The Association of Patients with Chronic Obstructive Pulmonary Disease (APEPOC) has expressed its deep displeasure over the decision of the Interministerial Commission for Drug Pricing (CIPM) not to include the biologic dupilumab in public funding. This refusal comes more than 700 days after the European Medicines Agency (EMA) gave the green light for its use, a delay that has led patients to wonder "how much" their lives are worth.
"COPD is a progressive disease that robs us of our breath and also our years of life. After more than 700 days of waiting, we wonder how much our lives are worth. It is difficult to understand that an innovation supported by scientific evidence and funded for other pathologies such as asthma remains unavailable to COPD patients," stated APEPOC spokesperson Nicole Hass.
The association emphasizes that dupilumab constitutes "the first truly disruptive innovation in more than 15 years" for the management of COPD. They recall that this pathology is the leading specific cause of respiratory mortality in Spain and one of the most significant globally. It can shorten life expectancy by up to 17 years, and around 24 percent of diagnosed individuals die within five years of diagnosis.
APEPOC warns that approximately half of patients with severe COPD continue to suffer significant exacerbations despite receiving the maximum available treatment. These exacerbations lead to irreversible deterioration of lung function and are the main reason for hospital admissions and consumption of healthcare system resources. The entity points out that after a first severe episode requiring hospitalization, only half of those affected are still alive three and a half years later.
Given this scenario, the association demands that the CIPM, which has already rejected the funding of dupilumab on three occasions, reverse its stance and approve it without further delay. "We do not have one more day to continue waiting for administrative procedures. Every day that passes without access to this innovation, there are patients who are admitted to the Emergency Room and will never be the same," warned Hass.
Dupilumab and its impact on COPD
Dupilumab is the first monoclonal antibody authorized to treat uncontrolled COPD associated with type 2 inflammation. The drug targets a very specific subgroup of patients, which, according to APEPOC, allows for maximizing the efficiency of healthcare spending and questions the argument that its incorporation entails an unmanageable budgetary impact.
In this regard, the organization maintains that the decision not to finance this treatment "does not represent real savings for public coffers, but rather a shift of expenditure towards less efficient resources." They recall that hospital readmissions linked to COPD absorb up to 55 percent of the budget dedicated to this chronic disease, when clinical trials have shown that the use of dupilumab reduces exacerbations and decreases hospitalizations and emergency room visits by more than 30 percent.
APEPOC also highlights that this therapy has the endorsement of the GesEPOC 2025 Guidelines and the GOLD 2026 Guidelines, and that it is already financed by the National Health System (SNS) for other indications, such as asthma or nasal polyposis. The medication is also available in Germany and in several European Union countries.
"The Administration's excuse cannot be savings. What is truly unmanageable for the system is to continue addressing the disease with the extremely high cost of hospitalizations and readmissions, which today consume up to 55 percent of the budget allocated to these chronic patients," APEPOC concluded.