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Exploring Ways to Enhance Evidence Generation & Communication Planning

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PAREXEL experts explore key aspects of successful evidence generation and communication plans and how to apply them in your organization.

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Exploring Ways to Enhance Evidence Generation & Communication Planning

  1. 1. © 2018 PAREXEL INTERNATIONAL CORP. EXPLORING WAYS TO ENHANCE EVIDENCE GENERATION & COMMUNICATION PLANNING Janet Johnson/Nichola Gokool
  2. 2. © 2018 PAREXEL INTERNATIONAL CORP. / 4 SHIFTING DYNAMICS AND DIFFERING NEEDS REQUIRE A TAILORED APPROACH TO PLANNING Shifting Regulatory Landscape Shifting Payer Landscape Increasing Costs of Accessing RWE Demand For Value Communication to Physicians and Patients Shifting RWE Data Sources Sub-Optimal RWE planning in Pre-approval Development
  3. 3. © 2018 PAREXEL INTERNATIONAL CORP. / 5 THE GOAL IS: A FOCUSED, VALUE-DRIVEN PLAN DRIVEN BY STAKEHOLDERS & COMMERCIAL NEEDS 5 Evidence planning and communicationNEED Needs to be Focused on the key needs of stakeholders Aligned with the key value drivers of stakeholders Aligned with key commercial drivers Optimally communicated to the stakeholders
  4. 4. © 2018 PAREXEL INTERNATIONAL CORP. / 6 WHAT ARE THE KEY COMPONENTS OF A VALUE- DRIVEN EVIDENCE PLAN? Identify and address all stakeholder needs Align the evidence plan with key value & commercial drivers Develop a strategic communication plan PAREXEL has developed a simple, online tool to enable you to objectively assess the robustness of your evidence planning
  5. 5. © 2018 PAREXEL INTERNATIONAL CORP. / 7 WHAT ARE THE KEY STEPS IN DEVELOPING A VALUE- DRIVEN EVIDENCE PLAN? 11 Strategic communication plans 9 1 2 4 8 Internal stakeholder input & validation Protocol development and optimization Selection of modality on appropriateness, cost, timeliness… Competitor/ comparator analysis External stakeholder needs analysis Define parameters that demonstrate product value 10 Expert and/or patient engagement plans Maximizing product value 3 Evidence-based prioritization of clinical & value needs/gaps 45 Disease area, treatment landscape & CoI analysis 6 7 Analysis of evidence generation modalities to fill needs/gaps CoI: cost of illness
  6. 6. © 2018 PAREXEL INTERNATIONAL CORP. / 8 LONDON, U.K. IDENTIFYING AND ADDRESSING ALL STAKEHOLDER NEEDS
  7. 7. © 2018 PAREXEL INTERNATIONAL CORP. / 9 KEY STAKEHOLDER INSIGHT CASE STUDY 1 Mid-2015 approved by the EMA1 EU payers did not consider the drug’s value was adequately demonstrated to grant reimbursement Developer had to await final data from larger studies that used more clinically meaningful, payer relevant cardiovascular outcomes2 Not understanding the specific needs of your payer can be costly 1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/05/ news_detail_002336.jsp&mid=WC0b01ac058004d5c1.; 2. https://www.statnews.com/pharmalot/2016/04/07/cholesterol-statin-heart-atack/. Repatha (evolocumba)
  8. 8. © 2018 PAREXEL INTERNATIONAL CORP. / 11 KEY STAKEHOLDER INSIGHT THE GROWING IMPORTANCE OF PATIENT CENTRICITY 21st Century Cures Act EU Clinical Trials Regulations NICE evaluation “It seems funny to me that you can go through the whole process of getting a clinical trial underway and never include a patient in the process” Patient interviewed on drug development: Lowe Value in Health 2016; 19: 869
  9. 9. © 2018 PAREXEL INTERNATIONAL CORP. / 12 WHO ARE THE STAKEHOLDERS AND WHAT ARE THEIR VALUE DRIVERS? • Improve patient care • Optimize reimbursement • Advance science Clinicians • Inform policy • Determine value • Monitor usage • Support coverage and reimbursement decisions Payors • Pharmacovigilance • Ensure long-term safety and effectiveness Regulators • Meet commitments • Demonstrate product value • Ensure reimbursement • Generate publications • Build relationships Industry/Sponsors • Support treatment decisions • Improve knowledge of disease state • Advance science • Help other patients Patients • Inform evidence-based guidelines • Advance science • Improve quality of care Professional Bodies
  10. 10. © 2018 PAREXEL INTERNATIONAL CORP. / 13 WHAT IS THE IDEAL APPROACH TO UNDERSTAND STAKEHOLDER NEEDS? Engage early & directly with key stakeholders to identify key value drivers Will your evidence resonate with stakeholders in each region? Identify key stakeholders and their needs in each region of interest
  11. 11. © 2018 PAREXEL INTERNATIONAL CORP. / 14 HOW DO YOU BEST REPRESENT THE VOICE OF ALL THESE DIFFERENT STAKEHOLDERS AND NEEDS? In a recent PAREXEL survey of 14 industry leaders in commercial, market access and HEOR, over 75% of respondents stated that commercial endpoints are not or are only moderately well incorporated into study design1 Industry leader insight 1. PAREXEL 2014: How companies prepare for commercialization during product development.
  12. 12. © 2018 PAREXEL INTERNATIONAL CORP. / 15 EARLY INTERNAL INTEGRATION AND ALIGNMENT IS KEY TO VALUE-DRIVEN EVIDENCE GENERATION Clinical Regulatory HEOR Epidemiology Market Access & pricing/reimburs ement R&D Commercial Medical Affairs
