Medical Technology and Medical Policy Formation Medical Device Regulatory, Reimbursement and Compliance Congress March 27, 2008 Alan Rosenberg, M.D. Vice President, Medical Policy, Technology Assessment and Credentialing Programs

Medical Technology and Medical Policy Formation How does WellPoint evaluate reported information in the determination of medical policy? What are current key issues regarding measurement and metrics in the determination of Medical Policy? 9/16/2018

Some Background Regarding WellPoint WellPoint plans provide health benefit coverage for almost 35 million Americans The primary data that we collect and which is intrinsic to our core business is claim data In 2007 WellPoint paid 379 million claims 379 million claims = $46B The significant majority of these claims are for our Medical and Pharmacy benefits The claim data does help identify variation

Magnetic Resonance Imaging (MRI) Variation in Use Average Manchester, NH New Haven, CT Terre Haute, IN Indianapolis, IN Louisville, KY Cincinnati, OH Cleveland, OH 9/16/2018 Note: Data represents 2003 Incurred dates for Fully Insured, Group Business only

Average # FESS/Patient by Provider Group 9/16/2018

HealthCore: Outcomes Research and Advancing Medical Knowledge Reporting Source Data Capture Study Design Analysis Drug Evaluation Intellectual Capital Lab “Real World” Research Drives Quality, Cost Effective Care Partnerships with health plans provide access to networks and data Integrates data sources for outcomes research and analysis Strong collaborative research relationships (Harvard, Sloan Kettering, USC) 9/16/2018

Process for Medical Policy Formation How does WellPoint evaluate reported information in the determination of medical policy? 9/16/2018

WellPoint Medical Policy Review Process Annual Policy Review Changing Practice Patterns FDA Decisions New TEC Findings - External Engagement - Decision Making Specialty Societies Academic Medical Centers Practicing Experts Internal Review Trigger New or Revised Policy Health Plan Research & Evaluation of Evidence Policy Formation Request by Network Providers Request by Specialty Societies Request by Practicing Experts Request by Vendors Review by HEM/ONC Sub- Committee* Review by MPTAC* Review by Behavioral Health Sub- Committee* Monitor Policy Outcomes Posting Policy Positions on the Internet MPTAC Adoption of Policy Position *The Hematology/Oncology Committee¹ (HEM/ONC), Medical Policy & Technology Assessment Committee² (MPTAC) and Behavioral Health Committee³ include external physician representation

WellPoint Medical Policy and Technology Assessment Committee (MPTAC) Multi-disciplinary group including: External physicians representing diverse medical specialties, clinical practice environments and geographic locations  Internal WellPoint medical directors Serves as primary medical policy decision-making body Two subcommittees: Hematology/Oncology and Behavioral Health Meets quarterly Immunization policies recommended by ACIP/CDC are adopted by WellPoint as medically necessary services

WellPoint Medical Policy and Technology Assessment Committee (MPTAC) When making decisions regarding the medical necessity of a technology and/or procedure, MPTAC considers: "Medically Necessary" are procedures, treatments, supplies, devices, equipment, facilities or drugs (all services) that a medical practitioner, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are: in accordance with generally accepted standards of medical practice; and clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient's illness, injury or disease; and not primarily for the convenience of the patient, physician or other health care provider; and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient's illness, injury or disease. For these purposes, "generally accepted standards of medical practice" means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, national physician specialty society recommendations and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. 

Process for Medical Policy Formation Some key issues regarding use of measurement and metrics in the determination of Medical Policy Good evidence, not lack of evidence Excellent research based evidence, and expert opinion, what are their roles? Measures, how valid are the ones chosen? What is the significance of the outcomes measure? 9/16/2018

Problem of Lack of Evidence Agency for HealthCare Research and Quality (AHRQ) Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer Executive Summary published 5 Feb 2008 “Prostate cancer is the most common nondermatologic cancer in men. In 2007 an estimated 218,890 men were diagnosed with, and 27,050 deaths were attributed to, prostate cancer in the United States.” “Limitations in the existing evidence include the following: Few randomized trials directly compared the relative effectiveness between (rather than within) major treatment categories. Many randomized trials are inadequately powered to provide long-term survival outcomes, with the majority reporting biochemical progression or recurrence as the main outcomes. Some randomized trials were old, conducted prior to prostate cancer detection with PSA testing (i.e., studies before the current era, when tumors are diagnosed in an earlier stage, giving more lead time, and there is a higher percentage of benign tumors, resulting in length bias and over diagnosis), and used technical aspects of treatment that may not reflect current practice; therefore, their results may not be generalizable to modern practice settings. Wide variation existed in reporting and definitions of outcomes. There was little reporting of outcomes according to major patient and tumor characteristics. Emerging technologies have not been evaluated in randomized trials.”

