1. Health Technology Assessment Program Senate Health Care Committee November 20, 2014 Josh Morse, MPH, Program Director, Health Technology Assessment Daniel Lessler, MD, Chief Medical Officer Charissa Fotinos, MD, Deputy Chief Medical Officer

2. Purpose Primary purpose: To ensure medical treatments and services paid for with state health care dollars are safe and proven to work. The program:  Is a resource for state agencies purchasing health care.  Develops scientific, evidence-based reports on medical devices, procedures, and tests.  Facilitates the independent clinical committee of health care practitioners to determine which medical devices, procedures, or tests meet safety, efficacy, and cost tests. 2

3. Program Background In 2006 HB 2575 created the HTA program in Chapter 70.14 (Public Health and Safety, Health care purchased by state agencies) Structured to use an evidence report and a clinician panel to make coverage decisions about whether agencies should pay for certain medical, devices, procedures and tests based on:  Safety  Efficacy/effectiveness, and  Cost-effectiveness HCA established the program and staffs the committee Multiple agencies participate to identify topics and implement policy decisions:  HCA (Uniform Medical Plan, Medicaid)  Dept of Labor and Industries  Dept of Corrections Implementation:  Agencies implement determinations of the HTA program within their existing statutory framework. 3

4. 4 Why Health Technology Assessment? The development and diffusion of medical technology are primary factors in explaining the persistent difference between health spending and overall economic growth. New medical technology may account for about one-half or more of real long-term spending growth. Kaiser Family Foundation, March 2007: How Changes in Medical Technology Affect Health Care Costs Since technological change is the biggest contributor, an effective long- term strategy for controlling health care spending will probably have to address the health care system’s way of incorporating new technologies into practice. U.S. Congressional Budget Office, Technological Change and the Growth in Health Care Spending, 2008. Report available at www.cbo.gov.www.cbo.gov Medical technology diffusing without evidence of improving quality. Highly correlated with misuses, overutilization, underutilization. Cathy Schoen, Karen Davis, Sabrina K.H. How, and Stephen C. Schoenbaum, “U.S. Health System Performance: A National Scorecard,” Health Affairs, Web Exclusive (September 20, 2006): w459

5. Regulatory Framework: Drugs vs Devices/Procedures DrugsMedical Devices Procedures Required for FDA Approval 2 prospective, placebo controlled RCTs “Substantial equivalence” to preexisting device No approval requirements Study OutcomesDisease-related endpoints Engineering performance only None Published Studies with Patient Outcomes CommonUncommonNot Considered Post-market Evaluation? Narrowly defined set of conditions (e.g., depression, dementia) Varies widely (e.g., implantable defibrillators, laparoscopes) Not Considered 5

6. WA HTA Process Topic Selection  State agencies identify technologies for review – Horizon scan for new technologies – Agency needs and experience with new or existing technologies inform selection  Prioritize technologies  HCA Director makes final selection  Interested parties may nominate topics 6

7. WA HTA Process Topic Selection Primary criteria are directly linked to the legislation : 1. Potential patient harm/safety concerns The safety criterion is directed at identifying the potential degree of harm that an individual may experience if the technology is used. 2. Concerns about therapeutic efficacy or diagnostic accuracy and appropriateness of outcomes for patients The efficacy criterion is directed at identifying whether there are issues related to the potential clinical impact that the technology, if used, can have for the individual with the condition indicated – including consideration of:  Range of potential benefits  Treatment alternatives  Realized benefits 3. Estimated total direct cost per year (estimated increase/decrease) The cost criterion is directed at identifying the potential budget impact (degree of change) that the technology coverage or non-coverage would have for the participating agencies. 7

8. 8 WA HTA Process Overview Agencies Implement Decision Implements within current process unless statutory conflict Clinical Committee makes Coverage Determination Review report, Public hearing Meets quarterly Vendor Produces Technology Assessment Report Key Questions and Work Plan, Draft, Comments, Finalize 2-8 Months HCA Director Selects Technology Nominate, Review, Public Input, Prioritize Semi-Annual

9. Key HTA Products Transparency: Publish topics, criteria, reports, open meetings Technology Assessment Report: Formal, systematic review of selected technologies Independent Coverage Decision: Committee of clinicians makes decisions that are based on the science, transparent, and consistent for state programs 9

10. 10 Technology Reports: Analyses completed  47 comprehensive technology assessment reports  6 in process Coverage Decisions  47 health technologies reviewed for coverage determinations  Estimated >$48 million cost avoided (annual) Transparent Processes  Topics, Key Questions, Draft Reports, Final Reports, Criteria Posted  More than 100 days of public comment period per technology  Committee reviews in public meetings – all deliberations open Process Measures Decision Results Covered (no conditions)2% (1) Covered with Conditions63% (41) Not Covered35% (23)

11. Recent HTA Process Updates Extended draft review/comment period for technology reports from 14 to 30 days (2012) Expanded background information with selection of new topics (2014) Adding meeting for new topic information and context (2014) Revised order of presentations to HTCC in public meetings (2014) 11

12. Measurement: Dollars and Quality Challenging to accurately assess impact: – Units and cost are most accessible – Quality and safety more difficult to quantify Current method is to estimate cost avoidance Working to conduct formal evaluation of program impact

13. HTA Estimated Cost Avoidance Projection of how future expenditures will change based on: – Health Technology Clinical Committee decision – Agencies’ utilization Published within the evidence report for agencies: PEB/UMP Medicaid L&I Estimated using – actual agency costs (does not include reduction in harms to patients or other speculative changes) – published rates and costs when agency experience is absent (e.g. Pediatric Bariatric surgery based on adult costs, childhood obesity rates)

14. Cost Avoidance Conservative Estimates Estimate based on actual costs and trends with conservative assumptions – No growth or conservative growth figures based population adjusted averages (e.g. Spinal Injections) – Moderate estimates of effect - 50% of best estimate (e.g. Upper Endoscopy for GERD) 5% growth used in estimate L&I 6% Growth UMP/PEB 12% Growth Medicaid 16% Growth Spinal Injections Estimate: Growth

15. HTA Program Summary 2007-2014 TechnologiesCoverage DecisionsCosts Avoided YearTopicsDecisionsYesNo Estimate (single year) 20073422($8.8M) 20086734($17.5M) 20096642($1.9M) 20107963($3.5M) 201161165($5.4M) 201271073($2.6M) 2013811101($7.7M) 20145541($1.1M) Total48634221(48.3M)

16. Questions? 16 Daniel Lessler, MD, Chief Medical Officer Daniel.lessler@hca.wa.gov Charissa Fotinos, MD, Deputy Chief Medical Officer Charissa.fotinos@hca.wa.gov Josh Morse, MPH, Program Director, Health Tech Assessment Josh.Morse@hca.wa.gov Phone: 360-725-1893