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Context Despite prevalent anti-osteoporosis medication (AOM) switching in real-world osteoporosis management, few studies have evaluated the impact of persistent AOM treatment, allowing for AOM switching, on the risk of subsequent fracture. Objective We examined the association between persistence in AOM and subsequent fractures, allowing for medication switching among patients with osteoporotic fractures. Methods This retrospective cohort study used Taiwan National Health Insurance claims data to select patients who initiated AOM between 2013 and 2016. Treatment persistence was defined as use of any AOM on a given day of interest with a 45-day grace period. Medication switch was allowed for persistence if remaining on treatment. AOMs with long-lasting inhibition of bone resorption (zoledronate and denosumab) were categorized as high-potency; others as low-potency. Multivariate Cox models were used to evaluate risk of subsequent fractures ≥3 months after initiating AOM. Results A total of 119 473 patients were included (mean [SD] follow-up 46.4 [15.6] months), and 26.8% switched from the index AOM. Within 1 year, 52% remained persistent with AOM. Compared to patients with persistent AOM, those not persistent had higher risk of subsequent hip (adjusted hazard ratio [aHR] = 1.31; 95% CI, 1.21-1.42), vertebral (aHR = 1.17; 95% CI, 1.13-1.22), and radius fractures (aHR = 1.16; 95% CI, 1.08-1.25). Patients with persistent AOM who switched from high- to low-potency AOM had higher risk of subsequent vertebral fractures than those with persistent AOM and no potency switch (aHR = 1.28; 95% CI, 1.02-1.60). Conclusion Patients with non-persistent AOM had higher risk of subsequent fractures than persistent users when allowing AOM switch. Switching AOM potency may influence the risk of subsequent vertebral fractures and warrants further investigation. [ABSTRACT FROM AUTHOR]

Michael Bogart,1 Guillaume Germain,2 François Laliberté,2 Dominique Lejeune,2 Mei Sheng Duh3 1U.S. Value Evidence and Outcomes, R&D US, GSK, Research Triangle Park, NC, USA; 2Groupe d’analyse, Ltée, Montréal, QC, Canada; 3Analysis Group, Boston, MA, USACorrespondence: Mei Sheng Duh, Analysis Group, 111 Huntington Ave 14th Floor, Boston, MA, 02199, USA, Tel +1 617 425 8131, Email mei.duh@analysisgroup.comPurpose: There is limited literature regarding real-world treatment patterns of patients with COPD, particularly since the introduction of once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in 2017. Here, we evaluated treatment patterns of patients with COPD before and after a COPD exacerbation.Patients and Methods: Retrospective, descriptive study using medical and pharmacy claims data and enrollment information from the Optum® Clinformatics® Data Mart database. Patients aged ≥ 40 years with ≥ 1 COPD exacerbation on or after September 18, 2017 were included. The index date was the last day of the first COPD exacerbation (ie day of visit for a moderate exacerbation or discharge date for a severe exacerbation). The baseline period was 12 months prior to index and the follow-up period (≥ 3 months) spanned from index until the earliest of health plan disenrollment, end of data availability (September 30, 2020), or death. Treatment patterns were evaluated during baseline and follow-up, with a focus on medication switching in the 90 days pre- and post-index.Results: COPD exacerbations were identified in 307,727 patients (125,942 severe; 181,785 moderate). Mean age at index was 72.8 years; 56.3% were female. Before and after first exacerbation, 37.7% and 48.2% of patients used ≥ 1 controller medication, respectively. In the 90 days pre-index, ICS, LABA, and LAMA medications were used by 27.5% of patients. Of these users, 64.3% remained on the same medication class, 21.7% discontinued, and 14.1% switched medication in the 90 days post-index. Among switchers, 44.0% switched to triple therapy. Most common switches were ICS/LABA to ICS/LABA/LAMA (20.7%) and LAMA to ICS/LABA/LAMA (16.4%).Conclusion: Many COPD exacerbations occur among patients not on controller medications. Although the percentage of patients receiving a controller medication increased following a first exacerbation, it remained below 50%. Of patients receiving controller medications pre-exacerbation, only a small proportion escalated to triple therapy post-exacerbation.Keywords: COPD, medication switching, medication discontinuation, single-inhaler triple therapy, FF/UMEC/VI

