A clinical and economic assessment of adjuvanted trivalent versus standard egg-derived quadrivalent influenza vaccines among older adults in the United States during the 2018-19 and 2019-20 influenza seasons.

BACKGROUND: Clinical evidence supports use of enhanced influenza vaccines in older adults. Few economic outcome studies have compared adjuvanted trivalent inactivated (aIIV3) and standard egg-derived quadrivalent inactivated influenza vaccines (IIV4e). RESEARCH DESIGN AND METHODS: A retrospective cohort study was conducted leveraging deidentified US hospital data linked to claims data during the 2018-19 and 2019-20 influenza seasons. Relative vaccine effectiveness (rVE) was compared in adults aged ≥ 65 years receiving aIIV3 or IIV4e using inverse probability of treatment weighting (IPTW) and Poisson regression. An economic assessment quantified potential real-world cost savings. RESULTS: The study included 715,807 aIIV3 and 320,991 IIV4e recipients in the 2018-19 and 844,169 aIIV3 and 306,270 IIV4e recipients in the 2019-20 influenza seasons. aIIV3 was significantly more effective than IIV4e in preventing cardiorespiratory disease (2018-19 rVE = 6.2%; and 2019-20 rVE = 6.0%) and respiratory disease (2018-19 rVE = 8.9%; and 2019-20 rVE = 10.1%). During the 2018-19 influenza season cardiorespiratory hospitalization cost savings for the aIIV3 population were $392 M, and $221 M for the 2019-20 season. Respiratory hospitalization cost savings for the aIIV3 population were $145 M and $97 M, respectively. CONCLUSIONS: Our findings suggest that aIIV3 provides clinical and economic advantages versus IIV4e in the elderly.

Flu vaccines do not work as well in older adults due to the aging of their immune system. One approach to improving vaccine efficacy is the addition of a substance, or adjuvant, to the vaccine in order to boost an individual's immune response. This study evaluated an adjuvanted vaccine compared to an unadjuvanted vaccine for preventing cardiorespiratory hospitalizations and hospitalization costs. The findings demonstrated that the adjuvanted flu vaccine, compared to the unadjuvanted vaccine, prevented more hospitalizations and greatly reduced associated hospital costs.

Eight-year trends in obesity-related complications and health care cost progression in a US population with obesity: A retrospective cohort study.

AIMS: Obesity-related complications (ORCs) impose a substantial health burden on affected individuals, and economic costs to health care systems. We examined ORCs and the progression of direct health care costs over 8 years, stratified by obesity class. MATERIALS AND METHODS: Adults with obesity were identified in linked US medical records and administrative claims databases. The index date was the first body mass index measurement of 30 to <70 kg/m2 between 1 January 2007 and 31 March 2012; a ≥8-year continuous enrolment post-index was required for inclusion. Diagnosis codes for five specific ORCs and total health care costs were recorded in each year of follow-up. Costs adjusted for clinical and demographic factors were also estimated. RESULTS: Of 28 583 eligible individuals, 17 892 had class I obesity, 6550 had class II obesity and 4141 had class III obesity. From baseline to year 8, the presence of type 2 diabetes and knee osteoarthritis doubled in all obesity classes, with even larger increases for chronic kidney disease and heart failure. Observed and adjusted total health care costs generally increased from the baseline year to year 8. The difference in costs between obesity classes increased over time: at year 1, individuals with class III obesity had 26.8% higher costs than those in class I, but at year 8, this difference was 40.7%. Outpatient costs constituted half of the total observed costs across obesity classes. CONCLUSIONS: ORC rates and health care costs increase over time, and are greater in higher obesity classes. This could be mitigated by approaches that limit obesity progression.

A Real-World Clinical and Economic Analysis of Cell-Derived Quadrivalent Influenza Vaccine Compared to Standard Egg-Derived Quadrivalent Influenza Vaccines During the 2019-2020 Influenza Season in the United States.

