PBS reason codes 162/163 when dispensing biosimilar brands

Page last updated: 8 December 2023

PBS pharmacies have been receiving a warning reason code 162/163 when substituting a biosimilar for the reference brand.

162        W          Item provided does not match to the authority approval.

163        W          Repeat item provided does not match the authority approval.

Pharmacists (and approved PBS suppliers) are reminded that they can substitute biosimilar brands that are ‘a’-flagged in consultation with the patient, and provided that the prescriber has not marked ‘brand substitution not permitted’ on the prescription.

When dispensing however, attention must be paid to selection of the correct PBS item code to ensure the correct product is claimed. Claiming incorrect item codes may result in a warning or rejection message from Services Australia.

What is triggering PBS warning codes when dispensing biosimilar brands?

Warning codes may flag when a biological medicine has been approved for PBS subsidy under an Authority Required listing and the PBS item code for the biosimilar is different to the PBS item code for the reference brand. A claim for a PBS item will return a reason code warning when substituting an item code that does not correspond with the approved item code.

In particular, we are aware that reason codes are displaying when pharmacists or PBS approved suppliers substitute biosimilar brands of adalimumab for the reference brand.

Can pharmacists still substitute biosimilar brands for the reference brand when a PBS warning code displays?

Importantly, reason codes 162/163 do not always mean the reference brand cannot be substituted with a biosimilar and pharmacists should review and action these as appropriate. Upon review when substituting, if the selected item code can be supplied in line with substitution arrangements, then the pharmacist can disregard the warning.

For any claim that has a return reason code of 162/163, if unsure, pharmacists can contact Services Australia if they would like to confirm if they can continue to supply the item. Services Australia will advise if the item can be supplied as a PBS benefit or if a different PBS item code will need to be used.

For Complex Authority Required (CAR) items, in most cases Services Australia provides the prescriber with the PBS item code to write on the prescription. Written applications should also have the PBS item code written on the prescription when it is returned to the prescriber.

Where can I find more information about PBS reason and rejection codes?

Information for PBS pharmacies about reason and rejection codes for online claiming is available on the Services Australia webpage or contact:

• PBS General Enquiries:   Phone: 132 290 (select Option 2 - All claim payment, Safety Net, stationery and general enquiries)
• RPBS Veterans' Affairs Pharmaceutical Advisory Centre: Phone 1800 552 580

‘a’- flagging

Recent changes to PBS listings for medicines for the treatment of severe active rheumatoid arthritis and ankylosing spondylitis, which occurred on 1 November and 1 December 2023 affect the substitution arrangements (‘a’-flagging) when substituting a biosimilar brand with a reference brand. Note that pharmacists can continue to substitute a reference brand with a biosimilar brand.

Initial therapy - Where the prescription for a biosimilar has been approved by Services Australia via telephone or immediate online assessment, brand substitution with the reference brand is not permitted. Brand substitution with another biosimilar brand (if applicable) is permitted. Please select the PBS item code carefully.

First continuing –where the prescription for a biosimilar is an Authority Required (Streamlined) prescription, brand substitution with the reference brand is not permitted. Brand substitution with another biosimilar brand (if applicable) is permitted.

Subsequent continuing – brand substitution between biosimilar and reference brands can occur in consultation with the patient, and provided that the prescriber has not marked ‘brand substitution not permitted’ on the prescription.

Where can I find more information about biosimilars?

The Australian Government has implemented policies to encourage greater use of biosimilar brands. Biosimilar medicines encourage market competition, which makes medicines more affordable.

For further information on biosimilar brands please visit the Department of Health and Aged Care website. Information on the Government’s biosimilar uptake drivers is available on the PBS website.