Cost‐effectiveness of amyloid‐targeting therapies: modelling based on 5724 biomarker positive AD patients in the Swedish Registry of Cognitive Disorders

Abstract

AbstractBackgroundLecanemab is an amyloid‐targeting therapy recently approved by the U.S. FDA for treatment of early Alzheimer’s disease. A phase III trial (Clarity AD) demonstrated a reduction of disease progression, however uncertainty remains around the long‐term health outcomes and implications for cost‐effectiveness. Previous economic evaluations have been limited by lack of long‐term follow‐up data on health outcomes and resource utilization in AD patients with biomarker‐confirmed amyloid pathology.Method5724 patients with longitudinal follow‐up data were included from the Swedish Registry of Cognitive Disorders (SveDem), linked to other data sources. Amyloid positivity was determined from the CSF beta amyloid 1‐42/p‐Tau ratio, with optimal cut‐off levels determined from Abeta 40/42 ratios. Patients were followed up to 12.9 years from diagnosis (mean 4.9 years). A disease model model was constructed with states defined by cognitive status (MCI/dementia, MMSE score) and care setting (community/institution). The semi‐Markov design allows transition probabilities to vary with time spend in individual states. Hazard rates for disease progression, institutionalization and mortality were estimated using semiparametric survival models based on SveDem linked to the municipal care and death registries. Costs by disease state were estimated from resource utilization data from the national patient and prescription drug registries on formal medical and community care. Health utility values by disease state were derived from previous observational studies in Sweden.ResultA therapy reducing disease progression to more severe cognitive states by 31% over a treatment period of 18 months (as in Clarity AD) was associated with savings in formal care costs of 41,000 SEK and 0.140 quality‐adjusted life‐years (QALYs) gained. At 1 million SEK per QALY, treatment would be cost‐effective at an annual cost of 121,000 SEK, including costs for diagnosis and monitoring. Almost half of estimated QALY gains were due to reduced mortality; setting survival equal in treated and untreated patients resulted in fewer QALYs gained but higher cost savings.ConclusionThis is the first study to report on the cost‐effectiveness of amyloid‐targeting therapy based on integrated disease progression and cost data from a large, representative cohort of amyloid‐positive early AD patients. Such data is of critical importance to enable cost‐effective introduction of lecanemab.