baseline period. Patients were observed for up to 12 months beginning on the index date (follow-up period). The EHR data were not sufficient to compute days supply and explicit duration of LCM and other antiepileptic drug (AED) therapies; therefore, LCM monotherapy was estimated from prescription dates of AEDs. Outcomes were change in seizures per month or change in seizure frequency category from baseline to follow-up. Descriptive statistics were used to describe baseline characteristics and study outcomes. RESULTS: A total of 10,988 patients with at least one LCM prescription were identified during the study period, 470 of whom met all the selection criteria and were included in the study sample. Although many patients had abstracted physician note records that referred to their seizures, only 3.2% of the patients had seizure frequency information that could be used to quantify the number of seizures per month in both the baseline and follow-up periods; thus, this information could not be used to assess the effectiveness of LCM monotherapy on seizure outcomes. CONCLUSION: Lacosamide monotherapy effectiveness was not estimated because the EHR prescription record data did not have sufficient information on days supply. Additionally, most patients' records did not contain adequate information to allow for evaluation of quantitative changes in seizure frequency based on the number of seizures per month. More studies are needed to validate these study findings.

Adherence, persistence, and discontinuation among Hispanic and African American patients with multiple sclerosis treated with fingolimod or glatiramer acetate.

OBJECTIVE: Few studies have examined compliance to disease-modifying therapies (DMTs) for multiple sclerosis (MS) in minority populations. This study compared adherence, discontinuation, and persistence for fingolimod (FTY) and glatiramer acetate (GA) initiators among Hispanic and African American patients with MS. METHODS: This retrospective claims data study examined Hispanic and African American adults with MS who initiated FTY or GA between September 1, 2010 and June 30, 2014. Outcomes (adherence, discontinuation, and persistence) were analyzed descriptively and with multivariable models, comparing FTY and GA cohorts within racial/ethnic groups. Adherence was assessed using medication possession ratio (MPR) and proportion of days covered (PDC). RESULTS: There were 171 patients in the Hispanic group (62 FTY, 109 GA) and 210 in the African American group (71 FTY, 139 GA). A larger proportion of GA initiators than FTY initiators were treatment-naïve; other baseline characteristics were similar between cohorts. Hispanic FTY initiators had greater mean MPR, PDC, and persistence and less discontinuation than GA initiators. African American FTY initiators had greater mean PDC than GA initiators; other outcomes favored FTY but were not statistically significant. Multivariable analysis results were consistent with the unadjusted results, but differences between treatment cohorts were not statistically significant. CONCLUSIONS: Hispanic and African American patients with MS who initiated FTY had higher adherence than those who initiated GA, similar to the general MS population. These findings suggest that adherence should be considered in DMT selection, and racial/ethnic variations in MS disease course may not be primarily attributable to differences in DMT compliance.

Healthcare costs for allergic rhinitis patients on allergy immunotherapy: a retrospective observational study.

OBJECTIVE: Subcutaneous immunotherapy (SCIT) for allergic rhinitis (AR) has been shown to control symptoms for up to several years following treatment discontinuation, but the effect of SCIT on healthcare costs for commercially insured patients is unknown. The objective of this study was to compare healthcare costs and resource utilization for patients with AR who received SCIT compared with those who discontinued SCIT shortly after initiation. METHODS: This retrospective cohort study evaluated medical and pharmacy claims from the Optum Research Database from January 2009 through February 2014 for adults and pediatric patients with >7 (continuers) vs. ≤7 (discontinuers) injection visits for SCIT within 60 days of initiation. RESULTS: After 1:1 propensity score matching, each cohort included 6710 patients. Continuers were less likely than discontinuers to use oral corticosteroids (27.7% vs. 29.6%, p = .018), or to have ≥1 respiratory-related emergency room visit (5.4% vs. 6.5%, p = .008) and ≥1 inpatient stay (1.1% vs. 1.7%; p = .002). Continuers were more likely than discontinuers to have ≥1 AR-related office (98.8% vs. 94.6%, p < .001) or outpatient visit (2.4% vs. 1.7%, p = .002). Continuers had greater mean total AR-related costs than discontinuers ($1918 vs. $646, p < .001). Unadjusted mean total respiratory-related costs were lower for continuers than discontinuers, although the difference was not statistically significant ($1589 vs. $1785, p = .077); when adjusted with a generalized linear model, these costs were significantly lower among continuers (p < .001). CONCLUSIONS: Continued SCIT use is associated with decreased emergency room visits and inpatient stays, decreased oral corticosteroid use, and lower respiratory-related costs, compared with early discontinuation.

