Katherine Lofgren

Katherine Lofgren

Senior Decision Scientist, Foundation Medicine

Dissertation Title:  "Informing Financial Investments in Health: Applications of Decision-Analytic Methods"In this dissertation, I use decision-analytic methods to investigate prospective financial allocation decisions in three health policy contexts: research, regulation, and insurance.

Chapter 1 developed an accessible entry point for non-decision scientists to gain intuition on how a value-based study design may differ from a power-calculation (constrained on Type I/II error) required sample size. Using a case study of implantable cardiac devices, we demonstrate that VOI has the potential to prioritize the study of patient subpopulations that may otherwise be overlooked.

Chapter 2 considers the potential pitfalls of regulatory decision-making based on surrogate outcomes. The Food and Drug Administration’s (FDS) Accelerated Approval Pathway (AAP) was established in 1992 to get high-need patients new therapeutic options faster. To achieve this goal, the FDA approves AAP drug-indications explicitly on surrogate outcomes. Using both simulation and a AAP case study, we find that regulators relying on surrogate outcomes may incorrectly perceive both the likelihood of a decision error and the consequences of review mistakes.

Chapter 3 studies how low- and middle-income countries can approach essential health benefits design using mathematical optimization to balance competing objectives. We estimate both expected health and financial risk protection benefits from 22 candidate interventions in the country-context of Ethiopia. When both objectives are considered jointly using bi-criterion integer programming optimization, the optimal benefits package flexibly changes based on the relative importance of health and financial protection.

 

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