Pradaxa – Stroke Prevention in Atrial Fibrillation

Analysis posted October 2013

Pradaxa-CI

Our analysis shows Pradaxa (dabigatran) to have high Clinical Innovation over warfarin as the previous SOC for preventing stroke in patients with atrial fibrillation (AF). The “Drivers of Improvement” graphic below summarizes the results of our analysis:

  • Warfarin’s total unmet need score in AF is 1.23, the yellow bar on the left side of the graphic
  • Dabigatran’s unmet need score is 1.04, the yellow bar on the right side of the graphic
  • Dabigatran’s Clinical Innovation, or percent reduction in medical need, is 15.9%: Patients treated with dabigatran have substantially lower unmet need than patients treated with warfarin
Drivers of ImprovementSPAF-Pradaxa1

This graphic also illustrates dabigatran’s advantages and disadvantages compared with the SOC:

  • An overwhelming efficacy advantage (fewer patients experiencing stroke/systemic embolism)
  • A small advantage in safety/side effects (less monitoring required and fewer drug-drug interactions)
  • A slight disadvantage in dosing (BID vs. QD)

Dabigatran’s higher cost diminishes its innovation score, but its net Clinical Innovation of nearly 16% is still high compared with historical norms. As our model predicts, dabigatran has performed well in the AF market since its launch in late 2010.

Following dabigatran’s launch, several other competitors entered the AF market. Rivaroxiban (Xarelto) was approved for this indication about a year after dabigatran, with similar Clinical Innovation relative to warfarin (with somewhat different strengths and weaknesses to those of dabigatran). Rivaroxiban has also competed effectively in this population. In early 2013, apixaban (Eliquis) was also approved, and again it has a similar level of Clinical Innovation compared with warfarin.

All three of these drugs offer substantial improvement over warfarin, and we expect that they will, collectively, dominate this market. However, we do not expect apixaban to achieve as high a patient share, due to its later market entry. For instance, if dabigatran is considered as the new SOC, then apixaban has minimal Clinical Innovation.