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Post-market Review of Pharmaceutical Benefits Scheme Medicines Used to Treat Asthma in Children

Page last updated: 9 July 2015

Background

Under the Australian Government’s National Medicines Policy framework, the Department of Health (the Department) conducted a Post-market review of medicines used to treat asthma in children.

The objective of this review was to evaluate the clinical evidence regarding asthma medicine interventions to ensure the most appropriate management of children with asthma in clinical practice.

The need for this review was first identified by the Paediatric Medicines Advisory Group (PMAG), which found that 40% of the children supplied with a fixed dose combination (FDC) product (of inhaled long-acting beta-agonists and inhaled corticosteroids), had not first been prescribed a single ingredient product (an inhaled corticosteroid). PMAG considered that the extent of FDC use in paediatric asthma was a serious quality use of medicines issue and subsequently referred the matter to the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC).

In 2011, the DUSC review indicated that there was a very high rate of initiation to a FDC without prior use of a single ingredient inhaler.  This is contrary to current asthma management guidelines (Asthma Management Handbook 2006, National Asthma Council Australia). The DUSC noted the issues and advised sponsors that this is a complex area of treatment and further clarification of the issues surrounding asthma management in children was needed.

In April 2012, the National Medicines Policy (NMP) Committee recommended to the Minister for Health the initiation of a Post-market review of Pharmaceutical Benefits Scheme (PBS) listed medicines used for treating asthma in children, to ensure that these medicines continue to be used safely and appropriately. The NMP Committee developed the draft Terms of Reference for this review.

At its November 2012 meeting, the PBAC agreed the Terms of Reference (see below) and will provide input to the review process.

The PBAC is the independent, expert advisory body comprising doctors, other health professionals and a consumer representative, which makes recommendations to the Australian Government about PBS listings.

Medicines included in this review

The PBS listed medicines included in this review were: salmeterol with fluticasone, eformoterol with budesonide, beclomethasone dipropionate, ciclesonide, sodium cromoglycate and nedocromil sodium, montelukast, salmeterol and eformoterol.

Terms of Reference

The Terms of Reference for the Review were to:

1.  Review the evidence on the efficacy and safety of single ingredient and combination product use of inhaled long acting beta2 agonist in children not previously considered by the PBAC in making recommendations to the Minister.

2.  Review the DUSC report on utilisation of combination inhaled ICS/LABA considered by PBAC and supplement this analysis with any additional data and clinical information sources available in Australia.

3.  Identify areas of prescribing for childhood asthma in Australia where clinical practice is inconsistent with clinical guidelines; and if there is evidence that supports this practice.

4.  Identify and review recent (past five years) healthcare professional and consumer education in the area of medication management in children with asthma.

5.  Identify effective interventions that have resulted in improvement of prescribing and quality use of medicines in the context of childhood asthma using overseas or Australian literature.

Outline of Process

The Australian Government understands the importance of effectively and safely treating children suffering from asthma and supports the review of these medicines.

An external contractor was engaged to conduct a literature search and evaluation of more recent clinical research on these medicines.

A Reference Group was formed to consider this area of clinical practice and the apparent divergence from Australian guidelines. This was done in conjunction with further analysis of PBS data and review of international guidelines for asthma.

Open public consultation processes, including a stakeholder forum, have been undertaken as a part of the review to ensure that all stakeholders are provided with various opportunities to contribute.

Call for submissions

Submissions addressing the Terms of Reference have been published on the Public Consultation of PBS Medicines Used to Treat Asthma in Children page.

Stakeholder Forum

A Stakeholder Forum for the Post-market Review of PBS Medicines Used to Treat Asthma in Children was held in Canberra on 18 November 2013. A summary of the Forum discussion has been published on the Public Consultation of PBS Medicines Used to Treat Asthma in Children page.

Draft Report

Submissions on the draft Report for the Post-market Review of PBS Medicines Used to Treat Asthma in Children have closed.  Thank you to everyone who made a submission.

PBAC Consideration of Final Report

The Report, including stakeholder comments, was provided to the PBAC for consideration in July 2014. The full PBAC Minutes and Final Report for this item are now available:

The Department appreciates the valuable contributions made by organisations and individuals who provided submissions or comments during this Review.

Further Information

Further information regarding Post-market reviews in general is available through the Reviews page.

For further information on this review or the submission process, please email PBS Post-market.

Subscribe to the news updates for the latest information regarding the reviews, including when public consultation opens, and when documentation is published.

If you would like further information regarding asthma, including facts and figures and other work undertaken please refer:

  • National Asthma Council Australia (2014). Australian Asthma Handbook, Please visit the National Asthma Council
  • Australian Institute of Health and Welfare (2011). Asthma in Australia 2011: with a focus chapter on chronic obstructive pulmonary disease. Please visit: the Australian Institute of Health and Welfare
  • Australian Bureau of Statistics (1997). 1995 National Health Survey. Please visit: the Australian Bureau of Statistics

Please direct all queries to PBS Post-market.

Thank you for your interest and contribution to this important review.