Beclometasone With FormoterolCIPLA BECLOMETASONE/FORMOTEROL
Maintenance treatment of asthma in adults aged 18 years and older who are not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2 agonist, or who are already adequately controlled on both ICS and long-acting beta2-agonists.
Decisions on record
- Meeting Mar 2024 Recommended Asthma
- Meeting Jul 2022 Recommended Asthma in patients previously treated with oral corticosteroids or optimal doses of inhaled corticosteroids
Access path
- TGA registered · CIPLA BECLOMETASONE/FORMOTEROL
TGA label equal than the PBS population
- Jul 2022Recommended · restricted
vs fluticasone propionate 500 microgram/actuation + salmeterol…
- PBS listing · Authority Required
From the public summary
The PBAC recommended an Authority Required (STREAMLINED) listing for Fostair® 200/6 µg metered dose inhaler (MDI), a fixed dose combination (FDC) of beclometasone (BEC), an inhaled corticosteroid (ICS) with formoterol (FOR), a long- acting beta agonist (LABA) as maintenance treatment of asthma. 24PSD · Jul 2022
The PBAC noted the input from Asthma Australia which supported the listing of BEC/FOR 200/6 µg for the maintenance treatment of asthma.PSD · Jul 2022
The submission presented a cost-minimisation analysis based on the DPMQ between BEC/FOR 200/6 μg and the nominated alternative therapies. The approach taken inPSD · Jul 2022
9 National Asthma Council. Australian Asthma Handbook. Version 2.1. September 2020. https://www.asthmahandbook.org.au/management/adults/stepped-adjustment/stepping-up [accessed 1-Apr- 22]PSD · Jul 2022
The submission described BEC/FOR (200/6 μg/actuation, two actuations b.i.d.) as:PSD · Jul 2022
7 National Asthma Council. Australian Asthma Handbook. Version 2.1. September 2020. https://www.asthmahandbook.org.au/management/adults/stepped-adjustment/stepping-up [accessed 5-Apr- 22] 17PSD · Jul 2022
The PBAC noted and welcomed the input from a consumer group/organisation (1) via the Consumer Comments facility on the PBS website. Asthma Australia supported the listing of BEC/FOR 200/6 μg for asthma, highlighting it would be recommended mostly for patients uncontrolled on low or medium-dose ICS-LABA; or considered where a patient has been using medium or high dose ICS monotherapy and continues to experience poor symptom control.PSD · Jul 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
Decision context
PopulationAdults aged 18 years and older with asthma not adequately controlled with inhaled corticosteroids and 'as needed' rapid-acting beta2 agonist, or already adequately controlled on both ICS and long-acting beta2-agonists
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Recommended · restricted | fluticasone propionate 500 microgram/actuation + salmeterol 50 microgram/actuation (FP/SAL 500/50 µg) | — | RCT · Other |
Consumer voice
Asthma Australia supported the listing of BEC/FOR 200/6 μg for asthma, indicating it would be appropriate for patients with inadequate control on lower-dose ICS-LABA therapy or ICS monotherapy, and as a step-up option for those already on BEC/FOR 100/6 μg.
Asthma Australia supported the listing of BEC/FOR 200/6 μg for asthma, highlighting it would be recommended mostly for patients uncontrolled on low or medium-dose ICS-LABA; or considered where a patient has been using medium or high dose ICS monotherapy and continues to experience poor symptom control. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe identical asthma populations: adults inadequately controlled on ICS monotherapy or adequately controlled on ICS+LABA combination.