TerbutalineBricanyl Injection
Management of bronchospasm in patients unable to achieve coordinated use of a metered dose inhaler containing a short-acting beta-2 agonist, or in patients who have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.
Decisions on record
- Meeting Jul 2020 Recommended Bronchospasm
- Meeting Jul 2013 Recommended Asthma no PSD
Access path
- TGA registered · Bricanyl Injection
TGA label narrower than the PBS population
- Jul 2019Recommended · restricted
vs salbutamol (short-acting beta-2 agonist alternatives)
- Jul 2020Recommended
Comparator changed: salbutamol (short-acting beta-2 agonist alternatives) → M2 Turbuhaler
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended an Authority Required (STREAMLINED) listing of a new form of terbutaline, M3 Turbuhaler, under the same eligibility criteria as the currently listed form of terbutaline, M2 Turbuhaler.PSD · Jul 2020
6.2 The PBAC noted that the TGA concluded that therapeutic equivalence of terbutaline sulfate was established between the M2 and M3 devices. 5PSD · Jul 2020
5.4 The submission claimed that the M3 Turbuhaler provided equivalent effectiveness and safety to the M2 Turbuhaler. The TGA concluded that therapeutic equivalence of terbutaline sulfate was established between the M2 and M3 devices and that the M3 Turbuhaler had a consistent safety profile and did not raise any major safety concerns (TGA Delegate’s Note, p5). Pricing considerationsPSD · Jul 2020
5.5 The submission requested a 20% increase in the AEMP for M3 Turbuhaler with 120 actuations, which is proportional to the current AEMP of M2 Turbuhaler with 100 actuations.PSD · Jul 2020
5.3 The PBAC noted and welcomed the input from an organisation (1) via the Consumer Comments facility on the PBS website. Lung Foundation Australia described that the new device with dosage counter and additional inhalations would improve patient experience and adherence, particularly for patients with chronic obstructive pulmonary disease (COPD).PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as M3 Turbuhaler is therapeutically equivalent to M2 Turbuhaler.
Decision context
PopulationPatients unable to achieve coordinated use of a metered dose inhaler containing a short-acting beta-2 agonist, or patients who have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended | M2 Turbuhaler | — | Cost-minimisation · Cost-minimisation |
| Jul 2019 | Recommended · restricted | salbutamol (short-acting beta-2 agonist alternatives) | — | Other |
Consumer voice
Lung Foundation Australia provided input noting that the new M3 device with dosage counter and additional inhalations would improve patient experience and adherence, particularly for patients with COPD.
the new device with dosage counter and additional inhalations would improve patient experience and adherence, particularly for patients with chronic obstructive pulmonary disease (COPD) Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unable to coordinate MDI use or with adverse events to other SABA; TGA label permits all bronchospasm management.