Submission to Post-Market Review of PBS Medicines Used to Treat Asthma in Children

Submission 7 - Australasian Society of Clinical Immunology and Allergy Inc.

Dear National Medicines Policy Committee,

In response to the call for submissions regarding the Review of the PBS medicines used to treat asthma in children, the ASCIA Paediatric Subcommittee has compiled the following submission.

In general terms ASCIA supports the evidenced based approach to the use of medications to treat asthma in children. Our recommendations are essentially in line with those of the Thoracic Society of Australia and New Zealand (TSANZ) submission.

We support the step up approach to the pharmaceutical management of asthma, as outlined by the TSANZ position statement¹, current GINI guidelines² and National Asthma Council (NAC) guidelines.

As you will be aware the NAC guidelines are currently being updated and are due to be released towards the end of 2014.

Most children with asthma will have infrequent intermittent asthma (as defined by NAC Asthma Management Handbook 2006) and do not require any preventer therapy at all. Most children with asthma who require a preventer therapy (those children with frequent intermittent, mild, moderate or severe persistent asthma) can be adequately managed with a single agent (LTRA or ICS).

There is evidence that children who require add on therapy to a single agent ICS can benefit from add on LTRA therapy³ (which is currently not a listed PBS indication for the use of LTRA in children aged <6 years). This may be preferable to combination ICS/LABA therapy. This may be particularly so in those children with an element of exercise induced asthma.

In addition to the DUSC report on the utilisation of combination ICS/LABA, we can confirm that some members of the ASCIA Paediatric committee commonly see patients referred for allergy and immunology review of their atopic diseases, who have been commenced on combination ICS/LABA as first line preventer therapy, without trial of a single agent (ICS or LABA).   There are potential well documented risks associated with the use of combination ICS/LABA in children, including the loss or diminution of response to beta agonist bronchodilator, increased rates of severe asthma episodes and loss of protection against exercise induced wheeze. They do however form a useful part of pharmaceutical management for asthma in a small proportion of children with asthma in the >5 years age group, who have not responded well to single agents.

The use of combination ICS/LABA is not recommended at all for children under 5 years of age. In this age group the first line therapy of choice for frequent intermittent and mild persistent asthma would generally be LTRA, because of its lower side effects profile compared with ICS, although both ICS and LTRA have been shown to be efficacious in this age group. ^4,5

In principle we would support the move to make combination ICS/LABA medications a PBS authority requiring medication, available for those children > 5 years requiring a preventer who have failed single agent therapy at the dosages of ICS outlined in the TSANZ position paper. We would not support the move to limit the prescribing of ICS/LABA to a particular sub speciality group, but rather the use of appropriate guidelines which specify under what conditions the prescription of ICS/LABA is appropriate. 

We look forward to your response to this submission.

Yours sincerely

Professor Dianne E Campbell MBBS FRACP PhD

Chair, ASCIA  Paediatric Committee

On behalf of the ASCIA Paediatric Committee

Copy: ASCIA Paediatric Committee members, ASCIA Council members,

RACP President (Adult Medicine), RACP President (Paediatrics).

References

1. Van Asperen PP, Mellis CM, Sly PD, Robertson CF TSANZ Position Paper. The role of corticosteroids in the management of childhood asthma. 2010

2. Global Initiative for Asthma (GINA). Global Strategy for the diagnosis and management of asthma in children 5 years and younger. www.ginasthma.org

3 Lipworth BJ, Basu K, Donald HP et al Tailored second-line therapy in asthmatic children with the Arg16 genotype. Clinical Science 2013; 124:521-528

4. Bisagaard H, Zielen S, Garcia Garcia ML, Johnston SL, Gilles L, Menten J et al. Montelukast reduces asthma exacerbations in 2- to 5-year old children with intermittent asthma. Am J Respir Crit Care Med 2005; 171:315-322.

5. McKean M, Ducharme F. Inhaled steroids for episodic viral wheeze of childhood (Cochrane Review). In: the Cochrane Library, Issue 1, 2001. Oxford: Update Software CD 001107