Assessing the Early Economic Feasibility of a Curative Gene Therapy for Multiple Sclerosis Using a Risk-Adjusted Valuation Framework.

Background/Objectives: Multiple sclerosis (MS) imposes a substantial clinical, humanistic, and economic burden, and current disease-modifying therapies require lifelong administration without restoring immune tolerance. IMMUTOL, a tolerogenic gene therapy under development within an EU-funded programme, aims to induce durable remission. Methods: This study assessed the early financial feasibility of IMMUTOL using a structured risk-adjusted net present value (rNPV) model, incorporating development and operating costs, probabilities of clinical and regulatory success, manufacturing expenditure, market dynamics, and revenue projections. Uncertainty was examined through one-way, probabilistic, and scenario analyses. Results: Under base-case assumptions, IMMUTOL generated a deterministic rNPV of -$223.8 million with an internal rate of return of 3.4%. Probabilistic analysis yielded a mean rNPV of -$99.4 million and a mean internal rate of return of 10.5%, with 70.2% of simulations producing negative values. Only scenarios combining higher treatment prices with lower manufacturing costs produced consistently positive rNPVs; a price of $1.5 million with a $200,000 production cost resulted in an rNPV of $711.2 million and an internal rate of return of 20.7%. Neither increased market size, reduced time to approval, nor modest cost reductions altered the conclusion. Conclusions: These findings emphasise a structural gap between value-based pricing and the pricing required for commercial viability. Without external support or reductions in cost structures, commercial development may be economically unattractive.