The Pharmaceutical Benefits Scheme (PBS) implemented changes to the restrictions on several medicines for treating type 2 diabetes mellitus (T2DM). These changes, recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in March and July 2023 and March 2024, aim to simplify and clarify the Pharmaceutical Benefits Scheme restrictions, ensuring they align with current clinical guidelines and the cost-effectiveness of treatments. This update follows a utilization analysis of T2DM medicines and consultations with consumer and prescriber groups, and sponsor companies.
Significant changes were made to the restrictions for glucagon-like peptide 1 receptor agonists (GLP-1 RAs). The authority type for initiating GLP-1 RA therapy has shifted from Authority Required (STREAMLINED) to Authority Required (telephone/electronic). Continuing access remains via a streamlined listing. Patients must be contraindicated, intolerant, or must not have achieved a clinically meaningful glycemic response to a sodium-glucose cotransporter 2 (SGLT2) inhibitor to access PBS-subsidized GLP-1 RA therapy. The definition of a ‘clinically meaningful glycemic response’ is left to the prescriber’s discretion based on the individual patient’s condition.
Other restrictions for GLP-1 RAs include: They are subsidized only when used in combination with metformin, a sulfonylurea, or insulin.They are not subsidized for use with a dipeptidyl peptidase-4 (DPP4) inhibitor or an SGLT2 inhibitor, except when the SGLT2 inhibitor is prescribed for another indication (e.g., heart failure or kidney disease) and the patient did not achieve a glycemic response.
Simplifying Access to T2 Diabetes Pharmaceuticals
The updates also remove the requirement for patients to be contraindicated to metformin to use DPP4 inhibitors, SGLT2 inhibitors, or GLP-1 RAs with insulin. Additionally, the restrictions for DPP4 inhibitors have been aligned to allow their use with insulin or SGLT2 inhibitors. Pioglitazone has been changed to a Restricted Benefit listing for T2DM without any clinical criteria, providing an additional first-line therapy for patients contraindicated or intolerant to other first-line therapies.
These changes aim to reduce the complexity of prescribing T2DM medicines and ensure that the restrictions are simple and clear. They also address the utilization patterns of these medicines outside the current Pharmaceutical Benefits Scheme restrictions, making them more accessible to patients who need them.
A significant driver behind these changes was the Drug Utilization Sub-Committee (DUSC) analysis of T2DM medicines. The analysis found that GLP-1 RAs accounted for 26% of PBS expenditure on T2DM medicines in 2021-22, with considerable use outside PBS restrictions. The report revealed that from 2017 to mid-2022, 18% of patients initiating GLP-1 RA therapy were not supplied with metformin, a sulfonylurea, or insulin, indicating use outside the restrictions. Furthermore, 42% were supplied GLP-1 RAs in combination with other non-subsidized medicines, highlighting the need for clearer guidelines and simpler access protocols.
PBAC Recommends Accessibility and Compliance Updates for GLP-1 RAs
The PBAC considered the high cost of GLP-1 RAs compared to other treatments and recommended changes to the restrictions to make them more accessible. The new changes allow for better alignment of the Pharmaceutical Benefits Scheme restrictions with clinical practice and reduce the administrative burden on prescribers.The PBAC recommended that the effectiveness of the restriction changes and compliance with the restrictions be investigated in future DUSC utilization reviews.
This ongoing evaluation will help ensure that the updated PBS restrictions continue to meet the needs of patients and healthcare providers while maintaining cost-effectiveness.The PBAC also emphasized the importance of consulting relevant clinical groups on the proposed restriction wording before implementation to ensure clarity and simplicity. Educational activities on the new restrictions will be pursued in conjunction with their implementation to promote the quality use of medicines.
The updated Pharmaceutical Benefits Scheme restrictions for T2DM medicines reflect a significant step towards simplifying access to important diabetes treatments while ensuring they are used appropriately and cost-effectively. By aligning these restrictions with current clinical guidelines and addressing the use of these medicines outside existing PBS guidelines, the changes aim to improve patient outcomes and streamline the prescribing process for healthcare providers.
Resource: Pharmaceutical Benefits Scheme, June 01, 2024
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