DapagliflozinGLIXAFOR
To reduce the risk of progressive decline in kidney function in adults with chronic kidney disease (CKD).
Decisions on record
- Meeting Sep 2025 Recommended Chronic kidney disease
- Meeting Jul 2023 Recommended Chronic heart failure with preserved ejection fraction (HFpEF)
- Meeting Mar 2022 Recommended Chronic kidney disease
- Meeting Nov 2021 Not recommended Chronic kidney disease no PSD
- Meeting Sep 2021 Not recommended Chronic kidney disease (CKD) no PSD
- Meeting Sep 2021 Recommended Heart failure with reduced ejection fraction (HFrEF) no PSD
- Meeting Jul 2021 Deferred Chronic kidney disease
- Meeting Jul 2021 Deferred Heart failure with reduced ejection fraction
11 earlier decisions
- Nov 2020 Not recommended Heart failure
- Jul 2017 Deferred Type 2 diabetes mellitus (T2DM)
- Jul 2017 Deferred Type 2 diabetes mellitus (T2DM)
- Jul 2015 Recommended Type 2 diabetes mellitus
- Mar 2015 Recommended Type 2 diabetes mellitus
- Nov 2014 Recommended 10 mg tablet, 28 Forxiga® AstraZeneca Pty Ltd Change to listing (Major submission) Diabetes mellitus type 2 Extend the current Authority Required listing to include the treatment of diabetes mellitus type 2, in combination with insulin, in patients who meet certain criteria.
- Jul 2014 Recommended dapagliflozin 10 mg + metformin hydrochloride 500 mg, dapagliflozin 10 mg + metformin hydrochloride 1000 mg, dapagliflozin 5 mg + metformin hydrochloride 1000 mg, Xigduo®XR AstraZeneca Pty Ltd New listing (Major submission) Type 2 diabetes Authority required listing for the treatment of diabetes mel
- Jul 2014 Not recommended AstraZeneca Australia Pty Ltd Change to listing (Minor submission) Type 2 diabetes Amendments to the current restriction for dapagliflozin for use in diabetes mellitus type 2 to provide prescribers with clarity regarding the eligible PBS population. Sponsor Comment: The sponsor had no comment.
- Jul 2013 Recommended Type 2 diabetes
- Mar 2012 Not recommended Type 2 diabetes
- Mar 2012 Not recommended Type 2 diabetes
Access path
- TGA registered · GLIXAFOR
TGA label narrower than the PBS population
- Mar 2012Not recommended
Streamlined Authority listing not appropriate for first-in-class agent with novel mode of action; efficacy dependent on…
- Mar 2012Not recommended
inadequate comparison across appropriate comparators, uncertain comparative clinical effectiveness, non-inferiority not…
- Mar 2012Not recommended
Non-inferiority to sitagliptin not demonstrated in indirect comparisons, lower proportion of patients achieving HbA1c…
- Mar 2012Rejected
insufficient evidence to accept the submission's clinical claim that dapagliflozin is non-inferior in terms of…
- ↻ resubmittedJul 2013Recommended · restricted
Comparator changed: pioglitazone (in combination with insulin) → sitagliptin 100 mg
- Jul 2014Not recommended
PBAC rejected the requested restriction changes because the data system does not allow the terminology change from…
- ↻ resubmittedNov 2014Recommended
Comparator changed: sitagliptin → insulin up-titration or intensification
- Mar 2015Recommended
Comparator changed: insulin up-titration or intensification → insulin glargine (main)…
- Jul 2017Deferred
Comparator changed: insulin glargine (main); exenatide (secondary) → Long-acting insulin…
- Nov 2017Recommended · restricted
Comparator changed: Long-acting insulin (insulin glargine/insulin detemir) in combination…
- Nov 2020Not recommended
cost-effectiveness of dapagliflozin compared to standard care not established, uncertain positioning relative to…
- Jul 2021Deferred
Comparator changed: sacubitril/valsartan plus standard care; standard care alone →…
- Jul 2021Deferred
Comparator changed: sacubitril/valsartan plus standard care; standard care alone →…
- Sep 2021Recommended · restricted
Comparator changed: standard care alone (beta-blocker plus ACE inhibitor or ARB, with or…
- Sep 2021Recommended · restricted
Comparator changed: standard care alone (beta-blocker plus ACE inhibitor or ARB, with or…
- Nov 2021Deferred
Comparator changed: Standard care alone (beta-blocker plus ACE inhibitor or ARB with or…
- Mar 2022Recommended
Comparator changed: standard of care (SOC) comprised of at least an ACEI or ARB →…
- Jul 2023Recommended
Comparator changed: standard care → empagliflozin added to standard of care
- Sep 2025Recommended · restricted
Comparator changed: empagliflozin added to standard of care → empagliflozin
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the extension of the current General Schedule Authority Required (STREAMLINED) listing of dapagliflozin (Forxiga®) for chronic kidney disease (CKD) to be consistent with the broadened CKD population recommended for empagliflozin at the May 2025 PBAC meeting.PSD · Sep 2025
5.2 The PBAC advised the equi-effective doses to be empagliflozin 10 mg once per day and dapagliflozin 10 mg once per day. 11 OFFICIALPSD · Sep 2025
4.16 The submission requested updating the listing on a cost-minimisation basis to empagliflozin, with no change to the current prices.PSD · Sep 2025
4.13 Based on the results of Optum, the submission considered dapagliflozin to be non- inferior in terms of effectiveness compared to empagliflozin as treatment for patients with CKD in the expanded population. The submission noted non-inferiority between dapagliflozin and empagliflozin has been established by the PBAC in other indications (T2DM, HF) and the current PBS listing in CKD.PSD · Sep 2025
4.14 No additional comparative safety data of dapagliflozin versus empagliflozin for the treatment of CKD were presented in this submission beyond that already reviewed by the PBAC in prior assessments.PSD · Sep 2025
4.2 Following the publication of the empagliflozin PBAC recommendation, the PBAC received inputs from health professionals (2) and organisations (1) to support the expansion of dapagliflozin restrictions to align with CKD populations recommended for empagliflozin at the May 2025 PBAC meeting.PSD · Sep 2025
4.3 The PBAC noted the Australian Diabetes Society stated the clinical evidence to date supports a class effect for renal benefit in a range of patients with CKD. The input stated both the DAPA-CKD and EMPA-KIDNEY clinical trials showed significant improvements in renal outcomes in people with and without type 2 diabetes.PSD · Sep 2025
5.6 An RSA was proposed by the sponsor in the context of the CKD population, combined with the agreed-upon utilisation caps for heart failure with reduced ejection fraction (HFrEF) and incorporating estimated utilisation for the currently listed T2DM indication. A % rebate of expenditure exceeding the cap was proposed by the sponsor.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission requested updating the listing on a cost-minimisation basis to empagliflozin, with no change to current prices.
