Comparative Effectiveness Research

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Comparative Effectiveness Research is designed to give insight into how companies are approaching CER in the pursuit of meeting payer demands. Many companies have turned to dedicated teams focused on developing CER. This report showcases benchmarks and insights that industry executives can leverage to prepare value dossiers for payers that include comprehensive CER data, to understand where to position a CER group and how to provide resource support for it, to ensure that all appropriate stakeholders are involved in demonstrating product value, and more.

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Report Details

This report showcases benchmarks and top executives’ insights into how companies approach comparative effectiveness research to meet payer demands.  CER compares therapies to determine which are the most effective clinically — and which bring the greatest overall benefit to patients.

  • Number of Chapters: 3
  • Number of Graphics: 40+
  • Number of Pages: 53
  • Number of Metrics: 400+

Data are split, where relevant:

Company Region:

  • Global
  • Country-level affiliates

Geography:

  • United States
  • Europe

The Report’s Overall Message:

Implement dedicated CER teams to provide the best value and allow groups to focus on high-quality research.

  • Ensure that those responsible for delivering CER data to payers are able to speak effectively on the whole picture (medical and financial data).
  • Recruit specialized vendors that can assist in parsing complex electronic medical records in order to collect real-world evidence for products.

This report is design to help executives who want to:

  • Prepare value dossiers for payers that include comprehensive comparative effectiveness data
  • Understand where to position a CER group and how to provide resource support for it
  • Benchmark CER study costs and duration
  • Ensure that stakeholders beyond payers — such as providers, patients and physicians — are involved in demonstrating product value
  • Develop evidence for the clinical superiority of a drug over competitors and/or different treatment pathways
  • Understand the role of CER in the context of health technology assessments (HTAs) and health economics and outcomes research (HEOR)

Top Reasons to Read This Comparative Effectiveness Research Report

Provide sufficient support to comparative effectiveness efforts with dedicated, well-resourced teams: From a market access perspective, dedicated groups are the best way to ensure that a product is ready for launch. These comparative effectiveness teams can leverage both prospective studies prior to launch and retrospective, post-launch studies, thereby ensuring a continued portfolio of recent and relevant comparative effectiveness data to present to payers. This report discusses managing cross-functional communication for comparative effectiveness activities, as well as ensuring proper resources for CER.

Ensure that those responsible for delivering CER data to payers are able to speak effectively on the whole picture (medical and financial data): Once data has been successfully generated, managed markets groups face the challenge of making sure that CER is useful to the payer and advantageous to the product in question. This process involved the efforts of managed markets account managers, MSLs, and/or HOLs so that they are prepared to effectively deliver a convincing value proposition. Comparative Effectiveness Research discusses how much time companies spend communicating with payers and the factors that drive payer concerns.

Work closely with comparative effectiveness vendors to maximize retrospective studies: The scale of comparative effectiveness research being requested from some payers can present challenges for small and large companies alike. Specialty, boutique health economics vendors can provide significant value to companies while still returning a high-quality product. Use this study for insight on how vendors can be best utilized during the CER process.

You may be interested in our market access library subscription or our individual market access research reports.

Excerpt fromPlanning and Benchmarking CER Activities

The gold standard of all health economics is to get started on research as early in development as possible. However, comparative effectiveness presents unique challenges in finding appropriate comparators and predicting market conditions before Phase 3, or in some cases, even shortly before launch. As a result, the timing and selection of comparative effectiveness studies is a continuing challenge for many companies, especially in the tough European markets.

BEGIN CONDUCTING CER AS EARLY IN DEVELOPMENT AS PRODUCT ALLOWS

The timing of comparative effectiveness research is an ongoing challenge for many companies. As discussed, early involvement is ideal, but identifying comparators can be complicated early in development. However, the scope of comparative effectiveness should not be limited to comparisons against competitor products. Successful CER can include a variety of comparisons that can be used to demonstrate the value of the product.
The benchmarking data show that companies often wait until Phase 3 or later to conduct comparative effectiveness research.
  • Sixty-seven percent of global groups surveyed conduct research as early as Phase 3, and this number rises to 83% by launch. Phase 4 trials after launch are similarly common at the global level (also 83% of surveyed companies).
  • Surveyed country-level groups wait longer to dive into comparative effectiveness. This delay is largely due to other priorities in resources allocation earlier in development. Just 40% of companies are conducting CER by Phase 3. However, post-launch research is still a high priority. Eighty percent of surveyed country-level groups try to collect these data once the product has been launched.

