Budget impact analysis of a digital monitoring platform for COPD

Abstract Background Chronic obstructive pulmonary disease (COPD) is a progressive debilitating condition with frequent exacerbations that have a high burden for patients and society. Digital tools may help to reduce the economic burden for patients and payers by improving outcomes. The Propeller platform is a digital self-management tool that facilitates passive monitoring of inhaler medication utilization, potentially assisting the healthcare team to identify patients at risk of a COPD exacerbation who may require further intervention. This study estimated the budget impact of Propeller from commercial payer and Medicare fee-for-service payer perspectives. Methods An Excel-based model was used to estimate the budget impact of Propeller for COPD patients in commercial and Medicare population sizes of 5 million members. Data on prevalence, baseline healthcare resource utilization (HCRU), and baseline use of rescue and controller inhaler medications with unit costs (adjusted to 2020 US dollars) were obtained from peer-reviewed literature. Data on reductions in HCRU during Propeller usage were based on direct evidence. Estimates for costs of remote monitoring were obtained from publicly available information. All patients were assumed to have insurance claims related to ongoing remote monitoring. Results The estimated number of annual eligible COPD patients for commercial and Medicare was 212,200 and 606,600, respectively. Propeller decreased costs by an estimated $2,475 (commercial) and$915 (Medicare) per enrolled patient. The greatest increase in expenditure was for remote monitoring related expenses. After accounting for estimated reductions in hospitalizations, emergency department visits and short-acting beta-agonist use, total net savings were approximately $1.60 and$1.70 per-member per-month for commercial and Medicare payers, respectively. Conclusion Propeller is projected to be cost saving from both the commercial and Medicare payer perspectives

The association between insurance coverage for insulin pen needles and healthcare resource utilization among insulin-dependent patients with diabetes in China

Abstract Background Pen needles are an important component of insulin delivery among patients with diabetes, but are not universally covered in China. We compared clinical and economic characteristics of insulin-dependent patients in China who have some level of pen needle (PN) reimbursement to those with no PN reimbursement. Methods A cross-sectional study was conducted among 400 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Demographics, medical history, healthcare resource utilization (RU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. Unit costs were assigned to healthcare RU and compared using descriptive statistics and multivariate regression models. Results A total of 400 patients were analyzed; 142 (35.5%) with some level of PN coverage/reimbursement and 258 (64.5%) without. Patients without PN reimbursement had a higher prevalence of lipohypertrophy (59.3% vs. 40.7%, p = 0.0007), greater median PN reuse (12 vs. 7 times per needle, p < 0.0001), greater 6-month insulin costs (1591 vs. 1328 Renminbi [RMB], p = 0.0025) and total unadjusted 6-month expenditures (6433 vs. 4432 RMB, p < 0.0001), respectively. After controlling for clinical and demographic characteristics, patients without PN reimbursement had 4.6 times greater odds of high costs compared to those with PN reimbursement. Conclusions Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Expansion of insurance coverage for insulin PNs can improve the quality of care and potentially help reduce the economic burden in this population

Exacerbation of Ventilation-Induced Lung Injury and Inflammation in Preterm Lambs by High-Dose Nanoparticles

Abstract Mechanical ventilation of preterm neonates causes lung inflammation and injury, with potential life-long consequences. Inert 50-nm polystyrene nanoparticles (PS50G) reduce allergic inflammation in the lungs of adult mice. We aimed to confirm the anti-inflammatory effects of PS50G in a sheep asthma model, and investigate the effects of prophylactic administration of PS50G on ventilation-induced lung injury (VILI) in preterm lambs. We assessed lung inflammatory cell infiltration, with and without PS50G, after airway allergen challenge in ewes sensitised to house dust mite. Preterm lambs (0.83 gestation) were delivered by caesarean section for immediate tissue collection (n = 5) or ventilation either with (n = 6) or without (n = 5) prophylactic intra-tracheal administration of PS50G nanoparticles (3% in 2 ml). Ventilation was continued for a total of 2 h before tissue collection for histological and biomolecular assessment of lung injury and inflammation. In ewes with experimental asthma, PS50G decreased eosinophilic infiltration of the lungs. Ventilated preterm lambs showed molecular and histological signs of lung injury and inflammation, which were exacerbated in lambs that received PSG50G. PS50G treatment decreased established inflammation in the lungs of asthmatic sheep. However, prophylactic administration of PSG50 exacerbated ventilation-induced lung injury and lung inflammation in preterm lambs

