Restrictions on infant formulas


inline image

On the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), the Australian Department of Health and Ageing recently changed the restrictions for prescribing amino acid formulas (Elecare, Neocate) for cow's milk allergy and extensively hydrolysed formulas (Alfare, Pepti-Junior) or amino acid formulas for cow's milk protein enteropathy. The restriction for eosinophilic oesophagitis has not changed.

The rationale for the changes is to try to curb the exponential increase in prescription of amino acid formulas, which has occurred without any increase in prescription of extensively hydrolysed formulas, and appears to be far greater than can be explained by any increase in cow's milk allergy or intolerance.

General paediatricians can prescribe extensively hydrolysed formulas for cow's milk enteropathy without consultation. They are only allowed to prescribe amino acid formulas for the indication of cow's milk allergy in consultation with a named specialist allergist, clinical immunologist or paediatric gastroenterologist. ‘In consultation’ can be a telephone consultation, telehealth or email, so it is not mandatory that the child has been seen by a specialist before treatment can be started.

The PBAC consulted widely before introducing the new restrictions and will assess their effects in terms of access and prescribing patterns. Every effort has been made to reduce inappropriate use without impairing access for deserving patients from urban and remote areas.

The two paediatricians on the PBAC, David Isaacs and Jim Buttery, are happy to try to answer queries about the new restrictions. The PBAC Secretariat are happy to receive feedback and submissions regarding this issue. These can be addressed to Mariana Crank at