Effectiveness of erenumab and onabotulinumtoxinA on acute medication usage and health care resource utilization as migraine prevention in the United States.

BACKGROUND: Migraine is a common neurological disease that can have a substantial impact on patients' lives and on society. Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, was specifically developed for migraine prevention. The efficacy of erenumab has been established in several clinical trials; however, the real-world comparative effectiveness of erenumab has not been fully investigated. OBJECTIVE: To evaluate the real-world impact of erenumab and onabotulinumtoxinA on acute medication usage and health care resource utilization (HCRU) among patients with migraine in the United States. METHODS: This retrospective US claims analysis (Optum's deidentified Clinformatics Data Mart Database) evaluated patients aged at least 18 years diagnosed with migraine who initiated erenumab or onabotulinumtoxinA between May 1, 2018, and September 30, 2019 (index date: first erenumab/onabotulinumtoxinA claim). Cohorts were matched 1:1 using the propensity score (PS) method (greedy match with caliper = 0.1). Stratification was performed based on gender, chronic migraine without aura diagnosis, onabotulinumtoxinA use, and acute/preventive drug use. The impact of erenumab and onabotulinumtoxinA on acute medication usage and HCRU was assessed in the 6-month post-index period. An exploratory analysis assessed the impact of erenumab and onabotulinumtoxinA on a composite endpoint of: (1) outpatient visit with a migraine diagnosis and associated acute medication claim, (2) hospital admission with a primary migraine diagnosis, or (3) emergency department visit with a primary migraine diagnosis. PS-matched data were used for comparative analyses; logistic regression with covariate adjustment was used for dichotomous variables, and a negative binomial model was used for count variables, with odds ratios or rate ratios (RRs) and 95% CIs calculated. RESULTS: Following stratified PS matching, 1,338 patients were included in both cohorts. At 6 months, the adjusted average number of claims per person for any acute medication was significantly lower in the erenumab cohort (1.13 vs 1.29 in the onabotulinumtoxinA cohort; RR = 0.88; 95% CI = 0.80-0.96; P = 0.0069), although the difference in the number of claims for triptans and barbiturates was statistically nonsignificant. The adjusted average number of all-cause and migraine-specific visits per person to health care providers was generally lower in the erenumab cohort compared with the onabotulinumtoxinA cohort. Patients in the erenumab cohort had a significantly lower number of composite events (0.44 vs 0.69 in the onabotulinumtoxinA cohort; RR = 0.63; 95% CI = 0.56-0.71; P < 0.0001). Similarly, the adjusted proportion of patients with any of the 3 composite events was lower in the erenumab cohort (31.7% vs 44.3% in the onabotulinumtoxinA cohort; OR = 0.59; 95% CI = 0.49-0.70; P < 0.0001). CONCLUSIONS: In this retrospective claims analysis study, erenumab significantly reduced acute medication usage (opioids and nonsteroidal anti-inflammatory drugs; any acute medication when analyzed together) and HCRU to a greater extent than onabotulinumtoxinA. DISCLOSURES: This study was supported by Novartis Pharma AG. Novartis employees contributed to the study design, analysis of the data, and the decision to publish the results. Fang, Abdrabboh, Glassberg, Vo, and Ferraris are employed by Novartis. Zhou and Shen are employed by KMK Consulting, Inc., which received funding from Novartis to conduct the study. Tepper reports grants from Allergan, Amgen, ElectroCore, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano, outside the submitted work; personal fees from Dartmouth-Hitchcock Medical Center, American Headache Society, Thomas Jefferson University, Aeon, Align Strategies, Allergan/AbbVie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CoolTech, CRG, Currax, Decision Resources, DeepBench, DRG, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, InteractiveForums, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurorelief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, System Analytic, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, Zosano, Krog and Partners, and Lundbeck, outside the submitted work; and CME honoraria from American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute PeerView, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians' Education Resource, Rockpointe, ScientiaCME, WebMD/Medscape. The abstract and poster of these results were presented at The Migraine Trust Virtual Symposium (MTIS), October 3-9, 2020.

Real-World Experience with Lifitegrast Ophthalmic Solution (Xiidra®) in the US and Canada: Retrospective Study of Patient Characteristics, Treatment Patterns, and Clinical Effectiveness in 600 Patients with Dry Eye Disease.

