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PBS restriction changes to type 2 diabetes mellitus (T2DM) medicines

Page last updated: 6 December 2024

Overview

On 1 June 2024, changes were made to the restrictions of several medicines listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of type 2 diabetes mellitus (T2DM) to implement recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2023, July 2023 and March 2024. These changes aim to simplify and clarify the PBS restrictions, ensure use in accordance with the PBS restrictions, and align the restrictions with current clinical guidelines while considering the cost-effectiveness of comparative treatments. The restriction changes were recommended following PBAC consideration of a utilisation analysis examining the extent of use of T2DM medicines outside of the current PBS restrictions. Relevant consumer and prescriber groups, and sponsor companies, were consulted regarding the restriction changes.

On 1 December 2024, the PBS restrictions for dapagliflozin were expanded to allow treatment of T2DM, in combination with metformin (unless contraindicated/intolerant), for patients with cardiovascular disease (CVD), at high risk of a cardiovascular (CV) event, or who identify as Aboriginal or Torres Strait Islander. These changes resulted from an acceptable price offer submitted by the sponsor of dapagliflozin to implement recommendations made by the PBAC in March 2022 and July 2024, following consideration of a cost-effectiveness report on sodium-glucose cotransporter 2 (SGLT2) inhibitors and cost modelling.

Further information on the PBAC’s consideration and the Drug Utilisation Sub-Committee report supporting these changes is available below.

Explanatory materials for prescribers - New PBS restrictions for T2DM medicines

Abridged summaries of the new PBS restrictions for T2DM medicines are provided below in flow diagram and table format (updated 1 December 2024):

These resources are not intended to replace clinical treatment guidelines. For the full PBS restrictions, please go to the PBS website and enter the medicine name. The PBS restrictions reflect the requirements for subsidy and include consideration of the comparative cost‑effectiveness of treatments.

Summary of the PBS restriction changes for T2DM medicines

Changes to PBS authority level and restrictions for glucagon-like peptide 1 receptor agonists (GLP-1 RAs)

  • The authority type for therapy initiation for GLP-1 RAs for all indications has been changed from Authority Required (STREAMLINED) to Authority Required (telephone/electronic). Continuing access to GLP-1 RAs will be via an Authority Required (STREAMLINED) listing.
  • Patients must be contraindicated, intolerant, or must not have achieved a clinically meaningful glycaemic response to a sodium-glucose cotransporter 2 (SGLT2) inhibitor to access PBS subsidised GLP-1 RA therapy. The definition of a ‘clinically meaningful glycaemic response’ has been left open to prescriber discretion in the context of the individual patient.
  • 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. 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.

Simplification of PBS restrictions for T2DM medicines

  • Removal of the requirement for patients to be contraindicated to metformin, to use DPP4 inhibitors, SGLT2 inhibitors, or GLP-1 RAs with insulin.
  • Alignment of DPP4 inhibitor restrictions to allow use of all DPP4 inhibitors with insulin or SGLT2 inhibitors.
  • Pioglitazone has been changed to a Restricted Benefit listing for T2DM without any clinical criteria. This provides an additional first-line therapy for patients who are contraindicated or intolerant to other first-line therapies.
  • DPP4 inhibitors and SGLT2 inhibitors are now subsidised for use in quadruple therapy, in combination with each other, metformin, and insulin.

Dapagliflozin in combination with metformin subsidised for initial T2DM therapy for patients with high CV risk

  • The PBS restrictions for dapagliflozin, and dapagliflozin with metformin fixed dose combination (FDC), have changed to allow patients to initiate T2DM therapy with dapagliflozin in combination with metformin (unless contraindicated/intolerant).
  • Patients must have CVD, be at high risk of a CV event, or identify as Aboriginal or Torres Strait Islander. There is no glycaemic requirement.

PBAC consideration of cost-effectiveness reviews of T2DM medicines – 2021-2022

In response to a stakeholder request for broader PBS access to SGLT2 inhibitors (dapagliflozin and empagliflozin) and GLP-1 RAs (dulaglutide and semaglutide), the Department has undertaken reviews of the cost-effectiveness of these medicines compared to sulfonylureas as add-on therapy to metformin in patients with T2DM without a glycaemic requirement. For further information on these reports and related PBAC considerations, please refer to Table 1 and the summary provided below.

