171 General Discussion potentially increasing awareness, acceptance and drug access. The drug label is kept by the manufacturer, and lower profits would not be of direct interest. Therefore, a lucrative return for the manufacturer might be necessary to motivate such initiatives. The cycle in Figure 3 is based on a plan–do–check–act approach, enabling change implementation and continuous improvements in healthcare [74]. Many lessons will presumably be learned by the research team during the seven steps of the cycle. I recommend including these valuable lessons, following the Standards for Reporting Implementation Studies (StaRI), in the dissemination plan and to execute this plan in step 7 [75]. Dissemination of the research is highly recommended to inspire others, because every innovation begins with a new idea. Critical notes Biopharmaceuticals would not be on the market or even developed without their manufacturers. The pharmaceutical industry follows a profit-driven model to bring a drug to the market, which can create tension between the industry and healthcare. Potential ways to overcome this tension include price arrangements or greater publicsector involvement [76], both at an early stage of research and development (R&D) and between manufacturers, government, health insurance companies and hospitals. Pharmaco-economic evaluations, for instance, based on quality-adjusted life-years, may assist in setting a valid price for a biopharmaceutical. However, one disadvantage of these ideas is that the incentive to invest in R&D might decrease as investigators lose interest due to lower potential rewards. Although it may seem unethical to profit from a person’s health, manufacturers have high expenses, such as obligations during expensive clinical studies, demanding regulatory requirements, risky R&D-development phases, patent constraints, high production-facility and marketing costs, as well as a need to generate a return on investment [77, 78]. Pharmaceutical companies and their investors take significant financial risks to gain high rewards. However, until government or health insurance companies also take such risks, it is crucial to find the right balance between financial profits and patient health. Therefore, researchers and clinicians must begin the cycles from Figure 3 to provide counterweight to the current profit-driven model. The four studies on emicizumab yielded a basis for designing a cost-efficient dosing framework for the biopharmaceuticals described in Theme 2. Our research team is currently on step 6 (Clinical evaluation) of the cycle in Figure 3. The results of the prospective clinical study are expected in 2026. These results will demonstrate whether there is a future role for the cost-efficient dosing and monitoring of emicizumab and whether the research team can proceed to the final measure, step 7 (Implementation in practice). If so, the team must perform the final step before the deal between the manufacturer and health insurance companies ends. 9
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