Determining the societal value of a prospective drug for ME/CFS in Germany.

Background: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) imposes a substantial societal and economic burden. The aim of this study is to ascertain the optimal level of public research and development (R&D) investment in Germany for a prospective drug, given the pressing need for effective treatments.

Methods: This study calculates the societal value from a German perspective by integrating health and economic outcomes in the context of public R&D investment for ME/CFS. It considers factors such as direct medical costs, productivity loss, and the effectiveness of a prospective drug.

Results: The anticipated introduction of a prospective drug is estimated to yield a quality-adjusted life year (QALY) gain of approximately 29,000 and a societal value of about €2.6 billion. The optimal R&D investment in Germany is estimated at €676 million, which represents about a quarter of the total investment required to bring a significant drug to market, considering diminishing returns and market constraints. Results were confirmed in the sensitivity analysis.

Conclusions: The study concludes that a coordinated international approach is imperative to address the funding and market size limitations effectively in developing treatments for ME/CFS and to realize the substantial societal and economic benefits.