Conclusion: Jardiance (empagliflozin) gets a Clinical Innovation score of 5.2% in type 2 diabetes patients with comorbid cardiovascular disease (CVD), based on data from the EMPA‑REG OUTCOME trial reported in September 2015. A 5.2% Clinical Innovation score suggests a “Good” ability to compete for patient share — far better than any other new oral agent launched in type 2 diabetes in many years.
To gain insight into the clinical and commercial meaning of new trial data reported for Jardiance in type 2 patients, we analyzed it in our unmet medical need model, which provides a quantitative measure of clinical improvement over the standard of care (SOC). These new data represent a notable improvement in the Clinical Innovation score for Jardiance in the tested population (those with CVD, who constitute 37% of all type 2 diabetics).
The most significant finding from the study is the relative reduction in all-cause mortality — 32% lower than in the control group (SOC plus placebo). That mortality benefit is the primary driver of Jardiance’s overall Clinical Innovation score, as reflected in our “Drivers of Improvement” chart (below). Unmet medical need in diabetics with CVD is relatively high; on our 0–5 scoring system it comes in at 3.16 for the standard of care (sitagliptan plus metformin). Adding Jardiance to this combination (and many other current combination regimens) reduces medical need by a notable 5.2%, to 2.99 (right side of the chart). Green bars show Jardiance’s advantages, red bars its disadvantages.
The efficacy improvement shown in the “Drivers” graphic above reflects the 14% reduction in cardiovascular events that were seen in the Jardiance-treated patients. The disadvantages of the Jardiance combination regimen — the additional side effects, dosing of an additional pill, and higher drug costs — are small in relation to its advantages in mortality, efficacy, and morbidity.
There have been many new drugs launched for type 2 diabetes in recent years, and despite the proliferation of novel mechanisms, all of them have low Clinical Innovation (close to 0%) and are therefore “undifferentiated”. Jardiance (in the CVD subpopulation) is the first to show Clinical Innovation above the 5% level.
We also analyzed Jardiance in the broader type 2 population, assuming relative reductions in mortality and hospitalizations as reflected in the study’s population. Those assumptions yield a Clinical Innovation score of 2% for Jardiance in the broader population.
Using our share prediction algorithm, we project that Jardiance will reach peak U.S. sales of $2.6 billion at its current price and an additional $1.5 to $2 billion outside the U.S. Most of those sales will come from the comorbid CVD population.