PURPOSE: This study evaluated real-world treatment of dry eye disease (DED) with lifitegrast. PATIENTS AND METHODS: Ophthalmologists and optometrists treating patients with DED were invited to participate through a healthcare provider (HCP)-based panel. HCPs completed a provider survey and contributed data toward a chart review for up to five qualifying patients with DED who initiated lifitegrast ophthalmic solution (index date) between 01/01/2017 (US) or 01/01/2018 (Canada) and 06/30/2019. Patient demographics, treatments, clinical characteristics, and outcomes (ie, severity, signs, symptoms) were collected for the 6-month pre-index period and up to 12-months post-index. RESULTS: For this study, 517 HCPs contributed 600 patient charts. Among 554 and 281 patients with follow-up at 6 and 12-months post-index, 512 (92.4%) and 238 (84.7%) patients had ongoing lifitegrast treatment, respectively. Other DED-related treatments were less frequently used post-index with lifitegrast vs pre-index: over-the-counter artificial tear use (45.2% vs 75.5%), topical corticosteroids (3.8% vs 18.8%), any cyclosporine (3.0% vs 20.5%). At 3-months (n=571) and 12-months (n=320) post-index vs pre-index, fewer patients had eye dryness (47 [8.2%] and 16 [5.0%] vs 525 [87.5%]), blurred vision (28 [4.9%] and 11 [3.4%] vs 346 [57.7%]), ocular burning/stinging (25 [4.4%] and 8 [2.5%] vs 336 [56.0%]), depression (8 [1.4%] and 9 [2.8%] vs 55 [9.2%]), fatigue (4 [0.7%] and 1 [0.3%] vs 82 [13.7%]), and headache (1 [0.2%] and 0 vs 19 [3.2%]). At 3 and 12-months post-index vs pre-index, average corneal staining score was numerically lower (2.7 and 2.0 vs 6.5), and average Schirmer score (10.6 and 10 vs 6.3) and tear film break-up time (7.3 and 8.0 vs 4.8) higher. CONCLUSION: The majority of patients had ongoing lifitegrast treatment 6-months post-index with reduction in overall treatment burden. Improvement in DED signs and symptoms, including QoL impacts, was evident at 3 months and up to 12 months after lifitegrast initiation.

Standardization of a cone beam computed tomography machine in evaluating bone density: a novel approach.

BACKGROUND: Advent of cone beam computed tomography (CBCT) in dentistry has brought us to a new era of precise imaging. Radiographic evaluation of a CBCT image is more informational when compared to CT. The density measurements in CBCT images are based on greyscale values, which are more accurate in CT and these values are inconsistent across various CBCT machines. Hence, we aim at standardizing a single CBCT scanner to evaluate or determine tissue density from the greyscale values. METHODS: A total of 8 halves of undamaged, dry goat mandibles are included in the study. Scans of the bone are obtained using the KODAK CBCT unit and the PHILLIPS CT machine respectively. Densities are evaluated at 96 points on both the CT scans and the CBCT scans, respectively, using the Radiant Dicom viewer. The obtained data is entered into the excel spreadsheet and subjected to statistical analysis. RESULTS: The greyscale values are obtained from each of the CBCT scans. Hounsfield units are calculated from CT images coinciding with the same points on CBCT scans. The collected data is subjected to linear regression analysis and an equation is derived to determine Hounsfield units (calculated HU units) from greyscale values of CBCT images. We found no significant difference between the mean original HU units and the mean calculated HU units, thus making the equation reliable for calculating HU units from CBCT greyscale values. CONCLUSIONS: Our results conclude that the technique was effective in calculating the Original density of tissues using grey standards of CBCT scans.

Accuracy of Prescription Claims Data in Identifying Truly Nonadherent Patients.

