Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018

Liu, Yifei; Skup, Martha; Yang, Min; Chang, Qi; Wu, Eric Q.

doi:10.1007/s12325-022-02173-7

Cited by 4 publications

(3 citation statements)

References 104 publications

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“…A meta-analysis showed that 6% to 9% of patients discontinue therapy upon being forced to switch tumor necrosis factor inhibitors. 43 For other antipsoriatic medications, we used the 9% to 19% discontinuation rate seen in a meta-analysis of nonmedical switching across multiple treatment classes 40 and in studies of nonmedical switching of biologics. 44 The rate of adverse events from all of these agents is high, and studies show that switching results in 15% to 35% of patients having adverse events.…”

Section: Resultsmentioning

confidence: 99%

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Sydor,

Bergin,

Kay

et al. 2024

Journal of Health Economics and Outcomes Research

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Background: Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. Methods: We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. Results: The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. Conclusion: Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.

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Section: Resultsmentioning

confidence: 99%

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Sydor,

Bergin,

Kay

et al. 2024

Journal of Health Economics and Outcomes Research

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“…A meta-analysis showed that 6% - 9% of patients discontinue therapy upon being forced to switch tumor necrosis factor inhibitors (TNFi). 37 For other anti-psoriatic medications, we used the 9% to 19% discontinuation rate seen in a meta-analysis of non-medical switching across multiple drug classes 34 and in studies of non-medical switching of biological medications. 38-40 The rate of adverse events from all of these agents is high, and studies show that switching results in 15% to 35% of patients having adverse events.…”

Section: Resultsmentioning

confidence: 99%

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Sydor,

Bergin,

Kay

et al. 2023

Preprint

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BackgroundDrug formularies, initially designed to promote the use of cost-effective generic drugs are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate drug purchase prices. In the largest publicly available formulary, 55% of mandated substitutions are not for generic versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients.MethodsWe modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the two largest U.S. formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion.ResultsThe number of people likely to have adverse events due to the exclusion could be as high as one million for atrial fibrillation/venous thromboembolism, 900,000 for migraine prevention, and 500,000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924,000 for atrial fibrillation/venous thromboembolism, 646,000 for migraine, and 138,000 for psoriasis.ConclusionSubstitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced drug substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.

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“…These negative perceptions may partly explain why providers were less satisfied with the biosimilar in terms of safety and efficacy. It is possible that some patients experienced side effects and loss of disease control, as reported in previous biosimilar brand changes (21,22). However, providers may unintentionally report more negatively on biosimilar safety and efficacy to support their existing beliefs (23).…”

Section: Discussionmentioning

confidence: 99%

Health Care Providers’ Experiences of a Mandatory Nationwide Transition to an Adalimumab Biosimilar

Gasteiger,

Lobo,

Wong

et al. 2023

ACR Open Rheumatology

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ObjectiveTransitioning patients to biosimilars has become common to reduce costs and improve access. However, it is unclear how the transition process impacts health care providers at the frontline of the brand change. This study explores health care providers’ experiences of a mandatory brand change to an adalimumab biosimilar.MethodsA cross‐sectional study was conducted in Aotearoa New Zealand with 164 providers involved in the nationwide adalimumab brand change. Rheumatologists (n = 39), rheumatology nurses (n = 16), and pharmacists (n = 109) completed a survey that assessed their satisfaction with logistics and supply, information and education, support, and administrative workload and reported what did and did not go well during the transition.ResultsThe mean satisfaction score (0‐10) with the transition was 5.7 (SD = 2.6). Providers were the least satisfied with training for the biosimilar device, information from government agencies, and administrative workload during the transition. Satisfaction with adalimumab safety, efficacy and device quality, and the availability of sharps bins, alcohol wipes, and patient support was lower following the transition. Satisfaction with administrative workload (B = 0.37, P < 0.001) and training for the device (B = 0.20, P = 0.020) predicted overall satisfaction. Providers reported that a poorly implemented initial authorization process, loss of a patient support program, and insufficient communication between providers complicated the transition. The citrate‐free preservative and longer authorization duration after the transition were viewed positively.ConclusionProviders experienced an increased workload and reported less satisfaction with the biosimilar following the transition. Experiences may be improved by ensuring training for the device, a high‐quality patient support program, and functioning authorization processes throughout the transition.

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Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018

Abstract: A total of 66 publications based on realworld studies were identified from 2012 to 2018.Biosimilar discontinuation was prevalent for non-medical switches.Switchback to originator TNF inhibitors was common following biosimilar discontinuation.

Cited by 4 publications

References 104 publications

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Health Care Providers’ Experiences of a Mandatory Nationwide Transition to an Adalimumab Biosimilar

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