Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development
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LEADING ARTICLE
Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development Meenakshi Srinivasan1 · Annesha White1 · Ayyappa Chaturvedula1 · Valvanera Vozmediano2 · Stephan Schmidt2 · Leo Plouffe3 · La’Marcus T. Wingate4
© The Author(s) 2020
Abstract Pharmacometrics is the science of quantifying the relationship between the pharmacokinetics and pharmacodynamics of drugs in combination with disease models and trial information to aid in drug development and dosing optimization for clinical practice. Considering the variability in the dose–concentration–effect relationship of drugs, an opportunity exists in linking pharmacokinetic and pharmacodynamic model-based estimates with pharmacoeconomic models. This link may provide early estimates of the cost effectiveness of drug therapies, thus informing late-stage drug development, pricing, and reimbursement decisions. Published case studies have demonstrated how integrated pharmacokinetic–pharmacodynamic– pharmacoeconomic models can complement traditional pharmacoeconomic analyses by identifying the impact of specific patient sub-groups, dose, dosing schedules, and adherence on the cost effectiveness of drugs, thus providing a mechanistic basis to predict the economic value of new drugs. Greater collaboration between the pharmacoeconomics and pharmacometrics community can enable methodological improvements in pharmacokinetic–pharmacodynamic–pharmacoeconomic models to support drug development.
1 Introduction 1.1 Modeling and Simulation Approaches to Improve Drug Development Efficiency The median costs incurred for bringing a new drug into the market is estimated to be US$985 million with return on investment for research and development expenditure at an all-time low for the pharmaceutical industry [1, 2]. Latephase drug development accounts for the major portion of the costs with roughly half of investigational drugs reaching this phase failing because of safety and efficacy concerns or poor economic viability [3, 4]. Recognizing this, the US
* Annesha White [email protected] 1
University of North Texas System College of Pharmacy, 3500 Camp Bowie Blvd, Fort Worth, TX 76107, USA
2
Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL, USA
3
Bayer HealthCare, Whippany, NJ, USA
4
College of Pharmacy, Howard University, Washington, DC, USA
Food and Drug Administration (FDA) in its “critical path” initiative, acknowledged the opportunity of using modeling and simulation approaches to optimize and advance the drug development process and reduce costs [5]. Pharmacometrics is the science of quantifying the relationship between pharmacokinetics and pharmacodynamics of drugs in combination with disease models and trial information (specific target population, medication adherence) to aid in drug development and dosing optimization for clinical practice [6, 7]. Model-based drug development (MBDD), a framework built on Sheiner’s “learn and confirm” paradigm, impleme
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