Patient Characteristics Associated With Use of Lurasidone Versus Other Atypical Antipsychotics in Patients With Bipolar Disorder: Analysis From a Claims Database in the United States.

OBJECTIVE: To compare patient characteristics, medical comorbidities, health care utilization, and health care costs among patients with bipolar disorder who initiated lurasidone versus other atypical antipsychotics in usual clinical practice. METHODS: A retrospective analysis of administrative claims data was conducted using the US Optum Research Database (December 30, 2012, through February 27, 2014). Adult, commercially insured patients with bipolar disorder with an atypical antipsychotic prescription between June 28, 2013, and November 30, 2013, were included. The lurasidone cohort first included any patients with a lurasidone prescription; remaining patients were assigned to their first atypical antipsychotic (aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone). Preindex patient characteristics comparisons to lurasidone were conducted with t tests (continuous variables) and χ² or Fisher exact tests (categorical variables). RESULTS: A total of 3,329 patients were included in this database analysis. A higher percentage of the lurasidone cohort (31.1%) had bipolar depression compared with the other cohorts (23.5%-28.0%). The lurasidone cohort had a statistically significantly higher percentage of patients with prior diabetes mellitus (13.3%) and lipid metabolism disorders (23.2%) than did the quetiapine cohort (8.4% and 16.3%, P < .01). In addition, the lurasidone cohort had significantly more prior antipsychotic polypharmacy (23.0% vs 6.7%-12.9%, P < .01) and atypical antipsychotic use (55.6% vs 11.8%-26.3%, P < .01) than other cohorts. The lurasidone cohort had a statistically significantly higher mean number of prior all-cause and mental health office visits (P < .001) and higher mean prior pharmacy costs than most cohorts (P < .01). CONCLUSIONS: Lurasidone-treated patients with bipolar disorder tended to have a more complex clinical profile, comorbidities, and prior treatment history compared to patients initiated with other atypical antipsychotics in this claims database study. This pattern of treatment may have reflected the overall clinical profile of lurasidone, the role perceived for lurasidone in the therapeutic armamentarium by practitioners, and the recent introduction of lurasidone into clinical practice during the study period.

Major depressive disorder with subthreshold hypomanic (mixed) features: A real-world assessment of treatment patterns and economic burden.

BACKGROUND: To compare outcomes for individuals with major depressive disorder (MDD) with or without subthreshold hypomania (mixed features) in naturalistic settings. METHODS: Using the Optum Research Database (1/1/2009─10/31/2014), a retrospective analysis of individuals newly diagnosed with MDD was conducted. Continuous enrollment for 12-months before and after the initial MDD diagnosis was required. MDD with subthreshold hypomania (mixed features) (MDD-MF) was defined based on ≥1 hypomania diagnosis within 30 days after an MDD diagnosis during the one-year follow-up period, in the absence of bipolar I diagnoses. Psychiatric medication use, healthcare utilization, and costs during the one-year follow-up period were compared using multivariate logistic and gamma regressions, controlling for baseline differences. RESULTS: Of 130,626 MDD individuals, 652 (0.5%) met the operational definition of MDD-MF. Compared to the MDD-only group, the MDD-MF group had more suicidality (2.0% vs. 0.5%), anxiety disorders (46.8% vs. 34.0%), and substance use disorders (15.5% vs. 6.1%, all P<0.001). More individuals with MDD-MF were treated with antidepressants (83.6% vs. 71.6%), mood stabilizers (50.5% vs. 2.7%), atypical antipsychotics (39.0% vs. 5.5%), and polypharmacy with multiple drug classes (72.1% vs. 22.7%, all P<0.001). Individuals with MDD-MF had higher hospitalizations rates (24.2% vs. 10.5%) and total healthcare costs (mean: $15,660 vs. $10,744, all P<0.001). LIMITATIONS: The commercial claims data used were not collected for research purposes and may over- or under-represent certain populations. No specific claims-based diagnostic code for MDD with mixed features exists. CONCLUSIONS: Greater use of mood stabilizers, atypical antipsychotics, polypharmacy, and healthcare resources provides evidence of the complexity and severity of MDD-MF. Identifying optimal treatment regimens for this population represents a major unmet medical need.

Impact of a Novel Cost-Saving Pharmacy Program on Pregabalin Use and Health Care Costs.

