November 2019 new listings wrap-up

Terbutaline powder for inhalation (Bricanyl Turbuhaler) is now listed on the PBS General Schedule (Section 85) as Authority Required (Streamlined) with the addition of new clinical criteria for the treatment of bronchospasm.¹

Terbutaline powder for inhalation was previously listed as an unrestricted benefit.²

The new clinical criteria for terbutaline powder for inhalation are that the patient must be unable to achieve coordinated use of a metered dose inhaler (MDI) containing a short-acting beta₂ agonist (SABA) or has developed a clinically important product-related adverse event during treatment with another SABA.¹

What is it?

Terbutaline is a short-acting beta₂ agonist (SABA). It stimulates beta₂ adrenoreceptors which results in relaxation of bronchial smooth muscle.³

Who is it for?

The TGA-approved indication for terbutaline powder for inhalation is for short-term management of bronchospasm as a result of asthma or chronic obstructive pulmonary disease (COPD).⁴ See the terbutaline powder for inhalation (Bricanyl Turbuhaler) product information for more information about indications.

In July 2019, the Pharmaceutical Benefits Advisory Committee (PBAC) was asked to advise whether terbutaline powder for inhalation should be retained on the PBS on the basis of clinical need or whether available forms of salbutamol for inhalation were suitable alternatives.⁵

If terbutaline was to be retained on the PBS on the basis of clinical need, the PBAC was asked to define the patient population that would be unable to use the alternative treatments.⁵

The PBAC noted the clinical advice from respiratory physicians regarding concerns about the potential withdrawal of terbutaline powder for oral inhalation from the PBS. The PBAC considered that terbutaline powder for inhalation is a valuable therapeutic option for patients who are unable to use an MDI, experience adverse effects with the use of salbutamol or experience paradoxical bronchoconstriction with MDI use.⁵

Safety issues

Serious hypokalaemia may occur with high doses of beta₂ agonists. This effect may be worsened by concurrent use of theophyllines, corticosteroids and diuretics.³ The risk may also be increased when hypoxia is present (such as in acute severe asthma).⁴

The risk of hyperglycaemia may be increased with use of high doses of terbutaline by patients with diabetes³ due to the blood glucose-increasing effects of beta₂ agonists.⁴

There is potential for cardiovascular adverse effects in patients with cardiovascular disorders (including hypertension, ischaemic heart disease, heart failure and arrhythmias) and also in patients with hyperthyroidism.³

The new PBS listing for terbutaline power for inhalation recommends that inhaler technique should be reviewed before commencing treatment with terbutaline powder for inhalation, and also at each clinical visit.¹ This is particularly important when asthma control is poor.³

The NPS MedicineWise inhaler checklist clarifies the steps involved in using different inhalers. The National Asthma Council Australia also provides instructional videos demonstrating proper inhaler technique.

Other items listed in November 2019 include:

• fingolimod for multiple sclerosis (General Schedule, Item 11818B)
• naloxone actuation nasal spray for opioid overdose (General Schedule, Item 11816X, 11817Y)

See the PBS Summary of Changes for a complete list of all additions, deletions and alterations