scholarly journals Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Peter McAllister ◽  
Lois Lamerato ◽  
Lynda J. Krasenbaum ◽  
Joshua M. Cohen ◽  
Krishna Tangirala ◽  
...  
Keyword(s):  
Resource Utilization ◽  
Real World ◽  
Medical Records ◽  
Index Date ◽  
Statistical Significance ◽  
Cohort Analysis ◽  
The United States ◽  
Headache Frequency ◽  
Patient Reported ◽  
Before And After

Abstract Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for migraine prevention in adults. Real-world data on the effectiveness of fremanezumab are limited. This retrospective, observational cohort study assessed patient-reported migraine symptoms, health care resource utilization (HCRU), and direct medical costs before and after fremanezumab treatment initiation. Methods Data were extracted from September 2018 through June 2020 from the Midwest component of EMRClaims+®, an integrated health services database containing > 20 million medical records from national commercial insurance claims, Medicare claims, and regional electronic medical records. Patients included in the cohort analysis were aged ≥ 18 years and were administered fremanezumab, with enrollment or treatment history for ≥ 6 months prior (pre-index) to initiating fremanezumab (index date) and ≥ 1 month after the index date (post-index), and without pregnancy or pregnancy-related encounters during the study period. Patient-reported headache frequency, migraine pain intensity (MPI), composite migraine symptoms, and HCRU were assessed pre-index and ≥ 1 month after fremanezumab initiation. Wilcoxon signed-rank tests were used to compare means of migraine symptoms and outcomes and HCRU before and after fremanezumab initiation. Results Overall, 172 patients were eligible for analysis. Of patients who self-reported (n = 129), 83.7% reported improvement in headache frequency or symptoms after fremanezumab treatment. Specifically, headache frequency decreased by 63% after fremanezumab initiation: mean (standard deviation) headache frequency was 22.24 (9.29) days per month pre-index versus 8.24 (7.42) days per month post-index (P < 0.0001). Mean MPI also decreased by 18% after fremanezumab initiation: MPI was 5.47 (3.19) pre-index versus 4.51 (3.34) post-index (P = 0.014). Mean emergency room (ER) visits per month decreased from 0.72 to 0.54 (P = 0.003), and mean outpatient visits per month decreased from 1.04 to 0.81 (P < 0.001). Mean hospitalizations per month decreased, but the results did not reach statistical significance (P = 0.095). Hospitalization and ER costs decreased, while outpatient costs increased, from pre-index to post-index, but differences were not statistically significant (P ≥ 0.232). Conclusions Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting.

Real-world clinical resource utilization of metastatic prostate cancer patients in the United States: Results from two large claims databases.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 204-204
Author(s):  
M. Lafeuille ◽  
M. Senbetta ◽  
R. S. McKenzie ◽  
P. Lefebvre
Keyword(s):  
Prostate Cancer ◽  
Resource Utilization ◽  
Real World ◽  
Metastatic Prostate Cancer ◽  
Index Date ◽  
Specific Antigen ◽  
The United States ◽  
Medicare Patients ◽  
Clinical Resource ◽  
Observation Period

