Dive Brief:
- Boehringer Ingelheim’s novel oral anticoagulant (NOAC) Pradaxa (dabigatran etexilate) showed effectiveness among patients in a real-world analysis in hospital and physician offices compared to top-selling warfarin in the multi-billion dollar market, according to a study published in the American Journal of Pharmacy Benefits.
- The findings released Friday showed that among the nearly 4,000 patients studied with non-valvular atrial fibrillation (NVAF), those treated with Pradaxa had lower all-cause hospitalizations that those treated with warfarin (42.8% vs. 47.5%). The data also showed Pradaxa patients had fewer stroke-related hospitalization and doctor visits, as well as fewer bleed-related emergency department visits.
- Boehringer may be counting on more good news about Pradaxa to push it further along in the NVAF market, where warfarin has been the standard of care for the last few decades.
Dive Insight:
Pradaxa is one of several oral anticoagulants that has hit the market since 2010 but has been struggling to gain market share against the vintage warfarin, the most popular blood thinner ever.
With these real-world study findings, the German drug maker may likely continue to tout its effectiveness as a significant alternative to warfarin, showing its impact for physicians and hospitals.
The data showed that, in comparison to warfarin, Pradaxa had significantly lower per-patient-per year (PPPY) hospitalizations, (1.07% vs. 1.20%) emergency department visits, (0.36% v. 0.51%) and physician office visits, (10.64% v. 18.13%).
Pradaxa was the first FDA-approved alternative to warfarin to reduce the risk of stroke in atrial fibrillation, (AF) not caused by a heart valve problem. NVAF accounts for more than 90% of all atrial fibrillation diseases in the U.S., the study said, noting that oral anticoagulants are seen as a therapy to substantially reduce the risk of patients with AF.
The most recent study is significant, said Matthew Sussman, lead author and associate management director of Boston Health Economics, because while NOACs, such as Pradaxa, have provided clinicians with effective options opposed to warfarin for stroke risk reduction there has been limited data about treatment using real-world data and impact on hospital resources.
With the emergence of drugs as alternatives to warfarin, insurers and other payers are using other drugs, "thereby intensifying the need for evaluations of the overall economic impact," Sussman wrote, particularly healthcare resource utilization and direct medical costs.
While warfarin has been the most widely used anticoagulant, having been shown to reduce the risk of stroke by two-thirds, it has challenges, such as the need for frequent monitoring and a high risk for bleeding. Yet, NOACs like Pradaxa, Eliquis (apixaban) and Xarelto (rivaroxaban) have been struggling since their market entrance, despite pushes by their big pharma developers.
Boehringer has been trying to get a leg up on competitors, hoping that having a reversal agent, Praxbind (idarucizumab), specifically designed for use with Pradaxa also will help bolster the drug's sales. Interim phase 3 data has shown it to be effective in stopping bleeding episodes in real world episodes.