Search

Introduction: Amivantamab, an EGFR-MET bispecific antibody, is approved for multiple indications in EGFR-mutated advanced non-small cell lung cancer (NSCLC) as monotherapy or combined with other agents. Intravenous amivantamab is associated with a 67% infusion-related reactions (IRR) rate., Methods: The phase 2 SKIPPirr study (NCT05663866) enrolled patients with EGFR-mutated (Ex19del/L858R) advanced NSCLC after progression on osimertinib and platinum-based chemotherapy who received intravenous amivantamab plus oral lazertinib (amivantamab-lazertinib), a third-generation tyrosine kinase inhibitor. Aiming to mitigate IRRs, 4 independent prophylactic approaches were evaluated using Simon's 2-stage design with an expansion stage if a cohort passed both stages: oral dexamethasone 4-mg twice daily (BID) given on cycle (C) 1 day (D) -1; oral dexamethasone 8-mg BID given on C1D-2, C1D-1, and morning of C1D1 (5 doses); oral montelukast 10-mg once daily given on C1D-4, C1D-3, C1D-2, C1D-1, and C1D1 (5 doses); subcutaneous methotrexate 25-mg (1 dose) given anytime between C1D-7 and C1D-3. Primary endpoint was C1D1 IRR incidence., Results: As of 24-June-2024, 68 patients were treated across all cohorts. The dexamethasone 8-mg cohort passed stages 1 and 2 proceeding to the expansion stage, with 24 additional patients treated. At C1D1, 9/40 patients (22.5%) experienced IRRs, resulting in an ∼3-fold decrease versus historical data (67.4%). By end of C3, 10/41 (24.4%) patients in the dexamethasone 8-mg cohort experienced IRRs (grades 1-2, except 1 grade 3 on C2D1). Amivantamab-lazertinib safety and efficacy were consistent with previous reports., Conclusion: Prophylaxis with 8-mg oral dexamethasone meaningfully reduced IRRs and can be readily implemented in clinical practice., (Copyright © 2025. Published by Elsevier Inc.)

Objectives: Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data., Methods: The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008. Data included the occurrence and number of visits to hospitals, emergency departments, urgent care centers, and outpatient offices for a respondent's and his or her household members' care. Administrative claims data from the MarketScan® Databases were assessed during the same time and evaluated relative to survey-based metrics. Only data for individuals with employer-sponsored health care coverage linkable to claims were included. The Kappa (κ) statistic was used to evaluate visit concordance, and the intraclass correlation coefficient was used to describe frequency consistency., Results: Agreement for presence of a health care visit and the number of visits were similar for self- and proxy-reported HCRU data. There was moderate to substantial agreement related to health care visit occurrence between survey-based and claims-based HCRU data for inpatient, emergency department, and office visits (κ: 0.47-0.77). There was less agreement on health care visit frequencies, with intraclass correlation coefficient values ranging from 0.14 to 0.71., Conclusions: This study's agreement values suggest that Internet-based surveys are an effective method to collect self- and proxy-reported HCRU data. These results should increase confidence in the use of the Internet for evaluating disease burden., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: During the period of this study, the American Academy of Pediatrics (AAP) 2006 guidelines recommended respiratory syncytial virus (RSV) prophylaxis for infants 32 to 35 weeks gestation age (wGA) with two or more of five risk factors (RFs). New recommendations have recently been published in 2009. The cost implications of expanding this list of RFs to include other evidence-based RFs like passive smoke exposure (PSE), crowded living conditions (CLCs), and young chronological age (YCA) are unclear., Methods: We estimated the prevalence of RSV RFs in a US sample of infants 32 to 35 wGA referred for prophylaxis from nine specialty pharmacy providers during the 2007-2008 season. We estimated the percent eligible for RSV prophylaxis under various potential RF coverage policies. Using a budget impact model, we calculated the per-member-per-month (PMPM) cost for each policy in 2007 USD for a hypothetical one million member plan., Results: Infants 32 to 35 wGA represented 0.08% of the plan. Approximately 20.2% of these infants met at least two or more of five AAP RFs. Expanding this list to include one additional RF of PSE, CLC, or YCA increased the percent of infants potentially prophylaxed to 29.9%, 23.9%, and 47%, respectively. Adding all three RFs to the list (two or more of eight) increased the percent of infants potentially prophylaxed to 55.6%, and increased payer costs by 9 cents PMPM., Conclusion: Expanding the AAP RF criteria to include PSE, CLC, and YCA would identify more 32 to 35 wGA infants at high risk for severe RSV disease at an acceptable budget impact.

Objective: Human intravenous immunoglobulin manufactured with chromatography and caprylate methods (IGIV-C, 10%) was associated with a reduction in validated infections (pneumonia and sinusitis) compared with treatment with a licensed immunoglobulin product manufactured using standard solvent-detergent methods (IGIV-SD, 10%) in participants with primary humoral immunodeficiency disorder (PIDD). Our objective was to determine the cost-consequences of using IGIV-C instead of IGIV-SD., Methods: Economic analysis of a double-blind, randomized, clinical trial was used. Participants were randomly assigned to IGIV-C (N = 87) or IGIV-SD (N = 85) and monitored for the development of validated infections over the course of 9 months. Consumed resources were enumerated including cost of physician and emergency room visits, medications (prescription and over-the-counter), work productivity losses, and hospitalizations. Resource data was obtained from case report forms, patient diaries and the trial medication database. Because the amount of IGIV-SD used exceeded that of IGIV-C (nonstatistically significant difference) and the products are equivalently priced, we conservatively excluded investigational product acquisition cost to avoid artificially biasing incremental cost differences. We used a societal perspective with indirect costs, measured in 2003 US dollars. Pricing of both IGIV products is anticipated to be equivalent., Results: In a multivariate analysis, annual mean per participant costs were significantly lower between those receiving IGIV-C compared with IGIV-SD for prescription medications [-US 302 dollars, 95% confidence interval (CI) -US 598 dollars to -US 6 dollars], hospitalization (-US 1454 dollars, 95% CI -US 1828 dollars to -US 1080 dollars) and total costs (-US 1304 dollars, 95% CI -US 1867 dollars to -US 742 dollars). Costs associated with lost work productivity and physician visits were similar in both groups (P > 0.10). In sensitivity analyses, varying costs of concomitant medications, hospitalization and outpatient care, did not significantly change our results., Conclusion: IGIV-C is cost-saving compared with IGIV-SD among persons with PIDD.