BACKGROUND: Cell-derived influenza vaccines are not subject to egg-adaptive mutations that have potential to decrease vaccine effectiveness. This retrospective analysis estimated the relative vaccine effectiveness (rVE) of cell-derived quadrivalent influenza vaccine (IIV4c) compared to standard egg-derived quadrivalent influenza vaccines (IIV4e) among recipients aged 4-64 years in the United States during the 2019-2020 influenza season. METHODS: The IQVIA PharMetrics Plus administrative claims database was utilized. Study outcomes were assessed postvaccination through the end of the study period (7 March 2020). Inverse probability of treatment weighting (IPTW) was implemented to adjust for covariate imbalance. Adjusted rVE against influenza-related hospitalizations/emergency room (ER) visits and other clinical outcomes was estimated through IPTW-weighted Poisson regression models for the IIV4c and IIV4e cohorts and for the subgroup with ≥1 high-risk condition. Sensitivity analyses modifying the outcome assessment period as well as a doubly-robust analysis were also conducted. IPTW-weighted generalized linear models were used to estimate predicted annualized all-cause costs. RESULTS: The final sample comprised 1 150 134 IIV4c and 3 924 819 IIV4e recipients following IPTW adjustment. IIV4c was more effective in preventing influenza-related hospitalizations/ER visits as well as respiratory-related hospitalizations/ER visits compared to IIV4e. IIV4c was also more effective for the high-risk subgroup and across the sensitivity analyses. IIV4c was also associated with significantly lower annualized all-cause total costs compared to IIV4e (-$467), driven by lower costs for outpatient medical services and inpatient hospitalizations. CONCLUSIONS: IIV4c was significantly more effective in preventing influenza-related hospitalizations/ER visits compared to IIV4e and was associated with significantly lower all-cause costs.

Health Care Resource Utilization and Costs for Adults With Mild Traumatic Brain Injury With Chronic Vestibular Impairment.

OBJECTIVE: To quantify the economic burden of all-cause health care resource utilization (HCRU) among adults with and without chronic vestibular impairment (CVI) after a mild traumatic brain injury (mTBI). DESIGN: Retrospective matched cohort study. SETTING: IQVIA Integrated Data Warehouse. PARTICIPANTS: People with mTBI+CVI (n=20,441) matched on baseline age, sex, year of mTBI event, and Charlson Comorbidity Index (CCI) score to people with mTBI only (n=20,441) (N=40,882). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: All-cause health HCRU and costs at 12 and 24 months post mTBI diagnosis. RESULTS: People with mTBI+CVI had significantly higher all-cause HCRU and costs at both time points than those with mTBI only. Multivariable regression analysis showed that, when controlling for baseline variables, costs of care were 1.5 times higher for mTBI+CVI than mTBI only. CONCLUSIONS: People who developed CVI after mTBI had greater overall HCRU and costs for up to 2 years after the injury event compared with people who did not develop CVI after controlling for age, sex, region, and CCI score. Further research on access to follow-up services and effectiveness of interventions to address CVI is warranted.

Comparing the Clinical and Economic Outcomes Associated with Adjuvanted versus High-Dose Trivalent Influenza Vaccine among Adults Aged ≥ 65 Years in the US during the 2019-20 Influenza Season-A Retrospective Cohort Analysis.

The burden of influenza is disproportionally higher among older adults. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent (aIIV3) compared to high-dose trivalent influenza vaccine (HD-IIV3e) against influenza and cardio-respiratory disease (CRD)-related hospitalizations/ER visits among adults ≥65 years during the 2019-2020 influenza season. Economic outcomes were also compared. A retrospective cohort analysis was conducted using prescription, professional fee claims, and hospital data. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding. IPTW-adjusted Poisson regression was used to evaluate the adjusted rVE of aIIV3 versus HD-IIV3e. All-cause and influenza-related healthcare resource utilization (HCRU) and costs were examined post-IPTW. Recycled predictions from generalized linear models were used to estimate adjusted costs. Adjusted analysis showed that aIIV3 (n = 798,987) was similarly effective compared to HD-IIV3e (n = 1,655,979) in preventing influenza-related hospitalizations/ER visits (rVE 3.1%; 95% CI: -2.8%; 8.6%), hospitalizations due to any cause (-0.7%; 95% CI: -1.6%; 0.3%), and any CRD-related hospitalization/ER visit (0.9%; 95% CI: 0.01%; 1.7%). Adjusted HCRU and annualized costs were also statistically insignificant between the two cohorts. The adjusted clinical and economic outcomes evaluated in this study were comparable between aIIV3 and HD-IIV3e during the 2019-2020 influenza season.

Economic Impact of Preoperative Meloxicam IV Administration in Total Knee Arthroplasty: A Randomized Trial Sub-Study.

We evaluated the economic impact associated with preoperative meloxicam IV 30 mg vs placebo administration among adult total knee arthroplasty (TKA) recipients enrolled in Phase IIIB NCT03434275 trial. Data on total hospital costs and length of stay (LOS) obtained from the trial were compared between meloxicam IV 30 mg and placebo groups. Patients in the meloxicam IV 30 mg vs placebo group (n = 93 vs 88) incurred an adjusted $2,266 (95% CI: -$1,035, $5,116; p = 0.1689) lower total hospital costs and an adjusted 8.6% (95% confidence interval [CI]: -2.0%, 18.1%; p = 0.1082) shorter LOS. While statistically non-significant, based on 95% CIs, the results from this sub-study may suggest a favorable impact associated with meloxicam IV 30 mg on hospital costs and LOS.

