Anouk Donners

166 Chapter 9 Figure 3. Cycle for the cost-efficient dosing strategy development of biopharmaceuticals. Building a framework 1. Idea Every innovation begins with an idea that trigger an hypothesis regarding cost-efficient dosing for a specific drug. This hypothesis can be checked with a quick literature scan. I recommend scanning and selecting biopharmaceuticals with high cost-efficient potential based on the following criteria: - Pricing of either >€40 million per year, or >€50,000 per treatment and >€10 million per year: This criterion follows the pricing criteria adopted for the Sluisgeneesmiddelen in the Netherlands [56], which are drugs with a substantially high financial effect on healthcare. - Limited or alternative dose-finding studies were performed in the Phase I/II clinical trials. This criterion can be checked in the literature or in the European Public Assessment Report. Theoretical assumptions are frequently employed in alternative dose-finding models, introducing greater uncertainty, so higher dosing is often