Model-informed approaches to develop drug cost-saving dosing strategies for pembrolizumab
European Journal of Cancer, vol. 243, pp. 116829
Abstract
BACKGROUND: The increasing use of pembrolizumab in oncological treatments results in substantial healthcare costs. The recently approved subcutaneous (SC) pembrolizumab formulation remains expensive. The aim of this study was to evaluate alternative SC pembrolizumab dosing strategies that reduce costs while maintaining equivalent exposure and improving convenience. METHODS: A previously published population pharmacokinetic model was used to evaluate alternative dosing strategies achieving exposure equivalent to the intravenous (IV) 2 mg/kg Q3W dosing (reference) compliant with FDA guidelines and reducing costs. First, extended fixed dosing intervals irrespective of bodyweight were investigated. Second, body-weight-adjusted dosing intervals were evaluated. Finally, we explored to inject SC formulation (790 mg) intravenously. RESULTS: Identified alternative regimens included SC 790 mg Q7W for all patients; SC 790 mg Q8W (<55 kg), 790 mg Q7W (55-85 kg), and 790 mg Q6W (>85 kg); and IV administration of 790 mg Q9W using the SC formulation. The extended-interval SC regimen (790 mg Q7W) would reduce annual cost to €85,000 (-14%). A bodyweight-adjusted SC strategy would reduce yearly cost from €99,166 to €85,000 (-14%; 55-85 kg) and to €74,375 (-25%; <55 kg). Using the SC formulation intravenously can potentially save annual costs by €33,055 (-33%). In addition, extracting 5 doses of 150 mg Q3W out of one 790 mg SC dose could reduce the annual costs even to €39,666 (-60%). CONCLUSIONS: Dose interval extension of subcutaneous pembrolizumab maintains equivalent exposure and complies with regulatory requirements. Intravenous administration of the subcutaneous formulation is a promising highly cost-effective intervention but requires prospective safety investigation before implementation.
Authors 21
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, the Netherlands
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Affiliation as printed
Leiden Academic of Drug research, Leiden, the Netherlands
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Affiliation as printed
Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands
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Affiliation as printed
Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Pharmacy & Pharmacology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, the Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Medical Oncology, Leiden University Medical Center, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Medical Oncology, Leiden University Medical Center, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, the Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Pulmonology, Amsterdam University Medical Center, the Netherlands
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University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Pulmonology, University of Groningen, University Medical Center Groningen, the Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Pulmonary Diseases, GROW - Research Institute for Oncology and Reproduction, Maastricht University Medical Center+, Maastricht, the Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Clinical Pharmacy & Toxicology, NUTRIM Research Institute of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Pulmonology, Radboudumc, Nijmegen, the Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Pulmonology, University Medical Center Utrecht, the Netherlands
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University Medical Center Groningen
Affiliation as printed
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Pulmonology, Leiden University Medical Center, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, the Netherlands. Electronic address: d.j.a.r.moes@lumc.nl
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Pharmacy, Pharmacology and Toxicology, Radboudumc, Nijmegen, the Netherlands
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