Author: The Lewin Group
Publication: November 21, 2016
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The development of value assessment frameworks in the U.S. has emerged in the broader context of a shift in emphasis from volume to value of health care. In the U.S., five value assessment frameworks and related tools that have recently emerged include the following:
- American College of Cardiology and American Heart Association (ACC-AHA) Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures
- American Society of Clinical Oncology (ASCO) Conceptual Framework to Assess the Value of Cancer Treatment Options
- Memorial Sloan Kettering Cancer Center’s (MSKCC) DrugAbacus
- Institute for Clinical and Economic Review (ICER) Value Framework
- National Comprehensive Cancer Network (NCCN) Evidence Blocks™
While these frameworks generally focus on assessing the value of different treatments and overlap in some ways, their respective intended purposes and target users differ. These five frameworks are in different stages of development, and all of their developers consider them to be works in progress.
The National Pharmaceutical Council (NPC)'s analysis of these five frameworks, titled Current Landscape: Value Assessment Frameworks, cited concerns about one or more of the frameworks, including the use of untested methodologies, limited evidence base, lack of patient-centeredness, lack of a health system-wide perspective, and unclear or confusing output for users.
Drawing from its analysis and seeking to address those concerns, NPC developed a set of guiding practices to ensure that value assessment tools are patient-centered and focused on supporting value in patient care and outcomes by meeting a set of good practices/standards. NPC’s Guiding Practices for Patient-Centered Value Assessment includes 28 specific elements comprising the following six key aspects of value assessments:
- Assessment process
- Dissemination and Utilization
The document also includes seven guiding practices for budget impact assessment (BIA), outlined separately, though not as a measure of value.
NPC contracted with The Lewin Group to conduct an independent analysis of the extent to which the five major value assessment frameworks address or align with NPC’s guiding practices. The purpose of this analysis is two-fold:
- Evaluate how the five major value assessment frameworks align with NPC’s Guiding Practices for Patient-Centered Value Assessment and compare and contrast these frameworks across the guiding practices.
- Continue to guide the field in ensuring that value assessment frameworks meet a set of standards/good practices that helps to ensure that these tools support patient care and outcomes.
Among The Lewin Group's findings:
- Intended audiences. These frameworks were designed for different purposes and audiences, with ACC-AHA, ASCO and NCCN developed primarily for clinicians and payers; ACC-AHA expects that its assessments will reach payers as well. ICER and DrugAbacus’ assessments are intended for policymakers, payers and industry. Framework developers should be clear about their intended audiences and how the framework addresses users’ interests.
- Transparency. Limitations in transparency, such as evidence sources, methods and management of stakeholder feedback, can diminish the credibility and utility of value frameworks.
- Stakeholder input and feedback. Clear, timely and responsive provisions for stakeholder input and feedback are recognized globally as standard attributes of publicly accountable health technology assessment programs and related efforts involving health and economic evaluations. It also is necessary to demonstrate responsiveness to such input.
- Patient involvement. To date, frameworks vary widely in the extent to which they seek or reﬂect patient involvement. Patients are ultimately affected by the value-based decisions of other stakeholders, so it is very important to engage with patients and consider their perspectives throughout the framework development and assessment processes.
- Expert involvement. The credibility of value assessments depends in part on the types and extent of expert involvement. As frameworks use more advanced methods to evaluate different types of evidence, conduct extensive economic modeling and serve more diverse users, they should revisit their mix of expertise and ways in which experts are involved in the processes.
- Types of interventions. Among these frameworks, the majority of focus is on drugs and biologics, leaving stakeholders without value assessments for devices, diagnostics, surgical procedures and other interventions. That limited focus will bias the basis for informed decision-making.
- Evidence sources and quality. The data that is selected and used as part of a value assessment can bias results. Frameworks should be transparent about the sources and types of evidence that are used, note their limitations and consider updating an assessment should new evidence become available.
- Costs and other economic aspects. There is wide variation among the value frameworks with respect to cost analyses and cost-effectiveness thresholds. This highlights the importance of transparency in the assumptions, evidence and methods used, but also the recognition of their impact on the findings of value assessments and how these findings will be applied.
- User preference entry. Value frameworks vary widely in enabling user input. All of the frameworks can be more user friendly and provide good user interfaces. To become more user friendly, frameworks should enable entry of user preferences by their primary target audience, as well as by others who might be affected by the findings. Most framework developers have generally indicated an interest in enabling this input.
- Potential misinterpretations and misuse. There is utility in having multiple frameworks address the same topic from different perspectives, but frameworks must be clear about their intended uses and assumptions to avoid confusion. They must make a concerted effort to ensure their work is transparent and comprehensible, and minimize or correct misinterpretation or misuse.