Patient Reported Outcome Data: Why PROs Will Be The Next Wave in Big Data. Neil B. Minkoff, M.D. Chief Medical Officer EmpiraMed

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1 Patient Reported Outcome Data: Why PROs Will Be The Next Wave in Big Data Neil B. Minkoff, M.D. Chief Medical Officer EmpiraMed

2 PRO Overview Presentation Proprietary & Confidential

3 PRO Use and Barriers Value Proposition Reimbursement Tier Management, Pricing Support Pharmacovigilance Brand Defense, Adverse Events, Safety Clinical Support New Guidelines, Segmentation, Adoption via CER Healthcare Provider P4P ACO PRO Quality Measure Tracking Obstacles Claims DBs/EMRs Don t Capture PRO Data RCTs Not Real World: Multiple Treatments, Comorbidities, Subgroups Neglected PRO Data Limited by Response Burden, Lack of Incentives, Self-Reporting Inaccuracy, & Data Obsolescence Advantage Lower Cost Observational Studies Leverages Healthcare Provider Partners Real Time Disease Registry Up-to-Date, Cross-Sectional, Longitudinal Incentives for Patient Adoption Real World Feedback, Social Networking, Rewards Low Response Burden Modern UI, Adaptive Algorithms, Event- Driven Diary, Web/Mobile/SMS Data Bias Reducers Validated Instruments, HCP Patient Recruitment, World Class PIs, EPI Partnerships, EMR Authentication, Transparent Respondent Scores 3

4 Current Data Sources APCD All Payer Claim Database Most under construction; lack public payers De-identified PHI; link to provider Annual updates, LONG claims lag; often nonspecific No clinical data & PBM data from carve-outs Best for population analysis (e.g. state cohort profiling) Examples: MA*, VT, NY (apcdcouncil.org) 4

5 Current Data Sources Aggregated Commercial Database Larger cross-state cohorts; less claims lag than APCDs Commercial data; open for contracting De-identified non-clinical data Examples: BCBS Assoc, Optum, HMO Research Group 5

6 Current Data Sources Health Plan PHI included; can track specific patients PBM data integrated; data limited to plan membership Wide variation in availability: Humana vs HPHC No clinical data except staff model plans (e.g. Intermountain or Henry Ford Health Care) 6

7 Current Data Sources EMR / Healthcare Provider PHI, clinical, and demographic data included Includes prescribed meds but no way to know if filled Access & formatting variable (lab vs imaging vs notes) No data from other providers of studied patients 7

8 Current Data Sources Self Insured Employer Claims download database for large, self-funded employers Health utilization and possibly work impact data included Usually outsourced (Mercer, Solucia*, etc.) Limited by employee privacy & profile of workforce 8

9 Current Data Sources CMS De-identifed Very broad Rx data not integrated DM Vendor Very narrow focus, but patient level data Registries Disease specific, narrow in scope Usually de-identified 9

10 Ideal Approach Claims data with PHI for full patient experience EMR clinical data on each patient: labs, office visits, other tests, etc. PRO data: patient experience, symptoms, subclinical issues, adherence Validate by finding best available data sources and compare results to literature 10

11 Specialty Pharmacy is In a Unique Position SPP is the only player in the continuum of care to have contact with all of the others In a perfect position to integrate claims, clinical and PRO data Connects directly with: PBM Plan Patient/caregiver Manufacturer Prescriber 11

12 Where to Get Data Specialty claims data can connect with the PBM for full medication list, refills, etc Clinical data such as viral load or diagnosis can be collected as part of the PA process Staff talks to patients, but difficulties there make us look for a new way to engage patients for PRO data 12

13 Three Part Framework Flexible Survey Tool & Event-Driven Diary Extensible Drug Dictionary & Symptom Database Measures Symptoms, Medication Adherence, ADL, Impact Manages Adverse Events, Lab Results, Alerts, & Notifications Program-Free Customization; Multi-Study Registries Validated Instruments: Import 3 rd Party Tools or Test Your Own 13

14 Patient Incentive System Help Researchers & Share Problems Comprehensive Rewards Program Incents Data Reporting Not Behavior Change Rewards Auto Fulfillment System Variety of Gift Cards including Online ecards & In-Store vcards Patient Feedback Loop Visualize What Works in the Real World Active Care Management 14

15 Data Verification Model Reports 15

16 Adherence Management System Once Patient is Engaged Regularly, You Can Ask Whatever You Want. Adherence Measurement Surveys Validated Instruments Web & Mobile Event-Driven Diary Data Verification Adherence Modification Web & Mobile Event-Driven Diary Triggered Medical Education 16

17 Adherence Surveys Periodic Surveys Notification Window Dynamic Workflow Reminders Rewards Challenges Validated Instruments Morisky Medication Adherence Scale Registry Instrument Comparison Testing 17

18 Adherence Tools Event-Driven Diary Real Time Improved Recall Rewards Challenges Web-Only or Mobile Data Verification EMR Integration SPP Refill Data Triggered Dynamic Medical Education Content 18

19 Platform Ecosystem HHD Secure Cloud HHD Servers PRO Portal and Database Desktop Browser Mobile Apps HOME HEALTHCARE DEVICES Patient & User EMR Integration IT Standards & Protocols EPIC McKesson Siemens Healthcare Allscripts Cerner 3M/Softmed Fusion Dictate Dictaphone (Nuance) Lanier QuadraMed CPSI Meditech HIPPA MLLP TCP/IP HTTP XML/JSON/SOAP MySQL Databases S/FTP SMTP JMS Web Services Java & JavaScript Web + Mobile

20 EMR Integration Approaches HCP Firewall Pull EMR Records Record Matching P R O s EMR Queries Server Parameterized Queries Aggregate EMR Subgroup Results PRO Portal and Database Record Matching Push PRO Records Holistic Reports PRO + EMR 20 No Personally Identifiable Health Information Transmitted Epidemiologists, Rx Firms Researchers, Healthcare Providers Payers & Other Stakeholders

21 Diabetes Registry What are the realworld hypoglycemia rates of diabetes patients? How do at-home hypoglycemia rates differ from those in RCTs and EMRs? What is the clinical significance of hypoglycemia and does it affect adherence? Platform for study to compare realworld drug effectiveness and side effects Severe Hypoglycemia is Well Documented Study Measures Undocumented Mild-to-Moderate Hypoglycemia 21

22 Inflammatory Bowel Disease Remission Study Characterize adult IBD patients in remission using PROs to evaluate treatment effectiveness Proposed Study Evaluate methods and establish baselines Collect real-time PROs including quality of life and functional status measures for 1000 adult IBD patients in remission for 6 months; identify factors affecting remission quality of life including adherence, diet, exercise, stress, and depression; measure real world flare rates including those not requiring medical assistance Profile normal condition of patients in clinical remission and compare real world flare rates with what s reported in the clinical literature and EMRs Potential Study Use baselines established to measure comparative treatment effectiveness Compare multiple classes of therapy using PROs and HCP EMR to assess most effective treatments for IBD patients in remission 22

23 Multiple Sclerosis PRO Registry Assess impact of therapy on patient quality of life Registry Build robust database of MS patients Utilize a dozen validated instruments to capture PROs of new starts on therapy patients to assess patient burden, quality of life, and activities of daily living patients over 2 years. Patients recruited through Specialty Pharmacy channel. Interventional Study Randomized Registry Trial Utilize platform to launch randomized clinical studies to research specific interventions. 23

24 24 QUESTIONS?

25 Please Check Your for the Evaluation Survey. Thank You for the Feedback! 25

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