Healthcare Resource Utilization Among Patients with Focal Seizures Treated with Eslicarbazepine Acetate in the US Long-Term Care Setting: A Retrospective Claims Database Analysis.

INTRODUCTION: The aim of this study was to compare healthcare resource utilization (HCRU) before and after initiation of eslicarbazepine acetate (ESL) in the long-term care (LTC) setting (rehabilitation center, mental health center, LTC non-skilled nursing facility/assisted-living facility, home health, assisted living, nursing home, other/unknown). METHODS: This retrospective analysis used IQVIA's New Data Warehouse, which includes deterministically linked LTC, prescription, and professional fee claims data and IQVIA Hospital Charge Data Master database. The study period was 1 April 2013 to 31 December 2019. The index date was the date of ESL initiation in the LTC setting. Inclusion criteria were: (1) ≥ 1 new ESL prescription between 1 April 2014 and 31 December 2018; (2) diagnosis of focal seizure (FS) during the 12 months pre-index date; and (3) no ESL prescription during the 12-month period pre-index. A 12-month pre-post analysis compared epilepsy-specific and all-cause HCRU before and after ESL initiation. Categorical variables were compared with McNemar's tests. RESULTS: A total of 307 patients (mean age 52.2 years, 57.7% male) with FS were included, of whom 24.8% were in nursing homes. Patients used a mean of 3.1 antiseizure drugs prior to initiation of ESL, and 87.9% of patients initiated ESL as adjunctive treatment. There were significant reductions in proportion of patients with epilepsy specific physician office visits, emergency department (ED) visits, hospitalizations, and all-cause physician office visits and hospitalizations in the post-index period compared to the pre-index period (P < 0.05). Similar results were observed in sensitivity (patients with an epilepsy diagnosis) and subgroup analyses [presence or absence of intellectual developmental disorders or age (≥ 65 and < 65 years)]. CONCLUSION: Proportion of patients with epilepsy-specific physician office visits, ED visits, hospitalizations, and all-cause physician office visits and hospitalizations were significantly reduced following initiation of ESL in patients with FS in LTC.

A retrospective cohort study assessing relative effectiveness of adjuvanted versus high-dose trivalent influenza vaccines among older adults in the United States during the 2018-19 influenza season.

PURPOSE: To evaluate the relative vaccine effectiveness (rVE) against influenza-related hospitalizations/emergency room (ER) visits, influenza-related office visits, and cardio-respiratory disease (CRD)-related hospitalizations/ER visits and compare all-cause and influenza-related costs associated with two vaccines specifically indicated for older adults (≥65 years), adjuvanted (aTIV) and high-dose trivalent influenza vaccine (TIV-HD), for the 2018-19 influenza season. METHODS: A retrospective analysis of older adults was conducted using claims and hospital data in the United States. For clinical evaluations, adjusted analyses were conducted following inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted rVE against influenza-related hospitalizations/ER visits, influenza-related office visits, and any CRD-related hospitalizations/ER visits. For the economic evaluation, treatment selection bias was adjusted through 1:1 propensity score matching (PSM). All-cause and influenza-related costs associated with hospitalizations/ER, physician office and pharmacy visits were adjusted using generalized estimating equation (GEE) models. RESULTS: After IPTW and Poisson regression, aTIV (n = 561,315) was slightly more effective in reducing influenza-related office visits compared to TIV-HD (n = 1,672,779) (6.6%; 95% CI: 2.8-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) in preventing influenza-related hospitalizations/ER visits but more effective in reducing hospitalizations/ER visits for any CRD (2.6%; 95% CI: 2.0-3.2%). In the PSM-adjusted cohorts (n = 561,243 pairs), following GEE adjustments, predicted mean annualized all-cause and influenza-related total costs per patient were statistically similar between aTIV and TIV-HD (US$9676 vs. US$9625 and US$18.74 vs. US$17.28, respectively; both p > 0.05). Finally, influenza-related pharmacy costs were slightly lower for aTIV as compared to TIV-HD ($1.75 vs $1.85; p < 0.0001). CONCLUSIONS: During the 2018-19 influenza season, influenza-related hospitalization/ER visits and associated costs among people aged ≥ 65 were comparable between aTIV and TIV-HD. aTIV was slightly more effective in preventing influenza-related office visits and any CRD event as compared to TIV-HD in this population.

Clinical and Economic Outcomes Associated with Cell-Based Quadrivalent Influenza Vaccine vs. Standard-Dose Egg-Based Quadrivalent Influenza Vaccines during the 2018-19 Influenza Season in the United States.

