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比較効果研究 (CER:Comparative Effectiveness Research) の分析:患者・医師・医療費支払い者の関わる価値の創出

Comparative Effectiveness Research: Value Stories that Engage Patients, Physicians and Payers

発行 Cutting Edge Information 商品コード 337766
出版日 ページ情報 英文 53 Pages
納期: 即日から翌営業日
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比較効果研究 (CER:Comparative Effectiveness Research) の分析:患者・医師・医療費支払い者の関わる価値の創出 Comparative Effectiveness Research: Value Stories that Engage Patients, Physicians and Payers
出版日: 2015年07月31日 ページ情報: 英文 53 Pages
概要

当レポートでは、医薬事業者による比較効果研究 (CER:Comparative Effectiveness Research) へのアプローチについて考察し、医療費払い者の要望を満たすためのCERの重要性、CERへの取り組みの体系化・組織化、十分なリソース配置の重要性、専門ベンダーの活用という選択肢、製品の提供価値の伝達の重要性とCERの影響力などについてまとめています。

エグゼクティブサマリー

比較効果研究 (CER:Comparative Effectiveness Research) の開発と伝達:医療費支払い者への説得力のある価値の提示

効果比較への取り組みとリソースの管理

  • 効果比較の取り組みの体系化・組織化
  • CERへの十分なリソースの配置
  • CERの取り組みのプランニングとベンチマーキング

医療費支払い者に償還を納得させる提供価値の創出

  • 個々の医療費支払い者のニーズへの対応
  • 新製品のための包括的な価値の主張の重要性

ダイナミックな市場におけるステークホルダーの関与

  • 意思決定プロセスへのエビデンスの影響の仕方に対する変化の検証
  • ステークホルダーの関与の改善による患者の転帰 (治療成績) の向上
目次
Product Code: PH213

A number of factors have contributed to the increasing importance of comparative effectiveness research (CER) - along with broader health economics and outcomes research - to payers.

  • Recession-level austerity measures remain in place worldwide, putting increased pressures on already strained healthcare systems.
  • The marketplace is becoming increasingly crowded.
  • Follow-on drugs face an uphill battle to convince payers to include their products on formularies.

This report is designed to give insight into how companies are approaching CER in the pursuit of meeting payer demands. To that end, many companies have turned to dedicated teams focused on developing CER. When it comes to delivering the all-important value proposition effectively, it is important to utilize the pharmacoeconomic expertise that medical science liaisons (MSLs) and health outcomes liaisons (HOLs) bring to the table. Identifying the appropriate comparators and minimizing potential risk are also key concerns. These can be alleviated with careful planning.

FOUR KEY FINDINGS FOR SUCCESSFUL COMPARATIVE EFFECTIVENESS RESEARCH

PROVIDE SUFFICIENT SUPPORT TO CER EFFORTS WITH WELL-RESOURCED DEDICATED TEAMS

Dedicated comparative effectiveness or health economics teams are the best way to ensure that a product is ready for launch from a market access perspective. These dedicated teams can be involved from early in development to begin planning for what payers will need and how to best position the new product on the marketplace.

In addition to the broad strategic outlook, dedicated groups are able to reach into both prospective studies prior to launch and retrospective studies after launch. This capability ensures a continued portfolio of recent and relevant comparative effectiveness data to present to payers.

For companies that do not have a product portfolio that justifies a dedicated group, teams from medical affairs and managed markets should work closely, especially as a product approaches launch, to coordinate their efforts and ensure that payer needs are met. One interviewed team leader suggests meeting at least weekly to update counterparts on product developments.

WORK CLOSELY WITH COMPARATIVE EFFECTIVENESS VENDORS TO MAXIMIZE RETROSPECTIVE STUDIES

For small companies with limited resources, the scale of comparative effectiveness research being requested from some payers can present a significant challenge. Even at larger operations, prioritization of resources often leaves comparative effectiveness close to the bottom of the list until the product is almost launched.

Companies in this position, and even after launch, should be able to find a useful role for specialty, boutique health economics vendors that provide significant value to companies while still returning a high-quality product. Several interviewed team leaders express confidence in the value of these boutique operations that pull heavily on their experience in health economics.

For some therapeutic areas, retrospective database studies in particular present a sizable challenge due to variations in how outcomes are recorded in different healthcare systems. In some cases, studies can be rendered impossible or wholly impractical by these challenges, so specialty therapeutic areas should be aware of these risks. However, in other cases, vendors can again be useful in collecting and then parsing the data down to a useable form that can be then be used in a retrospective study.

ENCOURAGE AND CULTIVATE STAKEHOLDER ENGAGEMENT TO POSITIVELY INFLUENCE RESEARCH AND IMPROVE PATIENT OUTCOMES

Engaging with key stakeholders in the healthcare landscape is a key component to successfully conducting comparative effectiveness research. Many companies have well-established relationships with payers, but other stakeholders involved in the patient care process should be considered and consulted before conducting research.

The model behind this kind of engagement is shown in Figure E.1. Companies should not think of engagement as a binary process of whether or not stakeholders are consulted in decision-making processes. Rather, engagement is a process by which research is affected, and then patient outcomes are improved as a result of that patient engagement.

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

Comparative effectiveness groups may encounter resistance in the engagement process, especially since it is very difficult to measure effectively. Tracking metrics such as the number or duration of contacts with stakeholders may not accurately convey the level of engagement. When they are showing the value of engaging stakeholders, groups should focus on demonstrating stakeholder engagement's impact on the research being conducted.

