FinerenoneKerendia
Treatment of chronic kidney disease in patients with type 2 diabetes mellitus (diabetic kidney disease) with eGFR >25 mL/min/1.73 m² and UACR ≥200 mg/g, in combination with standard of care.
Decisions on record
- Meeting Mar 2023 Recommended Chronic kidney disease (CKD) in Type 2 diabetes; diabetic kidney disease
- Meeting Jul 2022 Not recommended Diabetic kidney disease
Access path
- TGA registered · Kerendia
TGA label narrower than the PBS population
- Jul 2022Not recommended
vs placebo (standard of care)
- ↻ resubmittedMar 2023Recommended · restricted
Comparator changed: placebo (standard of care) → Placebo in combination with standard of…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the General Schedule Authority Required listing of finerenone for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (diabetic kidney disease; DKD). The PBAC was satisfied that finerenone in combination with standard of care provides, for some patients, a significant improvement in efficacy over standard of care alone.PSD · Mar 2023
7.2 The PBAC acknowledged the supportive comments in the clinician hearing and the consumer comments from Kidney health Australia. The PBAC shared the concern that the pill burden and risk of hyperkalaemia may limit uptake of finerenone.PSD · Mar 2023
The PBAC advised that the baseline risk in the economic Baseline patient characteristics were revised based on the model be adjusted to reflect the proposed PBS FIDELITY UACR ≥ 200 mg/g subgroup. population, including use only in patients with very high Baseline CKD, heart failure hospitalisation, cardiovascular albuminuria (UACR ≥ 300 mg/g), and expected use of mortality and hyperkalaemia risks were based on the concomitant SGLT2i therapy (para 7.10, …PSD · Mar 2023
In response to ESC advice (paragraph 6.46), the pre-PBAC response provided a revised economic model with equal rates of progression from CKD 5 to dialysis in both arms of the model (hazard ratio [HR] = 1).PSD · Mar 2023
combination with SoC. Source: Table 13, p3 of the resubmission.PSD · Mar 2023
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; eGFR, estimated glomerular filtration rate; SoC, standard of care; SGLT2i, sodium-glucose cotransporter-2 inhibitor; UACR, urinary albumin-creatinine ratio.PSD · Mar 2023
6.2 The PBAC noted and welcomed the input from 1 organisation (Kidney Health Australia) via the Consumer Comments facility on the PBS website. The statement provided by the organisation noted the benefits of treatment with finerenone, including its potential to slow disease progression and also provide a treatment option for patients who cannot tolerate renin angiotensin aldosterone system inhibitors (RAASi) or SGLT2is.PSD · Mar 2023
6.81 Overall, the ESC considered that the financial impact of finerenone may not be reliable due to the uncertainty of key sources and parameters used to estimate the size of the eligible and treated populations. The ESC considered a risk sharing arrangement (RSA) may minimise the risk due to uncertainty in the financial estimates.PSD · Mar 2023
Cost-effectiveness
ICER value is redacted (shown as $ AEMP in the pricing section); the economic evaluation exists but the numerical ICER is commercially sensitive and not published in the public summary document.
Decision context
PopulationAdults with chronic kidney disease associated with type 2 diabetes, eGFR >25 mL/min/1.73 m², UACR ≥200 mg/g, stabilised on ACEi or ARB for ≥4 weeks, and receiving SGLT2i unless contraindicated or intolerant, excluding those with established HFrEF.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended · restricted | Placebo in combination with standard of care (ACEi or ARB, and SGLT2i unless contraindicated) | — | RCT · Composite — onset of kidney failure, sustained decrease of eGFR ≥40% from baseline, or renal death; and composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for heart failure |
| Jul 2022 | Not recommended | placebo (standard of care) | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| FIDELIO-DKD | Ph 3 | 5,734 | The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Dec… | completed |
| FIGARO-DKD | Ph 3 | 7,352 | The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardi… | completed |
Consumer voice
Kidney Health Australia provided input highlighting finerenone's potential to slow disease progression and serve as an alternative for patients intolerant to RAASi or SGLT2i therapies, while noting concerns about pill burden and hyperkalaemia risk.
The statement provided by the organisation noted the benefits of treatment with finerenone, including its potential to slow disease progression and also provide a treatment option for patients who cannot tolerate renin angiotensin aldosterone system inhibitors (RAASi) or SGLT2is. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to eGFR >25, UACR ≥200 mg/g, prior ACEi/ARB stabilisation, and SGLT2i use; TGA label has no such biomarker thresholds or prior therapy requirements.