Non-egg-based influenza vaccines eliminate the potential for egg-adapted mutations and potentially increase vaccine effectiveness. This retrospective study compared hospitalizations/emergency room (ER) visits and all-cause annualized healthcare costs among subjects aged 4-64 years who received cell-based quadrivalent (QIVc) or standard-dose egg-based quadrivalent (QIVe-SD) influenza vaccine during the 2018-19 influenza season. Administrative claims data (IQVIA PharMetrics® Plus, IQVIA, USA) were utilized to evaluate clinical and economic outcomes. Adjusted relative vaccine effectiveness (rVE) of QIVc vs. QIVe-SD among overall cohort, as well as for three subgroups (age 4-17 years, age 18-64 years, and high-risk) was evaluated using inverse probability of treatment weighting (IPTW) and Poisson regression models. Generalized estimating equation models among the propensity score matched sample were used to estimate annualized all-cause costs. A total of 669,030 recipients of QIVc and 3,062,797 of QIVe-SD were identified after IPTW adjustments. Among the overall cohort, QIVc had higher adjusted rVEs against hospitalizations/ER visits related to influenza, all-cause hospitalizations, and hospitalizations/ER visits associated with any respiratory event compared to QIVe-SD. The adjusted annualized all-cause total costs were higher for QIVe-SD compared to QIVc ((+$461); p < 0.05).

Complication-specific direct medical costs by body mass index for 13 obesity-related complications: a retrospective database study.

BACKGROUND: Obesity, a multifactorial disease associated with many severe complications, affects more than 40% of adults in the United States. OBJECTIVE: To quantify the cost burden of 13 obesity-related complications (ORCs), overall and by body mass index (BMI) class. METHODS: Adult patients (aged ≥ 18 years) with ≥ 1 medical claim with an ICD-9/10 diagnosis code for the ORC of interest were identified using linked data from IQVIA's Ambulatory Electronic Medical Records and PharMetrics Plus. Thirteen ORCs were separately assessed (asthma, dyslipidemia, gastroesophageal reflux disease [GERD], heart failure with preserved ejection fraction [HFpEF], hypertension, musculoskeletal pain, obstructive sleep apnea [OSA], osteoarthritis [OA] of the knee, polycystic ovary syndrome [PCOS], prediabetes, psoriasis, type 2 diabetes mellitus [T2DM], and urinary incontinence); ORC cohorts were not mutually exclusive. For each ORC, the first claim identified for the ORC from January 2010-December 2016 was termed the index date. Patients had continuous enrollment in the 1-year pre-index (without a diagnosis code of the specific ORC under study) and the 1-year post-index, with ≥ 1 BMI value in the 6-months pre-index. Patients with underweight (BMI < 18.5 kg/m2) and those with cancer or pregnancy were excluded. Complication-specific costs were identified as claims with a diagnosis code for the ORC (primary position only for hospitalizations) or ORC-specific medications or procedures. Baseline demographic/clinical characteristics and complication-specific costs over the 1-year follow-up were assessed for each ORC cohort, overall and by BMI class (18.5-24.9; 25.0-29.9; 30.0-34.9; 35.0-39.9; ≥ 40 kg/m2). The association between total complication-specific costs and BMI class was assessed by generalized linear regression model for each ORC, adjusting for baseline characteristics. RESULTS: The total number of patients that comprised the ORC cohorts ranged from 1,275 (HFpEF) to 101,784 (musculoskeletal pain). Across ORC cohorts, 41.6% (musculoskeletal pain) to 73.5% (OSA) had obesity (BMI ≥ 30 kg/m2). For 4 ORC cohorts, more than one fifth of patients had class III obesity (BMI ≥ 40 kg/m2): T2DM, OSA, PCOS, and HFpEF. Baseline mean Charlson Comorbidity Index score increased with increasing BMI class for most ORC cohorts. The most costly ORCs overall based on mean total 1-year cost were: OA of the knee ($3,697 [range from normal weight (BMI: 18.5-24.9 kg/m2) to class III obesity: $2,453-$4,518]), HFpEF ($3,586 [range: $3,402-$4,685]), OSA ($2,768 [$2,442-$2,974]), and psoriasis ($2,711 [$2,131-$3,292]). The highest cost differences (≥20%) were observed among those with class III obesity versus those with normal weight for these aforementioned ORCs, as well as for GERD ($1,719 [$1,484-$1,893]) and asthma ($1,531 [$1,361-$1,780]). Following adjustment, most cost comparisons by BMI class were significantly higher versus those for normal weight for 6 ORCs. CONCLUSIONS: ORCs are important drivers of the economic burden of obesity, indicating an unmet need for the treatment of obesity. Appropriate weight management may reduce ORC-associated costs. DISCLOSURES: This study and its publication were supported by Novo Nordisk. Divino, Anupindi, and DeKoven are employed by IQVIA, which received funding from Novo Nordisk for this study. Ramasamy, Eriksen, Olsen, and Meincke are employed by and shareholders of Novo Nordisk. Material reported in this manuscript was presented in an abstract accepted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020, to be published in Value in Health. There was no presentation at ISPOR 2020.

