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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

Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents are widely used to treat neovascular age-related macular degeneration (nAMD). Although these treatments are effective, multiple injections have recently been recommended to ensure that there is a good long-term prognosis. However, sustained intraocular pressure (IOP) elevations have been reported to develop after multiple injections of anti-VEGF agents. We present our findings of a case of uncontrolled and persistent IOP elevation after switching from intravitreal ranibizumab injections to intravitreal aflibercept injections. A 74-year-old Japanese man without a history of glaucoma underwent 22 ranibizumab injections for nAMD and suddenly developed an elevated IOP after the 22nd injection. Although the subsequent medical treatment led to normalization of his IOP, the subretinal fluid under the central fovea remained even after the 25th injection of ranibizumab. Thus, ranibizumab treatment was switched to bimonthly intravitreal aflibercept injections in conjunction with glaucoma medications. His IOP recovered to within the normal range; however, after the 11th aflibercept injection, there was a sudden elevation of his IOP in spite of the continued glaucoma medications. Due to this sustained IOP elevation, his aflibercept injections were suspended for 16 weeks. Because his IOP could not be normalized by a full glaucoma medication regimen, the patient underwent trabeculotomy, which resulted in a lowering of the IOP to normal levels. We conclude that patients who receive serial intravitreal injections of anti-VEGF agents need to be closely monitored because severe and sustained ocular hypertension can develop.

Background and aim: Several studies have raised concerns over consequences of brand-to-generic and generic-togeneric pharmacy-generated medication substitutions in psychiatric and non-psychiatric patients. The purpose of this retrospective study was to assess behavioral and emotional responses of patients with schizophrenia to antipsychotic medication substitution performed by pharmacies. Methods: A group of Polish ambulatory patients with schizophrenia (n = 196) chronically treated with antipsychotic medications were asked whether antipsychotic medication substitution had been proposed by a pharmacist in the last 12 months. Ninety-nine patients answering positively were administered more questions addressing the patient's emotional and behavioral response to the pharmacy proposal. Results: The most important findings of the present study can be summarized as follows: (1) approximately half of the patients were confronted with a pharmacy proposal to switch their antipsychotic medications in the last 12 months, (2) one quarter of these patients did not accept the pharmacy switch, (3) a substantial proportion of patients (>40 %) did not receive any explanation from a pharmacist offering medication substitution, (4) pharmacygenerated substitution proposals were mainly associated with negative patient attitudes and negative emotional responses, (5) substitution proposals provoked an unscheduled psychiatric visit in approx. 10 % of patients, (6) despite the negative attitudes reported by patients, the pharmacy switch rarely led to treatment discontinuation, but did provoke a change in drug dosing in 7 % of patients accepting the switch. Conclusions: A pharmacy proposal to switch their antipsychotic medications is a relatively common experience of Polish ambulatory patients with schizophrenia. Pharmacy-generated substitution proposals are mainly associated with negative patient attitudes, but rarely lead to antipsychotic treatment discontinuation in this group of patients. [ABSTRACT FROM AUTHOR]

Background: Low adherence to bisphosphonate therapy is associated with increased fracture risk. Factors associated with discontinuation of osteoporosis medications have not been studied in-depth. This study assessed medication discontinuation and switching patterns among Medicare beneficiaries who were new users of bisphosphonates and evaluated factors possibly associated with discontinuation. Methods: We identified patients initiating bisphosphonate treatment using a 5% random sample of Medicare beneficiaries with at least 24 months of traditional fee-for-service and part D drug coverage from 2006 through 2009. We classified medication status at the end of follow-up as: continued original bisphosphonate, discontinued without switching or restarting, restarted the same drug after a treatment gap (≥ 90 days), or switched to another anti-osteoporosis medication. We conducted logistic regression analyses to identify baseline characteristics associated with discontinuation and a case-crossover analysis to identify factors that precipitate discontinuation. Results: Of 21,452 new users followed respectively for 12 months, 44% continued their original therapy, 36% discontinued without switching or restarting, 8% restarted the same drug after a gap greater than 90 days, and 11% switched to another anti-osteoporosis medication. Factors assessed during the 12-month period before initiation were weakly associated with discontinuation. Several Factors measured during follow-up were associated with discontinuation, including more physician visits, hospitalization, having a dual-energy X-ray absorptiometry test, higher Charlson comorbidity index scores, higher out-of-pocket drug payments, and upper gastrointestinal problems. Patterns were similar for 4,738 new users followed for 30 months. Conclusions: Among new bisphosphonates users, switching within and across drug classes and extended treatment gaps are common. Robust definitions and time-varying considerations should be considered to characterize medication discontinuation more accurately. [ABSTRACT FROM AUTHOR]