Treatment naive ‘a-flagging’ would not work: PBAC

Thursday, 10 Nov 2016

The PBAC rejected a request from MSD to restrict ‘a-flagging’ of its etanercept biosimilar Brenzys to patients who are naïve to the molecule, minutes from its July meeting reveal.

According to the PBAC it turned down the request out of a belief the concept would not work in practice.

“It relies on the dispenser knowing whether the patient is etanercept treatment naïve and this information is not always available to the dispenser,” it stated in the meeting notes.

The PBAC said it had also noted the potential for a Quality Use of Medicines issue relating to differences in auto injector devices for Brenzys and Enbrel.

However it said any differences were likely to be minor and could be managed through the regular patient education and counselling from prescribers and pharmacists.

The PBAC also noted that it had declined a request by the sponsor to make the authority listing of Brenzys streamlined (and other etanercept biosimilars), while the listing of Enbrel remained a written authority.

“The PBAC did not consider streamlined listings would be appropriate because of the large potential for leakage into less severe disease,” it said.

However it acknowledged the “ongoing need to examine the uptake drivers for biosimilar medicines.”

Related articles:

Rheumatologists must navigate patients through complex world of biosimilars

Etanercept biosimilar approval reignites ‘a-flagging’ concerns

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