Access To The New Alzheimer's Drugs: Why HTA Bodies Are Saying No
Alzheimer's disease (AD) has long been an area of unmet medical need, with few therapeutic options capable of altering the course of the disease. Recently, two disease-modifying treatments, LEQEMBI (lecanemab) and KISUNLA (donanemab), have emerged as potential breakthroughs. However, despite their regulatory approvals, these treatments are facing significant hurdles in achieving positive health technology assessment (HTA) outcomes. This article will examine the current HTA landscape for LEQEMBI and KISUNLA, analyse the reasons behind their unfavourable evaluations, and explore the implications for future assessments in key European markets. Generating data to prove disease modifying effectiveness in AD is very difficult. This is because AD is a slow, degenerative disease, with pathophysiological causes that are thought to act many years before symptoms arise. AD is characterised by patient heterogeneity and impacts patients and their caregivers in many different ways. This results ...