BACKGROUND: Pharmacy cost-saving programs often aim to reduce costs for members and payers by encouraging use of lower-tier or generic medications and lower-cost sales channels. In 2010, a national U.S. health plan began a novel pharmacy program directed at reducing pharmacy expenditures for targeted medications, including pregabalin. The program provided multiple options to avoid higher cost sharing: use mail order pharmacy or switch to a lower-cost alternative medication via mail order or retail. Members who did not choose any option eventually paid the full retail cost of pregabalin. OBJECTIVE: To evaluate the impact of the pharmacy program on pregabalin and alternative medication use, health care costs, and health care utilization. METHODS: This retrospective analysis of claims data included adult commercial health plan members with a retail claim for pregabalin in the first 13 months of the pharmacy program (identification [ID] period: February 1, 2010-February 28, 2011). Members whose benefit plan included the pharmacy program were assigned to the program cohort; all others were assigned to the nonprogram cohort. The program cohort index date was the first retail pregabalin claim during the ID period and after the program start; the nonprogram cohort index date was the first retail pregabalin claim during the ID period. All members were continuously enrolled for 12 months pre- and post-index and had at least 1 inpatient claim or ≥ 2 ambulatory visit claims for a pregabalin-indicated condition. Cohorts were propensity score matched (PSM) 1:1 with logistic regression on demographic and pre-index characteristics, including mail order and pregabalin use, comorbidity, health care costs, and health care utilization. Pregabalin, gabapentin and other alternative medication use, health care costs, and health care utilization were measured. The program cohort was also divided into 2 groups: members who changed to gabapentin post-index and those who did not. A difference-in-differences (DiD) analysis was used to compare the between-cohort change in pregabalin and alternative medication use patterns, health care costs, and health care resource utilization from pre- to post-index. The within-cohort change from pre- to post-index was analyzed by McNemar's test (categorical variables) or paired t-test (continuous variables). The Rao-Scott chi-square test (categorical) and general estimating equations (continuous) were used to analyze between-cohort differences at each time point. Differences in program member characteristics of those who changed versus those who did not change to gabapentin post-index were assessed by traditional chi-square test (categorical) or two-sample t-test (continuous variables). RESULTS: A total of 1,218 members in each cohort were PSM. Mean age was 51 years, 76.7% were women, and the most common pregabalin-indicated condition was fibromyalgia (77.6%). After the program start, the mean number of pregabalin claims from mail order and retail combined decreased in the program cohort from 4.7 pre-index to 3.8 post-index, and increased in the nonprogram cohort from 4.7 pre-index to 6.2 post-index (DiD, P < 0.001). Pregabalin mail order use increased from 3.1% to 48.1% of program members versus 2.8% to 9.4% of nonprogram members (DiD, P < 0.001). Program members were also more likely to change to the anticonvulsant gabapentin post-index than were nonprogram members (31.0% vs. 15.9%, P < 0.001). Mean total health care costs were similar between cohorts, and the pre- to post-index change did not differ between cohorts (DiD, P = 0.474). However, mean total pharmacy costs rose from pre-index to post-index by $820 and $790 in the program and nonprogram cohorts, respectively (both P < 0.001); the increase was similar between cohorts (DiD, P = 0.888). Program members who changed to gabapentin had a higher mean comorbidity score (P = 0.001) and greater post-index use of opioids, alternative medications, and health care resources (P < 0.050) than program members who did not change to gabapentin. CONCLUSIONS: The pharmacy program increased mail order use of pregabalin but reduced pregabalin claims from any venue. Program members were more likely to change to gabapentin than were nonprogram members, and those who changed had higher comorbidity, use of alternative medication, and health care resources. Despite increased mail order use for pregabalin and greater change to gabapentin by program members, the pharmacy program was not cost saving with respect to mean pharmacy or total health care costs.

Evaluating Guideline-recommended Pain Medication Use Among Patients with Newly Diagnosed Fibromyalgia.

