GVS assessment of Bevespi® aerosphere for the treatment of COPD

The National Health Care Institute has completed its assessment whether Bevespi® aerosphere can be included in the Medication Reimbursement System (GVS). Bevespi® is registered as a bronchodilating maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults. Because the active ingredients of Bevespi® have already been approved for inclusion in the GVS, a marginal test will be sufficient. The National Health Care Institute advises to include Bevespi® in List 1B of the GVS on technical grounds. 

Registered indication

Bevespi® is registered as a bronchodilating maintenance treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.

Active ingredients of Bevespi® have already been approved for inclusion

Bevespi® is a combination preparation with two active ingredients: the long-acting parasympathomimetic glycopyrronium and the long-acting β2-sympathicomimetic formoterol. The active ingredient glycopyrronium (as bromide) is included in the GVS as a capsule for inhalation powder with a dose of 44 micrograms (Seebri® and Tovanor®), but not as an aerosol. Formoterol fumarate dihydrate (Atimos®) as an aerosol 12 microgs (with a dose of 10.1 microgs) is already included in the GVS. Because the active ingredients of Bevespi® have already been approved for inclusion in the GVS, a marginal test will be sufficient. 

The National Health Care Institute's advice

The National Health Care Institute's advice is to include Bevespi® in List 1B of the GVS on technical grounds. 

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.