Value assessment is a young and emerging field in the United States, and several organizations have developed value assessment frameworks as a way to measure the value of health care treatments. Given the potential for these frameworks to be used as tools to determine whether therapies will be covered and reimbursed and made more broadly available to patients, as well as which therapies are chosen by patients and their doctors, it’s important for developers to “get it right.”
Seeking feedback from the public is an important way to pause and reflect on what’s working well, what isn’t, and how can we improve on those value assessment processes. This week, the Institute for Clinical and Economic Review (ICER) has announced that it is planning to revise its value assessment framework process, which it has pledged to do every two years. It’s a good opportunity for anyone with an interest in improving value assessment to weigh in.
In a perfect world, every framework developer would follow guiding practices to ensure they are using sound methodology and evidence, meaningfully incorporating patient input, and considering a broad array of benefits and costs over a longer timeframe. These basic principles are outlined in the National Pharmaceutical Council’s Guiding Practices for Patient-centered Value Assessment and highlighted below:
- Assessment process: Stakeholder input and feedback — especially from patients — should be meaningfully incorporated throughout the assessment process, from the selection of topics to be examined through the entire review cycle. Today, frameworks still vary widely in the extent to which they embed patients in the process. Patients are ultimately the ones affected by the value-based decisions of other stakeholders, so it is critically important to engage with patients and consider their perspectives throughout the framework development and assessment processes.
- Methodology: Assessments should focus on all aspects of the health care system. The majority of the focus is still on medicines and biologics, leaving stakeholders without value assessments for devices, diagnostics, surgical procedures and other interventions. Frameworks also should use established methods and transparent models and assumptions, and include guidance to help users understand key drivers behind the results. Sensitivity analyses should be performed to consider alternate scenarios and generate a range of results. Users should be able to adjust assessment assumptions and parameters to accommodate individual preferences and to represent different scenarios.
- Benefits: Assessments should include a broad array of factors that are important to patients and society, such as quality of life, the ability to work and reducing the burden on caregivers. Assessments also should consider individual treatment effects and view the value of a treatment over a long-term horizon.
- Costs: All health care costs and offsets over time should be considered, and these costs should be accurate and most relevant to the user of the framework. If cost thresholds are used, then they should be developed in a transparent manner, may vary by population and disease and should undergo a multi-stakeholder evaluation process.
- Evidence: All of the sound, high-quality evidence that is currently available should be utilized for the assessment, including real world evidence. It should be gathered and synthesized in a transparent and robust manner, using accepted methods. In addition, assessments should be regularly updated to keep pace with evolving evidence and continued medical innovation.
- Dissemination and Utilization: Assessments should be clearly labeled for their intended use, easy for users to interpret, and disseminated only after they are finalized. If a framework’s results are misinterpreted, it could inappropriately impact patients’ access to valuable treatments.