Biosimilar uptake push

THE Pharmaceutical Benefits Scheme (PBS) has specified dispensing regulations around infliximab biosimilars in both private and public hospitals.

A complex series of changes has been defined clarifying the situations in which biosimilars of the reference drug Remicade, from J&J’s Janssen Biotech division, can be dispensed.

These took effect 01 Nov and the PBS yesterday reminded pharmacists that it is an offence under the National Health Act 1953 to substitute medicines that are not marked as equivalent (‘a’ flagged) in the Schedule of Pharmaceutical Benefits.

The Inflectra, Remicade or Renflexis brands of infliximab may be substituted for initial and first continuing treatment.

However, substitution is not available between the reference brand Remicade and the biosimilar brands Inflectra and Renflexis for subsequent continuing treatment, the PBS site now explains.

For the indication of Moderate to Severe Ulcerative Colitis, substitution between the three Inflectra, Remicade or Renflexis brands is available for initial treatment and continuing treatment as a HSD private hospital prescription.

Due to the complexity of these arrangements and the need to have clarity when substituting in dispensary and claiming payment, the PBS has created a set of tables accessible at pbs.gov.au which clearly shows which biosimilars may be substituted under which conditions.

The PBS states, “If the relevant PBS Item for claiming is unclear, pharmacists should contact the prescriber in the first instance.

“Subsequently contact can be made with the Department of Human Services (Medicare) on 132 290 for confirmation of the approved item code, provided the medication and strength on the prescription matches the authority approval record.”