204 Background: In metastatic prostate cancer (MPC) patients, treatment options include hormonal therapies, chemotherapy, and radiotherapy. This study quantifies the real-world healthcare resource utilization of MPC patients. Methods: Health insurance claims from 40 self-insured companies across the US (Employer [E]; 01/1999-02/2009), and from the Medicare 5% ([M]; 1999-2008) databases were analyzed. Patients with a metastasis diagnosis (ICD-9: 196-199) following 2 prostate cancer diagnoses (ICD-9: 185, V10.46) within 365 days were identified. Patients with other malignant diagnoses at baseline, defined as 365 days prior to metastasis diagnosis (index date), were excluded. Patients were evaluated for baseline medical history and for chemotherapy, hormonal agents, radiation, and corticosteroids utilization during both baseline and observation periods. Hospitalization rates and prostate cancer-related procedures post index date were also reported. Results: The study population comprised 11,725 patients (E: 3,227; M: 8,498). Mean age (SD) was 72.8 (10.2) in Employer and 78.1 (7.7) in Medicare. Mean observation period (SD) was 803 (753) days in Employer and 9.2 (8.2) quarters in Medicare. During the baseline period, chemotherapy, hormonal agents, radiation therapy, and corticosteroids were administered to 5%, 52%, 9%, and 21% of Employer, and 2%, 45%, 8%, and 12% of Medicare patients respectively, whereas these interventions increased to 22%, 55%, 39%, and 46% for Employer, and to 21%, 50%, 33%, and 29% for Medicare during the observation period. A total of 66% Employer and 79% Medicare patients were hospitalized post index date. Most patients (E: 92%; M: 98%) had prostate cancer-related procedures, including prostate specific-antigen testing (E: 39%; M: 80%), computerized axial tomography scan (E: 72%; M: 81%), prostate biopsy (E: 47%; M: 54%), X-ray (E: 11%; M: 64%), bone scan (E: 56%; M: 60%), and magnetic resonance imaging scan (E: 35%; M: 37%). Conclusions: This observational study describes real-world utilization patterns in patients with advanced prostate cancer. [Table: see text]

Abstract 275: Cardiac Arrest Etiology and Associated Cognitive Impairment in Survivors

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_4) ◽  
Author(s):  
Allison C Koller ◽  
Jon C Rittenberger ◽  
Thomas J Songer ◽  
Andrea L Rosso ◽  
Jessica E Salerno ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Statistical Significance ◽  
Cohort Analysis ◽  
Public Health Problem ◽  
The United States ◽  
Exam Score ◽  
Modifying Factors ◽  
The Impact ◽  
Normal Cognition ◽  
Moca Score

Background: Cardiac arrest is a significant public health problem, impacting over 500,000 people in the United States annually. The four major etiologies of arrest are cardiac, respiratory, traumatic, and other. The objective was to determine the impact of etiology on cognition in cardiac arrest survivors using the Montreal Cognitive Assessment (MOCA). Hypothesis: Cardiac arrest etiology impacts cognitive exam score, and patient demographics and characteristics modify that relationship. Methods: A retrospective cohort analysis was performed on all Pittsburgh Post Cardiac Arrest Service (PCAS) patients from 2012-18. Data were acquired through medical record review. T-tests, linear and logistic regression were used to assess the relationships between exam score and modifying factors. MOCA score was analyzed as a binomial variable using a pass/fail threshold of 26/30 points (86.7%) and above for normal cognition. For statistical significance, an alpha level of 0.05 was used. Results: In total, 192 patients completed the MOCA: 104 with cardiac etiology, 35 with respiratory, 4 with trauma, and 49 with other. Median age for all patients was 59.3 years, and 58% were male. Mean (SE) MOCA score for all patients was 72.8 (1.1) percent. When MOCA score was converted to a binomial indicator of normal cognition, respiratory, traumatic, and other etiologies were more likely to exhibit impairment than cardiac etiology arrest when age, sex, witnessed status, length of ICU stay and coma were controlled for (OR: 2.52, 3.43, 2.18 respectively). These findings were nullified when time from arrest to MOCA administration was included. Of the MOCA subcategories, delayed recall was the most severely impacted, with patients recalling an average of 1.67 of 5 words after 5 minutes. Additionally, respiratory arrests performed significantly worse than cardiac etiology arrests in attention (4.1 vs 4.9 points, p=0.004) and language domains (1.9 vs. 2.3, p=0.04). Conclusions: Respiratory, traumatic, and other etiologies were more likely to exhibit abnormal cognition on the MOCA than those with a cardiac etiology. The etiological findings were nullified when time to cognitive examination was controlled for. Timing appears to influence cognitive assessments more than etiology.

scholarly journals 1782. Real-World HIV Diagnostic Testing Patterns in the United States

