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Rahul Dhanda,1 Della Varghese,2 Vijay R Nadipelli,1 Maurizio Fava,3 Namita Joshi,2 Caitlyn T Solem,2 James A Graham,4 Susan M Learned,4 Christian Heidbreder51Global Health Economics and Outcomes Research, Indivior Inc, Richmond, VA 23235, USA; 2Real-World Evidence and Data Analytics, Pharmerit International, Bethesda, MD 20814, USA; 3Clinical Trials Network Institute (CTNI), Massachusetts General Hospital (MGH) and Harvard Medical School, Boston, MA 02114, USA; 4Global Medicines Development, Indivior Inc, Richmond, VA 23235, USA; 5Global Research and Development, Indivior Inc, Richmond, VA 23235, USAPurpose: RBP-7000 (PERSERIS™) is a once-monthly subcutaneous extended-release risperidone formulation approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. The objective of this study was to describe the long-term impact of RBP-7000 on health-related quality of life (HRQoL), subjective well-being, treatment satisfaction and medication preference in patients with schizophrenia.Patients and methods: HRQoL was derived from a 52-week multicentre Phase III single-arm open-label outpatient study that assessed the safety and efficacy of RBP-7000 (120 mg) in patients with schizophrenia. HRQoL was measured using the EuroQol EQ-5D-5L and Short-Form Survey SF-36 version 2; well-being using the Subjective Well-being Under Neuroleptic Treatment – Short Version (SWN-S); satisfaction using the Medication Satisfaction Questionnaire and medication preference using the Preference of Medication questionnaire.Results: Of 482 participants at baseline, 234 remained through the end of study (EOS; week 52). Mean HRQoL and well-being scores remained stable between baseline (EQ-5D-5L index: 0.83; SF-36v2 Physical Component Score: 50; SF-36v2 Mental Component Score: 46; total SWN-S score: 89) and EOS (EQ-5D-5L index: 0.86; SF-36v2 Physical Component Score: 49; SF-36v2 Mental Component Score: 47; total SWN-S score: 90). The prop

Walter Ling,1 Vijay R Nadipelli,2 Caitlyn T Solem,3 David Farabee,1,4 Naoko A Ronquest,2 Brian Perrochet,1,5 Susan M Learned,6 Chinmay G Deshpande,3 Christian Heidbreder71UCLA Department of Family Medicine, Center for Behavioral and Addiction Medicine, Los Angeles, CA, USA; 2Global Health Economics and Outcomes Research, Indivior Inc, Richmond, VA, USA; 3Patient-centered outcomes Center of Excellence, Pharmerit International, Bethesda, ML, USA; 4Department of Population Health, School of Medicine,, New York, NY, USA; 5Marron Institute of Urban Management, Marron Institute, New York University, New York, NY, USA; 6Global Medicines Development, Indivior Inc, Richmond, VA, USA; 7Global Research and Development, Indivior Inc, Richmond, VA, USAPurpose: The Treatment Effectiveness Assessment (TEA) is a patient-centered instrument for evaluating treatment progress and recovery from substance use disorders, including opioid use disorder (OUD). We assessed the TEA’s reliability and validity and determined minimal clinically important differences (MIDs) in participants with moderate to severe OUD.Patients and methods: The TEA measures change in four single-item domains (substance use, health, lifestyle, community involvement) from treatment initiation across the duration of a treatment program. Self-reported responses range from 1 (“none or not much”) to 10 (“much better”) with items summed to a total score ranging from 4–40. We assessed floor and ceiling effects, internal consistency, test-retest reliability, known-groups validity (ANOVA stratified by current health status [36-Item Short Form Health Survey item 1]), convergent/divergent validity, and MIDs using data from a phase 3, open-label clinical trial of buprenorphine extended-release monthly injection for subcutaneous use (BUP-XR). Participants with OUD completed the TEA at screening and before monthly injections for up to 12 months.Results: Among 410 partici

Ahmed Shelbaya,1,2 Caitlyn T Solem,3 Chris Walker,4 Yin Wan,3 Courtney Johnson,3 Joseph C Cappelleri1 1Pfizer Inc., New York, NY, 2Columbia School of Public Health, New York, NY, 3Pharmerit International, Bethesda, MD, USA; 4Pfizer Ltd., Tadworth, Surrey, UK Objective: This study aimed to evaluate the characteristics associated with early versus late initiation of celecoxib treatment after osteoarthritis (OA) diagnosis and whether economic and safety outcomes differ between patients with early versus late initiation of celecoxib.Methods: Adults (≥18 years) with a confirmed OA diagnosis (International Classification of Diseases, 9th Edition, Clinical Modifications code: 715.XX), ≥12 months of continuous pre- and post-index enrollment, and ≥1 post-index claim for celecoxib were included from the MarketScan® Commercial Claims and Encounter Database (2009–2013). Index date was defined as initial OA diagnosis. Patients were categorized as initiating celecoxib early (within 6 months of index date) or late (≥6 months after index date). Logistic regressions were used to assess characteristics associated with early versus late celecoxib initiation. Key outcomes included health care resource utilization (HCRU) and costs post-index, and adverse event incidence post-celecoxib initiation. Unadjusted and adjusted comparisons (using generalized linear models with a gamma distribution for costs and Poisson distribution for event and resource utilization) were made between early and late celecoxib initiators.Results: Of the 62,434 OA patients identified, 27,402 were early and 35,032 were late initiators. Post-index hospital admissions and length of stay did not differ statistically between early versus late initiators after controlling for pre-index event rates and covariates, but early patients had significantly fewer outpatient (incidence rate ratio [IRR]: 0.96; 95% confidence interval [CI]: 0.95, 0.97) and emergency room visits (IRR

