Italian authorities reject reimbursement for new Alzheimer drugs while emphasizing biosimilar cost savings

The Italian Medicines Agency (AIFA) announced that its Scientific and Economic Committee (CSE) confirmed on 15‑19 June 2026 that the anti‑beta‑amyloid antibodies lecanemab and donanemab will not be reimbursed by the National Health Service. The committee judged that the drugs showed only modest slowing of Alzheimer’s disease progression over 18 months and raised safety concerns such as amyloid‑related imaging abnormalities. Patient group AIMA condemned the decision, calling it a missed opportunity for early‑stage Alzheimer treatment.

At the same time, Francesca Romana Ramundo, Country Head and CEO of Sandoz Italy, highlighted the strategic role of equivalent and biosimilar medicines in controlling pharmaceutical spending. She noted that biosimilars have generated €56 billion in savings across Europe between 2016 and 2024, including €3 billion in Italy, and that Italy’s market penetration now exceeds 72 percent. Ramundo warned that aggressive price erosion could threaten future industry investment and stressed the need for robust governance of biosimilars.

Both statements illustrate the tension in Italy’s drug policy between introducing innovative therapies and managing long‑term fiscal sustainability.