Table 1. Cost-effectiveness reviews of T2DM medicines

Review

PBAC outcome

PBAC Public Summary Document

Cost-effectiveness review of SGLT2 inhibitors

PBAC Outcomes March 2022

 

PBAC PSD – SGLT2 inhibitors report – November 2021

PBAC PSD – SGLT2 inhibitors report – March 2022

Cost-effectiveness review of GLP-1 RAs

PBAC Outcomes July 2022

 

PBAC PSD – GLP-1 RAs report – July 2022

Please note that PSDs may contain deletions or redacted text to protect commercially sensitive information.

In March 2022, the PBAC considered a report on the cost-effectiveness of SGLT2 inhibitors and recommended the restrictions for empagliflozin and dapagliflozin be expanded to allow earlier subsidised access to SGLT2 inhibitors for patients with T2DM as add-on therapy to metformin if they have established CVD or are at high CV risk (i.e. the CV risk population), without the requirement to have a specific unmet glycaemic target. The PBAC recommended an additional clinical criterion for patients who identify as Aboriginal or Torres Strait Islander, recognising the higher risk of CVD in this population. The recommendation was contingent upon a financial cap.

In July 2022, the PBAC considered a report on the cost-effectiveness of GLP-1 RAs compared to sulfonylureas for the treatment of T2DM. The PBAC considered the clinical outcomes to be uncertain due to the paucity of trial data. Noting the potentially high and uncertain estimates of cost-effectiveness, the PBAC did not recommend broadening the current restrictions for GLP-1 RAs. The PBAC expressed concern over the rapid growth in PBS-subsidised use of GLP-1 RAs and recommended that the Drug Utilisation Sub-Committee (DUSC) of the PBAC undertake a utilisation analysis of T2DM medicines, which would include an estimation of the extent of use of GLP‑1 RAs outside the PBS restrictions.

DUSC analysis of medicines for the treatment of type 2 diabetes - September 2022

Purpose

To review the utilisation of medicines for the treatment of T2DM, with a focus on the use of GLP‑1 RAs, SGLT2 inhibitors and DPP4 inhibitors outside of the PBS restrictions.

Key findings

  • In 2021-22, GLP-1 RAs were the highest expenditure class of medicines on the PBS for the treatment of T2DM, accounting for 26% of PBS expenditure on T2DM medicines ($194 million).
  • The DUSC analysis found several examples of apparent use outside the PBS restrictions:
    • 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 is inconsistent with the PBS restrictions:
      • 42% were supplied a GLP-1 RA in combination with another GLP‑1 RA, a DPP4 inhibitor, an SGLT2 inhibitor or a combination of these medicines.
      • 27% were supplied a GLP-1 RA without concomitant use of metformin, sulfonylurea, or insulin.
      • 9.5% crossed both above categories and were supplied a GLP-1 RA without concomitant use of metformin, sulfonylurea, or insulin and in combination with another GLP‑1 RA, a DPP4 inhibitor, an SGLT2 inhibitor, or a combination of these medicines.
  • In 2021, around 15% of people supplied an SGLT2 inhibitor and 16% of people supplied a DPP4 inhibitor received these medicines without concomitant use of metformin, sulfonylurea, or insulin, as required by the PBS restrictions.
  • In 2021, around 14% of people supplied an SGLT2 inhibitor and 7% of people supplied a DPP4 inhibitor received these medicines in combination with a GLP‑1 RA, use which is inconsistent with the PBS restrictions.

Full report

For the full report, including the DUSC consideration, please refer to the DUSC Public Release Document for the utilisation analysis of medicines for the treatment of type 2 diabetes.

PBAC consideration of the DUSC analysis and PBS restrictions for T2DM medicines

Consideration of the DUSC analysis – November 2022

The PBAC considered the DUSC analysis of medicines for the treatment of T2DM and noted the high use of GLP-1 RAs outside of the PBS restrictions. The PBAC also noted that there was some use of SGLT2 and DPP4 inhibitors outside of the PBS restrictions.

The PBAC considered that it would be appropriate to change the restriction type for GLP‑1 RAs from Authority Required (STREAMLINED) to Authority Required (telephone/online). 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. 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 PBAC considered that changes to the restrictions for GLP-1 RAs, DPP4 inhibitors and SGLT2 inhibitors to explicitly exclude their use in combination with some classes of medicines may be useful. The PBAC requested the draft restriction changes be presented at a future meeting.

Noting the proportion of use of DPP4 inhibitors and SGLT2 inhibitors outside of the PBS restrictions, the PBAC considered that a price reduction of at least 15% in the cost of these medicines would be appropriate. The PBAC recommended that if the price reduction to SGLT2 inhibitors was enacted, then the March 2022 recommendation to expand the listings of dapagliflozin and empagliflozin to the CV risk population could be implemented without further price reductions or a financial cap. The price reductions for DPP4 inhibitors were implemented throughout 2024.

