Understanding Alternative Methods and Metrics for Value Assessment
It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so.
Use PIPC’s resources to learn more about alternative methods and metrics for value assessment.
Use PIPC’s resources to learn more about alternative methods and metrics for value assessment.
Advancing Patient-Centered Approaches to Value Assessment
Health care value is being defined through new payment incentives and value standards proposed and implemented by health care payers, policy-makers and providers - which can have a significant impact in how patients are treated. PIPC supports assessing value to the patient using tools that are consistent with the goals of shared decision-making and personalized medicine. By implementing the reforms described below, policy-makers can ensure that value assessment frameworks support value that matters to patients.
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- Develop a transparent process through which frameworks are developed, implemented and validated. Value frameworks and assessments should be transparent and available to patients to fully understand the assumptions that serve as their foundation. Value framework developers should also be transparent about the feedback they receive from patients and other stakeholders, noting where the framework incorporates the feedback received or their rationale for doing or not doing so.
- Meaningfully engage with patient and provider organizations. Value framework developers should engage with organizations representing the impacted patient communities and clinical experts in the specific treatment area under consideration in advance of scoping their projects to ensure that both frameworks and assessments are achieving consensus on the assumptions, definitions and underlying questions. Engagement should continue throughout the process of developing and updating value frameworks.
- Rely on a range of sound, patient-centered sources of evidence. Value assessment frameworks should rely on high-quality, rigorously developed methods of evidence that fully capture value that matters to patients. Value frameworks should also be completely transparent about the evidence on which the assessments are based, as well as the limitations of the evidence. By better articulating the limitations of the data that informs value frameworks, it will be clear where evidence gaps exist to inform future research efforts. For example, PCORI was called upon by Congress to articulate the limits of its research and could provide a useful model for consideration.
- Reflect patient-centered outcomes. Quantifying value in a way that is useful and meaningful to patients and people with disabilities requires a basic understanding of their values and preferences. Doing so will benefit both patient and payer as they identify and integrate the appropriate patient-centered criteria in assessing the value of treatments for a particular condition.
- Address costs holistically, including costs that matter to patients. Value frameworks and assessments should have a holistic perspective on the economic component of value, and include long-term, personal and societal costs, such as risk of disability and the potential need for caregiving. Broader costs should be considered rather than focusing only on short-term costs so that value assessments are relevant to decision-making by patients, people with disabilities and their providers.
- Support shared decision-making. Focus efforts on advancing shared decision-making between patients and physicians. Well-informed decisions by patients and consumers are foundational to advancing value in ways that are patient-centered.
- Acknowledge diversity and differences among patients, and avoid the “one-size-fits-all” mentality of value. Value frameworks should ensure that their models and methods account for important differences in patient preferences, characteristics and treatment goals.
- Preserve protections in the Affordable Care Act against use of comparative or cost effectiveness research to make centralized value judgements. Value frameworks have the potential to support informed treatment decision-making between patients and their physicians. However, if used in appropriately to make centralized value judgements, value assessments could also limit patient access to necessary medical treatments.
Disability Advocates Respond to Proposed Rule on Health Care NondiscriminationRecently, the Department of Health and Human Services (HHS) proposed to strengthen prohibitions against discrimination on the basis of disability in health care. Disability advocates banded together to comment on the proposed rulemaking and to call upon HHS to take additional action in banning discriminatory metrics. Read what the experts are saying about this vitally important effort.
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The German Health Care System and its Impact on Patient Access – Lessons for the U.SSince its inception over a decade ago, PIPC has focused on infusing patient-centricity in our health care system. We have been highly focused on patient-centered solutions for evidence-based decision-making, including advocating for the development of high-quality patient reported outcomes data and development of high quality patient-centered comparative clinical effective research, as well as opposing reliance on one-size fits all cost-effectiveness thresholds. Our goal is for high-quality patient-centered data to equip and empower patients and people with disabilities to make decisions, with their providers, about the care and treatment best to address their individual needs. Click here to read the white paper.
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Aligning Health Technology Assessment with Efforts to Advance Health EquityThe Partnership to Improve Patient Care (PIPC), Global Liver Institute, National Minority Quality Forum, and the Preparedness & Treatment Equity Coalition published a report (executive summary) to assist organizations, health systems, payers, and policymakers that want to center their value assessment work on health equity.
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Value for Whom? Incorporating Patient Perspectives into Value Assessment for Novel Cell and Gene TherapiesCell and gene therapies (C>s) are revolutionary advancements that offer potentially life-altering therapies – and in some cases even cures – for patients with rare and severe diseases. Around the globe, various health technology assessment (HTA) and value assessment organizations are attempting to estimate the health and economic value of new C>s to better inform healthcare decision making. These organizations most commonly employ cost-effectiveness analysis (CEA), which seeks to determine whether the costs of a given therapy are justified by its benefits; that is, whether it is a “good buy.” Click here to read the white paper.
