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GPs now need to gain additional approval prior to starting patients on all GLP-1 RAs, including semaglutide.
GPs seeking to initiate PBS-subsidised semaglutide or dulaglutide prescriptions are now required to get clearance from Services Australia.
The Authority Required listing to initiate PBS prescriptions for glucagon-like peptide 1 receptor agonists (GLP-1 RAs) has been upgraded from ‘streamlined’ to ‘phone/electronic’, in a bid to ensure GPs are prescribing within approved criteria.
The change, recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in March and July 2023, means GPs seeking to prescribe the medicine to a patient for the first time now need to navigate a system described as outdated, complex and lacking basic functionality.
Announced over the weekend by the Department of Health and Aged Care (DoHAC), the new requirements are reportedly designed to ‘simplify and clarify’ the PBS restrictions, as well as align them with current clinical guidelines while ‘considering the cost-effectiveness of comparative treatments’.
The RACGP opposed placing restrictions on GPs seeking to help patients gain access to the medication in a submission to the PBS in May 2023.
According to Services Australia, nearly $788 million in PBS benefits have been issued to support patient access to dulaglutide ($306 million) and semaglutide ($481 million) since 2018 and 2020, respectively.
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, told newsGP the ‘huge costs’ of these prescriptions required a response that ‘unfortunately’ has created a barrier to prescribing.
‘These changes are reflective of the recent DUSC review into the cost of medicines in [treating] type 2 diabetes, including GLP-1 RAs,’ he said.
‘This review identified significant issues of prescribing outside of the pre-existing PBS restrictions.
‘Concerningly, some were prescribed even without any past metformin usage and also larger numbers with SGLT2 [sodium-glucose cotransporter 2] inhibitors in combination, which has never been PBS authorised.’
To be eligible under the new criteria, patients must be contraindicated, intolerant, or not have achieved a clinically meaningful glycaemic response to a SGLT2 inhibitor.
‘Prior to 1 June, 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,’ the DoHAC announcement states.
‘Therefore, the GLP‑1 RA restriction changes have broadened access … by allowing use in patients that are not only contraindicated or intolerant to an alternative medicine, but also those who do not achieve a clinically meaningful glycaemic response to an alternative medicine.’
It goes on to state that 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, and/or 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 still access the medicine via the streamlined listing and do not need to requalify for access under the revised restriction.
Given that the definition of a ‘clinically meaningful glycaemic response’ has been left open to prescriber discretion in the context of the individual patient, Dr Deed suggests GPs record each case in their clinical records, while noting that the ‘absolute definition’ usually equates with the SGLT2 inhibitor lowering HBA1c levels by no more than 0.4–0.5%.
Total expenditure based on the published list prices on type 2 diabetes medicines increased from around $516 million in 2017–18 to around $756 million in 2021–22.
In that financial year, GLP-1 RAs accounted for 26% of PBS expenditure on type 2 diabetes medicines ($194 million), making them the highest expenditure class of medicines on the PBS for this condition.
The DUSC analysis cited by Dr Deed also found several examples of apparent use outside the PBS restrictions, including that:
- From 2017 to mid-2022, 18% of people initiating GLP-1 RA therapy were not supplied metformin, a sulfonylurea or insulin prior to or at initiation, indicating clear use outside of the PBS restrictions. A further 57% were supplied only insulin, a sulfonylurea, or metformin prior to or at initiation of a GLP-1 RA, indicating possible use outside of the PBS restrictions.
- According to analysis of the prevalent population in 2021, almost 60% of people supplied a GLP-1 RA received this medicine in a regimen that was inconsistent with the PBS restrictions
However, while ‘supportive’ of education about quality use of medicines, Dr Deed wonders whether previously funded programs could have helped shape practitioner prescribing to the extent where additional restrictions were not needed.
‘The Government defunded NPS Medicinewise, whose role could have assisted this process before radical changes occurred,’ he said.
‘These changes were [also] released quickly without much communication, so I worry how our GP colleagues are coping at the start of a busy week.’
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