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INSIGHTS | REAL-WORLD EVIDENCE The increasing demand for real-world evidence by a growing body of decision makers is creating a need for new capabilities, data considerations, and effective planning for RWE generation across the entire product lifecycle. The authors Jon Resnick, MBA is Vice President Real-World Evidence Solutions, IMS Health Jresnick@uk.imshealth.com Jacco Keja, PHD is Regional Principal HEOR, IMS Health Jkeja@nl.imshealth.com PAGE 10 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH
A global plan for success REAL-WORLD EVIDENCE | INSIGHTS Preparing for a lifecycle of real-world evidence The concept of real-world evidence (RWE) is not a new one: researchers have been generating RWE to support product use among physicians and payers for nearly 20 years. However, recent growth in the demand for RWE to inform market access decisions has shifted the timeframe over which value is determined far into the post-launch lifecycle with significant implications for manufacturers. Traditionally, much of the work already completed for market access at the time of launch was based on evidence from randomized clinical trials (RCTs). While these remain the gold standard for demonstrating product safety and efficacy, the inherent limitations of their data – small sample size, controlled environment and focus on short-term outcomes – meant negotiations were primarily focused on qualitative documentation of value. Quantification was mainly extrapolated using health economic modeling. Increased payer interest in RWE reflects a shift toward more quantitative measurements of value and acceptance of data sources and endpoints that are not explicitly derived from RCTs. This comes with growing acknowledgment that while RWE may have limitations in data quality relative to RCTs, its findings are more relevant to the payer perspective. Regulators, too, recognize the value of RWE on safety, relative to that offered by RCTs. Other trends are also broadening the use of RWE. In recent years, payers have been experimenting with approaches that shift the risk to manufacturers, such as value-based contracting and conditional reimbursement or access, as well as to other stakeholders through pay-for-performance and consumer-directed plans. Disease management pilots with riskshifting consequences are also underway in several European countries. These developments converge with another important trend - the deferral of risk to healthcare practitioners, who need to understand in detail the right patient for a product and the way in which treatment algorithms can be optimized in the real world. If these models form the basis of future practice in healthcare delivery, RWE perspectives and endpoints will need to start resonating with the broader range of stakeholders, including providers and patients, who have been delegated more decision-making power. The future for RWE is one of certain challenge for all key stakeholders as scientific advancements and external dynamics place increasing demands on decision making. However, it is also one of tremendous potential for the expanded role of RWE. ACCESSPOINT • VOLUME 2 ISSUE 4 PAGE 11
Page 1 and 2: Volume 2, Issue 4 • May 2012 Acce
Page 3 and 4: “2012 is shaping a future that wi
Page 5 and 6: IMS DE-IDENTIFICATION ENGINE IMS LI
Page 7 and 8: IMS HEOR Bibliography Health econom
Page 9 and 10: REAL-WORLD EVIDENCE COLLABORATION |
Page 11: • Significance of HbA1c durabilit
Page 15 and 16: REAL-WORLD EVIDENCE | INSIGHTS 3. A
Page 17 and 18: 3.Tactical planning VALUE OF COLLAB
Page 19 and 20: PATIENT-REPORTED OUTCOMES | INSIGHT
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Page 23 and 24: DRUG EXPOSURE MEASUREMENT | INSIGHT
Page 25 and 26: DRUG EXPOSURE MEASUREMENT | INSIGHT
Page 27 and 28: CONCLUSIONS DRUG EXPOSURE MEASUREME
Page 29 and 30: INDIRECT TREATMENT COMPARISONS | IN
Page 35 and 36: US PRIVATE HEALTHCARE SPENDING | IN
Page 41 and 42: SUMMARY US PRIVATE HEALTHCARE SPEND
Page 43 and 44: IMPLEMENTING HTA IN ASIA PACIFIC |
Page 45 and 46: IMPLEMENTING HTA IN ASIA PACIFIC |
Page 47 and 48: PHARMACOGENOMICS | INSIGHTS Pharmac
Page 49 and 50: PHARMACOGENOMICS | INSIGHTS DO WE N
Page 51 and 52: PHARMACOGENOMICS | INSIGHTS INITIAT
Page 53 and 54: IMS CORE BUDGET IMPACT MODEL | PROJ
Page 55 and 56: DATA LINKAGE IN ONCOLOGY | PROJECT
Page 57 and 58: METASTATIC COLORECTAL CANCER | PROJ
Page 59 and 60: Global scope, local expertise IMS H
Page 61 and 62: EXPERTISE | IMS Karin Berger, MBA
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EXPERTISE | IMS Claude Le Pen, PHD
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EXPERTISE | IMS Vernon Schabert, PH
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Powering a patient perspective LIFE
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