BACKGROUND: Administrative claims data are increasingly used to identify nonadherent patients. This necessitates a comprehensive review and assessment of their accuracy in identifying nonadherent patients. OBJECTIVES: To (a) compare administrative claims-based measures of adherence with nonadherence verified by patient interview; (b) determine if and to what extent patients classified as nonadherent based on prescription claims differ from patients classified as nonadherent based on interventions designed to gather multiple types of medication lists to compare against the prescription fill history; and (c) assess the various patient-reported reasons for nonadherence. METHODS: A cross-sectional study was used to identify patients from the Southern Piedmont Community Care Network of North Carolina who were enrolled with Medicaid between January 1, 2012, and May 31, 2013, and were using prescription medications for 1 or more chronic conditions. Patients with more than a 30-day gap in refill history were identified using prescription claims and were interviewed by pharmacists to assess the reasons for nonadherence. Based on the patient-reported reasons for a gap in refill, patients were classified as interview-verified nonadherent patients or interview-verified adherent patients. The positive predictive value of prescription claims in identifying nonadherent patients was calculated, and descriptive statistics were reported. Characteristics of interview-verified nonadherent patients were compared with adherent patients using t-tests and chi-square statistics. RESULTS: 1,425 patients representing 2,936 patient-class of medication combinations were included in the final analysis. 824 (28.07%) of the 2,936 records that were flagged as nonadherent using claims analysis were confirmed as adherent during patient interviews. The positive predictive value of claims records in identifying nonadherent patients was 0.72. The 2 most common reasons for patients to be misclassified as nonadherent in claims data following self-report were discontinuation of medication on prescribers' directions (21.93%) and having an alternate channel for receiving the medication (6.13%). Among interview-verified nonadherent patients, side effects, patient beliefs, education, and socioeconomic barriers were the most common patient-reported reasons for gaps in refill. CONCLUSIONS: Prescription claims may underestimate adherence in patients. When interviewed directly by a pharmacist, most patients reported discontinuation of medication as per prescribers' directions. To determine the overall validity of prescription claims data, further analysis is required to assess its accuracy in identifying truly nonadherent patients among those who are identified as nonadherent by claims data. DISCLOSURES: No outside funding supported this study. Glassberg and Wei were employees at Community Care of North Carolina when this research was conducted. Trygstad is an employee of Community Care of North Carolina; Robinson is an employee of Community Care of Southern Piedmont, a subsidiary of Community Care of North Carolina. The geographies, health care professionals, and subjects involved in the study were related to the care coordination work that Community Care of North Carolina was charged with implementing through its informatics and subject matter expertise assistance provided to these local entities to augment primary care activities. Farley has received funding from the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, American College of Clinical Pharmacy, the National Institutes of Health, and Community Care of North Carolina and has also received consulting funds from UCB. The other authors have nothing additional to report.

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

PURPOSE: Percutaneous ablation techniques, including microwave ablation (MWA) and radiofrequency ablation (RFA), have become important minimally invasive treatment options for liver cancer. This systematic review compared MWA with RFA for treatment of liver cancer. METHODS: The systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was conducted for randomized and observational studies published from 2006 onwards. A random-effects model was used for meta-analyses and local tumor progression (LTP), technique efficacy, overall survival (OS), disease-free survival (DFS), intrahepatic de novo lesions (IDL), extrahepatic metastases (EHM), length of stay (LOS), and complications were analyzed. Subgroup and sensitivity analyses were also conducted. RESULTS: Of 1379 studies identified, 28 randomized and observational studies met inclusion criteria. The main analysis demonstrated that LTP was significantly reduced by 30% with MWA versus RFA (RR=0.70; P=0.02) (all studies) and by 45% with MWA versus RFA (RR=0.55; P=0.007) (randomized studies only). There were no significant differences between MWA and RFA for other efficacy and safety outcomes. Higher frequency (2450 MHz) and larger tumor size (≥2.5 cm) are amongst variables that may be associated with improved outcomes for MWA. Sensitivity analyses were generally congruent with the main results. CONCLUSION: MWA is at least as safe and effective as RFA for treating liver cancer and demonstrated significantly reduced LTP rates. Future studies should assess time and costs associated with these two treatment modalities.

Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

BACKGROUND: Hepatic resection (HR) is the gold standard liver cancer treatment, but few patients are eligible due to comorbidities or tumor location. Microwave ablation (MWA) is an important complementary liver cancer treatment to HR. This systematic review compared MWA with HR for liver cancer treatment. METHODS: A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted for randomized and observational studies published from 2006 onwards. The primary outcome was local tumor recurrence (LTR), and a random effects model was used for meta-analyses. RESULTS: Of the 1845 studies identified, 1 randomized and 15 observational studies met the inclusion criteria. LTR was significantly increased with MWA versus HR (risk ratio (RR) = 2.49; P = 0.016). In secondary measures, HR provided significantly higher 3- and 5-year overall survival (RR = 0.94; P = 0.03 and RR = 0.88; P = 0.01, respectively) and 3-year disease-free survival (RR = 0.78; P = 0.009). MWA exhibited significantly shorter length of stay (weighted mean difference (WMD) = - 6.16 days; P < 0.001) and operative time (WMD = - 58.69 min; P < 0.001), less intraoperative blood loss (WMD = - 189.09 mL; P = 0.006), and fewer complications than HR (RR = 0.31; P < 0.001). When MWA was combined with HR and compared with either modality alone, complications and blood loss were significantly lower with the combination treatment; however, there were no differences in other outcomes. Subgroup and sensitivity analyses were generally aligned with the main results. CONCLUSIONS: MWA can be an effective and safe alternative to HR in patients/tumors that are not amenable to resection. More randomized and economic studies should be performed that compare the two treatments, especially to determine the target population that benefits most from MWA.

