SGLT2 Inhibitors as a Class Effect: Payer and Formulary Considerations

"SGLT2 Inhibitors as a Class Effect: Payer and Formulary Considerations" takes up the question of how payers and formulary committees should weigh the SGLT2 inhibitor evidence base.

Dr. Vaduganathan turns to how payers and formulary committees should weigh the SGLT2 inhibitor evidence base. He restates that while individual trials show subtle differences in point estimates, the class shows broad consistency in cardiovascular and kidney benefit. His central recommendation for payers is that any SGLT2 inhibitor studied in a large, well-controlled randomized trial that met its primary endpoint for a given indication should remain a preferred option, since a class effect is largely present for the major outcomes these programs were designed to detect.

He then narrows in on mortality, a frequent point of scrutiny for payers and committee members. Taking the totality of evidence together, Dr. Vaduganathan says there is modest mortality protection with SGLT2 inhibitors in patients with type 2 diabetes, but that protection is most discernible in the highest-risk patients, those with established atherosclerotic cardiovascular disease. He explains that this is why a cardiovascular death signal emerged in EMPA-REG OUTCOME, which enrolled that high-risk group, but was not clearly replicated in DECLARE-TIMI, which enrolled a broader and comparatively lower-risk population. The absence of a mortality signal in a broader trial, he argues, reflects the population studied rather than a meaningful difference between the drugs themselves.

Importantly, Dr. Vaduganathan cautions against letting that mortality nuance drive access decisions in clinical practice. He does not believe the difference in cardiovascular death findings between trials should be used to restrict which patients can obtain a given SGLT2 inhibitor, since the broader body of evidence on cardiovascular and kidney outcomes remains consistent across the class. His guidance to payers is to anchor formulary and utilization decisions in the totality of trial evidence for each indication, rather than in a single, population-dependent endpoint like mortality.

The next episode, "Switching SGLT2 Inhibitors: Generic Transitions and Continuity of Care," addresses a practical question payers and clinicians both face: what happens when a stable patient switches agents.