Access to Dupilumab for COPD Patients Faces Hurdles in Spain
Madrid, Spain – February 17, 2026 – A recent decision by the Spanish National Health System (SNS) not to finance dupilumab for the treatment of Chronic Obstructive Pulmonary Disease (COPD) has sparked concern among patient advocacy groups and medical professionals. The Federación Nacional de Asociaciones de Enfermos Respiratorios (FENAER), EPOC España, and the Sociedad Española de Neumología y Cirugía Torácica (SEPAR) are jointly calling for dialogue to facilitate access to this innovative therapy for a specific subgroup of COPD patients.
COPD: A Significant Public Health Challenge in Spain
COPD remains a leading cause of morbidity and mortality in Spain, characterized by high hospitalization rates and a substantial reduction in life expectancy, as highlighted in the SNS Report 2025 [1]. Despite advancements in treatment, a subset of individuals with COPD continues to experience frequent exacerbations, significantly impacting their quality of life and overall prognosis.
Dupilumab: A Potential Benefit for a Specific COPD Phenotype
A particular subgroup of COPD patients exhibits bronchial inflammation similar to that observed in asthma. These patients, even with optimal inhaled treatment, continue to suffer from frequent exacerbations. Clinical trials have demonstrated that dupilumab can significantly reduce these exacerbations in this specific patient profile [1], [2].
Regulatory Approval and Existing Funding in Spain and Europe
Dupilumab received approval from the European Medicines Agency (EMA) over a year and a half ago and is currently included in major international and national clinical guidelines, including the GOLD 2025 (Global Initiative for Chronic Obstructive Lung Disease) and the Spanish COPD Guide (GesEPOC) 2025 [1], [2]. The drug is already funded in Spain for other conditions such as severe asthma, chronic rhinosinusitis with nasal polyposis, and atopic dermatitis, and is prescribed in other European countries for COPD patients meeting similar clinical criteria [1], [2].
Concerns Regarding Equity and Access
The organizations emphasize that the current situation creates a double inequity: between patients with different respiratory conditions sharing similar inflammatory mechanisms, and between patients in different European countries regarding access to this therapeutic option [1], [2]. They are not advocating for a generalized indication but rather for a responsible, focused, and evaluable access pathway for a limited group of patients who currently lack effective treatment alternatives.
Call for Dialogue and Collaboration
FENAER, EPOC España, and SEPAR are requesting an open dialogue with health authorities to explore potential avenues for agreement within the existing regulatory framework. They reiterate their willingness to collaborate on initiatives aimed at improving responsible access to innovation, prioritizing patient well-being [1], [2]. The ultimate goal is a system that incorporates innovation equitably, responsibly, and with a patient-centered approach.