Spain Denies Public Funding for Alzheimer’s Drugs Lecanemab and Donanemab

The Spanish Ministry of Health and the autonomous communities have officially declined to include lecanemab and donanemab in the national public health system. Despite both medications receiving authorization from the European Medicines Agency (EMA), Spanish health authorities determined that the high costs and significant safety risks associated with these treatments do not currently justify their public financing.

The Decision on Lecanemab and Donanemab

The Interministerial Commission for Pharmaceutical Prices, the body responsible for determining public coverage for medications in Spain, confirmed its rejection of both therapies this week. This decision follows a similar refusal issued earlier in the spring.

Minister of Health Mónica García and Secretary of State for Health Javier Padilla stated that the government engaged in “intense, continuous and constructive” dialogue with the pharmaceutical manufacturers, Biogen and Lilly. Despite these efforts, the Ministry concluded that no agreement on pricing or access could be reached that satisfied the criteria for public funding.

According to Javier Padilla, these medications are not currently publicly financed in any other European Union member state. The Ministry maintains that these drugs do not represent the definitive solution that patients and families are seeking, citing a complex benefit-risk profile identified during the EMA’s rigorous evaluation process.

Clinical Risks and Administration Barriers

The primary concerns cited by health authorities involve both patient safety and the logistical demands of the treatments. Both lecanemab and donanemab are monoclonal antibodies designed to target and remove amyloid plaques in the brain, which are associated with the progression of Alzheimer’s disease.

* Safety Profile: Clinical trials revealed a risk of serious side effects, including brain swelling and hemorrhaging. These adverse events were significant enough to be linked to three deaths during the clinical development of donanemab.
* Target Population: The treatments are only indicated for patients in the early stages of the disease. Furthermore, they are not suitable for all patients; only an estimated 10% of those affected by Alzheimer’s meet the specific criteria for treatment, which excludes those with certain genetic predispositions to side effects.
* Logistics and Cost: Each treatment carries a high estimated cost per patient. Administration is intensive, requiring intravenous infusions every 15 days in a hospital setting, alongside a rigorous patient selection process and continuous monitoring.

Industry and Patient Perspectives

The decision has drawn sharp criticism from patient advocacy groups and neurological societies. Jesús Rodríguez, executive director of the Spanish Confederation of Alzheimer’s and other Dementias (Ceafa), expressed frustration that Spain continues to reject treatments that have been approved by over 50 countries and the EMA. He questioned the equity of denying access to patients who have contributed to the social security system throughout their lives, particularly when these drugs can slow disease progression by approximately 30%.

The Spanish Society of Neurology (SEN) issued a formal statement expressing “deep regret” over the resolution. The society argues that the decision has major clinical implications, as it denies patients access to therapies that could delay the evolution of their condition. The SEN has urged the Ministry of Health and the regional representatives to reconsider their stance.

Conversely, some members of the medical community acknowledge the difficulty of the decision. Alfredo Rodríguez-Antigüedad, head of Neurology at the Hospital de Cruces, noted that given the high costs and safety complications, it is not unexpected that authorities have declined funding. Nora Bengoa, researcher Ikerbasque of the Achucarro Basque Center of Neuroscience, emphasized that while the disappointment of patients is understandable, the scientific community expects that future research and refinements may eventually lead to more accessible or effective versions of these therapeutic agents.