PBS rejigs rules on GLP-1s and other diabetes meds

4 minute read

As the costliest class of T2DM medicine, incretins got special attention in the updates.

The PBS has moved to “simplify and clarify” restrictions for PBS subsidy of type 2 diabetes medication, in an attempt to improve accordance and better align with current clinical guidelines. 

In 2022, the Department of Health and Aged Care undertook cost-effectiveness analyses into type 2 diabetes drugs, sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), after demand for broader access. 

The Pharmaceutical Benefits Advisory Committee’s drug utilisation sub-committee found that in 2021-22, GLP-1 RAs were the highest expenditure class of medicine on the PBS for the treatment of T2DM, making up 26% of the $194 million yearly spend. 

In the 2022-23 financial year, 16 million prescriptions for drugs used in diabetes were PBS-subsidised, with an additional three million under copayment. 

The sub-committee also found a high proportion of uses that fell outside the PBS restrictions. 

An analysis of the population in 2021 found that almost 60% of patients given GLP-1 RAs weren’t taking the drug in line with PBS restrictions.  

Over 40% were given a GLP-1 RA in combination with another GLP-1 RA, a DPP4 inhibitor or an SGLT2 inhibitor and almost 30% were given GLP-1 RA without concurrent use of metformin, sulfonylurea or insulin. Just under 10% spanned both categories. 

After PBAC consultation, changes were made to the PBS restrictions for type 2 diabetes medication in an attempt to safely broaden access, taking effect this month. 

“The PBAC considered that sulfonylureas were increasingly viewed by clinicians as contraindicated for most patients due to their association with weight gain and increased risk of hypoglycaemia,” the committee found. 

“Noting the high cost of GLP-1 RAs compared to other available treatments, the PBAC further considered it would be appropriate to alter the dual therapy restrictions for GLP- 1 RAs, for use with metformin or a sulfonylurea, to remove the requirement for contraindication/intolerance to a combination of metformin and a sulfonylurea and replace this with a requirement for contraindication/intolerance to an SGLT2 inhibitor.” 

The changes clarified who was eligible for GLP-1 RA subsidies and altered the authority type required for prescription. 

Before this month, subsidised prescription for GLP-1 RAs was only allowed for patients contraindicated or intolerant to the combination of metformin and a sulfonylurea. The new restriction changes broadened access to include those who don’t achieve clinically meaningful glycaemic response to a SGLT2 inhibitor. 

The restrictions also clarified that GLP-1 RAs should only be subsidised in combination with at least one of metformin, a sulfonylurea or insulin and cannot be subsided in combination with a dipeptidyl peptidase-4 (DPP4) inhibitor. 

GLP-1 RAs also should be not subsidised for use 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. 

The update also changed the authority type from Authority Required (STREAMLINED) to Authority Required (telephone/electronic), though access can still be sought through the streamlined authority. 

Patients who are already on GLP-1 RAs for T2DM do not need to requalify. 

PBS restrictions were also simplified for a number of other diabetes medications. 

The requirement for contraindication to metformin was removed for use of dipeptidyl peptidase-4 inhibitors, SGLT2 inhibitors or GLP-1 RAs with insulin. 

All DPP4 inhibitors can now be used with insulin or SGLT2 inhibitors. 

To provide an additional first line therapy for patients with tolerance issues, pioglitazone has been changed to a restricted benefit listing for T2DM without any clinical criteria.  

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

A spokesperson for DoHAC told Oncology Republic that the drug utilisation sub-committee would be discussing the use of semaglutide and other GLP-1 RAs at its 6-7 June 2024 meeting. 

“It is expected that the June 2024 DUSC report will be publicly released in October 2024,” they said.  

“To date, the PBAC has not recommended a price change for GLP1 RAs for the treatment of type 2 diabetes.” 

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