GVS assessment of formoterol/ glycopyrronium/ budesonide (Trixeo® aerosphere)

Zorginstituut Nederland has completed its assessment whether the product formoterol/glycopyrronium/budesonide (Trixeo® aerosphere), a dose aerosol combination preparation, can be included in the medicine reimbursement system (GVS). Trixeo® Aerosphere is registered for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD). The Zorginstituut's advice is to include Trixeo® Aerosphere in List 1B of the GVS on technical grounds. 

Registered indication

Trixeo® is a combination preparation with 3 active ingredients:

  • formoterol fumarate dihydrate, a long-acting β2 agonist;
  • glycopyrronium bromide, a long-acting muscarine antagonist;
  • budesonide, an inhalational corticosteroid.

Trixeo® Aerosphere is registered for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) that cannot be adequately treated by a combination of an inhaled corticosteroid and a long-acting β2 agonist, or a combination of a long-acting β2 agonist and a long-acting muscarine antagonist. 

Zorginstituut's advice

The Zorginstituut'sadvice is to include Trixeo® Aerosphere in List 1B of the GVS on technical grounds. (with additional conditions).

Reimbursement of medicinal products in the GVS

Medicinal products in the GVS are reimbursed from the standard health care benefit package. The size of the reimbursement depends on which list they have been placed. Medicinal products that are interchangeable are clustered on List 1A. A reimbursement limit may apply to these. Unique medicinal products are placed on List 1B. No reimbursement limit applies to these. 

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.