The submission requested updating the listing on a cost-minimisation basis to empagliflozin, with no change to the current prices. PSD · 2025
Decision context
PopulationAdults with CKD meeting specific eGFR and UACR criteria: eGFR 20 to 90 mL/min/1.73 m² with varying UACR thresholds depending on eGFR range (UACR ≥200 mg/g for eGFR 45-90, UACR ≥5,000 mg/g for eGFR 25-75, or no UACR minimum for eGFR 20-<25).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2025 | Recommended · restricted | empagliflozin | — | Registry · Surrogate |
| Jul 2023 | Recommended | empagliflozin added to standard of care | — | RCT · Composite of CV death or hospitalisation for heart failure |
| Mar 2022 | Recommended | standard care | — | RCT · PFS |
| Nov 2021 | Deferred | standard of care (SOC) comprised of at least an ACEI or ARB | — | RCT |
| Sep 2021 | Recommended · restricted | standard of care (ACEI or ARB) | — | RCT · Composite: time to first occurrence of ≥50% sustained decline in eGFR, end-stage kidney disease, cardiovascular death, or renal death |
| Sep 2021 | Recommended · restricted | Standard care alone (beta-blocker plus ACE inhibitor or ARB with or without MRA and other heart failure medications for | — | RCT · Time to hospitalisation for heart failure; time to urgent heart failure visit; time to cardiovascular death; death; time to death from any cause; heart failure-related quality of life |
| Jul 2021 | Deferred | Standard of care (ACEI or ARB) | — | RCT · Composite: time to first occurrence of ≥50% sustained decline in eGFR, end-stage kidney disease, cardiovascular death or renal death |
| Jul 2021 | Deferred | standard care alone (beta-blocker plus ACE inhibitor or ARB, with or without MRA and other heart failure medications for | — | RCT |
| Nov 2020 | Not recommended | sacubitril/valsartan plus standard care; standard care alone | — | RCT · Surrogate |
| Nov 2017 | Recommended · restricted | empagliflozin with linagliptin | — | Cost-minimisation · Cost-minimisation |
| Jul 2017 | Deferred | Long-acting insulin (insulin glargine/insulin detemir) in combination with metformin and DPP4 inhibitor; sulfonylurea in | — | RCT · HbA1c |
| Mar 2015 | Recommended | insulin glargine (main); exenatide (secondary) | — | Indirect comparison (network meta-analysis and single-arm data) · HbA1c |
| Nov 2014 | Recommended | insulin up-titration or intensification | — | RCT · HbA1c |
| Jul 2014 | Not recommended | sitagliptin | — | Cost-minimisation · Cost-minimisation |
| Jul 2013 | Recommended · restricted | sitagliptin 100 mg | — | Meta-analysis · HbA1c |
| Mar 2012 | Not recommended | sitagliptin | — | RCT | Single-arm · HbA1c |
| Mar 2012 | Not recommended | pioglitazone | — | RCT | Single-arm · HbA1c |
| Mar 2012 | Not recommended | sitagliptin | — | Meta-analysis · HbA1c |
| Mar 2012 | Rejected | pioglitazone (in combination with insulin) | — | RCT | Single-arm · HbA1c | ORR (for hypoglycaemic episodes) |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DAPA-CKD | Ph 3 | 4,304 | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Dec… | completed |
| Study 10 (NCT00984867) | Ph 3 | 833 | Adjusted Mean Change in HbA1c Levels | completed |
| TRANSITION (NCT00789191) | Ph 3 | 222 | HbA1c (Glycosylated Haemoglobin A1c) | completed |
Consumer voice
Three stakeholders (Australian Diabetes Society and two health professionals) supported alignment of dapagliflozin restrictions with empagliflozin based on clinical evidence of class effect for renal benefit across CKD populations. They emphasized that divergent PBS criteria create unnecessary complexity and barriers to patient care, and advocated for equitable access and clinical clarity for pres
The inputs considered the divergence in PBS criteria between dapagliflozin and empagliflozin is problematic and risks introducing unnecessary complexity and barriers to patient care. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific eGFR (20–90) and UACR thresholds, whereas TGA label covers all CKD Stages 2–4 without biomarker criteria.