Case Study

NMSOAP: National Medication Safety, Outcomes and Adherence Program

Collected Real-World Data (RWD) and Analyzed Real-World Evidence (RWE) on Patients Treated with Novel Oral Anticoagulants vs. Warfarin

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

Real-World Evidence:

“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

For More Information About the NMSOAP Please Contact MediMergent