The annual economic burden among patients hospitalized for community-acquired pneumonia (CAP): a retrospective US cohort study.

Objective: To assess the 1-year economic burden among patients hospitalized for community-acquired pneumonia (CAP) in the US.Methods: Adult patients hospitalized for CAP between 1/2012 and 12/2016 were identified from the IQVIA hospital charge data master (CDM) linked to the IQVIA Real-World Data Adjudicated Claims - US Database (date of admission = index date). Patients had continuous enrollment 180-days pre- and 360-days post-index, and empiric antimicrobial treatment (monotherapy [EM] or combination therapy [EC]) and chest x-ray on the index date or day after. All-cause and CAP-related healthcare resource utilization and cost were assessed over the 1-year follow-up. Generalized linear models (GLM) examined adjusted total cost.Results: The cohort comprised 1624 patients hospitalized for CAP (mean age 50.3; 52.8% female). The majority (78.2%) initiated EC, most frequently with beta-lactams + macrolides (30.4%). The index hospitalization was associated with a mean length of stay (LOS) of 5.7 days and mean cost of $17,736; 22.7% had a transfer to the intensive care unit (ICU). All-cause readmission rates at 30- and 180-days were 8.8% and 20.1%, respectively. Mean annual all-cause total cost was $61,928; one-third (33.8%, $20,954) was related to CAP. The primary cost driver was inpatient care, which accounted for more than half (56.0%) of total all-cause cost and 94.3% of total CAP-related cost. Mean total inpatient cost was significantly higher among EC versus EM patients ($37,106 versus $25,999, p = .0399). Adjusted mean total all-cause cost was $55,391.Conclusions: Patients hospitalized for CAP incurred a significant annual economic burden, driven substantially by the high cost of hospitalizations.

The 1-year economic burden of community-acquired pneumonia (CAP) initially managed in the outpatient setting in the USA.

Aim: To assess the annual economic burden of community-acquired pneumonia (CAP) initially managed in the outpatient setting. Patients & methods: Patients with an outpatient diagnosis of CAP between January 2012 and December 2016 were identified from the IQVIA (Danbury, CT & Durham, NC, USA) Real-World Data Adjudicated Claims - US Database. All-cause and CAP-related healthcare resource utilization and costs were assessed over the 1-year follow-up. Generalized linear model examined adjusted total cost. Results: Among 256,916 patients with outpatient CAP, a tenth (10.6%) had ≥1 hospitalization and, of these, 18.7% had ≥1 CAP-related hospitalization. The mean total cost per patient was US$14,372; 10.9% was CAP-related and 26.1% was due to inpatient care. The adjusted mean total all-cause cost was US$13,788. Conclusion: Patients with outpatient CAP incurred a substantial annual economic burden.

Ospemifene versus local estrogen: adherence and costs in postmenopausal dyspareunia.

Aim: Objective was to compare adherence and persistence, as well as direct healthcare costs and utilization, of ospemifene to available local estrogen therapies (LETs). Patients & methods: This retrospective database study used integrated medical and pharmacy claims data from the IQVIA Real-World Data Adjudicated Claims - US Database. Results: Ospemifene patients had significantly greater adherence and persistence compared with the other nonring LETs. Ospemifene had the lowest mean outpatient costs of any of the LET cohorts, including the estradiol vaginal ring. Total all-cause healthcare costs were also significantly less for ospemifene patients compared with all other LETs.

Effect of Weight Change on Economic Outcomes Among Persons with Type 2 Diabetes Mellitus in the United States: Beyond Glycemic Control.

