This document has been updated since its original release. [Details]

From 1 July 2012 there are several changes to the PBS authority-required listings for synthetic infant formulas:

  • protein hydrolysate formula with medium-chain triglycerides (Alfaré, Karicare Aptamil Pepti-Junior Gold)
  • amino acid synthetic formula (EleCare, Neocate Advance, Neocate Advance Vanilla, Neocate Advance Tropical Flavour)
  • amino acid synthetic formula with long-chain polyunsaturated fatty acids (Neocate LCP, EleCare LCP)
  • amino acid synthetic formula with long-chain polyunsaturated fatty acids and medium-chain triglycerides (Neocate Gold).

Depending on the indication, there are changes relating to the need to consult with, or refer to, a specialist before prescribing. In addition, the definitions of combined intolerance and severe intolerance to cows' milk protein have been revised.

The listing changes come after increases in the number of prescriptions of synthetic infant formulas and a larger-than-expected proportion of infants with protein intolerances who start on an amino acid formula without first trying a protein hydrolysate formula.1

Protein hydrolysate formula listing changes

The listings of protein hydrolysate formulas for protein intolerances now require general practitioners (GPs) to prescribe in consultation with a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist. Consultation may be by telephone. For children older than 24 months, the existing requirement — that the child must be seen by the specialist — is unchanged.

The listings are intended for children who have failed to respond to a strict cows'-milk-protein-free diet using soy formula.

Protein hydrolysate formulas are no longer listed for severe intolerance to cows' milk protein. See below for details of the revised listings of amino acid synthetic formulas for severe intolerance — these may be applicable.

Listings for other indications (e.g. cystic fibrosis) remain unchanged.

Amino acid synthetic formula listing changes

Along with the specific changes described further below, the following overall changes have been made to the listings of amino acid synthetic formulas for protein intolerances:

  • clinical immunologists have been added to the list of specialists that may be consulted, along with specialist allergists and specialist paediatric gastroenterologists
  • the length of initial treatment has changed from 3 months to 6 months
  • when the listing requires a specialist assessment, the name of the specialist must be included in the authority application
  • for children aged up to 24 months, continuing treatment can be authorised if the child has an appointment and is waiting to be assessed by a specialist.

Listings for other indications (e.g. severe intestinal malabsorption) remain unchanged.

Combined protein intolerance

As previously, the listings of amino acid synthetic formulas for combined protein intolerance require that the child has tried a strict diet using protein hydrolysate as the principal formula (i.e. free of cows' milk protein and soy protein) and failed to respond. The definition of combined intolerance has been revised to specify cows' milk protein enteropathy that is not isolated colic or reflux.

Initial treatment for infants up to 24 months must now be in consultation with a specialist, as for the severe intolerance restriction.

For a child aged over 24 months, the requirement remains that a specialist must see the child before the initial prescription. Continuing treatment requires repeat specialist assessment at least every 12 months (this was previously every 6 months).

Severe intolerance

The definition of severe cows' milk protein intolerance has been revised to specify a diagnosis of severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux). Unlike the old 'severe intolerance' restriction, it does not apply to children older than 24 months.

New listing for cows' milk anaphylaxis

Amino acid synthetic formulas are now listed for cows' milk anaphylaxis. Treatment must be in consultation with a specialist allergist or clinical immunologist. Consultation may be by telephone. The listing is for infants up to 24 months old, and anaphylaxis is defined as a severe and/or potentially life-threatening allergic reaction.

Reference

  1. Australian Government Department of Health and Ageing. Drug Utilisation Subcommittee (DUSC) review of PBS listed nutritional products. October 2011.

Revision history

Updated July 2012 to correct the list of brand names.
First published 1 July 2012.