Navigate the transition to value-based care in life sciences has been saved
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Navigate the transition to value-based care in life sciences
A framework to help assess the value of MedTech products and offerings
The health care ecosystem is transitioning from a volume-based, fee-for-service model to a value-based care approach, emphasizing cost reduction and enhanced patient experiences. This shift puts diagnostic technologies under increased scrutiny from various stakeholders, including patients, care delivery decision-makers, and payers. Learn how a comprehensive framework, developed in collaboration with AdvaMedDx, can help life sciences organizations better assess the value of their diagnostics.
Understanding the shift to value-based care in MedTech
In the emerging landscape of value-based care technology, diagnostics face a unique challenge compared to other medical devices: The value of a diagnostic test or technology lies in enabling improved clinical decision-making and therapy selection, which is often distinct from the value of the underlying therapy or intervention itself. Additionally, recent years have witnessed growth in the availability and advancements of new digital diagnostic devices, e.g., incorporation of artificial or augmented intelligence (AI) and machine learning (ML) into diagnostic tests. This trend, along with a paradigm shift in industry toward environmental, social, and governance (ESG) considerations, requires stakeholders to assess the value of a diagnostic technology with these market changes in mind.
In this changing environment, it’s a business imperative for diagnostic manufacturers to understand, demonstrate, and clearly articulate how their offerings can not only lead to improved patient outcomes but also create value for a variety of key stakeholders. There are many ways that diagnostic technologies can impact the quality and cost of care. In our report, these are referred to as “value drivers.” Different stakeholders care about and prioritize different but overlapping sets of value drivers against which they judge the benefits of a diagnostic test.
Diagnostic device manufacturers must understand and speak effectively to each stakeholder’s unique set of value drivers. This may require new insights into how diagnostic testing can improve the effectiveness and efficiency of care delivery for providers or payers and how tests go beyond improving clinical outcomes for a patient population to deliver non-clinical patient benefits, such as the patient experience during testing and patient economic considerations.
AdvaMedDx launched a Strategic Value Initiative in 2017, in collaboration with Deloitte Consulting LLP, to develop principles and an approach for assessing the value of diagnostics that can be adopted by diagnostic device manufacturers, health systems, payers, and other stakeholders. The viewpoints of multiple stakeholders were incorporated into the process of developing the approach, with the overall goal of encouraging the adoption of the proposed principles and supporting practices into existing frameworks and assessment models as they evolve over time.
Since 2017, the diagnostics landscape has witnessed significant changes and advancements, especially with the advancements in digital diagnostic devices and a paradigm shift in industry toward ESG priorities. Due to these recent market changes, the diagnostics value framework has been refined and refreshed, incorporating important stakeholder viewpoints and feedback.
Embracing the eight core principles of MedTech valuation
Our recommended approach begins with a set of core principles that guide an effective process for comprehensively assessing the value of diagnostic tests. We believe that these principles warrant broad adoption by all stakeholders involved in value assessments—payers, providers, health technology assessment (HTA) bodies, patient advocates, laboratories, and diagnostic device manufacturers.
- The comprehensiveness principle: Value assessments should consider a broad array of patient-centric value drivers and their relevance and importance for different stakeholders.
- The evidentiary principle: Value assessments should utilize an appropriate range of available evidence, and the type of evidence and assessment methodology should be based on test type and the potential risks and benefits to patients.
- The cost principle: Value assessments should consider and report costs incurred and costs avoided over time frames appropriate for the test or technology (including, where available, costs incurred and avoided outside the health care system).
- The specificity principle: Value assessments should account for representative patient populations and applicable time frames for patient impact.
- The flexibility principle: Value assessments should be flexible to account for different types of tests or technologies and utilize an appropriate range of impact analyses.
- The engagement principle: Value assessment processes should involve the perspectives of multiple stakeholders and provide sufficient opportunities and time for all to engage in the process.
- The transparency principle: Value assessment processes and methodologies should be transparent to all stakeholders.
- The relevancy principle: Value assessments should be updated regularly to keep pace with innovation in standards of care or when there is significant new evidence.
Translating the guiding principles into effective decision-making
The path to an effective value assessment depends first on what the assessment includes in terms of the different ways a diagnostic test or technology can have an impact on (value drivers), and thereby benefit, the patient care pathway, as described in the Comprehensiveness Principle.
Five broad categories of 'value drivers'—clinical impact, nonclinical patient impact, care delivery revenue and cost impact, public or population impact, and environmental impact—can be incorporated in the value assessment process to capture the full spectrum of ways a diagnostic test may create value.
These assessment categories go beyond the traditional measure of clinical efficacy to capture additional patient-focused and ESG-focused considerations. They consider the impact on the effectiveness and efficiency of care delivered under new value-based performance metrics and reimbursement models.
It’s important to recognize that these five categories are relevant across the health care ecosystem and reflect the perspectives and priorities of many different stakeholders—payers, providers, new 'at-risk' providers who must think like payers, and government agencies; and, of course, patients, caregivers, and patient groups.