BACKGROUND: Previous studies report weight loss to be associated with significantly lower total health care costs among patients with type 2 diabetes mellitus (T2DM). The effect of weight change on health care costs, independent of glycemic control and after controlling for time-varying covariates among T2DM patients, remains unknown. OBJECTIVE: To evaluate the effect of weight change, independent of glycemic control, on all-cause and T2DM-related health care resource utilization (HCRU) and costs among T2DM patients in the United States. METHODS: A retrospective cohort study was conducted using a linked data extract composed of IQVIA's RWI Data Adjudicated Claims-US and Ambulatory Electronic Medical Record data. Adults (aged ≥ 18 years) with T2DM receiving ≥ 1 oral antidiabetic drug (OAD) medication, glucagon-like peptide-1 receptor agonist (GLP-1RA), and/or short- or long-acting insulin between January 1, 2010, and December 31, 2014 were included (the date of the first observed medical claim with a diagnosis code or medication prescription claim was the index date). Baseline characteristics were evaluated in the 6-month pre-index period. Weight loss (3%, 5%, or 7% from baseline) was evaluated over two 6-month periods (months 1-6 and 7-12) following the index date. Covariates included time-varying weight, hemoglobin A1c (A1c), costs, and HCRU within each 6-month period. Outcomes of interest (all-cause and T2DM-related HCRU and costs) were evaluated in the 6-month (months 13-18) and 12-month (months 13-24) periods following the initial 1- to 6-month and 7- to 12-month post-index periods. Structural nested mean models were used to evaluate the effect of weight change on these outcomes, independent of glycemic control. RESULTS: 1,407 patients were included (mean age = 55 years; 55% male), with a mean baseline weight of 102.2 kg (median = 99.7 kg) and a mean baseline A1c of 7.4% (median = 6.9%). In adjusted analysis, weight loss was associated with significantly lower all-cause and T2DM-related annual total health care costs. Compared with those showing no weight change, a 3%, 5%, and 7% weight loss resulted in approximately $500, $800, and $1,100 in savings, respectively, in all-cause annual total health care costs per patient in the year following the weight loss. Similarly, compared with those with no weight change, a 3%, 5%, and 7% weight loss resulted in approximately $200, $300, and $400 in savings, respectively, in T2DM-related annual total health care costs per patient in the following year. Even greater savings (up to ~$2,000 and ~$800 in all-cause and T2DM-related annual costs per patient, respectively) were experienced by those who lost weight compared with those who gained weight. CONCLUSIONS: After accounting for glycemic control, this study found that weight loss was associated with additional significant reductions in all-cause and T2DM-related annual total health care costs. Understanding the role of weight loss in T2DM may provide useful evidence for decision makers as they evaluate therapy options for T2DM. DISCLOSURES: This study was funded by Novo Nordisk. Dang-Tan, Smolarz, and Iyer are employees of Novo Nordisk. Karkare and DeKoven (employees of IQVIA) and Fridman (employed by AMF Consulting) were contracted by Novo Nordisk to conduct this study. Fridman also reports personal fees from Shire, GSK, and CSL Behring, outside of the submitted work. Lu, an employee of IQVIA, accessed the database and conducted the statistical analysis for this study.

The economic burden of CIDP in the United States: A case-control study.

BACKGROUND: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder of the peripheral nervous system. The economic burden of CIDP is not well understood. OBJECTIVES: To assess the economic and clinical burden of CIDP and to compare the incremental burden relative to a matched control group without CIDP. METHODS: This retrospective case-control analysis was conducted using data from the IQVIA Real-World Data Adjudicated Claims. Adults newly diagnosed with CIDP between 7/1/2010 and 6/30/2014 were identified and direct matched to controls without CIDP. Baseline characteristics were assessed and compared over a 6-month pre-index period. Healthcare resource use, costs and clinical characteristics were assessed and compared over a 2-year follow-up. Total cost differences over the 2-year follow-up were compared between matched cohorts using a generalized estimating equation model. RESULTS: The final sample comprised a total of 790 cases matched to 790 controls. Over the 2-year follow-up, cases more frequently experienced neuropathic pain, back pain and osteoarthritis and more commonly utilized opioids, anti-convulsants and anti-depressants. Compared to controls, more cases had ≥1 hospitalization (26.2% vs. 9.0%), and cases had a higher mean number of outpatient prescription fills (62.8 vs. 32.0) and physician office visits (34.7 vs. 13.0) (all p<0.0001). Cases had 7.5x higher mean total costs ($116,330 vs. $15,586, p<0.0001). Important cost drivers were costs for outpatient ancillary, radiology and HCPCS drugs (mean $76,366 vs. $4,292) and costs for inpatient care (mean $16,357 vs. $2,862) (both p<0.0001). Among cases, CIDP therapy (inclusive of both outpatient pharmacy and medical claims) accounted for 51.2% of mean total costs. After further adjusting for baseline clinical characteristics, cases were associated with a 6.1x increase in total costs compared to controls (p<0.0001). CONCLUSIONS: Our findings suggest a substantial clinical and economic burden among patients with CIDP relative to matched controls over a 2-year follow-up.

Resource utilization and charges of patients with and without diagnosed venous thromboembolism during primary hospitalization and after elective inpatient surgery: a retrospective study.

