PBAC recommends GLP-1 RA restrictions


By Geir O'Rourke

30 Aug 2023

GLP-1 receptor agonists look set to become a third line treatment on the PBS in all type 2 diabetes indications, after the PBAC confirmed it would push ahead with recommendations for a clampdown on prescribing.

If accepted by the Federal Government, it would mean PBS scripts for drugs in the class would be restricted to patients who are “contraindicated, intolerant or inadequately responsive” to SGLT2 inhibitors.

The only potential exception would be patients with a BMI greater than 35, who would become eligible for GLP1-RA therapy in combination with metformin, a sulfonylurea or insulin, without the a requirement to trial an SGLT2 inhibitor.

But this possible expanded listing would need to be confirmed at a later date and would depend on financial estimates, the expert committee stressed in its July 2023 meeting outcomes statement (link here).

Australian Diabetes Society spokesperson Professor Jonathan Shaw said:  “We hope the proposal goes through and it will be available for people with a BMI over 35, which is in keeping with our living evidence guidelines.”

The outcomes statement released last Friday also confirmed plans outlined by the committee in April to require phone or electronic Authority approval prior to initiating PBS prescriptions for GLP-1 RAs across all indications.

In addition, the level of restriction for pioglitazone be changed to a Restricted Benefit listing, without any additional clinical criteria, it said.

The PBAC also recommended removal of the requirement for contraindication or intolerance to metformin for patients to use DPP4 inhibitors, SGLT2 inhibitors and GLP-1 RAs in dual therapy with insulin.

It also backed an alignment of the PBS restrictions for DPP4 inhibitors, no longer restricting the use of some of these medicines in combination with insulin or SGLT2 inhibitors.

These changes had been informed by an extensive consultation process, the committee stressed.

“The PBAC noted that stakeholders generally supported the simplification of the restrictions, and clarification of combinations of medicines that are not PBS-subsidised,” it added.

The recommendations followed an analysis by the expert group’s Drug Utilisation Sub Committee (DUSC), which the PBAC said raised concerns about spiralling costs and use outside the PBS restrictions.

Professor Shaw, deputy director at Melbourne’s Baker Heart and Diabetes Institute, said that more broadly, the ADS had advocated for eligibility to be expanded to enable prescribing for patients with elevated CV and renal risk, irrespective of age.

“But we still have PBS reimbursement only for people who have an elevated HbA1c,” he said.

“That means that currently someone with type 2 diabetes who has had a myocardial infarction but does not have elevated HbA1c is not eligible for reimbursement, despite the fact that many studies show that such people benefit significantly from these drugs.”

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