All stakeholders value clinical impact. They also consider the drivers of value identified in this framework but may prioritize them differently. As market dynamics and priorities shift under emerging value-based payment models, the prominence of patient-centric measures is growing. Providers are beginning to look at efficiency in new ways and across the care continuum. Stakeholders likely will continue to prioritize drivers in different ways, but there may be a greater push to emphasize these broader drivers of value—especially patient-centered measures—across stakeholder groups.
Download the complete report for a deeper dive into the value drivers.
Each stakeholder is ultimately looking to generate a robust assessment of the value that a specific diagnostic test is expected to deliver; this occurs after considering the offsetting costs of adoption and calculating the costs of potential risks. In the traditional fee-for-service model of care delivery, many factors in an assessment may have been less relevant. In this new environment, stakeholders must optimize decisions on use of resources while considering new performance goals for the effectiveness and efficiency of care for different patient populations.
An effective assessment process will result in a final analysis of the expected 'value proposition' that:
- Details the ways a diagnostic test will deliver an impact, together with scenarios to describe the magnitude of the impact and offsetting costs.
- Reflects the unique characteristics that should be considered based on the type of diagnostic test being assessed.
- Considers the range of relevant time frames associated with testing or impact of a test.
- Acknowledges relevant patient sub-populations that may experience significantly greater or lesser impacts than the general (intended use) population.
This expected value proposition should be explicitly tied to the available credible evidence that supports the calculation and valuation of the estimated impacts. The type of evidence that is appropriate and available will vary by value driver and by the specific purpose of the assessment.
As the US health care system shifts further toward value-based payment models, diagnostic test developers increasingly will need to adopt a systematic approach to diagnostics value assessment. While there are benefits to such an approach, the broad range of diagnostic test applications present unique challenges in demonstrating value in a systematic manner. The distinctions between different types of tests must be accounted for in value assessment to help ensure access to all types of diagnostic innovations.
The major types of diagnostic tests include screening, detection, prognostic, theranostic, monitoring, and recurrence.
To explore our list of considerations in demonstrating value by diagnostic test type, download the complete report.
AdvaMedDx's approach uses the five categories of value drivers to define the ways that a test can create value and includes sample questions and metrics to consider in building or assessing the value proposition of a specific diagnostic test.
Download our report to explore how these questions and metrics indicate how multiple factors can be combined to capture the unique value profile of a particular diagnostic test.
Clinical impact
The clinical impact assessment captures subcategories of unique value drivers: sources of value created by traditional value subcategories, as well as patient safety/tolerability/ compliance and patient response to diagnostic results.
Non-clinical patient impact
The assessment of non-clinical patient impact aligns two subcategories of value drivers: 1) sources of value stemming from patient experience and 2) patient economics. These can be specific to the patient population being treated as well as inclusive of value to family members or caregivers. Some of these patient-centric or patient-reported value drivers are tracked and measured using qualitative versus quantitative sources. While the metrics are not always easily or robustly quantifiable, they are measurable and important and should be accounted for in impact assessments.
Care delivery revenue and cost impact
Care delivery revenue and cost impact consider the economic effect on the health system of both the immediate episode of care and long-term disease progression. The care delivery driver recognizes that a new diagnostic test can impact both the ability of health care providers to earn incremental revenue but also incur costs. Two subcategories of this value driver include sources of value resulting from improving quality of care economics and care efficiency.
Public/population impact
This category considers the impact of a diagnostic test or technology’s introduction for large segments of the patient population on overall population health as well as health care systems’ costs to society on a macro level. The assessment focuses on two subcategories of value drivers: sources of value linked to population health and workforce productivity.
Environmental impact
This category considers the impact of ESG initiatives with a focus on environment, which are increasingly gaining momentum across various stakeholders. This value category assesses the value of a diagnostic device taking into consideration the monetary impact of a diagnostic test and the impact on an organization’s perception and differentiation due to environment-focused initiatives.
Diagnostic test developers recognize that payers and providers are intensifying their scrutiny of choices with respect to diagnostic tests and other technologies and are changing their expectations regarding the levels and types of evidence used to demonstrate value. The desires to keep the patient “first” and to better incorporate the patient perspective in value assessment methodologies are gaining broader stakeholder acceptance and changing the dialogue on appropriate types of evidence to consider.
For diagnostics, the patient perspective can be particularly challenging with respect to details about the test itself, access to testing, specimen collection, and the understanding of the test result because most patients do not order tests directly; nor do they interpret the test results themselves. However, patients will have important perspective on the choices available to them based on information provided by the diagnostic test. So, it’s increasingly important to include the patient in the dialogue.
For a deeper dive into the development of evidence guidelines, download the full report.
Improve health and economic outcomes for patients
The recommendations outlined in the report can be used to reach a common understanding of what enables effective assessment of the value of a diagnostic test or technology. These overarching principles and the approach for assessing value can be adopted by diagnostic companies and diagnostic test developers as well as by other stakeholders involved in value assessments, including health systems and providers, payers, HTA bodies, and patient advocates.
As health care’s volume-to-value shift accelerates, Deloitte can help medical technology companies navigate the increased scrutiny and changing decision-making dynamics that they face. Connect with our team to learn how we can help MedTech companies use the value assessment framework to clearly articulate and credibly demonstrate how their offerings can improve patient outcomes and create value for other stakeholders across the health care ecosystem.
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