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S656-S656
Author(s):  
James Karichu ◽  
Mindy Cheng ◽  
Pedro Rodriguez ◽  
Nicole Robinson ◽  
Chakkarin Burudpakdee ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Clinical Laboratory ◽  
The United States ◽  
Fourth Generation ◽  
Test Results ◽  
Confirmatory Testing ◽  
Confirmatory Tests ◽  
Testing Patterns ◽  
Hiv 1

Abstract Background Current HIV diagnostic laboratory testing guidelines from the US Centers for Disease Control and Prevention (CDC) recommend a sequence of tests for detection, differentiation, and confirmation of HIV-1 and HIV-2 diagnosis. There is a gap in knowledge about real-world implementation of the testing algorithm. The aim of this study was to characterize the population that underwent HIV antibody differentiation and confirmatory testing and to describe subsequent testing patterns from a large US clinical laboratory database. Methods Patients who received one or more HIV-1/2 antibody differentiation test (BioRad Geenius™ HIV 1/2 Supplemental Assay [Geenius]) in the Quest Diagnostics laboratory database between January 1, 2017 and December 31, 2017 were selected into the study; earliest test date was index date. Geenius tests, HIV-1 qualitative RNA (Aptima HIV-1 RNA Qualitative Assay [Aptima]), and HIV-2 DNA/RNA confirmatory tests subsequent to index date were captured. Study measures included pt demographic characteristics, testing frequency and sequencing, and test results. For patients with >1 Geenius test in 2017, concordance between index and subsequent test results was assessed. Results There were 26,319 unique patients identified who received ≥1 HIV antibody differentiation result from the Geenius assay. Mean age was 40.7 ± 14.3 years, 66.4% were male, and 42.5% were from southern states. Among the study population, there were 28,954 Geenius, 7,234 Aptima, and 298 HIV-2 DNA/RNA confirmatory tests. 26.4% of Geenius test results were discordant with the initial positive fourth-generation HIV screening results and required subsequent confirmatory testing. In terms of sequencing, the CDC-recommended HIV diagnostic algorithm was followed 74% of the time after screening. 8.5% of patients had >1 Geenius test in 2017; 11.2% of the retests returned different results compared with the first test. Conclusion The CDC recommended algorithm for HIV diagnosis is complex for laboratories to implement and currently available assays do not support testing efficiency. To mitigate observed inefficiencies and reduce the laboratory burden of HIV testing, a more accurate and reliable approach for HIV differentiation and confirmatory testing is needed. Disclosures All authors: No reported disclosures.

Final Results From the Multicenter Compact Study of Complications in Patients with Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2106-2106
Author(s):  
Lanetta B Jordan ◽  
Patricia Adams-Graves ◽  
Julie Kanter-Washko ◽  
Patricia Ann Oneal ◽  
Francis Vekeman ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Resource Utilization ◽  
Medical Records ◽  
Research Funding ◽  
Index Date ◽  
Chelation Therapy ◽  
Iron Chelation ◽  
Complication Rates ◽  
Iron Chelation Therapy ◽  
Cell Disease

