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. © 2018 PAREXEL INTERNATIONAL CORP. EXPLORING WAYS TO ENHANCE EVIDENCE GENERATION & COMMUNICATION PLANNING Janet Johnson/Nichola Gokool
- 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. © 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. © 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. © 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. © 2018 PAREXEL INTERNATIONAL CORP. / 8 LONDON, U.K. IDENTIFYING AND ADDRESSING ALL STAKEHOLDER NEEDS
- 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. © 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. © 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. © 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. © 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. © 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. © 2018 PAREXEL INTERNATIONAL CORP. / 16 BERLIN, GERMANY ALIGNING THE EVIDENCE PLAN WITH KEY VALUE AND COMMERCIAL DRIVERS
- 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. © 2018 PAREXEL INTERNATIONAL CORP. / 19 A FULL LANDSCAPE ANALYSIS IS THE FOUNDATION OF A STRONG PRODUCT VALUE STORY
- 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. © 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. © 2018 PAREXEL INTERNATIONAL CORP. / 22 BOSTON, MASSACHUSETTS WHAT ADDED VALUE CAN A STRATEGIC COMMUNICATIONS PLAN BRING?
- 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. © 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. © 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. © 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. © 2018 PAREXEL INTERNATIONAL CORP. / 28 THANK YOU © 2018 PAREXEL INTERNATIONAL CORP. / 28
Notas do Editor
- With a strategic plan as the backdrop we can move on to the specifics of the science that must be applied to ensure the validity and optimisation of the protocol with respect to COAs. This can involve one or more of the listed activities and is supported by PAREXEL subject matter experts. Recommendations made as a result of the PAREXEL SME team consultation enable an informed discussion with the sponsor on instrument selection data collection modality and any additional preparation / costs required before a COA is ready for use in a study e.g. Qualitative or quantitative equivalence testing for instruments migrated to e-modality.
- Evidence planning consists of a systematic approach to review the evidence for product value, assess all stakeholder needs and evaluate the evidence generation strategy. We will now explore each of these elements in further detail
- As we heard in Richard’s presentation, to succeed in today’s environment, companies must integrate payer input with regulatory, clinical and patient input throughout the product development. With this in mind, it is essential to have a clear understanding of who will be the key stakeholders within your target therapy area in each of your targeted geographies. A stakeholder mapping exercise should be conducted to identify who are the key decision makers and who are the key influencers (for example from a regulatory, pricing, reimbursement, access and uptake perspective). Not understanding the diverse needs of your key stakeholders can be costly. Failing to meet regulators and payer requirements can result in additional evidence requirements of failure to secure reimbursement. In mid-2015 the hypercholesterolaemia drug Repatha® was approved by the European Medicines Agency (EMA) after it successfully lowered blood levels of LDL cholesterol (LDL-C) in randomized controlled trials.1 (LDL-C is a “surrogate marker” thought to predict clinical benefit.) However, EU payers did not consider the drug’s value was adequately demonstrated to grant reimbursement. In order to secure reimbursement, the developer had to wait for final data from larger trials that used more clinically meaningful, payer relevant cardiovascular outcomes including death, heart attacks, strokes and hospitalizations.2
- The voice of the patient is likely to become even more important in light of regulatory developments With the passing of the 21st Century Cures Act, the FDA is now required to issue new guidance on capturing and measuring patients’ experiences and perspectives; the final guidance is not scheduled until Quarter 4, 2021. In addition, the EU Clinical Trials Regulations coming into effect in 2018 will likely drive patient involvement in trial design. Trial protocols will be required to describe ‘where patients were involved in the design of the clinical trial, a description of their involvement’ Patients are also involved in HTA assessments, As part of dossier review process by IQWiG, input is sought from patients or patient organisations. As part of NICE’s evaluation by patients or their carers are asked for their views, with patient experts selected to take part in the appraisal.
- Not understanding the diverse needs of your key stakeholders can be costly. Failing to meet regulators and payer requirements can result in additional evidence requirements of failure to secure reimbursement. Once the stakeholders have been identified, their evidence requirements should be determined. A question to ask yourself, is how have you evaluated how your evidence will resonate with your key stakeholder groups. Will you conduct a literature review or will you utilize face to face engagement opportunities such as advisory boards, interviews/surveys with all stakeholders. It is important to engage directly all stakeholders in evidence planning discussions – there is no replacement for hearing feedback directly and posing complex questions in person.
- PAREXEL research indicates many companies have limited formal engagement from all commercial stakeholders PAREXEL research suggests this is increasingly common practice but there are still opportunities for improvement. In a PAREXEL survey of 14 industry leaders, in commercialization, HEOR and/or market access, 75% of respondents stated that commercial endpoints were not well incorporated into trial design.
- Involving all internal stakeholder groups early and throughout the planning process will enhance understanding and ability to address external stakeholder needs and commercial drivers! A critical component for the successful commercialization of a product is its evidence generation plan. Drug development must integrate both clinical and market access perspectives from an early stage. All internal teams should provide input into the codification and validation of the evidence generation plan at all phases – this is to ensure the perspectives and needs of all external stakeholders are considered. The market access team should be involved to ensure the needs of payers are addressed and to ensure that market access endpoints are integrated into clinical studies.
- PAREXEL conducted a landscape analysis to help a client decide between conducting a large, fast-enrolling trial of standard infections or simultaneously pursuing a smaller indication. PAREXEL undertook a rapid assessment of the marketplace and the existing and future market for the primary indication was found to be overcrowded. Based on this analysis, PAREXEL recommended , pursuing the smaller indication as part of a fast-enrolling trial of standard infections. Although pursuing the smaller indication would increase costs and increase the challenges of enrolment, PAREXEL advised that pursuing both indications would lessen risk to the company. Why? Because our landscape analysis clearly demonstrated that new treatments may not gain market share due to last-line positioning, whereas niche positioning could offer an advantage for pricing negotiations and ultimately uptake
- Selecting the right patient population early on is critical. This is demonstrated by the case of pembrolizumab. In the pivotal KEYNOTE-042 study, pembrolizumab and standard first-line platinum-based chemotherapy were assessed in treatment-naïve patients who had tumours with ≥ 1% PD-L1 positivity. The patients were stratified according to PD-L1 expression (strong (≥ 50%) vs. weak (1–49%)). The extended use of pembrolizumab in the first-line setting is limited by the trial’s exclusion criteria with all the consequences for return on investment. The pool of eligible patients is likely to be closer to 10% rather than the 30% of all chemotherapy-naïve patients with NSCLC whose tumours express PD-L1 highly (≥ 50%).
- The ADAPTABLE study, a three-year study of aspirin for the prevention of heart attacks and strokes in individuals with heart disease is using real world evidence. The cost of ADAPTABLE is estimated to be approximately $14 million. In comparison a classic RCT of similar size was recently completed at a cost of about $420 million.
- Evidence planning consists of a systematic approach to review the evidence for product value, assess all stakeholder needs and evaluate the evidence generation strategy. We will now explore each of these elements in further detail
- Boost enrollment to onboard 3,000 patients in 2.5 years in highly competitive environment, and engage for >3-year follow-up
- Clinical-value driven planning Timely interim analyses High-quality content relevant to the target audience