AIMS: To assess incremental charges of patients experiencing venous thromboembolisms (VTE) across various types of elective inpatient surgical procedures with administration of general anesthesia in the US. METHODS: The authors performed a retrospective study utilizing data from a nationwide hospital operational records database from July 2014 through June 2015 to compare a group of inpatients experiencing a VTE event post-operatively to a propensity score matched group of inpatients who did not experience a VTE. Patients included in the analysis had a hospital admission for an elective inpatient surgical procedure with the use of general anesthesia. Procedures of the heart, brain, lungs, and obstetrical procedures were excluded, as these procedures often require a scheduled ICU stay post-operatively. Outcomes examined included VTE events during hospitalization, length of stay, unscheduled ICU transfers, number of days spent in the ICU if transferred, 3- and 30-day re-admissions, and total hospital charges incurred. RESULTS: The study included 17,727 patients undergoing elective inpatient surgical procedures. Of these, 36 patients who experienced a VTE event were matched to 108 patients who did not. VTE events occurred in 0.2% of the study population, with most events occurring for patients undergoing total knee replacement. VTE patients had a mean total hospital charge of $60,814 vs $48,325 for non-VTE patients, resulting in a mean incremental charge of $11,979 (p < .05). Compared to non-VTE patients, VTE patients had longer length of stay (5.9 days vs 3.7 days, p < .001), experienced a higher rate of 3-day re-admissions (3 vs 0 patients) and 30-day re-admissions (7 vs 2 patients). CONCLUSIONS: Patients undergoing elective inpatient surgical procedures with general anesthesia who had a VTE event during their primary hospitalization had a significantly longer length of stay and significantly higher total hospital charges than comparable patients without a VTE event.

Slow Titration and Delayed Intensification of Basal Insulin Among Patients with Type 2 Diabetes.

BACKGROUND: Clinical inertia in type 2 diabetes mellitus (T2DM) refers to the failure of clinicians to intensify therapy when indicated. Many T2DM patients remain suboptimally controlled after initiating basal insulin. OBJECTIVE: To examine the prevalence of patients treated with basal insulin but in poor glycemic control (hemoglobin A1c [A1c] ≥ 7%) after initiation and subsequent treatment intensification patterns and glycemic outcomes in a real-world setting. METHODS: Adults diagnosed with T2DM newly initiating a basal insulin analog (insulin glargine or detemir) from January 2010 to September 2014 were identified in the QuintilesIMS Real-World Data Adjudicated Claims linked to the QuintilesIMS Real-World Data Electronic Medical Records. Patients were previously naive to insulin and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), were persistent on therapy for ≥ 6 months, and had ≥ 12 months of continuous health plan enrollment after initiation. First treatment intensification (increase in basal insulin dose [of ≥ 10%], addition of bolus insulin, GLP-1 RA, or a new oral antidiabetic drug [OAD]) was assessed among patients in poor glycemic control at 6 months after initiation over the available (minimum ≥ 12-month) follow-up. Subsequent glycemic outcomes and treatment intensification were assessed. Kaplan-Meier (KM) analysis evaluated time-to-treatment intensification and time to A1c goal. RESULTS: Of 427 eligible patients with A1c available at 6 months, 59.3% were male; mean age was 53.9 years; mean follow-up was 29.4 months; and mean dose of the initiated prescription was 29.6 insulin units (U) (median 24U). Six months after initiating basal insulin, 81.0% of patients (n = 346) remained in poor glycemic control, and mean basal insulin dose was 31.0U (median 25U). Most (88.4%; n = 306) of these uncontrolled patients subsequently intensified treatment over the available follow-up. Using KM analysis, these patients intensified treatment in a median of 58 days (range: 17.5 days [GLP-1 RA addition] to 52 days [increase in basal insulin dose]) from the first elevated A1c measurement taken after 6 months, and 72.5% (GLP-1 RA addition) to 91.1% (OAD addition) of patients continued to remain in poor glycemic control at 12 months after intensification. Most patients (66.8%; n = 231/346) first intensified treatment by increasing their basal insulin dose, and mean dose increased to 61.7U (median 38U) at intensification. Six months following basal insulin increase, almost all patients remained on basal insulin therapy and among those with available A1c, 92.1% (140 of 152) were in poor glycemic control. In the subsequent 12 months, only a third (34%) of uncontrolled patients added another antihyperglycemic agent. CONCLUSIONS: The vast majority of patients remained uncontrolled in the 6 months following basal insulin initiation. Basal insulin up-titration was slow and insufficient in the 6 months after initiation, indicating treatment inertia. Subsequently, most patients failed to achieve glycemic targets despite intensification with basal insulin. This finding suggests a substantial unmet need for effective treatment intensification among T2DM patients treated with basal insulin who remain uncontrolled. Improved provider education and guidelines on appropriate intensification are warranted. DISCLOSURES: This study was funded by Novo Nordisk. Mocarski, Guerrero, Langer, and Thorsted are employees and shareholders of Novo Nordisk. Yeaw, Divino, and DeKoven are employed by QuintilesIMS, which received remuneration from Novo Nordisk for work on this study. Study concept and design were contributed by Mocarski, DeKoven, Langer, and Thorsted. Yeaw took the lead in data collection, along with Divino and DeKoven. Data interpretation was performed by Yeaw, Divino, DeKoven, and Guerrero. The manuscript was written by Mocarski and Divino and revised by Guerrero, Langer, and Thorsted, along with Yeaw and DeKoven. Some of the data from this study were presented via poster at the AMCP Annual Meeting in March 2017 and at the 53rd EASD Annual Meeting in September 2017.

