Bringing Together Clinical, Economic and Patient Reported Outcomes Data Future Of Real World Evidence. March IIeX Health, Philadelphia, PA

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1 Bringing Together Clinical, Economic and Patient Reported Outcomes Data Future Of Real World Evidence March IIeX Health, Philadelphia, PA

2 Overview Current Landscape Data Sources to generate Real World Evidence Rising needs in Oncology Summary 2018 Ipsos 2

3 Current landscape FDA Sentinel Initiative launched in 2008 for safety surveillance post-approval As of September 2017, the Sentinel System has more than 223 million members within a network of 17 data partners and many more collaborating institutions. The data is largely claims and pharmacy data Acceptance of RWE data for drug approvals Particularly in rare diseases and oncology: single arm trials, historic clinical data as control or reference group to provide information that can define the untreated course of disease. Utilize data in drug development programs for more timely access to innovative, safe and effective medicines to the patients FDA has also used RWE to understand treatment patterns, define target populations and monitor post-approval safety Ipsos 3

4 Drug development cycle Discovery / Preclinical Phase I Phase II Phase III Post Launch / Phase IV Product Value Strategy Competitive Analysis Clinical / Safety Benchmarking Cost Effectiveness Benchmarking Patient Groups Analysis Evidence Map: Gap and Opportunity Analysis Payer Input Reimbursement Landscape Global Payer Review Payer Input HTA Assessment Site of Care Analysis Benchmark Reimbursable File Target Product Profile Develop Value Hypotheses Stakeholder Value Analysis Target population selection Active comparator selection Target endpoints and claims Integrated Devt. Plans HEOR / PRO plans Detailed study designs Dissemination planning Pricing Analysis Pricing Value Concept Early pricing research and range assessment Market / sales projections Filing & Launch Final Value Proposition Reimbursement & Policy Strategy Global and Local Value Dossiers Global Price Corridor Launch Sequence Payer Input Evidence Message Development ICER Scenario Planning Dissemination Strategies Value Expansion New indications New target populations Supporting evidence plans Payer engagement External Advisory Promotional Effectiveness Evidence Generation Evidence Needs Assessment Literature Reviews Meta Analysis Burden of Illness Unmet Needs analysis HTA Assessment PRO Evaluation Trial Simulation Modeling Early Economic Models Cost effectiveness Cost of illness Early Evidence Develop Heterogeneity Res. Treatment Patterns Burden and Cost of Illness Subpopulations Prospective Evidence Generation, Strategy, Phase IV Planning Policy Research Updated Economic Models w/ph III data Budget Impact Trial Extrapolation Risk Benefit Real World Studies Prospective and Retrospective Studies Registries Pragmatic Trials Meta Analyses Policy Research 2018 Ipsos 4

Drug development cycle Discovery / Preclinical Phase I Phase II Phase III Post Launch / Phase IV Product Value Strategy Competitive Analysis Clinical / Safety Benchmarking Cost Effectiveness

5 Drug development cycle Discovery / Preclinical Phase I Phase II Phase III Post Launch / Phase IV Product Value Strategy Competitive Analysis Clinical / Safety Benchmarking Cost Effectiveness Benchmarking Patient Groups Analysis Evidence Map: Gap and Opportunity Analysis Payer Input Evidence Generation Reimbursement Landscape Global Payer Review Payer Input HTA Assessment Site of Care Analysis Benchmark Reimbursable File Target Product Profile Develop Value Hypotheses Stakeholder Value Analysis Target population selection Active comparator selection Target endpoints and claims Integrated Devt. Plans HEOR / PRO plans Detailed study designs Dissemination planning Pricing Analysis Pricing Value Concept Early pricing research and range assessment Market / sales projections Filing & Launch Final Value Proposition Reimbursement & Policy Strategy Global and Local Value Dossiers Global Price Corridor Launch Sequence Payer Input Evidence Message Development ICER Scenario Planning Dissemination Strategies Value Expansion New indications New target populations Supporting evidence plans Payer engagement External Advisory Promotional Effectiveness Evidence Needs Assessment Literature Reviews Meta Analysis Burden of Illness Unmet Needs analysis HTA Assessment PRO Evaluation Trial Simulation Modeling Early Economic Models Cost effectiveness Cost of illness Early Evidence Develop Heterogeneity Res. Treatment Patterns Burden and Cost of Illness Subpopulations Prospective Evidence Generation, Strategy, Phase IV Planning Policy Research Updated Economic Models w/ph III data Budget Impact Trial Extrapolation Risk Benefit Real World Studies Prospective and Retrospective Studies Registries Pragmatic Trials Meta Analyses Policy Research 2018 Ipsos 5

6 Data sources to generate RWE Clinical measures Patient reported outcomes/quality of Life (QoL) Administrative Insurance Claims Chart Reviews Registries Lab measures Biomarkers Electronic Medical Records Hospital Discharge Data Qualitative Research Treatment use current and history including start/stop dates, dose and reasons for discontinuation/switch Existing Surveys Sales Data Primary Data Collection Adverse events Healthcare resource utilization Social Media and Social Listening 2018 Ipsos 6

