Indacaterol acetate/mometasone furoate (Atectura® Breezhaler®) for the maintenance treatment for asthma in adults and adolescents of 12 years and older

Zorginstituut Nederland has completed its assessment whether indacaterol acetate/mometasone furoate (Atectura® Breezhaler®) can be included in the Medication Reimbursement System (GVS). The Zorginstituut's advice is to include Atectura® Breezhaler® in List 1B of the GVS on technical grounds.

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

Atectura® Breezhaler® is a combination preparation with two active ingredients:
indacaterol as acetate, a long-acting beta 2-adrenergic agonist, and mometasone furoate, a synthetic corticosteroid. Indacaterol as acetate has already been included in the GVS, as an inhalation powder administered through a Breezhaler® under the brand names Onbrez® and Hirobriz®. In 2011, the Dutch Health Care Insurance Board (CVZ) decided that mometasone furoate can be included as inhalation powder in the GVS.

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

Registered indication

Atectura® Breezhaler® is registered as a maintenance treatment for asthma in adults and adolescents 12 years and older whose condition is not sufficiently controlled by inhalation corticosteroids and inhaled short-acting beta 2 agonists.

Zorginstituut's advice

The proposed price of Atectura® 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 Atectura® 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.