OBJECTIVES: To compare pain medication treatment changes across cohorts of newly diagnosed patients with fibromyalgia (FM) treated with guideline-recommended medications or opioids. METHODS AND DESIGN: Retrospective claims data analysis examined adult commercial health plan members newly diagnosed with FM (initial diagnosis = index date) from January 2008 to February 2012. Patients had 6-month pre-index and 12-month postindex periods and received pain medication within 6 months postindex; cohorts were based on the first postindex medication. Guideline-recommended medication cohorts were anti-epileptic drug (AED), serotonin-norepinephrine reuptake inhibitor (SNRI), selective serotonin reuptake inhibitor (SSRI), and tricyclic antidepressant (TCA). Short-acting and long-acting opioid (SAO, LAO) cohorts were also identified. Pairwise comparisons with the SAO cohort were conducted. Cox proportional hazards regressions modeled the likelihood of receiving guideline-recommended therapy. RESULTS: The final sample was 96,175 patients (mean age 47.3 years; 72.5% female), distributed into SAO (57%), SSRI (22%), AED (10%), SNRI (6%), TCA (3%), and LAO (2%) cohorts. The SAO cohort had the most discontinuation (49% vs. 6% to 22%, P < 0.01) and the least augmentation (29% vs. 35% to 50%, P < 0.01). Regression analyses indicated that patients with (vs. without) pre-index guideline-recommended medications were 2 to 4 times more likely to receive them postindex. Patients in the opioid cohorts were about half as likely to receive subsequent guideline-recommended medications. CONCLUSIONS: Opioid use was widespread among patients with FM. Once patients received opioids postdiagnosis, the likelihood of receiving guideline-recommended medications was small. These real-world results indicate an opportunity may exist for improved FM management using recommended therapies in clinical practice.

Comparison of Real-world Outcomes Between Patients Treated with Tapentadol ER or Oxycodone CR.

Background: The objective of this study was to compare health care utilization and costs between matched cohorts of chronic pain patients treated with the opioids tapentadol extended release (ER) or oxycodone controlled release (CR). Methods: This retrospective study used claims data from the Optum Research Database. Commercial and Medicare Advantage adult patients with ≥1 prescription fill for oxycodone CR or tapentadol ER between September 1, 2011 and September 30, 2012 were eligible. The date of the first observed oxycodone CR or tapentadol ER claim was the index date. Patients had continuous health plan enrollment for 6 months before and after the index date, ≥ 90 days supply of opioid therapy, and no index drug claims in the preindex period. Patients were propensity score matched in a 1:2 ratio (tapentadol ER : oxycodone CR). Results: The attributes of the matched cohorts (1,120 tapentadol ER and 2,240 oxycodone CR patients) appeared similar. In the 6 month post-index period, lower proportions of the tapentadol ER cohort than the oxycodone CR cohort had ≥1 inpatient stay (14.6% versus 20.5%; p<0.001) and ≥1 emergency department visit (33.4% versus 37.5%; p=0.021). The tapentadol ER compared with the oxycodone CR cohort had higher mean pharmacy costs ($4,263 versus $3,694; p <0.001), lower mean inpatient costs ($3,625 versus $6,309; p<0.001), and lower mean total healthcare costs ($16,510 versus $19,330; p=0.004). Conclusions: During follow-up, total mean healthcare costs were lower among tapentadol ER patients than oxycodone CR patients, and tapentadol ER patients were less likely to have an inpatient admission or emergency department visit.

Adherence associated with oral medications in the treatment of spasticity.

OBJECTIVE: To examine adherence to baclofen, tizanidine, and dantrolene (U.S. Food and Drug Administration-approved oral spasticity medications), and identified determinants of adherence. DESIGN: A retrospective administrative claims data analysis that used medical and pharmacy claims data and enrollment information from a large, national U.S. health plan. SUBJECTS AND METHODS: The subjects were commercial health plan members who initiated treatment on baclofen, tizanidine, or dantrolene from January 1, 2004, through September 30, 2009, and who had stroke, spinal cord injury, traumatic brain injury, cerebral palsy, or multiple sclerosis. Descriptive and logistic regression statistical analyses were performed. MAIN OUTCOME MEASUREMENTS: Outcomes were adherence, measured as continuous medication possession ratio (MPR) and as a binary indicator (MPR ≥0.80, adherent; MPR <0.80, nonadherent), change in oral spasticity medication, and use of nonoral spasticity therapy. RESULTS: The study population included 2840 subjects. Adherence overall was poor: the range of mean unadjusted MPR values was 0.10-0.50, which indicated that, at best, the subjects were adherent to their index spasticity medications for 50% of their treatment periods. Unadjusted overall MPRs for baclofen and tizanidine were 20.4% and 9.1%, respectively. Fewer than 5% of subjects changed oral spasticity medications. The results of logistic regression to identify determinants of adherence showed that subjects treated with tizanidine versus baclofen had 37.4% lower odds of adherence and that subjects with traumatic brain injury versus stroke had 77.5% lower odds of adherence. The odds of adherence increased with age and with preindex contracture or decubitus ulcer. CONCLUSIONS: Adherence to oral spasticity medication was poor irrespective of index spasticity medication or condition. Results from this study indicated that physicians cannot assume that patients are adherent to prescribed oral spasticity medications. A more complete understanding of the reasons behind nonadherence is required.

