A Framework for Comprehensive Assessment of the Value of Diagnostic Tests

Transcription

1 A Framework for Comprehensive Assessment of the Value of Diagnostic Tests Chandra N. Branham, JD VP, Payment & Health Care Delivery Policy AdvaMed/AdvaMedDx October 18, 2017

2 Overview AdvaMed s Framework for Comprehensive Assessment of Diagnostic Technologies Bringing it to life: a successful use case Available resources and moving forward 2

3 AdvaMed Value Initiative 3

4 AdvaMedDx Value Initiative Taskforce Diagnostics Value Framework Taskforce Abbott Agendia Alere Becton Dickinson BioMerieux, Inc. Cardinal Health Cepheid Danaher Exact Sciences Hologic Illumina Janssen Philips QIAGEN Quidel Roche Siemens 4

5 AdvaMed s Value Principles The Comprehensiveness Principle The Evidentiary Principle The Cost Principle The Specificity Principle The Flexibility Principle The Engagement Principle The Transparency Principle The Relevancy Principle Value assessments should consider a broad array of patient centric value drivers and their relevance and importance for different stakeholders. 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 risk to patients Value assessments should consider and report costs incurred and costs avoided over timeframes appropriate for the test or the technology (including, where available, costs incurred and avoided outside the health care system) Value assessments should account for representative patient populations and applicable timeframes for patient impact. Value assessments should be flexible to account for different types of tests or technologies and utilize an appropriate range of impact analyses. Value assessment processes should involve the perspectives of multiple stakeholders and provide sufficient opportunities and time for all to engage in the process. Value assessment processes and methodologies should be transparent to all stakeholders. Value assessments should be updated regularly to keep pace with innovation in standards of care or when there is significant new evidence. 5

6 Multiple Stakeholders Assessing Value Payers Providers Clinical Laboratories Government Patient Professional Medical Associations Employers Quality Organizations Patient Advocates 6

7 Comprehensive Approach to Value Clinical Impact Non- Clinical Patient Impact Care Delivery Revenue and Cost Impact Public/ Population Impact Analytical and Clinical Validity Patient Experience Quality of Care Economics Population Health Clinical Utility Patient Economics Care Efficiency Workforce Productivity Safety and Tolerability Patient Response to Diagnostic Results 7

8 Our Reports Go Into More Detail 8

9 Factors Affecting Value Analysis Patient Populations Relevant patient sub-populations with higher or lower impact Test Type Type of diagnostic test Time Frames Timeframes relevant to impact 9

10 Comprehensive Approach for Assessing Diagnostic Test Value Patient Needs New Dx Test/ Technology Stakeholders Stakeholders Patient Physician Hospital Clinical Labs Payer Government Employer Clinical Impact Value Drivers Non- Clinical Patient Impact Test Type Care Delivery Revenue and Cost Impact Value Drivers Public/ Population Impact Patient Populations Evidentiary Support Time Frames Expected Impacts (Value) Source: A Framework for Comprehensive Assessment of the Value of Diagnostic Tests, available at and co-developed with Deloitte Consulting LLP. 10

11 Broad Range of Evidentiary Support 11

12 Value Framework Use Cases 12

13 Exact Sciences Cologuard Value Drivers llllllllllllllllllllllllllllllllllllll Approved for Public Release 13

14 Creating and Articulating Value Solve a big problem in a big market Identify the full practice ecology in which the product will be placed to identify all the opportunities to identify value Invest in the evidence to support the clinical value - Address the individual needs of all stakeholders up front Patients, Providers, Payors (Commercial and CMS) Employers Regulators (FDA, CLIA) Quality Metrics (NCQA, Other) Guidelines - Continue to refresh the evidence and expand indications 14

15 NEJM Publication April 2014 Imperiale TF et al. N Engl J Med. 2014;370(14):

16 Getting Results With the Framework In Your Organization Educate & align Shared understanding and approach to consistently articulate and evaluate all elements of value for each stakeholder Diagnose & assess Tool to support portfolio and product-specific decisions on go-to-market priorities, improving value propositions, and messaging to stakeholders (eg VACs) Plan for adoption Shape and prioritize investment choices on regulatory, clinical and HEOR strategies for reimbursement and market adoption throughout lifecycle Innovate Basis for informing and assessing new product development investments given expected value impact 16

17 AdvaMed Value Initiative Webpage 17

18 AdvaMed Value Initiative Resources 18

19 AdvaMed Value Initiative Next Steps Outreach to AdvaMed members Outreach to payer/employer groups; hospitals; patient groups; lab groups AdvaMed Events & Education Working With Private Payers Dec., th Annual Payment Policy Conference Apr.,

20 Thank you! Questions? Chandra N. Branham, JD Vice President, Payment & Health Care Delivery Policy AdvaMed/AdvaMedDx 701 Pennsylvania Ave., NW, #800 Washington, DC