Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia

<p><b>Aims:</b> Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis.</p> <p><b>Methods:</b> A cost-efficiency analysis of the prophylaxis of one patient during one chemotherapy cycle under 1–14 days’ time horizon was conducted using the unit dose average selling price (ASP) and Current Procedural Terminology (CPT) codes for subcutaneous prophylactic injection under four scenarios: cost of medication only (COSTMED), patient self-administration (SELFADMIN), healthcare provider (HCP) initiating administration followed by self-administration (HCPSTART), and HCP providing full administration (HCPALL). Two case studies were created to illustrate real-world clinical implications. The analyses were replicated using wholesale acquisition cost (WAC).</p> <p><b>Results:</b> Using ASP + CPT, cost savings achieved with filgrastim-sndz relative to reference filgrastim ranged from $65 (1 day) to$916 (14 days) across all scenarios. Relative to pegfilgrastim, savings with filgrastim-sndz ranged from $834 (14 days) up to$3,666 (1 day) under the COSTMED, SELFADMIN, and HPOSTART scenarios; and from $284 (14 days) up to$3,666 (1 day) under the HPOALL scenario. Similar to the cost-savings compared to pegfilgrastim, filgrastim-sndz achieved savings relative to pegfilgrastim-injector: from $834 (14 days) to$3,666 (1 day) under the COSTMED scenario, from $859 (14 days) to$3,692 (1 day) under SELFADMIN, from $817 (14 days) to$3,649 (1 day) under HPOSTART, and from $267 (14 days) to$3,649 (1 day) under HPOALL. Cost savings of filgrastim-sndz using WAC + CPT were even greater under all scenarios.</p> <p><b>Conclusions:</b> Prophylaxis with filgrastim-sndz, a biosimilar filgrastim, was associated consistently with significant cost-savings over prophylaxis with reference filgrastim, pegfilgrastim, and pegfilgrastim-injector, and this across various administration scenarios.</p

The economic value of knowing BRCA status: universal BRCA testing for breast cancer prevention

This study aimed to estimate the incremental lifetime effects, costs, and net monetary benefit (NMB) of knowing BRCA information by universal genetic testing of all US women without breast cancer turning 40 in a given year, and the cumulative savings or losses of yearly cohort testing over 16 years. We compared two strategies: (1) ‘with BRCA information’ and (2) ‘without BRCA information.’ Incremental NMB (INMB) was calculated as the monetized benefit per person of knowing BRCA status. The net monetized value (cumulated INMB) of knowing BRCA information was estimated by multiplying the INMB with the eligible population or the year 2020 cohort of US women age 40 and extended for a total of 16 yearly cohorts. Universal testing of the female population at the age of 40 in a given year provided aan INMB of $663/person (payer) and$1,006/person (society).Escalated to the U.S. population of women age 40 , knowing BRCA status resulted in lifetime cumulated INMB of $1.3 billion (payer) and$2.0 billion (society) for the 2020 cohort; and yielded accumulated monetized value of $18.3 billion (payer) and$27.6 billion (society) over 16 yearly cohorts of 40-year-old women. The universal testing for BRCA status of all US women at age 40 provides compelling short-term and long-term economic value.</p

Economic value of knowing BRCA status: BRCA testing for prostate cancer prevention and optimal treatment

We aimed to estimate the incremental lifetime effects, costs, and net-monetary-benefit (NMB) of knowing BRCA information by testing of patients with low-risk localized prostate cancer (PCa) in the US and guiding subsequent screening and treatment, and the cumulative savings or losses of yearly cohort testing over 16 years. We compared two strategies: (1)‘with BRCA information’ and (2)‘without BRCA information.’ We also estimated the expected value of perfect information. The incremental NMB (INMB) quantified the monetized benefit per person of knowing BRCA status. The net-monetized-value of knowing BRCA information was estimated by multiplying the INMB with the eligible population. The INMBs of knowing BRCA information were $43,357 (payer) and$43,487 (society). in payer and societal perspectives, respectively. Escalated to the eligible patients in 2020, knowing BRCA status resulted in net monetized lifetime value of $1.7 billion (payer and society) for the 2020 cohort; and yielded accumulated net-monetized-value of$28.0 billion (payer) and $28.1 billion (society) over 16 yearly cohorts of eligible PCa patients. The economic value of knowing BRCA status for all low-risk localized PCa patients in the US provides short-term and long-term evidence for BRCA testing to screen early and optimize treatment.</p