Examples of companies that have participated in this study:

Comparative Effectiveness Research Study Participants

Table of Contents

Executive Summary

5             Developing and Communicating Comparative Effectiveness Research

12           Managing Comparative Effectiveness Activities and Resources

13           Organizing Comparative Effectiveness Operations

22           Allocating Sufficient Resources to CER

27           Planning And Benchmarking CER Activities

35           Use CER to Develop a Convincing Value Proposition

36           Addressing Individual Payer Needs

42           Importance of Comprehensive Value Stories for New Products

48           Stakeholder Engagement in a Dynamic Marketplace

49           Examining Changes in How Evidence Impacts Decision-Making Processes

52           Advance Patient Outcomes Through Improved Stakeholder Engagement

CHARTS AND GRAPHICS

5             Developing and Communicating Comparative Effectiveness Research

8             Figure E.1: Develop Engagement Systems to Improve Patient Outcomes

12           Managing Comparative Effectiveness Activities and Resources

13           Organizing Comparative Effectiveness Operations

14           Figure 1.1: Management of CER Responsibilities at Company B (Top 50)

16           Figure 1.2: Frequency of Cross-Functional Interaction During CER Activities

17           Figure 1.3: Function Managing Comparative Effectiveness Activities: Global Groups

18           Figure 1.4: Function Managing Comparative Effectiveness Activities: Country-Level Groups

18           Figure 1.5: Composition of Ad Hoc CER Teams

19           Figure 1.6: Functions Involved in CER: Global Groups

20           Figure 1.7: Functions Involved in CER: Country-Level Groups

21           Figure 1.8: Level of Executive Leading Dedicated Comparative Effectiveness Teams

22           Figure 1.9: Number of FTEs Dedicated to Comparative Effectiveness Activities

22           Allocating Sufficient Resources to CER

23           Figure 1.10: Comparative Effectiveness Spending: Global Groups

24           Figure 1.11: Comparative Effectiveness Spending: Country-Level Groups

24           Figure 1.12: Comparative Effectiveness Spending per Product in 2014: All Groups

25           Figure 1.13: Number of CER Studies Conducted (2013-2015): Global Groups

26           Figure 1.14: Number of CER Studies Conducted (2013-2015): Country-Level Groups

27           Planning And Benchmarking CER Activities

28           Figure 1.15: Phase in Which Companies Conduct Comparative Effectiveness Research: Global Groups

28           Figure 1.16: Phase in Which Companies Conduct Comparative Effectiveness Research: Country-Level Groups

30           Figure 1.17: Means of Collecting Comparative Effectiveness Data: Global Groups

30           Figure 1.18: Means of Collecting Comparative Effectiveness Data: Country-Level Groups

32           Figure 1.19: Cost of Comparative Effectiveness Studies: Global Groups

32           Figure 1.20: Cost of Comparative Effectiveness Studies: Country-Level Groups

33           Figure 1.21: Duration of Comparative Effectiveness Studies: Global Groups

33           Figure 1.22: Duration of Comparative Effectiveness Studies: Country-Level Groups

34           Figure 1.23: Cost per Month of Comparative Effectiveness Studies: Global Groups

34           Figure 1.24: Cost per Month of Comparative Effectiveness Studies: Country-Level Groups

35           Use CER to Develop a Convincing Value Proposition

36           Addressing Individual Payer Needs

37           Figure 2.1: Importance of Specific Factors in CER Decision Making

38           Figure 2.2: Roles that Share CER with Payers: Global Groups

39           Figure 2.3: Roles that Share CER with Payers: Country-Level Groups

40           Figure 2.4: Percentage of Meeting Time Discussing CER with Private Payers

41           Figure 2.5: Percentage of Meeting Time Discussing CER with Government Payers

42           Figure 2.6: Impact of Comparative Effectiveness Research on Product Pricing: All Payers

42           Importance of Comprehensive Value Stories for New Products

43           Figure 2.7: Impact of Comparative Effectiveness Research on Formulary Position: Payers

44           Figure 2.8: Impact of Comparative Effective Research on Pricing and Formulary Position: All Payers

44           Figure 2.9: Impact of Health Economics and Outcomes Research on Pricing and Formulary Position: All Payers

45           Figure 2.10: Stage in Which Companies Begin Preparatory Health Technology Assessment Discussions

46           Figure 2.11: Percentage of Time Spent on Health Technology Assessments

47           Figure 2.12: Percentage of Spending on Health Technology Assessments

48           Stakeholder Engagement in a Dynamic Marketplace

49           Examining Changes in How Evidence Impacts Decision-Making Processes

49           Figure 3.1: Manufacturer and Payer Priorities: Old Model

50           Figure 3.2: Manufacturer and Payer Priorities: New Model

52           Advance Patient Outcomes Through Improved Stakeholder Engagement

53           Figure 3.3: Develop Engagement Systems to Improve Patient Outcomes