Mepolizumab (Nucala)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Nucala be reimbursed by public drug plans as add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophil levels inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) only if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Nucala demonstrates acceptable clinical value in adult patients with COPD. This determination was enough for CDEC to recommend that Nucala be reimbursed. Given that Nucala is expected to be an additive treatment to ICS-LABA-LAMA background therapy, acceptable clinical value refers to added value versus ICS-LABA-LAMA combination therapy.
• Evidence from 1 clinical trial and 1 meta-analysis demonstrated that in adult patients with COPD characterized by elevated levels of blood eosinophils (≥ 300 cells/µL) and moderate to severe airflow obstruction despite receiving triple inhaler therapy (ICS-LABA-LAMA therapy), Nucala likely resulted in a clinically meaningful reduction in moderate or severe COPD exacerbations compared to placebo when used in addition to standard of care (SOC) therapy (ICS-LABA-LAMA combination therapy).
• Patients said that despite benefits they derive from available treatments, they continue to face challenges in their daily lives due to residual COPD symptoms (e.g., shortness of breath upon exertion), adverse events from medications, disease exacerbations, and disease progression. Nucala may address some of the needs patients identified, such as decreasing the frequency of COPD-related exacerbations and reducing the severity of symptoms.
• Based on all the preceding considerations, CDEC recommended that mepolizumab be reimbursed.
• Nucala should only be reimbursed as add-on maintenance treatment in adult patients with COPD who have obstructed airflow confirmed by lung function testing, whose disease has been stable while receiving optimized inhaler therapy for at least 3 months, who have experienced at least 2 moderate COPD exacerbations or 1 severe exacerbation within the past 12 months (with at least 1 occurring after the patient had been receiving optimized inhaler therapy for 3 months), and who have elevated blood eosinophil levels. Optimized inhaler therapy must consist of ICS-LABA-LAMA combination therapy or LABA-LAMA combination therapy if the use of an ICS is inappropriate.
• Nucala should only be reimbursed if the number and severity of a patient’s COPD exacerbations in the previous 12 months are assessed before treatment is started. The patient’s response to treatment should be reviewed every 12 months to determine whether reimbursement should continue. For the first renewal, reimbursement may continue if, compared with baseline, the patient has experienced fewer moderate or severe exacerbations, or less severe exacerbations despite no change in their number, unless the lack of improvement is explained by a medical comorbidity. For subsequent renewals, the physician should provide evidence that the number of moderate or severe exacerbations has not increased compared with baseline, unless any increase is explained by a medical comorbidity. Nucala should be prescribed by, or in consultation with, a respirologist (lung specialist) and should not be reimbursed when used in combination with another biologic drug indicated for COPD. The cost of Nucala should also be reduced.
• Important budget impact considerations must be addressed for health systems to be able to adopt Nucala.