Characteristics and treatment patterns among US patients with hairy cell leukemia: a retrospective claims analysis.

AIM: Describe hairy cell leukemia (HCL) treatment patterns using a large, nationally representative US database. PATIENTS & METHODS: Adults newly diagnosed with HCL (1 January 2006 to 30 June 2014) with continuous health plan enrollment ≥180 days pre- and 90 days post-diagnosis were identified from the QuintilesIMS PharMetrics Plus Health Plan Claims Database. Treatment patterns by line of therapy were assessed over the variable follow-up. RESULTS: Among 749 HCL patients (77.4% male; mean age 55.6; mean 32.3 months follow-up), only 37.7% initiated first-line therapy during the available follow-up in a mean of 4.4 months following diagnosis; the majority (75.5%) received cladribine (mean duration 7.3 days). Thirty-eight patients (5.1%) received second-line treatment. CONCLUSION: Over 2.7 years follow-up, more than a third of patients initiated first-line therapy which appeared to provide a long-lasting response.

Orphan Drug Expenditures In The United States: A Historical And Prospective Analysis, 2007-18.

The Orphan Drug Act of 1983 established incentives for the development of drugs that treat rare, or orphan, diseases. We used the IMS Health MIDAS database of audited biopharmaceutical sales to measure US annual spending on orphan drugs in the period 2007-13, and we estimated spending on the drugs for the period 2014-18. We identified 356 brand-name orphan drugs that were approved by the Food and Drug Administration in the period 1983-2013. While we included orphan drugs with both orphan and other indications, we adjusted spending to include only spending for orphan indications. In 2014 dollars, expenditures on orphan drugs totaled $15 billion in 2007 and $30 billion in 2013-representing 4.8 percent and 8.9 percent of total pharmaceutical expenditures, respectively. Our future trend analysis for the period 2014-18 suggests a slowing in the growth of orphan drug expenditures. The overall impact of orphan drugs on payers' drug budgets is relatively small, and spending on orphan drugs as a percentage of total pharmaceutical expenditures has remained fairly stable. Concerns that growth in orphan drug expenditures may lead to unsustainable drug expenditures do not appear to be justified.

Clinical and cost outcomes from different hyaluronic acid treatments in patients with knee osteoarthritis: evidence from a US health plan claims database.

BACKGROUND: Intra-articular injection of hyaluronic acid (HA) for knee osteoarthritis (OA) effectively reduces pain and delays total knee replacement (TKR) surgery; however, little is known about relative differences in clinical and cost outcomes among different HA products. OBJECTIVE: To compare disease-specific costs and risk of TKR among patients receiving different HA treatments in a commercially insured cohort of patients with knee OA in the USA. METHOD: Retrospective analyses using IMS Health's PharMetrics Plus Health Plan Claims Database were conducted by identifying knee OA patients with claims indicating initiation of HA treatment at an 'index date' during the selection period (2007-2010). Patients were required to be continuously enrolled in the database for 12 months preindex to 36 months postindex. A generalized linear model (GLM) with a gamma distribution and log-link function was used to model aggregate patient-based changes in disease-specific costs. A Cox proportional hazards model (PHM) was used to model the risk of TKR. Both multivariate models included covariates such as age, gender, comorbidities, and preindex healthcare costs. RESULTS: 50,389 patients with HA treatment for knee OA were identified. 18,217 (36.2%) patients were treated with HA products indicated for five injections per treatment course (Supartz and Hyalgan). The remainder were treated with HA products indicated for fewer than five injections per treatment course, with 20,518 patients (40.7%) receiving Synvisc; 6,263 (12.4%), Euflexxa; and 5,391 (10.7%), Orthovisc. Synvisc- and Orthovisc-injected patients had greater disease-specific costs compared to Supartz/Hyalgan (9.0%, p<0.0001 and 6.8%, p=0.0050, respectively). Hazard ratios (HRs) showed a significantly higher risk of TKR for patients receiving Synvisc compared to Supartz/Hyalgan (HR=1.069, p=0.0009). Patients treated with Supartz/Hyalgan, Euflexxa, and Orthovisc had longer delays to TKR than those treated with Synvisc. CONCLUSION: Analysis of administrative claims data provides real-world evidence that meaningful differences exist among some HA products in disease-specific cost and time to knee replacement surgery.