Justine Alderfer,1 Jyoti Aggarwal,2 Kim Gilchrist,1 Jose Maria Jimenez Alvir,3 Joseph Cook,4 Sang Hee Park,5 Jennifer M Stephens5 1Medical Affairs, Pfizer Inc., Collegeville, PA, USA; 2Evidence & Access, OPEN Health, Newton, MA, USA; 3Global Product Development, Pfizer Inc., New York, NY, USA; 4Clinical Development and Medical Affairs, Viatris, Canonsburg, PA, USA; 5Evidence & Access, OPEN Health, Bethesda, MD, USACorrespondence: Justine Alderfer, US Medical Affairs, Pfizer, 500 Arcola Rd., Collegeville, PA, 19426, USA, Tel +1 484-865-3105, Email Justine.Alderfer@pfizer.comBackground: Despite demonstration of bioequivalence of generics to brands and the potential for reduced costs, some patients switch back from a generic to the brand. A prior retrospective analysis suggested that this switchback rate may be lower among patients that had initially switched to authorized generics (AG), often both produced and marketed by the brand company, compared to those initially switched to another generic.Objective: Explore switching patterns of brands, AGs, and generics, switchback rates, and the potential impact of switchbacks on healthcare costs.Methods: An analysis of the Pharmetrics Plus™ database (2007– 2019), a United States (US) payer administrative database, was conducted to examine the use of Upjohn medications available as AGs across multiple therapeutic areas. Patients initiating treatment with brand medication in the 6 months prior to generic market entry were identified and switch rates to generics and AGs, as well as switchback rates, were evaluated. Costs were descriptively compared between patients who switched back to brand and those who remained on any generic.Results: Across 14 brand medications, more than half of the patients initiating treatment with the brand medication were switched to a generic. Generally, switching to AG, which ranged from 0.5 to 39.6%, was lower than switching to non-AG generics (16.7– 79.9%). The comparison of switchback rates from AGs to brand and non-AGs to brand showed similar results (AG:1.3– 7.5%; non-AG:1.4– 12.9%); however, the most substantial differences were observed where non-AG switchbacks were higher. Patients that switched back to brand remained on AG or generic for an average of 1– 3 months (32– 88 days). The analysis showed a tendency towards increased medical costs in the period immediately preceding switchback for all medications except sildenafil in both indications (erectile dysfunction and pulmonary arterial hypertension). For the remaining medications, medical costs ranged from $63 to $1544 higher for the switchback population. Pharmacy costs similarly tended to be higher for patients who had a switchback, with the exception of sildenafil for pulmonary arterial hypertension and sirolimus.Conclusion: Patients receiving a brand medication are likely to be switched to a generic upon market availability. Some patients switch back to the brand medication, usually within 1– 3 months; this may be associated with increased medical costs. Additional research is needed to understand switching, its potential disruption to patients, and the role of brands, generics, and AGs.Keywords: authorized generic, Generic, medication switching, costs

Context: Despite prevalent anti-osteoporosis medication (AOM) switching in real-world osteoporosis management, few studies have evaluated the impact of persistent AOM treatment, allowing for AOM switching, on the risk of subsequent fracture., Objective: We examined the association between persistence in AOM and subsequent fractures, allowing for medication switching among patients with osteoporotic fractures., Methods: This retrospective cohort study used Taiwan National Health Insurance claims data to select patients who initiated AOM between 2013 and 2016. Treatment persistence was defined as use of any AOM on a given day of interest with a 45-day grace period. Medication switch was allowed for persistence if remaining on treatment. AOMs with long-lasting inhibition of bone resorption (zoledronate and denosumab) were categorized as high-potency; others as low-potency. Multivariate Cox models were used to evaluate risk of subsequent fractures ≥3 months after initiating AOM., Results: A total of 119 473 patients were included (mean [SD] follow-up 46.4 [15.6] months), and 26.8% switched from the index AOM. Within 1 year, 52% remained persistent with AOM. Compared to patients with persistent AOM, those not persistent had higher risk of subsequent hip (adjusted hazard ratio [aHR] = 1.31; 95% CI, 1.21-1.42), vertebral (aHR = 1.17; 95% CI, 1.13-1.22), and radius fractures (aHR = 1.16; 95% CI, 1.08-1.25). Patients with persistent AOM who switched from high- to low-potency AOM had higher risk of subsequent vertebral fractures than those with persistent AOM and no potency switch (aHR = 1.28; 95% CI, 1.02-1.60)., Conclusion: Patients with non-persistent AOM had higher risk of subsequent fractures than persistent users when allowing AOM switch. Switching AOM potency may influence the risk of subsequent vertebral fractures and warrants further investigation., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Major depressive disorder (MDD) in children and adolescents is a significant health problem, causing profound impairments in social, academic, and family functioning and substantial morbidity and mortality. Up to 15% of children and adolescents suffer from MDD, and a proportion, around 30 to 40% of them, failed to respond to initial selective serotonin reuptake inhibitor (SSRI) treatment. The only evidence-based recommendation is medication switching to another SSRI and augmentation with cognitive behavioral therapy. Newly developing treatment, including ketamine, transcranial magnetic stimulation, psychotherapy other than cognitive behavioral therapy, and combined pharmacotherapy with other interventions, requires further longitudinal controlled trials regarding efficacy and safety in this vulnerable population., (Copyright © 2023 Elsevier B.V. All rights reserved.)