Description
Background: Donanemab was recently approved following the 2023 approval of lecanemab for early Alzheimers disease (AD). While both therapies represent important advances in disease-modifying treatments, substantial concerns remain regarding their clinical value and affordability. Existing cost-effectiveness analyses have only compared each drug to placebo. A direct economic comparison between the two therapies is needed to better inform healthcare decision-making. Methods: We developed a five-state Markov model to evaluate the lifetime cost-effectiveness of donanemab versus lecanemab from the US healthcare system perspective. Clinical inputs were derived from an indirect treatment comparison using published trial data. Costs, utilities, and transition probabilities were sourced from the literature. The model estimated incremental cost-effectiveness ratios (ICERs), quality-adjusted life years (QALYs), and value-based prices (VBPs). A willingness-to-pay (WTP) threshold of $150,000 per QALY was used to determine cost-effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess model robustness. Results: Donanemab was associated with an incremental cost of $28,688.53 and an incremental QALY of 0.10 compared to lecanemab, resulting in an ICER of $295,054.43 per QALY. The VBPs for lecanemab and donanemab were estimated at $9,551 and $12,664 annually, respectively. Sensitivity analyses identified the drug price of donanemab and lecanemab as the primary driver of ICER. Conclusions: Donanemab is not a cost-effective alternative to lecanemab under current WTP thresholds. These findings highlight the urgent need to reassess pricing strategies for novel AD therapies. Although the Inflation Reduction Act (IRA) currently exempts biologics from price negotiation for 13 years post-approval, such policies may delay access to affordable treatments. Our findings support the need for ongoing value assessments of disease-modifying therapies and underscore the importance of aligning drug prices with clinical benefit to ensure sustainable access for AD patients.
Publication Info
2026.