TDM-Based Tailored Dosing of Durvalumab in Lung Cancer Patients: A Comprehensive Population Pharmacokinetic-Pharmacoeconomic Evaluation.

BACKGROUND

The increasing use of immune checkpoint inhibitors, such as durvalumab, places a significant financial burden on healthcare systems, strains hospital capacities, and contributes to environmental concerns.

OBJECTIVE

We aimed to develop alternative dosing strategies to optimize durvalumab administration, reduce unnecessary drug use, and ensure sustainable cancer care without sacrificing efficacy.

METHODS

Using the population pharmacokinetic model developed by the licensing holder, we designed two alternative dosing strategies for non-small cell lung cancer based on therapeutic drug monitoring. Adjustments were made to the dose or administration interval, following regulatory standards for in silico dose optimization. A pharmacoeconomic evaluation was conducted to estimate potential cost savings from a medical perspective.

RESULTS

Both alternative strategies achieved high exposure levels, with 98.1-99.0% of patients exceeding a predefined efficacy target, surpassing the 95.4% predicted by the license holder for the approved 10 mg/kg 2-weekly regimen. They also reduced overall drug exposure by 7-24% and eliminated drug wastage, resulting in an average annual cost reduction of €25,163 (22.9%) per patient.

CONCLUSION

Therapeutic drug monitoring-guided adjustments for durvalumab offer a potentially cost-saving way to optimize drug use, reduce healthcare burdens, and lessen environmental impact while ensuring adequate patient exposure. Our proposal's evidence provides a solid basis for a non-inferiority study.