Caitlyn T Solem,1 Shawn X Sun,2 Sizhu Liu,1 Cynthia Macahilig,3 Monica Katyal,3 Xin Gao,1 Andrew F Shorr4 1Pharmerit International, Bethesda, MD, 2Forest Research Institute, Jersey City, NJ, 3Medical Data Analytics, Parsippany, NJ, 4Pulmonary Critical Care, Washington Hospital Center and Georgetown University, Washington, DC, USA Objective: This study aimed to compare spirometry- and risk + symptom-based classification systems to physician-based severity assessment and find which system is most predictive of patient-reported health status, as measured by the St George's Respiratory Questionnaire for COPD (chronic obstructive pulmonary disease; SGRQ-C).Materials and methods: In this chart review/patient survey, 99 physicians recruited patients with physician-assessed severe or very severe COPD who had recently experienced a moderate or severe exacerbation. A cross-tabulation was undertaken comparing physician report, spirometry (mild/moderate, forced expiratory volume in 1 second [FEV1] ≥50%; severe, 30% ≤ FEV1 <50%; very severe, FEV1 <30% predicted), and risk + symptom-based (A, low risk/fewer symptoms; B, low risk/more symptoms; C, high risk/fewer symptoms; D, high risk/more symptoms) severity systems. Analysis of covariance models were run for SGRQ-C, varying COPD-severity systems.Results: Of 244 patients, 58.6% were severe and 34.8% very severe by physician report, 70% had FEV1 ≤50% at their most recent visit, and 86% fell into quadrant D. Spirometry and physician report had 57.4% agreement, with physicians often indicating higher severity. Physician report and risk + symptom agreement was high (81.2% severe/very severe and D). Physician-reported severity, risk + symptoms, exacerbations in the previous year, and symptoms were significant SGRQ-C predictors, while spirometry was not.Conclusion: For recently exacerbating severe or very severe COPD patients, risk + symptoms more closely aligned with physician-reported severi

Azza AbuDagga,1 Shawn X Sun,2 Hiangkiat Tan,1 Caitlyn T Solem3 1HealthCore Inc, Wilmington, DE, 2Forest Research Institute, Jersey City, NJ, 3Pharmerit North America, Bethesda, MD, USA Purpose: Chronic obstructive pulmonary disease (COPD) exacerbations are the leading cause of hospital admission and death among chronic bronchitis (CB) patients. This study estimated annual COPD exacerbation rates, related costs, and their predictors among patients treated for CB. Methods: This was a retrospective study using claims data from the HealthCore Integrated Research Database (HIRDSM). The study sample included CB patients aged ≥ 40 years with at least one inpatient hospitalization or emergency department visit or at least two office visits with CB diagnosis from January 1, 2004 to May 31, 2011, at least two pharmacy fills for COPD medications during the follow-up year, and ≥2 years of continuous enrollment. COPD exacerbations were categorized as severe or moderate. Annual rates, costs, and predictors of exacerbations during follow-up were assessed. Results: A total of 17,382 individuals treated for CB met the selection criteria (50.6% female; mean ± standard deviation age 66.7 ± 11.4 years). During the follow-up year, the mean ± standard deviation number of COPD maintenance medication fills was 7.6 ± 6.3; 42.6% had at least one exacerbation and 69.5% of patients with two or more exacerbations during the 1 year prior to the index date (baseline period) had any exacerbation during the follow-up year. The mean ± standard deviation cost per any exacerbation was $269 ± $748 for moderate and $18,120 ± $31,592 for severe exacerbation. The number of baseline exacerbations was a significant predictor of the number of exacerbations and exacerbation costs during follow-up. Conclusion: Exacerbation rates remained high among CB patients despite treatment with COPD maintenance medications. New trea

Guy Young,1 Caitlyn T Solem,2,3 Kate Hoffman,4 Jenna Kabawat,4 A Simon Pickard,3 Robert Z Gut,5 David L Cooper51Children's Center for Cancer and Blood Disorders, Children's Hospital Los Angeles, Los Angeles, CA, 2Pharmerit, Bethesda, MD, 3Center for Pharmacoeconomic Research, University of Illinois at Chicago, Chicago, IL, 4Outcome Sciences, Cambridge, MA, 5Novo Nordisk Inc, Princeton, NJ, USAObjective: The daily recordings of treatment by patients with congenital hemophilia with inhibitors and their caregivers were assessed as part of the Dosing Observational Study in Hemophilia (DOSE) to understand the patterns of bypassing agent use and health-related quality of life.Methods: Frequently bleeding patients prescribed recombinant activated factor VII as first-line therapy were eligible. Participants recorded daily paper diaries for at least 90 days and until at least four bleeding episodes had occurred. Web-based entry was optional. Assessment included bleeding status, work or school day status, bleeding episode, treatment, impact on planned activities, and health-related quality of life.Results: Diaries were completed by 18 adults and 19 caregivers (21 children). A total of 4063 diary days and 194 bleeding episodes over 491 bleed days were recorded. A small proportion of diary days were bleed days (8.2%) or treatment days (8.2%). Half the bleed days were not planned work or school days for patients (53%) or caregivers (48%). An exact agreement was observed between electronic and paper records for 93% of the reviewed health-related quality of life measurements.Conclusion: Daily diary completion by patients and caregivers is feasible and provides insight into the impact of congenital hemophilia with inhibitors on daily activities and overall quality of life. Positive participation and completion rates were supported by frequent patient contact made by independent patient support liaison personnel.Keywords: daily assessment, recombinant activated facto