  13. 13. © 2018 PAREXEL INTERNATIONAL CORP. / 16 BERLIN, GERMANY ALIGNING THE EVIDENCE PLAN WITH KEY VALUE AND COMMERCIAL DRIVERS
  14. 14. © 2018 PAREXEL INTERNATIONAL CORP. / 18 DEVELOPING A STRONG PRODUCT VALUE STORY CASE STUDY 2 In the pivotal KEYNOTE-042 study, pembrolizumab versus standard first-line platinum-based chemotherapy is being assessed in treatment-naïve patients who have tumors with ≥ 1% PD-L1 positivity. The patients are stratified according to PD- L1 expression (strong (≥ 50%) vs. weak (1–49%) The strict exclusion criteria mean that the pool of eligible patients whose tumours express PD-L1 highly (≥ 50%) is likely to be ~10% rather than the ~30% of all chemotherapy-naïve patients with NSCLC This study’s strict exclusion criteria is likely to limit the use of pembrolizumab in the first-line setting and thus impact return on investment Selecting the right target patient population early on is critical 1. Remon J, et al. Successes and failures: what did we learn from recent first-line treatment immunotherapy trials in non-small cell lung cancer? BMC Med. 2017 Mar 13;15(1):55. KEYTRUDA (pembrolizumab)
  15. 15. © 2018 PAREXEL INTERNATIONAL CORP. / 19 A FULL LANDSCAPE ANALYSIS IS THE FOUNDATION OF A STRONG PRODUCT VALUE STORY
  16. 16. © 2018 PAREXEL INTERNATIONAL CORP. / 20 A STRATEGIC APPROACH TO RW STUDIES CAN ENHANCE ROI CASE STUDY The cost of ADAPTABLE, a real-world study of aspirin in the prevention of heart attack and stroke in those with heart disease is estimated to be ~$14 million1 The cost of a classic RCT of similar size looking at similar outcomes was recently completed at a cost of ~$420 million Calculating the return on investment can support appropriate study selection Adaptable The Aspirin Study 1. http://theaspirinstudy.org/wp-content/uploads/2015/10/PCORI-Aspirin-Trial-Fact-Sheet.pdf
  17. 17. © 2018 PAREXEL INTERNATIONAL CORP. / 21 REAL-WORLD RESEARCH MODELS PRAGMATIC ‘SPECTRUM’ Primary Interventional Studies Retrospective Chart Reviews Secondary Database Analyses EMR Data Analysis Primary NIS / Observational Studies / Registries Hybrid Studies Interventional Observational Minimally Interventional Studies
  18. 18. © 2018 PAREXEL INTERNATIONAL CORP. / 22 BOSTON, MASSACHUSETTS WHAT ADDED VALUE CAN A STRATEGIC COMMUNICATIONS PLAN BRING?
  19. 19. © 2018 PAREXEL INTERNATIONAL CORP. / 23 HOW CAN STRATEGIC COMMUNICATION PLANNING ADD VALUE TO RWE? Establish rationale & clinical value of the study/data Engage stakeholders & generate anticipation for the results Extend the reach of the data
  20. 20. © 2018 PAREXEL INTERNATIONAL CORP. / 24 A FORMAL ENGAGEMENT PLAN DESIGNED TO MOTIVATE AND EMPOWER MSLs AND SITES TO SUPPORT EVIDENCE GENERATION ENHANCE ENGAGEMENT & REDUCE THE BURDEN TO DRIVE ENROLLMENT & RETENTIONProvide sites with tools to engage and explain the value to patients, as required Ensure physicians understand the scientific value of the plan Adopt a patient- centric approach throughout the process Ensure MSLs understand the scientific value of the plan
  21. 21. © 2018 PAREXEL INTERNATIONAL CORP. / 25 Low enrollment in a 3,000-patient, international, prospective registry designed to elucidate poorly understood treatment patterns in a major indication Convince physicians of the rationale for and clinical value of the evidence to be generated and maintain long-term engagement (3-5 years) An Expert-led plan of value communication activities • Identified and engaged Expert Working Group • Developed clear clinical value story/messaging and unique identity • Personally and regularly re-engaging investigators • Interim results communicated via professional channels Clinical value accepted: to date, abstracts at key societies (ECC, ISPOR, ASCO, ESMO), and peer-review manuscripts planned Created an external and internal ‘buzz’: enrollment of 3,000+ patients achieved on time, across ~200 sites in 16 countries “This is a really, really impressive project. Just imagine the data we’ll have available to analyze!” Key external expert “Thanks to the systematic data collection of the Registry, I have changed the way I manage medical notes in my clinic.” Key external expert AN EXPERT-LED APPROACH CAN OPTIMIZE CREDIBILITY, AWARENESS, AND ENGAGEMENT
  22. 22. © 2018 PAREXEL INTERNATIONAL CORP. / 26 STRATEGIC COMMUNICATION PLANNING CAN SIGNIFICANTLY ENHANCE DATA REACH/VALUE • Visual abstract • Interactive scientific posters • Augmented reality-style technology • Advanced QR codes Lay summary • Infographics of key data • Factsheet / FAQS • Annotated references Interactive MSL slide deck Social sharing and digital thought leaders SEO strategy • Trials in progress/methodology publications • Rapid publication of study design/baseline data at LPI • Interim analyses abstracts • Simultaneous publication of final data in journal and at key congress • Rapid online publication of final results • Lay summaries • Sub-population analyses and outputs
  23. 23. © 2018 PAREXEL INTERNATIONAL CORP. / 28 THANK YOU © 2018 PAREXEL INTERNATIONAL CORP. / 28

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