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
Of the ~10,000 patients prescribed an Oral Anticoagulant (OACs) for stroke prevention enrolled in MediMergent’s program:
- 38% of patients reported use of Aspirin (ASA) on their PRO Survey.1
- 14% of patients used aspirin as reported in their Medical Records
- No Data reported from either Pharmacy or Payer sources since ASA is an over-the-counter product
Importantly, use of aspirin by patients taking an OAC increases the risk of major GI bleeding and/or intracranial hemorrhage by 6.4%.1
“Voice of the Patient” data enabled MediMergent to notify the pharmacists &/or prescribers that ~2,400 (24%) more patients were taking ASA than were identified by medical records. These patients had significantly increased risk for major bleeding events.
Estimated Impact on Healthcare Cost:
Of these ~2,400 patients, it was predicted that 154 (6.4%) patients could experience a major bleeding event due to combined use of OAC + ASA.
- Typical cost for an emergency room visit = $1,500
- Mean length of hospital stay for major bleeding event = 5 days at $40,000/stay
- Total estimate increased aspirin related healthcare cost = $231,000 + $6,160,000 = $6,391,000
1This is comparable to the 37% baseline use of aspirin in a 14,455 patient Phase 3 trial of OACs. Goodman SG, et al. J Am Coll Cardiol 2012:63:891-900