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Oregon Advocates Comment Opposes Options to Use QALYs by HERCOn November 1, 2022, letters (option 1; option 2) with 36 signatures were provided to the Oregon Health Evidence Review Commission (HERC) related to its proposed guide for use of quality-adjusted life years (QALYs) in HERC’s meeting materials, processes and decisions, particularly related to the prioritized list of services for coverage under Medicaid.
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AJMC: Is the QALY Fit for Purpose?“Our aim in this paper is to assess whether the QALY is an adequate proxy measure of health value for the purposes of health care priority setting or whether the limitations inherent in how it is calculated and used in cost-utility analysis have the potential to be harmful. To do this we pose 3 questions. First, does the QALY accurately measure what it purports to measure? Second, does it value the health of all people equally and avoid the ethical and economic harms that arise when this is not the case? Third, does the QALY manage to fairly balance the needs of individuals and society as a whole? We argue that the QALY does not currently pass these 3 tests to an acceptable standard.” Click here to read the AJMC article.
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White Paper: A Roadmap to Increased Patient Engagement in Value AssessmentsHealth care stakeholders – ranging from patients, providers, and innovators – understand that patients must have a seat at the table in defining value through the development of value frameworks and tools in order for the transition to a value-based health system to achieve outcomes that matter to patients. In this White Paper, PIPC builds on existing calls for patient engagement by providing a guide to developers seeking to create value frameworks and tools that can become the foundation of a truly patient-centered health system.
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PIPC Submits Letter to HHS on Oregon Medicaid WaiverPIPC Chairman Tony Coelho recently sent a letter to the Department of Health and Human Services (HHS) expressing concerns with a proposed extension of Oregon's Medicaid Health Plan Extension. Currently, Oregon has a unique waiver from “EPSDT” – a foundational principle of Medicaid that makes health care for children a national priority, and specifically requires coverage of “all medically necessary diagnostic and treatment services." The system underlying the Oregon Health Plan is a prioritized list of services, that uses quality-adjusted life-years (QALYs) to help rank treatments in order of importance. High ranked treatments are funded; low ranked treatments are automatically denied regardless of medical necessity.
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PIPC Letter to ICER on Value Assessment ProcessPIPC and over 40 organizations representing patients, people with disabilities and providers submitted a letter to the Institute for Clinical and Economic Review (ICER) in response to their request for input on their value assessment process. In the letter, the organizations stated, “Simply put, if we aren’t paying for care that patients’ value, we aren’t really paying for value-based care.” Following the release, PIPC Chairman Tony Coelho stated, “It is my hope that ICER will give sincere and careful consideration to the input of all organizations representing patients and people with disabilities, many of which have direct experiences with ICER’s process and whose input would be very constructive. It is my hope that our concerns will not be dismissed as myths, but instead be given the consideration they deserve.”
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PIPC Roundtable: Assessing Value to the PatientPIPC convened a roundtable on May 6, 2016, to discuss the challenges of value frameworks in determining patient access. PIPC has continuously advocated that value should first and foremost be considered through the lens of patients and people with disabilities who are the ultimate beneficiaries of health care. Participants agreed to advocate for value framework developers to use the National Health Council’s Patient-Centered Value Model Rubric, and to work to advance alternatives to existing value frameworks. By engaging patients and people with disabilities, assessments of treatment value would support the effectiveness of shared decision-making and personalized medicine, instead of driving one-size-fits-all coverage decisions.
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National Health Council’s (NHC) Patient-Centered Value ModelPrivate payers are already relying on one-size-fits-all assessments of value, often making it difficult for patients to access the care they want and need. Therefore, PIPC and its partners support the use of the National Health Council’s (NHC) Patient-Centered Value Model Rubric by developers of value assessments to mitigate the existing shortcomings of value assessments and tools. The NHC’s rubric already provides a guide to evaluate the patient-centeredness of value models and to guide value model developers on the meaningful incorporation of patient engagement throughout their processes.
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'Patient Voices' on Value FrameworksIn response to CMS’ recently proposed Medicare Part B drug demonstration, dozens of individual patients and patient advocacy groups have mobilized to voice their concerns with the model’s use of "comparative effectiveness" research and "cost-effectiveness" data to make coverage decisions. Indeed, patients have expressed a wide range of concerns – from the reliance on assessments such as those generated by the Institute for Clinical and Economic Review (ICER), to the lack of patient engagement in the development of the new reimbursement model.
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