Abstract Abstract 2106 Introduction: Over the past few decades, lifespans of sickle cell disease (SCD) patients have increased; hence, they encounter multiple complications. Early detection, appropriate comprehensive care, and treatment may prevent or delay onset of complications. There is a gap in the literature describing the SCD complication rates, blood transfusion patterns, iron chelation therapy (ICT) use, and associated resource utilization in SCD patients ≥16 years old. This study contributes to addressing this gap. Method: Medical records of 254 SCD patients ≥ 16 were retrospectively reviewed between August 2011 and July 2012 at three US tertiary care centers (University of Tennessee: 117; Tulane University: 72; Howard University: 65). Data were collected from patient's first visit after age 16 (index date) until the earliest indication of death, loss to follow-up, or last patient record on file prior to the centers' IRB submission dates. Patients were classified into one of three cohorts based on cumulative units of blood transfused and history of ICT: <15 units of blood and no ICT (minimally transfused, Cohort 1 [C1]), ≥15 units of blood and no ICT (Cohort 2 [C2]), and ≥15 units of blood and receiving ICT (Cohort 3 [C3]). SCD complication rates were expressed as the number of SCD complications recorded from patient charts per patient per year (PPPY) and compared among cohorts using rate ratios (RRs). Results: Cohorts 1, 2, and 3 consisted of 69, 91, and 94 patients, respectively. Mean (range) age at index date was similar across cohorts (27 yrs [16–65]) and all patients were African American. Mean length of observation was shorter among patients in C1 (yrs, C1: 6.6; C2: 8.2; C3: 8.1). Post index date, patients in C1 received an average of 1 unit of blood PPPY (p<0.001 vs. C2 and C3), whereas patients in C2 and C3 received an average of 10 and 15 units PPPY (p=0.112), respectively. Among patients with serum ferritin (SF) assessment within 60 days before ICT (n=57), mean (median) SF level was 4,881 ng/mL (4,040). Across all three cohorts, the most common SCD complication was acute pain crisis (69.8%), followed by infection/sepsis (5.1%), leg ulcers (2.9%), and avascular necrosis (2.3%). The rate (95% CI) of any SCD complications was the highest in C2 at 3.02 PPPY (2.89–3.14), followed by 2.26 PPPY (2.16–2.37) in C3, and 1.66 PPPY (1.54–1.77) in C1 (Table 1). Among transfused patients (C2+C3), those receiving ICT were less likely to experience SCD complications than those who did not (RR [95% CI] C2 vs. C3: 1.33 [1.25–1.42]). Similar trends (RR [95% CI]) were observed in emergency room (ER) visits and hospitalizations associated with SCD complications (C2 vs. C3, ER: 1.94 [1.70–2.21]; hospitalizations: 1.61 [1.45–1.78]), but not in outpatient visits. Conclusion: Results from this study highlight the significant burden of complications and the associated healthcare resource utilization for SCD patients. The results suggest that among regularly transfused patients, those who received ICT were less likely to experience complications than those without ICT. However, transfusions are not necessary for all patients with SCD and patients with more complications may have started transfusion therapy earlier. Patients receiving ICT may also receive closer monitoring, which may help with early identification and intervention to delay or prevent the development of complications and improve outcomes. Disclosures: Jordan: Novartis Pharmaceuticals Corporation: Consultancy, Speakers Bureau. Oneal:Novartis Pharmaceuticals Corporation: Honoraria. Vekeman:Novartis Pharmaceuticals: Research Funding. Bieri:Novartis Pharmaceuticals Corporation: Research Funding. Sasane:Novartis Pharmaceuticals: Employment. Marcellari:Novartis Pharmaceuticals Corporation: Employment. Magestro:Novartis Pharmaceuticals: Employment. Gorn:Novartis Pharmaceuticals Corporation: Research Funding. Duh:Novartis Pharmaceuticals: Research Funding.

Comparison of the real-world adherence and compliance patterns with trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) for the treatment of metastatic colorectal cancer (mCRC).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 666-666
Author(s):  
Anuj K. Patel ◽  
Mei Sheng Duh ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Yongling Xiao ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Proportional Hazards ◽  
Medication Possession Ratio ◽  
Cox Proportional Hazards ◽  
Clinical Activity ◽  
Cox Proportional Hazards Models ◽  
The Us ◽  
Before And After ◽  
Observation Period

