Case Studies

MedNavigate played a crucial role in staff augmentation for a major pharmaceutical organization, contributing to the preparedness of the health economic team for the launch of an oncolytic based on a phase IB clinical study. Integrated within the health economics and value demonstration team of the pharmaceutical company, MedNavigate provided hands-on support in various aspects. This included the execution of two systematic reviews—one focused on clinical aspects and the other on economic factors. Additionally, MedNavigate contributed to development of a budget impact model and crafting both pre- and post-market approval AMCP (Academy of Managed Care Pharmacy) value dossiers. MedNaviagate also actively participated in parameter formulation for a value-based contracting strategy. Beyond these core responsibilities, MedNavigate engaged in numerous ad-hoc activities, addressing additional needs as they arose, thereby ensuring holistic and well-rounded support for market launch.

The described initiative aimed to gain valuable insights into patient experiences and the overall burden of a specific disease. The collaboration involved MedNavigate, a Medical Affairs consultancy, and a rare disease patient organization, collectively conducting research to support a potential label expansion for a prominent pharmaceutical corporation. Working closely with all stakeholder groups, MedNavigate facilitated a comprehensive understanding of research objectives and spearheaded lead design of a retrospective study protocol and accompanying statistical analysis plan.  Multiple check-ins were conducted with stakeholders with iterative document updates. Additionally, MedNavigate took charge of establishing a HIPAA-compliant AWS infrastructure for secure data storage and analysis. Seeking and obtaining IRB approval from a renowned academic institution was a crucial milestone in the process. With all necessary approvals now in place, MedNavigate is poised to commence data analysis activities in early 2024, marking a significant step toward enhancing understanding and addressing the challenges associated with the targeted disease.

MedNavigate played a pivotal role in advising on the design of multiple class 3 device clinical trials, emphasizing the inclusion of patient-centric and economic value endpoints for various. The advisory services encompassed a thorough review of company materials and external scientific publications, focusing on understanding the disease burden associated with each respective disease indication and synthesizing key findings. Additionally, a comprehensive analysis of the comparative clinical trial landscape was conducted, summarizing critical insights. Our founder, Nancy Hedlund, actively participated in multiple project team calls, contributing insights and support in discussions related to study design elements and economic strategies. The culmination of these efforts resulted in the development of a PowerPoint slide deck for each respective use case, providing a comprehensive guide for the client team to inform decision-making.

MedNavigate initiated the development of a semi-automated Excel-based cost calculator for an implantable medical device company. In the first phase, an intake session was conducted with the client, delving into discussions about the current reimbursement landscape and capturing the desired value statements meant for presentation to health system stakeholders. Subsequently, a comprehensive specifications document was crafted, delineating data input tables, fields, formulas, and automation scripts, serving as a blueprint for the upcoming phases. The calculator’s programming code underwent meticulous development and testing, undergoing two rounds of updates to seamlessly incorporate feedback from stakeholders. Finally, a detailed instructions document was prepared, intended for regulatory reviews and facilitating the onboarding of team members, thereby ensuring a smooth approval process and deployment across the organization.