BUDESONIDE WITH GLYCOPYRRONIUM AND FORMOTEROL
Information current as at: 1 November 2026
Submission Details
- Brand name:
-
- Breztri Aerosphere®
- Form and strength:
-
- Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 14.4 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses
- Submission sponsor:
- ASTRAZENECA PTY LTD
- Condition/indication:
(therapeutic use) -
- Severe asthma
- Listing requested:
- To consider a request for listing of a new form of budesonide with glycopyrronium and formoterol for the maintenance treatment of severe asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta agonist (LABA) and an inhaled corticosteroid (ICS) who experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma.
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - September 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 04/09/2026
-
5Lodgement of required documentation:
- 08/10/2026
-
Acceptance of complete documentation:
- Under consideration
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended listing of the fixed dose combination (FDC) of budesonide (BUD) with formoterol (FOR) and glycopyrronium (GLY) (BUD/FOR/GLY) for maintenance treatment of severe asthma.
The PBAC welcomed the input from Asthma Australia supporting the listing of BUD/FOR/GLY for this use. The input highlighted the burden severe asthma can place on people and their families and noted that BUD/FOR/GLY offered another inhaler option.
Based on the evidence included in the submission, the PBAC was satisfied that medium dose BUD/FOR/GLY was as effective as medium dose beclometasone (BEC)/FOR/GLY and had similar safety. The PBAC considered that the cost of BUD/FOR/GLY should be no greater than the lowest price combination at approved ex-manufacturer price level of the PBS listed components of triple therapy that are available for asthma at comparable doses. The PBAC advised the equi-effective doses for severe asthma were: BUD/FOR/GLY (160/5/14.4 μg), 2 actuations twice daily equals BEC/FOR/GLY (100/6/10 μg), 2 actuations twice daily. The PBAC advised that the equi-effective doses of alternative therapies for severe asthma should be based on that previously accepted by the PBAC at the time of recommendation.
The PBAC agreed with the evaluation that mometasone should be included in the administrative advice describing ICS. The PBAC also considered that the administrative advice on therapies that should not be used in combination with BUD/FOR/GLY should refer to ICS/LABA/LAMA therapy. It was considered appropriate for both of these changes to flow on to other listings that have the relevant Concept IDs.