Purpose:Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is approved in Germany and the United Kingdom (UK) for patients experiencing migraine ≥4 days per month, and it is reimbursed for patients where ≥4-5 (Germany) or ≥3 (UK) prior migraine preventive treatments have failed. We evaluated real-world clinical effectiveness and healthcare resource utilization (HCRU) in patients initiating fremanezumab in Germany and the UK. Methods:This non-interventional, retrospective, physician panel-based, online, multicenter chart review study included adult patients with chronic migraine (CM) or episodic migraine (EM) with first fremanezumab treatment initiation (index date) from June 2019 or later (Germany), and from June 2020 or later (UK). Changes in monthly migraine days (MMD), monthly headache days (MHD), and disability outcomes (Migraine Disability Assessment [MIDAS] and Headache Impact Test-6 [HIT-6]) were evaluated from baseline (pre-index) to 3 months post-index, and changes in HCRU were evaluated from 6 months pre-index to 6 months post-index. Results:The study population included 207 German and 183 UK patients (CM, 48.3% and 95.1%; monthly dosing, 59.4% and 51.9%, respectively). Reductions in MMD and MHD were observed in the German cohort (percent reductions: 60.2% and 55.1%, respectively) and the UK cohort (51.9% and 47.3%, respectively; all p < 0.001 vs baseline). Reductions in mean MIDAS and HIT-6 scores (all p < 0.01 vs baseline), outpatient office visits, urgent care/emergency room visits, and inpatient admissions were also observed (all p < 0.05 vs baseline) for both countries. Conclusion:Fremanezumab demonstrated real-world clinical effectiveness in German and UK cohorts and may decrease the burden of migraine for patients and providers.
Purpose:This real-world evidence study sought to evaluate the effectiveness of benralizumab on reducing both asthma and COPD exacerbations among patients with a diagnosis of asthma and concomitant COPD. Patients and Methods:This study was a non-interventional, single-arm, retrospective database analysis of the MORE2 Registry® and the 100% Medicare Fee-for-Service (FFS) claims databases from 2017-2022. Inclusion criteria were as follows: 1) prescription claim for benralizumab and ≥1 refill within 90 days (earliest claim=index date), 2) 12 months of database enrollment preceding (baseline) and following (follow-up) the index date, 3) medical claims with diagnoses of asthma and COPD during the baseline period, and 4) presence of ≥2 asthma exacerbations during the baseline period. Percent change in the annual rates of both asthma and COPD exacerbations were assessed from the baseline to follow-up, with paired t-tests used to examine statistically significant differences. Subgroup analyses were also conducted among the subset of patients with blood eosinophil levels, and by payer type. Results:A total of 2894 patients with asthma and concomitant COPD were included. Following initiation of benralizumab, the mean (SD) number of total asthma exacerbations decreased by 39.2% (from 4.0 (2.2) to 2.4 (2.4) exacerbations/year; p < 0.001), while COPD exacerbations decreased by 45.6% (from 3.6 (2.5) to 1.9 (2.2) exacerbations/year; p < 0.001). The proportion of patients receiving systemic corticosteroids decreased by 11.4% from 100% to 88.6% (p < 0.001). Subgroup analyses revealed that patients with the highest eosinophil levels (≥ 300 eosinophils/µL) experienced the greatest reductions in asthma exacerbations (42.7%) and COPD exacerbations (50.8%; all p < 0.001). Conclusion:This study provides real-world evidence supporting the effectiveness of benralizumab in reducing both asthma and COPD exacerbations and decreasing reliance on corticosteroids, particularly among those with elevated eosinophil levels.
James R Bentham,1 Jet Neervoort,2 Timon Louwsma,2 Lambertus F Wolters,2 Julie Lyon,3 Erik J Landaas,4 Mitesh Nakum31Department of Paediatric Cardiology, Leeds General Infirmary, Leeds, UK; 2Asc Academics B.V, Groningen, the Netherlands; 3Department of Health Economics, GORE UK Medical Ltd., Livingston, West Lothian, Scotland; 4Department of Health Economics, W.L. Gore & Associates, Newark, DE, USACorrespondence: Mitesh Nakum, Department of Health Economics, GORE UK Medical Ltd., Simpson Parkway, Kirkton Campus, Livingston, West Lothian, EH54 7BH, Scotland, Tel +44 7971 352220, Email mnakum@wlgore.comPurpose: This study evaluated the cost-effectiveness and budget impact of two patent foramen ovale (PFO) closure devices and medical management for the prevention of recurrent PFO-associated strokes in the UK.Patients and Methods: We used a Markov model to simulate 1000 individuals with a history of PFO-associated stroke over a five-year time horizon. Treatment options included GORE® CARDIOFORM Septal Occluder (GSO Device), Amplatzer™ Talisman PFO Occluder (ATO Device), and Medical Therapy Alone. Effectiveness data were drawn from the REDUCE and RESPECT trials and prior cost-effectiveness analyses (CEAs). No head-to-head clinical trial comparing the ATO and GSO Device was identified; therefore, comparative clinical effectiveness estimates were derived from a matching-adjusted indirect comparison (MAIC). Costs were assessed from a UK payer perspective (2023 GBP). Outcomes included quality-adjusted life-years (QALYs), prevented strokes, incremental cost-effectiveness ratio (ICER), and budget impact.Results: GSO Device was estimated to be cost-saving and generate 24.66 additional QALYs versus ATO Device (dominant ICER) over five years and in a cohort of 1000 patients. Compared with Medical Therapy Alone, it provided 406.66 additional QALYs at an ICER of £ 14,343/QALY. It also prevented 27.86 and 67.05 strokes versus ATO Device and Medical Therapy Alone, respectively.Conclusion: The use of GSO Device is a cost-effective option for the prevention of secondary PFO-associated strokes, with favorable estimated clinical outcomes. Future studies providing direct comparative evidence between GSO and ATO could further inform the relative clinical and cost-effectiveness of available PFO closure devices.Keywords: cardioform, amplatzer, budget impact, cost-effectiveness, cryptogenic stroke, PFO closure