Research based evidence and expert opinion Cardiac CT Imaging: Technology Assessment Program Agency for Healthcare Research and Quality Non-Invasive Imaging for Coronary Artery Disease Duke Evidence-based Practice Center October 3, 2006 OR   ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging: Appropriateness Criteria Type: Appropriateness Criteria Reference: J Am Coll Cardiol 2006

Primary Measures-What is being measured? New England Journal of Medicine 357:2666-2676 December 27, 2007 Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer Kathy Miller, M.D., Molin Wang, Ph.D., Julie Gralow, M.D., Maura Dickler, M.D., Melody Cobleigh, M.D., Edith A. Perez, M.D., Tamara Shenkier, M.D., David Cella, Ph.D., and Nancy E. Davidson, M.D. Results: Paclitaxel plus bevacizumab significantly prolonged progression-free survival as compared with paclitaxel alone (median, 11.8 vs. 5.9 months). The overall survival rate, however, was similar in the two groups (median, 26.7 vs. 25.2 months). Grade 3 or 4 hypertension (14.8% vs. 0.0%, P<0.001), proteinuria (3.6% vs. 0.0%, P<0.001), headache (2.2% vs. 0.0%, P=0.008), and cerebrovascular ischemia (1.9% vs. 0.0%, P=0.02) were more frequent in patients receiving paclitaxel plus bevacizumab. Infection was more common in patients receiving paclitaxel plus bevacizumab (9.3% vs. 2.9%, P<0.001), but febrile neutropenia was uncommon (<1% overall).

Primary Measures-What is being measured? Genzyme Study of Myozyme® for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints Date: December 13, 2007 Genzyme Corp. (Nasdaq: GENZ) announced today that its Late Onset Treatment Study (LOTS) of Myozyme® (alglucosidase alfa) met its co-primary efficacy endpoints. The study was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients with Pompe disease. Myozyme was first approved in 2006, and the product is now registered in 36 countries. The randomized, double-blind, placebo-controlled study enrolled 90 patients at eight primary sites in the United States and Europe. Participants received either Myozyme or a placebo every other week for 18 months. The average age of study participants was 44 years. The primary efficacy endpoints of the study sought to determine the effect of Myozyme on functional endurance as measured by the six-minute walk test and to determine the effect of Myozyme on pulmonary function as measured by percent predicted forced vital capacity. The results showed that, at 18 months, patients treated with Myozyme increased their distance walked in six minutes by an average of approximately 30 meters as compared with the placebo group (P=0.0283; Wilcoxon test). The placebo group did not show any improvement from baseline. The average baseline distance walked in six minutes in both groups was approximately 325 meters.

Primary Measures-What is being measured? Compound measures that mix clinically significant measures with other measures and create a statistically significant result that is not achieved based on the clinically significant measure alone

Comparative Effectiveness Research Challenges Related to Comparative Effectiveness Research Setting Priorities Conducting Research Utilizing Findings Establishing the most appropriate priority- setting process Weighing costs vs. benefits of conducting CE research Addressing political opposition to research agenda Differences in methodology may produce different results  must develop consensus on methodological approach How to maintain process transparency and stakeholder participation while maintaining objectivity Need for randomized clinical trials (RCTs) Findings may not apply to subsets of the population When evaluating medical procedures, how to take into account physician training/skill, impact of procedure volume, ease of use, etc. How to effectively communicate/use findings Timeliness 9/16/2018

"Make everything as simple as possible, but not simpler.“ 2 Quotes "Make everything as simple as possible, but not simpler.“ Albert Einstein “I would not give a fig for the simplicity this side of complexity, but I would give my life for the simplicity on the other side of complexity.” Oliver Wendell Holmes