PBS biologics approval shakeup on the way

3 minute read

BREAKING: Biosimilars set to go to phone or online for RA and AS, and almost all RA agents to go streamline for continuing; plus news meds for PsA.

Australian rheumatologists can look forward to handing patients newly starting biologics their script in the clinic, without any written paperwork at all, thanks to new recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) released late on Friday.

The recommendations, which still need to get sign-off from the Department of Health before they are enacted, will slash the paperwork burden rheumatologists have long faced for targeted agents.

Patients on biosimilars for RA and AS will soon be able to get their initial script via phone or online approval, with all continuing scripts on good to go with a streamline code.

Meanwhile, RA and AS patients getting any targeted agent except for upadacitinib will come under the approval process biosimilars are in now. This change will mean streamline subsequent continuing scripts for all biologics, including originator TNF inhibitors Humira, Enbrel and Remicade, as well as JAK inhibitors tofacitinib and baricitinib.

The outcomes, decided at the March 2022 PBAC meeting and released without fanfare on the PBS website late on Friday afternoon, stated that the “PBAC noted the administrative burden for prescribers associated with the high volume of written authority applications and the objective initial and continuing treatment PBS restriction criteria for RA” and that “reducing the authority administrative burden for prescribers and patients may result in a preference for prescribing the older medicines where appropriate and a stabilisation of PBS expenditure.”

Left behind, though, were approvals for non-biosimilars for AS and psoriatic arthritis, with the PBAC meeting decisions stating the PsA market was not stable “due to increasing utilisation, substantial increases in expenditure and the potential for use beyond the restriction within and outside of the indication”.

This comes on the back of multiple new agents becoming available for PsA in recent years, including most recently guselkumab. In fact, in better news for PsA patients, this included positive recommendations for AbbVie’s risankizumab (Skyrizi) and free flow of secukinumab 300mg injections for all its indications.

In the wake of the recent parliamentary inquiry into the paediatric rheumatology crisis, probably the best news was saved for juvenile idiopathic arthritis (JIA), with authority approvals for all agents (adalimumab, etanercept, tocilizumab) going to phone or online for initial scripts, and streamline for all continuing agents. This loosening was extended to systemic JIA as well, meaning quick relief for patients with hyperinflammatory disease.

Changes in authority mechanism have previously led to large shifts in use without any rigid blocks to PBS access for newer meds. Such changes were introduced as part of the biosimilar uptake drivers introduced in 2017, and subsequently led to biosimilars gaining a substantial foothold in the Australian market.

It remains to be seen how this will affect upadacitinib use, which according to the published decision was not included in the authority review. Upadacitinib has had a bumper introduction to the rheumatoid arthritis market since its release and was noted by the review to have the potential for market disruption. While these changes might affect that in the RA market, approval mechanisms will remain the same for upadacitinib in RA and it will continue to hold an equal footing with authority approval mechanisms in AS and PsA.

All these changes come on the back of last year’s PBAC recommendation that rituximab should be allowed to be used for any indication without restriction or authority required, although this has yet to be enacted and an exact date for implementation remains uncertain. Similar to rituximab, list prices for infliximab, etanercept and adalimumab have plummeted since the introduction of biosimilars.

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