7 Data sources to generate RWE Need for comprehensive view of patient journey and opportunities to connect with patients to improve access and outcomes Clinical response Economic Value/Cost-benefit Patient reported outcomes and Impact on Quality of Life Response to federal agencies, payers, clinicians and also patient involvement in decision making 2018 Ipsos 7

8 Rising Needs in Oncology Treatment sequencing Biomarker identification Indication expansion Confirmatory benefit Safety/Dose Modification Nature of the disease Fast pace of research under development Accelerated approvals for new and extended label indications 2018 Ipsos 8

9 Rising Needs in Oncology Leveraging available data sources Oncology monitors EMRs Claims Custom build databases Social Media and Social Intelligence 2018 Ipsos 9

10 Rising Needs in Oncology Leveraging available data sources Oncology monitors EMRs Claims Custom build databases Social Media and Social Intelligence 2018 Ipsos 10

11 Rising Needs in Oncology Leveraging available data sources Oncology monitors EMRs Claims Custom build databases Social Media and Social Intelligence ASCO and its affiliate organizations manage social media channels across several platforms, including Twitter, Facebook, YouTube, LinkedIn, Google+, Storify, and Instagram. Opens the lines of communications between doctors and the patient community like never before 2018 Ipsos 11

CASE STUDIES 2018 Ipsos. All rights reserved.

13 Real-world usage and Clinical Outcomes: Alectinib among NSCLC Patients OBJECTIVE To provide real-world information on the usage and patient outcomes of those treated with alectinib post-crizotinib progression METHOD Participating oncologists (N=95) in the USA were recruited from an online physician panel to participate in a retrospective patient chart review Physicians abstracted data on patient demographics and clinical history from their medical charts (N=207) Physician and patient characteristics were reported descriptively. Differences in response rates across patient characteristic strata were compared using chi-square tests Clinical outcomes of a newly approved product in a real world setting and understanding the differences in patient profiles, who participated in clinical trials previously 2018 Ipsos DiBonaventura M, Wong W, Shah-Manek B, Schulz M. Real-world usage and clinical outcomes of alectinib among post-crizotinib progression 13 anaplastic lymphoma kinase positive non-small-cell lung cancer patients in the USA. OncoTargets and Therapy. December 2017, 22(11),75-82.

14 Development of communications strategy for new medication launch OBJECTIVE The objective of this study was to provide a basis for developing a communication strategy for the drug, specifically focusing on patient journey. METHOD For patient journey and typology components, researcher based content analyses on patient generated online conversations Key word analysis for search engine optimization phase of the study Qualitative exploration of collected posts to identify overarching issues (including openness to new treatment options, information seeking behavior and disease burden) FIRST SYMPTOMS OPPORTUNITY ZONE Squeeze/ Cut open OPPORTUNITY ZONE REPRESSION DIFFERENT MISDIAGNOSIS & DOCTORS CHANGE PRE-DIAGNOSIS 10+YEARS Shame/ Embarassment CONCERN STRONGER SYMPTOMS Causes/ Therapy Balms/ Creams ADVANCED SYMPTOMS Assumption Confrontation With assumption Shame/ Pain Strong pain DIAGNOSE PHASE 2 OPPORTUNITY ZONE Complete surgery Fear of surgery/ googling images Incurable! ACCEPTANCE Short term freedom of symptoms Emotional Support Social Assistance Depression/ Wound care HELPLESSNESS NEW SYMPTOMS Pain/ Employment/ Self-disgust/ Psyche Numerous surgical Little interventions consulting Further surgery PHASE 3 Clinic Fear of surgeries/ Wound care/ Employment/P ain ADVANCED SYMPTOMS OPTIMISM OPPORTUNITY ZONE DESPAIR Emotional support/ Wound care Social support In addition, quantitative metrics were tabulated Phases: Repression, Acceptance, Optimism, Concern, Helplessness, Despair Deeper insights on patient journey to inform communication strategies of the product 2018 Ipsos Presented at MR conference in 2016, Germany; Study designed and executed by the German Rx and SMX teams 14

15 Summary Growing need to leverage existing data sources, custom built databases and innovative methods like social intelligence to generate RWE solutions in comparatively shorter time span with reasonable cost and resources Comprehensive approach to assess effectiveness, cost and drug access Create value proposition and frameworks in understanding the need, priority and value of the drug to the providers 2018 Ipsos 15

comprehensive story to understand the patient experiences of the product and the value of the drug in a real

16 Bringing together, in addition to leveraging currently available resources to assess clinical, PROs, cost/benefit; utilizing novel approaches like customized data builds & social intelligence provide a comprehensive story to understand the patient experiences of the product and the value of the drug in a real world setting Customized data builds Comprehensive understanding of Patient Experience Product Impact and Value in the Real World 2018 Ipsos 16

17 Thank you Chris Blanchette, PhD, MBA Senior Vice President, Global Evidence, Value and Access Chitra Karki, MPH Director, Global Evidence, Value and Access 2018 Ipsos 17