Additional file 1: Figure S1. of Targeting epigenetic pathways in acute myeloid leukemia and myelodysplastic syndrome: a systematic review of hypomethylating agents trials

Funnel plot. Figure S2. Subgroup analysis of OS rate from available data. Figure S3. Subgroup analysis of ORR from available data. Figure S4. Comparison of OS rates between HMA vs. LDAC in AML patients. Table S1. Search detail in PubMed, EMBASE, and Cochrane database of systematic review. Table S2. Additional characteristics of randomized trials. Table S3. Risk of bias assessment of studies according to Cochrane risk bias assessment tool. Table S4. Characteristics of trials (ad hoc studies) comparing HMAs and LDAC in AML patients. (DOC 1145 kb

Additional file 1: of Clinical failure with and without empiric atypical bacteria coverage in hospitalized adults with community-acquired pneumonia: a systematic review and meta-analysis

Search Strategy. Figure S1. Forest Plots for Bacteriologic Failure and Adverse Events in All Included Studies. Figure S2. Forest Plots for Subgroup Analyses of Clinical Failure. Figure S3. Funnel Plot of Included Studies for Clinical Failure. Table S1. PRISMA Check List. Table S2. Quality Assessment of Included Studies. Table S3. Characteristics of Excluded Full-Text Articles. (DOC 428 kb

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

<p><b>Introduction</b>: Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice.</p> <p><b>Areas covered</b>: This review of 84 observational effectiveness studies covers treatments (dosing, medication use), clinical outcomes (treatment response, disease activity, quality of life), and safety.</p> <p><b>Expert opinion</b>: The clinical outcomes observed across studies underscore the real-world effectiveness of omalizumab in the management of CIU/CSU. Continued treatment may assist patients showing an initial response to achieve a complete treatment response. Response rates are aligned with observed changes in disease activity, symptom experience, and quality of life, and this across subtypes of CIU/CSU. The positive therapeutic profile is complemented by a positive safety profile. The real-world evidence summarized here points convincingly at the high degree of effectiveness of omalizumab in the treatment of CIU/CSU in daily clinical practice.</p

Table_1_Extended Medicaid coverage will improve access but insufficient to enhance postpartum care utilization: a secondary analysis of the 2016–2019 Arizona Medicaid claims.DOCX

IntroductionPostpartum Medicaid eligibility extensions may increase access to healthcare for low-income women. However, its implications for healthcare utilization are unknown.MethodsWe analyzed the linked-infant birth certificate and claims data of women whose childbirths were paid for by Medicaid between 2016 and 2019 in Arizona, United States. We evaluated associations between postpartum care visits and Medicaid insurance type and assessed effect modification by the delivery route and type of residence.ResultsWomen with pregnancy-related Medicaid insurance were less likely to attend postpartum visits, with an adjusted odds ratio (aOR) of 0.70 and a 95% confidence interval (CI) of 0.66 to 0.74 than those with continuous Medicaid insurance. Younger age, rural residence [aOR 0.83, CI 0.78, 0.88], vaginal delivery route [aOR 0.11, CI 0.10, 0.12], and the absence of complications during/after childbirth [aOR 0.58, CI 0.49, 0.70] were associated with the absence of postpartum care visit. Low-income women who lost their pregnancy-related Medicaid coverage after 60 days in Arizona experienced lower rates of postpartum care utilization.DiscussionInterventions to improve postpartum utilization should be considered beyond extending postpartum Medicaid coverage for low-income women.</p