Medical costs and hospitalizations among patients with depression treated with adjunctive atypical antipsychotic therapy: an analysis of health insurance claims data.

BACKGROUND: Depression is frequently debilitating. The American Psychiatric Association recommends adjunctive atypical antipsychotics as a treatment option when response to antidepressants is inadequate. OBJECTIVE: To compare medical costs and hospitalizations among patients with depression treated with adjunctive aripiprazole, olanzapine, or quetiapine. METHODS: This retrospective analysis used medical and pharmacy claims data and enrollment information from a large US health plan. Patients were adult members of a commercial health plan who were diagnosed with depression (ie, ICD-9-CM 296.2x, 296.3x, or 311) and who received an antidepressant with adjunctive atypical antipsychotic therapy (aripiprazole, olanzapine, or quetiapine) between January 1, 2004, and January 31, 2010. Patients were continuously enrolled for 6-month pre- and 12-month postaugmentation periods. Those with schizophrenia or bipolar disorder were excluded. Postaugmentation outcomes were total and mental health-related medical costs and hospitalizations. Costs and hospitalizations were modeled with generalized linear models (ie, gamma distribution, log link) and logistic regression, respectively. Regressions controlled for dose, demographics, and general and medical health-related health status. RESULTS: A total of 10,292 patients were identified across atypical antipsychotic cohorts: 3849 used aripiprazole, 1033 used olanzapine, and 5410 used quetiapine. Mean (SD) age was 44.1 (11.6) years and 70.3% were female. Compared with patients in the aripiprazole cohort, those in the olanzapine cohort had higher total medical costs (cost ratio [CR] 1.22, 95% CI 1.07-1.39) and higher mental health-related medical costs (CR 1.33, 95% CI 1.11-1.59), as well as higher odds of any (total) hospitalization (OR 1.58, 95% CI 1.30-1.92) and any mental health-related hospitalization (OR 1.81, 95% CI 1.38-2.38). Similarly, the quetiapine cohort had higher total medical costs (CR 1.27, 95% CI 1.16-1.39) and higher mental health-related medical costs (CR 1.23, 95% CI 1.09-1.39), as well as higher odds of any (total) hospitalization (OR 1.65, 95% CI 1.44-1.90) and any mental health-related hospitalizations (OR 1.78, 95% CI 1.45-2.18), compared with the aripiprazole cohort. CONCLUSIONS: Compared with adjunctive olanzapine or quetiapine, adjunctive aripiprazole was associated with lower mean total and mental health-related medical costs and with lower odds of total and mental health-related hospitalizations in patients with depression.

Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin.

BACKGROUND AND OBJECTIVES: There are limited data examining the real-world use of gabapentin and pregabalin for the treatment of post-herpetic neuralgia (PHN). This study examines dosing patterns, therapy outcomes, healthcare utilization and costs of patients with PHN who initiate treatment with gabapentin or pregabalin. METHODS: This was a retrospective administrative claims data analysis from July 2005 to February 2010. Patients with PHN initiating gabapentin or pregabalin (index therapy) from January 2006 to February 2009 were identified and were observed for 12 months after index therapy initiation. Outcomes were mean daily dosages of the index therapy, attainment of minimally effective dosages of gabapentin (≥ 1,800 mg/day) or pregabalin (≥ 150 and ≥ 300 mg/day) persistence, discontinuation, index therapy switching, addition of neuropathic pain medications to index therapy, and healthcare resource use and costs. RESULTS: 1,645 patients were identified. The mean daily dosage was 826 mg for gabapentin and 187 mg for pregabalin. Only 52.6 % of patients initiating gabapentin and 56.9 % initiating pregabalin obtained a refill during the post-index period. Approximately 14 % of patients treated with gabapentin reached the target dosage (1,800 mg/day). For pregabalin, 87 % reached ≥ 150 mg/day and 27 % reached ≥ 300 mg/day. On average, patients took 10 weeks to reach 1,800 mg/day gabapentin, and 5.0 and 9.2 weeks to reach ≥ 150 mg/day and ≥ 300 mg/day pregabalin, respectively. Approximately one-third of patients in both index therapy cohorts added a pain medication; more than half added opioids. The percentage of patients switching from either drug (57 %) or adding a therapy (34 %) were similar between index therapy cohorts; opioids were the most common therapy patients switched to or added. CONCLUSION: It appears that gabapentin and pregabalin are not used effectively to treat PHN. Suboptimal dosing and discontinuation may be associated with supplementary use of other analgesics, especially opioids.