
Unlocking the Value of Real-World Evidence (RWE): Insights for Payers and Manufacturers
Overview
Pricing: Free for Members and $30 for Non-Members
Course Description
Real-world evidence (RWE), generated from real-world data (RWD), is transforming health care by bridging the gap between research and everyday practice. RWD refers to data collected from patients' health status and routine healthcare delivery, while RWE represents clinical insights derived from analyzing RWD. As regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) increasingly consider RWE to inform their regulatory decisions, including post-market safety monitoring and drug approvals, its national and global significance continues to grow. Most pharmaceutical companies are investing in RWE creating opportunities for payers to incorporate RWE into formulary and medical policy decision-making. Furthermore, payers are interested in using RWE as part of their decision-making process but expressed a need for more training on how to assess the quality of RWD for research purposes, evaluate RWE studies, and practically apply it to their decisions.
Through an interactive panel discussion, attendees will learn practical approaches to obtaining RWD, assessing data for quality and research purposes, generating RWE and interpreting findings, and examining diverse applications of RWE throughout the drug lifecycle, from development to post-market evaluation, offering participants a comprehensive understanding of how RWE can inform strategic decision-making.
Target Audience
Pharmacists who practice in managed care settings.
Learning Objectives
At the completion of this activity, participants should be able to:
- Compare RWE with outcomes from randomized clinical trials, highlighting their unique and complementary roles in managed care, regulatory, and clinical decision-making.
- Identify the strengths and limitations of various data sources used in RWE generation in relation to the different states of the drug development lifecycle, from pre-approval to post-marketing surveillance.
- Discuss the quality and reliability of RWD and its RWE generation, focusing on methodologies to address biases, data gaps, and variability to inform managed care formulary and policy strategies.
Faculty
Ashley Jaksa, MPH
VP Science
Aetion, Inc
Northampton, MA
Elizabeth Powers, MBA
VP & GM, Regulatory Science and Study Innovation
IQVIA
New York, NY
Brian Sweet, BS Pharm, MBA
Executive Director, Health Economics & Outcomes Research
Geron
Naples, FL
Cate Lockhart, PharmD, PhD
Chief Science Officer & Executive Director
AMCP & BBCIC
Alexandria, Virginia
Financial Relationship Disclosures
FACULTY/REVIEWER/PLANNER | REPORTED RELEVANT FINANCIAL RELATIONSHIPS |
Ashley Jaksa, MPH Faculty | Aetion, Inc, Employee, Individual Stocks/Stock Options; CVS Health, Individual Stocks/Stock Options |
Elizabeth Powers, MBA Faculty | IQVIA Employee, Individual Stocks/Stock Options |
Brian Sweet, BS Pharm, MBA Faculty | Geron Employee |
Michelle Aslami, PharmD Reviewer | Disclosed no relevant financial relationships. |
Jennifer Evans, PharmD, BCACP Planner | Disclosed no relevant financial relationships. |
- If applicable, relevant financial relationships have been mitigated and documented.
- Content has undergone a peer review to ensure content validity.
Accreditation
Accreditation:
The Academy of Managed Care Pharmacy (AMCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
ACPE UAN: 0233-0000-25-006-H04-P • Activity Type: Knowledge-Based
Contact Hours: 1.25
Release Date: April 18, 2024 • Expiration Date: December 31, 2026
Activity Fee: Free for Members and $30 for Non-Members
Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP 2024. CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.
To receive credit for an online activity you must:
- Review the full content of the activity.
- Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
- Complete a specific activity evaluation.
Available Credit
- 1.25 ACPE
The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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