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Finerenone for treating chronic kidney disease in type 2 diabetes

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1 Recommendations

1.1 The committee was minded not to recommend finerenone as an option for treating stage 3 and 4 chronic kidney disease with albuminuria associated with type 2 diabetes in adults.

1.2 The committee recommends that NICE requests further clarification and analyses from the company, which should be made available for the second appraisal committee meeting, and should include:

  • a comparison of finerenone with sodium–glucose cotransporter‑2 (SGLT2) inhibitors

  • all data from the FIGARO-DKD and FIDELITY studies that are directly relevant to the decision problem in this appraisal

  • updating the effectiveness data in the cost-effectiveness model with new point estimates from the additional clinical data

  • cost-effectiveness scenario analyses of finerenone used at second line (compared with SGLT2 inhibitors in an SGLT2 inhibitor-naive population) and at third line (as an add-on to second-line SGLT2 inhibitors in an SGLT2 inhibitor-experienced population)

  • comparisons of transition probabilities over time, and model predictions of time to events compared with empirical data from the trial

  • base cases with both trial-based utilities and utilities from literature sources that are more recent and relevant than currently used in the model

  • scenario analyses of alternative treatment waning effects for finerenone.

  • a valid probabilistic sensitivity analysis that includes accounting for parameter uncertainty in transition probabilities to reflect CKD progression

Why the committee made these recommendations

Standard care for chronic kidney disease in people with type 2 diabetes includes angiotensin‑converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and SGLT2 inhibitors. Finerenone would be used after ACE inhibitors and ARBs, and could be given before, after, or with SGLT2 inhibitors.

The clinical evidence suggests that, when compared with placebo plus standard care, finerenone plus standard care improves kidney function and helps to slow the worsening of disease. But there were not enough people in the trial to provide enough data to be certain. Also, the company did not compare finerenone with SGLT2 inhibitors, and it did not present evidence from other studies that may have helped to reduce the uncertainty.

Because of this, the cost-effectiveness estimates are highly uncertain. So, the committee was minded not to recommend finerenone until these uncertainties have been explored further.