Indacaterol/glycopyrronium/mometasone (Enerzair® Breezhaler®) for maintenance treatment of asthma in adult patients

Zorginstituut Nederland has completed its assessment whether indacaterol/glycopyrronium/mometasone (Enerzair® Breezhaler®) for maintenance treatment of asthma in adult patients can be included in the Medication Reimbursement System (GVS). The Zorginstituut's advice is to include Enerzair® Breezhaler® in List 1B of the GVS on technical grounds.

Active ingredients of Enerzair® Breezhaler® already included in the GVS

Enerzair® Breezhaler® is a combination preparation with three active ingredients:
indacaterol as acetate, glycopyrronium bromide and mometasone furoate. Indacaterol as acetate and glycopyrronium bromide have already been included in the GVS. In 2011, the Dutch Health Care Insurance Board (CVZ) decided that mometasone furoate can be included as inhalation powder in the GVS.

Since the active ingredients of Enerzair® Breezhaler® have already been approved for inclusion in the GVS, a marginal test will suffice.

Registered indication

Enerzair® Breezhaler® is registered as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid, who experienced one or more asthma exacerbations in the previous year.

Zorginstituut's advice

The proposed price of Enerzair® Breezhaler® as a combination therapy is lower than the price of the sum of the individual components. Therefore, the Zorginstituut advices the Minister of Medical Care to include Enerzair® Breezhaler® in List 1B of the GVS on technical grounds.

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