Health-Related Quality of Life (HRQoL) Among Patients with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in Linker-MM1: Interim Assessment up to 36 Weeks of Treatment

Background Patients with multiple myeloma (MM) have worsened HRQoL that deteriorates with progression or with increasing lines of therapy (Fonseca et al. Clin Lymphoma Myeloma Leuk. 2023). Assessing HRQoL in patients with RRMM provides insights on the full benefit of treatment. LINKER-MM1 (NCT03761108) is an ongoing open-label, multicenter Phase 1/2 dose-escalation and dose-expansion trial evaluating linvoseltamab, a B-cell maturation antigen (BCMA)×CD3 bispecific antibody that targets CD3 on T-cells and BCMA on myeloma cells resulting in T-cell-mediated cytotoxicity. Results have demonstrated promising efficacy and generally manageable safety for linvoseltamab in patients with RRMM (Lee et al. ASCO. 2023). Patient-reported outcomes (PRO) from the Phase 1 portion have shown improvements in quality of life (QoL) and pain symptoms. We report PRO for the combined Phase 1/2 cohort receiving the linvoseltamab 5-25-200 mg dosing regimen. Methods Patients in LINKER-MM1 (June 7, 2023 data cut-off with a July 20, 2023 data extraction) who were enrolled to receive the 5-25-200 mg dosing regimen during Phase 1 (n=12) and Phase 2 (n=105) were included in the analysis. Patients were ≥18 years of age with RRMM after triple-class exposure to a proteasome inhibitor, immunomodulatory drug, and an anti-CD38 antibody. Linvoseltamab was administered at Week 1 (5 mg), Week 2 (25 mg), and Week 3 (200 mg), followed by weekly dosing through Week 14 (Phase 2) or Week 16 (Phase 1), then every 2 weeks thereafter until progression. Patients in Phase 2 who achieved a very good partial response by Week 24 could transition to every 4 week dosing from Week 24. The PRO instruments included the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma module (QLQ-MY20), and European Quality of Life 5 Dimensions 3 Level questionnaire (EQ-5D-3L) administered at baseline, Week 4, and every 4 weeks thereafter. Six scales across the three instruments were pre-specified in the clinical statistical analysis plan. We present analyses of the first 36 weeks of treatment. Least squares (LS) mean change from baseline to each assessment visit in PRO scores was estimated using a mixed effects model for repeated measures. Clinically meaningful improvements for EORTC QLQ-C30 were defined based on the minimally important difference (MID) of ≥10 points, with higher scores indicating better global health status (GHS)/QoL and physical functioning (PF). For EORTC QLQ-C30 fatigue (MID ≥10 points) and EORTC QLQ-MY20 Disease Symptoms (MID ≥16 points) and Side Effects of Treatment symptom scales (MID ≥6 points), lower scores indicate a lower symptom burden. For EQ-5D-3L visual analog scale (VAS), changes ≥12 points were considered clinically meaningful, with higher scores indicating better health status. LS mean change from baseline was considered statistically significant if the 95% confidence interval (CI) did not cross 0. No adjustment for multiplicity was performed, hence all statistical significance is nominal. Results PRO completion rates were high with ≥85% for the majority of time points among expected visits. Estimated mean changes from baseline by time point were statistically significant for GHS/QoL from Week 12 up to Week 36, with a LS mean change of 9.97 (95% CI 5.51, 14.43) at Week 36 (Figure 1A). Statistically significant improvements were observed for fatigue at Week 16 up to Week 36 with a LS mean change of −9.66 (95% CI −13.35, −5.98) at Week 36. Notably, both statistically significant and clinically meaningful improvements were observed for pain at Week 20 (−18.43; 95% CI −23.54, −13.32) through Week 36 (−12.28; 95% CI −18.15, −6.42) (Figure 1B). Statistically significant improvements were observed in PF at Week 20 up to Week 36 (Figure 1A) and most assessment time points for the EORTC QLQ-MY20 Disease Symptoms and Side Effects of Treatment scales during the 36-week period, although these changes did not reach the MID thresholds for clinically meaningful improvement. Scores on the EQ-5D-3L VAS were maintained from baseline throughout the 36-week period. Conclusions During 36 weeks of treatment, improvements in measures of HRQoL, including pain, were reported among patients with RRMM receiving linvoseltamab. These PRO findings support a favorable benefit-risk profile of linvoseltamab consistent with clinical results