GLP-1 receptor agonists have become a third line therapy and moved to telephone/electronic PBS authority under a shake-up to the restrictions for type 2 diabetes medicines.

Commencing on 1 June, the changes (link here) mean that patients must be contraindicated, intolerant, or have not have achieved a clinically meaningful glycaemic response to SGLT2i to access initial GLP-1 RA therapy.

What makes a ‘clinically meaningful glycaemic response’ has been left open to prescriber discretion in the context of the individual patient.

It follows a series of reviews into the sky-rocketing demand for GLP1-RAs, culminating with a recommendation to revamp the requirements for initiating the medicines.

The restrictions have been revised to clarify that GLP-1 RAs:

• are only subsidised for use in combination with at least one of: metformin, a sulfonylurea, insulin
• are not subsidised for use in combination with a dipeptidyl peptidase-4 (DPP4) inhibitor
• are not subsidised for use in combination with an SGLT2 inhibitor, except where the SGLT2 inhibitor is prescribed for a different indication (e.g., heart failure or kidney disease) and the patient did not achieve a clinically meaningful glycaemic response to the SGLT2 inhibitor.

Patients who have previously received a PBS-subsidised prescription for a GLP-1 RA can access this medicine via the streamlined listing, per an update on the PBS website (link here).

They do not need to requalify for access under the revised restriction.

Prior to 1 June 2024, the PBS restrictions for GLP-1 RAs required patients to be contraindicated or intolerant to a combination of metformin and a sulfonylurea to use a GLP‑1 RA in dual therapy with metformin or a sulfonylurea.

“Therefore, the GLP‑1 RA restriction changes have broadened access to GLP-1 RAs, by allowing use in patients that are not only contraindicated or intolerant to an alternative medicine (now SGLT2 inhibitors), but also those who do not achieve a clinically meaningful glycaemic response to an alternative medicine,” the website said.

Simplification of PBS restrictions for other type 2 diabetes drugs

Under the changes, the government has also removed the requirement for patients to be contraindicated to metformin, to use DPP4 inhibitors, SGLT2 inhibitors, or GLP-1 RAs with insulin.

Meanwhile, DPP4 inhibitor restrictions have been aligned to allow use of all DPP4 inhibitors with insulin or SGLT2 inhibitors.

Pioglitazone has been changed to a Restricted Benefit listing for type 2 diabetes without any clinical criteria. This provides an additional first-line therapy for patients who are contraindicated or intolerant to other first-line therapies, according to the government.

Finally, DPP4 inhibitors and SGLT2 inhibitors are now subsidised for use in quadruple therapy, in combination with each other, metformin, and insulin.