MediMergent and FDA Launch New Stakeholder Initiative against Medication Non-Adherence/Persistence Crisis

• There are approximately 117 million Americans who have chronic diseases requiring lifelong medications; the non-adherence rate to their medicine by six months post initiation of therapy is approximately 50%. This results in approximately 125,000 deaths/year, nearly twice as high as the death rate due to opioid overdoses.
• Poor medication adherence/persistence results in up to $300 billion per year of added healthcare costs, a wastage of approximately 10% of the total annual healthcare budget.

Attendees to the Advisory Board meeting included healthcare stakeholders from FDA, biopharma companies, prescribers, pharmacies, insurers, health plans, data analytics companies and academia. The agenda focused on alignment of stakeholder incentives and implementation plans for sustainable strategies to improve medication non-adherence and persistence. The Advisory Board will provide oversight to program design, including delineation of outcome measures. Programs will enroll patients at pharmacies, infusion centers and physicians’ offices, including patients with Type II diabetes, cardiovascular disease, and cancer.

This new initiative to fight the medication non-adherence/persistence crisis represents the first effort for the FDA to engage with multiple stakeholders focused on a public health issue unrelated to regulatory approval or post-approval surveillance of a specific medication. It is developed through a five-year Research Collaboration Agreement (RCA) between MediMergent and CDER to deploy data collection and analytic tools for real-world evidence using MediMergent’s proprietary platform, the National Medication Safety Outcomes and Adherence Program (NMSOAP).

Norman Stockbridge, MD, PhD, Director, Division of Cardiovascular and Renal Products, CDER, FDA stated, “The lack of medication adherence and persistence is a public health crisis that should be remediable. It is a problem that affects drugs that are prescribed for major morbidity and mortality indications, like atrial fibrillation, with many patients discontinuing their anticoagulant therapy within 6 months from the initiation of dosing. The goal of this Advisory Board is to focus on methodologies that can impact patients’ behaviors to ensure positive outcomes.”

Fred Senatore MD, PhD, FACC, Medical Officer, Division of Cardiovascular and Renal Products, CDER, FDA, stated: “Issues leading to medication non-adherence are embedded in every hierarchical level of the ecological healthcare model. Making a difference must involve a collaboration of key stakeholders. Strategies to engage and incentivize patients have been shown to improve medication adherence and decrease the incidence of major adverse cardiovascular events. It is vital that we promote patient engagement and incentivize patients and other key stakeholders to effectively improve medication adherence.”

Robert Temple MD, Deputy Center Director for Clinical Science, CDER, FDA, noted that, “This Advisory Board represents a unique opportunity to explore methods of improving medication adherence and persistence with life-saving treatments of largely asymptomatic conditions, such as hypertension and/or hyperlipidemia, where a majority of patients across all ages and demographics stop therapy within a year or so. There is no more pressing medical problem facing the healthcare system.”

About the NMSOAP

The NMSOAP combines Patient Reported Outcome (PRO) instruments with medical records, prescription and claims data. These data determine longitudinal risk-related profiles on disease management and treatment, medication non-adherence/persistence, patient safety, clinical outcomes, drug effectiveness, REMs, and comparative effectiveness. The NMSOAP serves as an early warning surveillance tool for patients at risk of important adverse events.

About MediMergent, LLC

MediMergent is a data collection and analytics company that utilizes its NMSOAP platform to implement customized, patient centric, real-world evidence projects for health care companies to support their commercial interests and regulators to better understand real world patient safety and medication effectiveness.

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