Implementing CER: What Will It Take?

BACKGROUND: Comparative effectiveness research (CER) is undeniably changing how drugs are developed, launched, priced, and reimbursed inthe United States. But most organizations are still evaluating what CERcan do for them and how and when they can utilize the data. A roundtable of stakeholders, including formulary decision makers, evaluated CER’s possible effects on managed care organizations (MCOs) and what it maytake to fully integrate CER into decision making. OBJECTIVES: To examine the role of CER in current formulary decision making, compare CER to modeling, discuss ways CER may be used in thefuture, and describe CER funding sources. SUMMARY: While decision makers from different types of organizations, such as pharmacy benefit management (PBM) companies and MCOs, may have varying definitions and expectations of CER, most thought leadersfrom a roundtable of stakeholders, including formulary decision makers,see value in CER’s ability to enhance their formulary decision making. Formulary decision makers may be able to use CER to better inform their coverage decisions in areas such as benefit design, contracting, conditional reimbursement, pay for performance, and other alternative pricing arrangements. Real-world CER will require improvement in the health information technology infrastructure to better capture value-related information. The federal government is viewed as a key driver and funding source behind CER, especially for infrastructure and methods development, while industry will adapt the clinical development and create increasing CER evidence. CER then needs to be applied to determining value (or cost efficacy). CONCLUSIONS: It is expected that CER will continue to grow as a valuable component of formulary decision making. Future integration of CERinto formulary decision making will require federal government and academic leadership, improvements in the health information technology infrastructure, ongoing funding, and improved and more consistent methodologies.