From 1 December 2013 a pressurised metered-dose inhaler (pMDI) presentation of the fixed-dose combination (FDC) budesonide with eformoterol will be PBS listed for treatment of asthma and COPD .1

The PBAC recommended the listing on a cost-minimisation basis compared with Symbicort Turbuhaler, an FDC dry powder inhaler (DPI)1 containing the same active ingredients and already PBS listed for the treatment of asthma and COPD.2

Similar efficacy and safety between Symbicort Rapihaler and Turbuhaler have been demonstrated in adults and adolescents with asthma and for COPD.3,4

The 200 microgram/6 microgram strength will be listed for COPD treatment and asthma maintenance therapy only, so patients taking the 200/6-strength Symbicort Turbuhaler for asthma maintenance and reliever therapy (the sponsor of Symbicort refers to this regimen as 'Symbicort maintenance and reliever therapy', or SMART) are not able to switch to the 200/6 Rapihaler.3

May be prescribed by nurse practitioners

Authorised nurse practitioners may prescribe this medicine. See the PBS website for more information on nurse practitioner PBS prescribing.

Ensure appropriate dose selection

The new listing is for three dose levels: budesonide with eformoterol fumarate dehydrate 50 micrograms/3 micrograms, 100 micrograms/3 micrograms and 200 micrograms/6 micrograms per dose.

These doses are half the respective doses available in the Turbuhaler DPI device (see Table 1) because dosing with the Rapihaler is designed to be given in multiples of two actuations to ensure adequate dose uniformity, while Turbuhaler can be given as single actuations.4 Ensure patients are made aware of the dosage differences between the two products.

Table 1 Dose strengths available for pMDI and DPI presentations
Budesonide (micrograms) / eformoterol (micrograms)
Rapihaler pMDI3 Turbuhaler DPI5

50/3

100/3

200/6

100/6

200/6

400/12

Selecting a device

Base a decision to use a pMDI or a DPI device on patient preference and their ability to use a device correctly.6 In general, patients with adequate inspiratory force and adequate hand–inhalation coordination can use either a DPI or a pMDI.

Use of a spacer is recommended for all patients using a corticosteroid-containing inhaler.7 Spacers improve dose delivery and also lower the amount of drug deposited in the mouth, reducing the incidence of adverse events such as oropharyngeal candidiasis (thrush).7

Minimise the use of different devices

Guidelines recommend that patients use one type of device and avoid switching.6 If a patient is responding well to treatment with a Turbuhaler, it may not be appropriate to consider changing to the Rapihaler device.

The Rapihaler device may be a good alternative for those whose symptoms have not been successfully controlled using a Turbuhaler despite repeated instructions on its appropriate use.6

Both pMDI and DPIs such as Turbuhalers, have been associated with incorrect inhaler technique in patients with asthma or COPD resulting in suboptimal treatment.8 Guidelines recommend repeated demonstration and reassessment of device technique to optimise drug delivery.6

References

  1. Australian Government Department of Health and Ageing. July 2013 PBAC Outcomes – Positive Recommendations. 2013. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2013-07/positive-recommendations
  2. Australian Government Department of Health. Pharmaceutical Benefits Scheme. 2013. http://www.pbs.gov.au/medicine/item/8625Y-8750M-8796Y
  3. AstraZeneca Pty Ltd. Symbicort Rapihaler Product Information. 2012. http://www.tga.gov.au/pdf/auspar/auspar-budesonide-130226-pi.pdf .
  4. Australian Government Department of Health and Ageing. Australian Public Assessment Report for Budesonide/Eformoterol. Updated February 2013. http://www.tga.gov.au/pdf/auspar/auspar-budesonide-130226.pdf .
  5. AstraZeneca Pty Ltd. Symbicort Turbuhaler Product Information. 2010. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-06877-3 .
  6. eTG complete [Internet]. Therapeutic Guidelines: Respiratory. Melbourne: Therapeutic Guidelines Ltd, 2012. http://etg.hcn.com.au/desktop/index.htm (accessed 30 September 2013).
  7. Global Initiative for Asthma. Global Initiative for Asthma Management and Prevention. Updated 2012. .
  8. National Asthma Council Australia. Inhaler technique in adults with asthma or COPD. 2008. http://www.nationalasthma.org.au/uploads/content/237-Inhaler_technique_in_adults_with_asthma_or_COPD.pdf .