The full Public Summary Document (PSD) is provided here:

Please note that PSDs may contain deletions or redacted text to protect commercially sensitive information.

PBS restrictions for T2DM medicines – March 2023

The PBAC considered revised restrictions for T2DM medicines in March 2023.

The PBAC recommended changes to the restrictions for DPP4 inhibitors and SGLT2 inhibitors to reduce complexity. For DPP4 inhibitors, SGLT2 inhibitors and GLP‑1 RAs, the PBAC recommended removal of the requirement for contraindication or intolerance to metformin for patients to use these medicines in dual therapy with insulin.

The PBAC recommended that the authority type for GLP-1 RAs, for therapy initiation for all indications, be changed from Authority Required (STREAMLINED) to Authority Required (telephone/electronic), but that continuing access should be via a streamlined authority. In making this recommendation, the PBAC considered the high use of GLP-1 RAs outside of the PBS restrictions, their high cost versus comparator treatments, and the administrative burden on prescribers associated with telephone/electronic authorities. The PBAC further recommended that the use of GLP-1 RAs in all T2DM indications should be restricted to patients who are contraindicated, intolerant or inadequately responsive to SGLT2 inhibitors. The PBAC noted that both SGLT2 inhibitors and GLP-1 RAs were PBS-listed based on a series of non-inferiority comparisons originating from insulin. The PBAC considered that the price reduction to SGLT2 inhibitors in 2015 meant that SGLT2 inhibitors were now more cost-effective than GLP-1 RAs.

The PBAC recommended that relevant clinical groups be consulted on the proposed T2DM medicines restriction wording prior to implementation to ensure the restrictions are simple and clear and that the Department pursue quality use of medicines educational activities on the restrictions in concert with implementation. The PBAC recommended that the effectiveness of the restriction changes and compliance with the restrictions be investigated as part of future DUSC utilisation reviews.

The full PSD is provided here:

Please note that PSDs may contain deletions or redacted text to protect commercially sensitive information.

PBS restrictions for T2DM medicines – July 2023

Following consultation with relevant prescriber and consumer groups, the PBAC recommended changes to the PBS restrictions for T2DM medicines in July 2023.

The PBAC noted the comments received from a range of T2DM stakeholders on the proposed changes to the PBS restrictions for T2DM medicines. The PBAC noted that stakeholders generally supported the simplification of the restrictions, and clarification of combinations of medicines that are not PBS-subsidised.

The PBAC recommended that the authority type for pioglitazone be changed to a Restricted Benefit listing, without any additional clinical criteria.

The PBAC 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. The PBAC recommended 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.

The PBAC recommended that the authority type for GLP-1 RAs, for therapy initiation for all indications, be changed from Authority Required (STREAMLINED) to Authority Required (telephone/electronic), but that continuing access should be via a streamlined authority. The PBAC further recommended that the use of GLP-1 RAs in all T2DM indications should be restricted to patients who are contraindicated or intolerant to an SGLT2 inhibitor, or who do not achieve a clinically meaningful glycaemic response with an SGLT2 inhibitor.

The full PSD is provided here:

Please note that PSDs may contain deletions or redacted text to protect commercially sensitive information.

Relevant aspects of the consideration of dapagliflozin with sitagliptin – March 2024

In March 2024, when considering a submission to list an SGLT2 inhibitor + DPP4 inhibitor fixed dose combination (FDC) on the PBS, the PBAC recommended extending the PBS listings for all SGLT2 inhibitor + DPP4 inhibitor FDCs to allow subsidised use in combination with metformin and insulin.

For further information, please refer to the dapagliflozin with sitagliptin PSD from the March 2024 PBAC meeting.

Revised cost estimates for SGLT2 inhibitors (CV risk population) – July 2024

In July 2024, the PBAC considered revised cost estimates and confirmed its March 2022 recommendation to expand the PBS listings of SGLT2 inhibitors. The PBAC recommended that SGLT2 inhibitors be PBS-subsidised for the treatment of T2DM, in combination with metformin (unless contraindicated/intolerant), for patients with established CVD, at high risk of a CV event, or who identify as Aboriginal or Torres Strait Islander. The PBAC considered that the cost-effectiveness of expanding the listings for SGLT2 inhibitors was acceptable with a 15% price reduction to the cost of SGLT2 inhibitors for T2DM indications.

The full PSD is provided here:

Please note that PSDs may contain deletions or redacted text to protect commercially sensitive information