The NMSOAP collected serial patient reported survey data, medical records, pharmacy data and claims data. All patients were prescribed FDA-approved novel oral anticoagulants [NOACs: Xarelto® (rivaroxaban), Pradaxa® (dabigatran), or Eliquis® (apixaban)] or standard-of-care Coumadin® (warfarin or generics). Indications for oral anticoagulation (OAC) therapy included prevention of cardiac thrombi and stroke associated with atrial fibrillation (AFib), deep venous thrombo-embolism and pulmonary embolism, or other physician prescribed uses of oral anticoagulants. Clinical outcomes including gastro-intestinal bleeding, all-cause mortality and stroke were reported to the FDA.
The data confirmed that the NMSOAP program:
- improved post-marketing tracking of safety events
- successfully evaluated evolving patterns of real-world medication adherence and persistence
- was capable of using multiple digital data sources and proprietary tools to enroll the study and collect patient-centric information
- could establish the effectiveness of post-approval risk mitigation strategies
The real-world post-marketing data collected in the NMSOAP demonstrated that:
- this approach can recruit and retain patients and collect longitudinal data related to safety, outcomes, drug adherence and comparative effectiveness
- the methodology can collect real-world outcomes information consistent with published data from a meta-analysis of four large pivotal Phase III clinical trials for stroke prevention in patients with atrial fibrillation
- the three NMSOAP data sources [PROs, medical records and pharmacy data] are complementary and can serve as a foundation for cross-validation
- the platform can create mutual incentives among providers, pharmacists and patients that support patient retention
Sample Impact of RWD on Outcomes and Cost