666 Background: FTD/TPI and REG both prolong survival in refractory mCRC and have similar indications with different side effect profiles. This study compares real-world treatment patterns with FTD/TPI and REG for mCRC in a large, representative US claims database. Methods: Retrospective data from 10/2014 to 7/2016 from the US Symphony Health Solutions’ Integrated Dataverse (IDV®) database were analyzed for patients receiving FTD/TPI or REG. The index date was the date of first FTD/TPI or REG prescription. Patients were included if: 1) age ≥18 years old, 2) ≥1 CRC diagnosis, 3) no diagnosis of gastric cancer or gastrointestinal stromal tumor, and 4) continuous clinical activity for ≥3 months before and after index date. The observation period spanned from index date to end of data, end of continuous clinical activity, or switch to another mCRC treatment. Adherence was assessed using medication possession ratio (MPR) ≥0.80 and proportion of days covered (PDC) ≥0.80 at 3 months. Compliance was assessed using time to discontinuation over the observation period using allowable gaps of 45, 60, or 90 days. Patients who never discontinued therapy were censored at the end of the observation period. Outcomes were compared between FTD/TPI and REG using multivariate logistic regression and Cox proportional hazards models, adjusting for demographic and clinical baseline characteristics. Results: A total of 1,630 FTD/TPI patients and 1,425 REG patients were identified. Mean ± standard deviation (SD) age of FTD/TPI patients was 61.0 ± 11.0 compared to 62.8 ± 10.9 for REG patients (p < 0.001). FTD/TPI patients were 80% more likely to have a MPR ≥0.80 compared to those on REG (Odds Ratio [OR] = 1.80, p < 0.001) and more than twice as likely to have a PDC ≥0.80 (OR = 2.66, p < 0.001) at 3 months. FTD/TPI patients were 37% less likely to discontinue their treatment compared to those on REG when using gaps of 60 days (Hazard Ratio = 0.63, p < 0.001). Similar results were found with 45 and 90 days. Conclusions: In this retrospective study of mCRC patients, patients on FTD/TPI were significantly more likely to adhere and comply with therapy compared to those on REG.

The Neat-HER Virtual Registry: A novel registry following HER2+ ESBC patients receiving neratinib in the extended adjuvant setting.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12035-e12035 ◽  
Author(s):  
Debu Tripathy ◽  
Gregory A. Vidal ◽  
Deepa Lalla ◽  
Richard Bryce ◽  
Gillian Hanson ◽  
...  
Keyword(s):  
Real World ◽  
Medical Records ◽  
Clinical History ◽  
The United States ◽  
World Population ◽  
Duration Of Treatment ◽  
Cancer History ◽  
Data Points ◽  
Research Questions ◽  
Study Sites

e12035 Background: While data from traditional registries are limited to patients (pts) treated at study sites, virtual registries can enroll a more diverse real-world population. Neat-HER is a US-based, non-interventional pilot virtual registry through PicnicHealth that will enroll 100 pts with HER2+ BC receiving neratinib as extended adjuvant therapy. Methods: Neat-HER will evaluate the feasibility of enrolling pts & answering research questions using this novel methodology. Eligibility includes receipt of neratinib, signed informed consent for medical record retrieval/data abstraction & > 18 years age at study consent. Pts who fail to complete enrollment procedures, are participating in a clinical trial, have metastatic disease, or who lack adequate medical records will be excluded. For each pt discontinuing neratinib within 60 days of starting treatment, an additional pt will be recruited, but all pts will be included in the analysis. Pts are recruited through multiple mechanisms incl. private social media groups, treating clinicians & pts enrolled in the Puma texting program. PicnicHealth will collect & structure medical records from medical practices in the United States for ~7 years prior to enrolment up to 1 year after enrolment. Research questions focus on descriptive pt characteristics & demographics, breast cancer history [(neo)adjuvant treatment/outcomes], use of diarrhea prophylaxis, incidence of diarrhea & duration of neratinib. Results: Enrollment began in 12/2018 with target completion in 4/2019. As of 2/2019, 42 pts have initiated enrolment. Of these, 19 pts completed enrolment & 69,750 data points have been extracted from medical records. Descriptive statistics will be used to characterize the pt cohort. Duration of treatment, receipt & type of prophylaxis, incidence of diarrhea, treatment discontinuation & reasons for discontinuation will be summarized for all pts. Conclusions: A virtual registry allows assessment of medication use & outcomes in a diverse population in a rapid timeframe. Neat-HER will provide comprehensive information on clinical history & treatment patterns in a real-world cohort of pts receiving extended adjuvant neratinib.

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