LEVERAGE SPECIALIZED SKILLSETS TO DELIVER A COHESIVE VALUE PROPOSITION

Among interviewed CER and health economics and outcomes research (HEOR) team leaders, the usefulness of the finished comparative effectiveness product to account managers is a common concern. This potential issue can be addressed in a number of ways. The first tactic is to make sure that the presentation that account managers take to payers has been appropriately streamlined and tailored to match each payer's need. One HEOR director stated that once the payer message had been trimmed down, account managers were more comfortable with presenting the data, and it generated positive feedback from payers.

In cases where the message cannot be streamlined, managed markets teams should be encouraged to work closely with MSL and HOL teams that bring in specialized pharmacoeconomic skillsets. This expertise can provide a significant assist to account managers in the field. Some companies prefer to use these roles in a training capacity, giving account managers guidance on the technical aspects of the payer presentation. For other companies, the partnership may involve MSLs or HOLs accompanying account managers to talk with payers directly.

Overall, CER teams can take steps to make sure that their clinical outputs are being actively utilized in the field. They can make themselves available as a resource throughout the company, ensuring that everyone who could have a use for the data is familiar not only with the data itself, but the process and methodology used to generate it.

Table of Contents

Executive Summary

Developing and Communicating Comparative Effectiveness Research: Making a Convincing Value Proposition To Payers

Managing Comparative Effectiveness Activities and resources

  • Organizing Comparative Effectiveness Operations
  • Allocating Sufficient Resources for CER
  • Planning And Benchmarking CER Activities

Developing a Value Proposition that Convinces Payers For Reimbursement

  • Addressing Individual Payer Needs
  • Importance of Comprehensive Value Stories for New Products

Stakeholder Engagement in a Dynamic Marketplace

  • Examining Changes in How Evidence Impacts Decision-Making Processes
  • Advance Patient Outcomes Through Improved Stakeholder Engagement

FIGURES

Executive Summary

Developing and Communicating Comparative Effectiveness Research: Making a Convincing Value Proposition To Payers

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

Managing Comparative Effectiveness Activities and resources

Organizing Comparative Effectiveness Operations

  • Figure 1.1: Management of CER Responsibilities at Company B (Top 50)
  • Figure 1.2: Frequency of Cross-Functional Interaction During CER Activities
  • Figure 1.3: Function Managing Comparative Effectiveness Activities: Global Groups
  • Figure 1.4: Function Managing of Comparative Effectiveness Activities: Country-Level Groups
  • Figure 1.5: Composition of Ad Hoc CER Teams
  • Figure 1.6: Functions Involved in CER: Global Groups
  • Figure 1.7: Functions Involved in CER: Country-Level Groups
  • Figure 1.8: Level of Executive Leading Dedicated Comparative Effectiveness Teams
  • Figure 1.9: Number of FTEs Dedicated to Comparative Effectiveness Activities

Allocating Sufficient Resources for CER

  • Figure 1.10: Comparative Effectiveness Spending: Global Groups
  • Figure 1.11: Comparative Effectiveness Spending: Country-Level Groups
  • Figure 1.12: Comparative Effectiveness Spending per Product in 2014: All Groups
  • Figure 1.13: Number of CER Studies Conducted (2013-2015): Global Groups
  • Figure 1.14: Number of CER Studies Conducted (2013-2015): Country-level Groups

Planning And Benchmarking CER Activities

  • Figure 1.15: Phase in Which Companies Conduct Comparative Effectiveness Research: Global Groups
  • Figure 1.16: Phase in Which Companies Conduct Comparative Effectiveness Research: Country- Level Groups
  • Figure 1.17: Means of Collecting Comparative Effectiveness Data: Global Groups
  • Figure 1.18: Means of Collecting Comparative Effectiveness Data: Country-Level Groups
  • Figure 1.19: Cost of Comparative Effectiveness Studies: Global Groups
  • Figure 1.20: Cost of Comparative Effectiveness Studies: Country-Level Groups
  • Figure 1.21: Duration of Comparative Effectiveness Studies: Global Groups
  • Figure 1.22: Duration of Comparative Effectiveness Studies: Country-Level Groups
  • Figure 1.23: Cost per Month of Comparative Effectiveness Studies: Global Groups
  • Figure 1.24: Cost per Month of Comparative Effectiveness Studies: Country-Level Groups

Developing a Value Proposition that Convinces Payers For Reimbursement

Addressing Individual Payer Needs

  • Figure 2.1: Importance of Specific Factors in CER Decision Making
  • Figure 2.2: Roles that Share CER with Payers: Global Groups
  • Figure 2.3: Roles that Share CER with Payers: Country-Level Groups
  • Figure 2.4: Percentage of Meeting Time Discussing CER with Private Payers
  • Figure 2.5: Percentage of Meeting Time Discussing CER with Government Payers

Importance of Comprehensive Value Stories for New Products

  • Figure 2.6: Impact of Comparative Effectiveness Research on Product Pricing: All Payers
  • Figure 2.7: Impact of Comparative Effectiveness Research on Formulary Position: Payers
  • Figure 2.8: Impact of Comparative Effective Research on Pricing and Formulary Position: All Payers
  • Figure 2.9: Impact of Health Economics and Outcomes Research on Pricing and Formulary Position: All Payers
  • Figure 2.10: Stage in Which Companies Begin Preparatory Health Technology Discussions
  • Figure 2.11: Percentage of Time Spent on Health Technology Assessments
  • Figure 2.12: Percentage of Spending on Health Technology Assessments

Stakeholder Engagement in a Dynamic Marketplace

  • Figure 3.1: Manufacturer and Payer Priorities: Old Model

Examining Changes in How Evidence Impacts Decision-Making Processes

  • Figure 3.2: Manufacturer and Payer Priorities: New Model

Advance Patient Outcomes Through Improved Stakeholder Engagement

  • Figure 3.3: Develop Engagement Systems to Improve Patient Outcomes
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