What are value assessment frameworks?
Value assessment frameworks are intended to be used as tools in measuring the value of health interventions and treatments, but “value” can mean different things to payers, clinicians and patients.
What do decision-makers need to know about frameworks?
In the United States, several organizations have developed value assessment frameworks to inform health care decision-making. Each framework tends to reflect the interests and expertise of the developing organization and has been designed with different end-users and types of decisions in mind. For this reason, frameworks may use different types of methods, data and inputs when evaluating a health care treatment, device or service. One approach will not meet everyone’s needs.
There is no 'best' framework and they all have strengths and limitations. A conscientious user will rely on multiple frameworks and tools to assess value rather than looking to a single framework to inform health care decisions.
What frameworks are in use?
As of 2021, a few organizations in the United States have developed value frameworks to assist patients, clinicians and payers as they assess the relative value of health care treatments and services. These include assessment tools created by the American College of Cardiology/American Heart Association, American Society of Clinical Oncology (ASCO), Institute for Clinical and Economic Review (ICER), Memorial Sloan-Kettering Cancer Center (DrugAbacus), and National Comprehensive Cancer Network (NCCN), and the Innovation and Value Initiative (IVI). However, only three framework developers are conducting regular assessments.
The Institute for Clinical and Economic Review (ICER) Value Framework, primarily intended for insurers, informs assessments that generate three key value outputs: a cost-effectiveness analysis (CEA) output, a health-benefit price benchmark, and an assessment of long-term value for money. A majority of ICER's work is funded by the Laura and John Arnold Foundation.
The Innovation and Value Initiative (IVI) Open-Source Value Project (OSVP) offers “a transparent and open-source system for estimating the value of medical technologies in a way that centers on the patient, allows for a broad range of perspectives, incorporates the latest available evidence, and considers the full range of scientifically defensible approaches.” IVI does not promote a specific framework or a singular method of assessing value, but rather provides a testing ground for new methods and model design. The customizable nature of their models enables the user to adapt the framework design and inputs.
The National Comprehensive Cancer Network (NCCN) Evidence Blocks (EB) are “intended as a visual representation of five key measures that provide important information about specific recommendations contained within the NCCN Clinical Practice Guidelines in Oncology. … The goal is to provide the health care provider and the patient information to make informed choices when selecting systemic therapies based upon measures related to treatment, supporting data, and cost.” In 2017, NCCN began incorporating Categories of Preference (COP) within its Guidelines, which aim to “provide guidance on which recommendations within the NCCN Guidelines are optimal, while providing a range of recommendations to accommodate a variety of clinical circumstances.”
In addition, the newest U.S. framework, the Patient-Perspective Value Framework (PPVF), created by Avalere and FasterCures, offers a new way to “assess the value of health care services that considers factors that matter to patients — such as functional and cognitive status, symptom relief, complexity of regimen and medical as well as non-medical out-of-pocket costs to the patient and family — and weights them in accordance with assessed patient preferences. As of April 2021, the PPVF has not been used to conduct any public value assessments.
What are the challenges of current frameworks?
Now that value assessment frameworks are being used more often in health care decision-making, it is critically important that decision-makers consider the strengths and limitations associated with each framework. Currently, there are several areas of caution where there is room for improvement among the frameworks, including:
- Lack of patient-centeredness: Frameworks should incorporate the elements that matter most to patients. Patients’ clinical characteristics and preferences vary considerably, and therefore assessments of value should not be one-size-fits-all.
- Lack of transparency: To ensure the validity and credibility of value assessments, framework methodologies and models should be fully transparent and reproducible.
- Limited evidence base: All high-quality evidence, including real-world evidence, should be incorporated into assessments, and assessments should be updated regularly as new evidence becomes available.
- Untested methods: It is crucial that frameworks’ underlying methodologies are sound and validated, and their potential impact on patients is understood.
- Confusing output: Value assessment outputs can be confusing or misleading to end users. Misinterpretation of a value assessment’s output could result in a health care decision that is misinformed or erroneous at best, or harmful to the patient at worst.
- Lack of system-wide perspective: Moving to value-based health care requires a comprehensive focus on all health care components. Value assessments should be conducted for a broad range of treatments and health care services, rather than focusing primarily on drugs.