Changing Patterns of Anticoagulation After Total Hip Arthroplasty in the United States: Frequency of Deep Vein Thrombosis, Pulmonary Embolism, and Complications With Rivaroxaban and Warfarin.

BACKGROUND: This study evaluated the trends in anticoagulation use after total hip arthroplasty (THA), and the effectiveness and safety of rivaroxaban compared to warfarin. METHODS: This retrospective database analysis used healthcare claims from the Truven Health MarketScan database (2010-2015). Patients undergoing elective THA were followed for use of anticoagulants after surgery. Logistic regression models were used to compare differences in deep vein thrombosis (DVT), pulmonary embolism (PE), and adverse events, within 90 days after THA, among warfarin and rivaroxaban users. Inverse probability treatment weighting was used to account for selection bias. RESULTS: There were 12,876 users of warfarin and 10,892 users of rivaroxaban in commercially insured (CI) patients, and 7416 warfarin users and 4739 rivaroxaban users in Medicare supplement (MS) patients. Warfarin use decreased over time in both insurance cohorts, whereas rivaroxaban use increased from 2011 to 2015. Warfarin users were significantly more likely to experience both DVT (CI: odds ratio [OR] 2.63, 95% confidence interval 1.97-3.50; MS: OR 1.78, 95% confidence interval 1.38-2.29) and PE (CI: OR 2.60, 95% confidence interval 2.04-3.31; MS: OR 2.09, 95% confidence interval 1.66-2.65). There was no significant difference in rates of bleeding between the 2 agents, but warfarin users had higher odds of periprosthetic joint infection in both cohorts (CI: OR 1.57, 95% confidence interval 1.16-2.13; MS: OR 1.79, 95% confidence interval 1.14-2.81). CONCLUSION: There has been an increase in prophylaxis with rivaroxaban, and a decrease in warfarin use after elective THA over 4 years. Warfarin users were more likely to experience DVT and PE than rivaroxaban, and bleeding risks were similar.

Impact of prompt versus delayed initiation of triple therapy post COPD exacerbation in a US-managed care setting.

BACKGROUND: It is unknown whether there is a benefit to initiating triple therapy (TT; inhaled corticosteroids combined with long-acting ß2-agonists and long-acting muscarinic antagonists) promptly (within 30 days) following a chronic obstructive pulmonary disease (COPD)-related hospitalization or emergency-department (ED) visit compared with delaying treatment (31-180 days). METHODS: This retrospective, observational study (GSK: HO-15-15256) used healthcare claims from a commercial and Medicare claims database (January 1, 2008-December 31, 2015). PATIENTS: ≥40 years of age, diagnosed with COPD and no history of TT 12 months pre-index. Patients experiencing a COPD-related hospitalization or ED visit (index) who initiated TT ≤ 6 months following index were included (January 1, 2009-December 31, 2014). Patients initiating TT ≤ 30 or 31-180 days following index were included in the Prompt or Delayed cohorts, respectively. All-cause and COPD-related costs (total, medical and prescription), and exacerbations (severe and moderate) per patient per year were determined for 12 months post index. Outcomes were adjusted by cohort, weighted for a balanced distribution of baseline covariates between cohorts using inverse probability weights. RESULTS: Overall, 10,902 patients were identified (Prompt: n = 5701; Delayed: n = 5201). Total, medical and prescription all-cause costs were significantly higher in the Delayed versus Prompt cohorts (percent increase: 18.7%, 22.8% and 8.8%, respectively; all p < 0.0001). COPD-related total, medical and prescription costs were 49.3%, 66.3% and 10.3% higher in the Delayed versus Prompt cohorts, respectively (all p < 0.0001). Total and severe COPD-related exacerbation rates were 28.2% and 64.7% higher in the Delayed versus Prompt cohorts (p < 0.0001). CONCLUSION: Prompt use of TT following a COPD-inpatient or ED visit may reduce future costs and subsequent exacerbations compared with delaying the initiation of TT.