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How to Make Postmarket Surveillance More Cost Effective

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When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.

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How to Make Postmarket Surveillance More Cost Effective

  1. 1. How to Make Postmarket Surveillance More Cost Effective June 16, 2016
  2. 2. − Introduction − Post Market Surveillance Status in the Industry − Value Based Healthcare and Real World Evidence − Rising Costs and Opportunities for Cost Effectiveness − Case Studies Agenda
  3. 3. Vicki Anastasi Vice President and Global Head Medical Device and Diagnostics Research ICON Medical Device and Diagnostics Research Group
  4. 4. 4,300 + Europe, Middle East, Africa 2,000 + Asia Pacific 4,900 + The Americas ICON: A market leader positioned for continued growth Operating from 90 offices in 37 countries with 11,900 employees PHD or Higher - 9% Master Degree - 24% Bachelor Degree - 39% Diploma/Certificate - 13% Other - 15%
  5. 5. Seren Phillips HTA training slides ICON Expertise Over the Medical Device Lifecycle
  6. 6. Medical Device Clearance / Approval Process Concept & Design (≈ 12 mo) Pre-Clinical Development (≈ 24-36 mo) Clinical Trials Proof of Concept / Pivotal Trial (Timing varies) FDA Review (510K≈3-5 mo) (PMA≈ 12 -24 mo) Reimbursement Assignment (≈ 0-24 mo) Post Market Activities Regulatory strategy Pre-submission meeting Quality System support Pre-clinical test plans Human factors testing Study conduct & report preparation IDE Submission 510K / PMA Submission FDA discussion / negotiations Post Market studies Registry studies Product enhancements / new submissionsTechnology
  7. 7. Rise of Post Market Surveillance – Global Impact 6 – 50% increase in the number of PMS studies conducted by top 5 medical device manufacturers between 2009 and 2015 (ClinicalTrials.gov analysis) – Worldwide requirements from regulators, payers – To intensify under EU MDR/IVDR – Major changes proposed by the Commission – Impact on non-grandfathered CE-approved products already on the market – Effect of changes on diagnostics and companion diagnostics – Changes in clinical evidence requirements – Impact on the industry of increased requirements, as the number of Notified Bodies is reduced – Costs are not the only challenge! Viability of product in the value-based healthcare environment will become paramount.
  8. 8. Value-Based Healthcare is Driving Increase in Post-Market Data – Global market launch needs to be aligned with future requirements – Requires a different framework to define value and commercial success – Bundled payment model: CMS Comprehensive Care for Joint Replacement – Model program delivers on CMS’ pledge to shift 50% of Medicare payments to ACOs and bundles by 2018 – Expect the next area, based on volume and variance in per-procedure costs, to be cardiovascular How does your product fit in to these programs? What is next? 7
  9. 9. Global Rationale of Value Driven Data Collection – What are the effects? (e.g., providers have targeted manufacturers for price concessions first, before reforming care protocols or delivery) – Lessons from UK [e.g., payments differ between indications, thus requiring careful choice of patient population (e.g., co-morbidities) as hospitals become smarter about codes] – Start earlier to accelerate true time-to-market: Arrival at regulatory clearance with limited evidence of real-world cost effectiveness and a suboptimal prioritization of payer targets will delay market access, restrain early revenue potential, and concede control of a product’s value story. 8
  10. 10. Broadening Opportunities for Real World Evidence – The "top programmatic priority" for the US Food and Drug Administration (FDA), under Commissioner Robert Califf, is to leverage real world evidence from the healthcare system to inform FDA decision making “Prospectively designed registries and cohort studies in the context of clinical practice are highly valuable, and randomized trials conducted in the context of clinical practice, often called a pragmatic clinical trial may be the most important source of knowledge in the future” Robert Califf, FDA Commissioner Food and Drug Law Institute's Annual Conference, May, 2016 – First, both data sources and research methods must be optimized 9
  11. 11. Seren Phillips HTA training slides Real World Evidence Solutions – As healthcare accelerates towards a patient-centric, value based approach, a new set of questions are emerging from key stakeholders : – How will patients respond to your product when it enters the ‘real world’? – How does it’s value proposition hold up within the competitive set and current standards of care? – Which subset of patients are likely to see the greatest benefit? – Reasons for optimism – Digitization of healthcare continues to increase – New technologies improving data capture, connectivity and access – Numerous RWE data sources available
  12. 12. Seren Phillips HTA training slides Robust RWE Strategy Drives Commercial Success – Preliminary Objectives – Situational Assessment – Disease and subtype dynamics – Treatment Landscape • Current standard of care, treatment algorithms • Clinical and in market targets with indications – current and anticipated profiles for safety and efficacy – Review of clinical research programs – Determine Opportunities and Potential Challenges – How can these be better identified, quantified exploited and mitigated through RWE – What is of ‘primary’ importance and what can be addressed by ‘secondary’ RWE data
  13. 13. Seren Phillips HTA training slides Real World Evidence Solutions – Herein lies the challenge with Real World Evidence – Industry has a plethora, perhaps too many, real world evidence options to consider – How should companies go about navigating what should be generated de novo ‘primary’ RWE (i.e. Registries) versus sourced, ‘secondary’ RWE (available data) – Determining a sound RWE strategy requires a multifaceted approach – You need expertise in both realms as well as clinical, medical, operational, data and outcomes expertise, to define your RWE strategy
  14. 14. Real World Evidence Case Study Maestro Rechargeable System’s approved based on Patient Preference Information Real World Intelligence (RWE): drive R&D with insights from RWE that is provided earlier in the process and across the usual clinical–medical affairs– commercial divide (facilitates deeper payer and patient-centric insights into optimal target indications, opportunities to improve care management, product feature profiles that align to potentially non-obvious patient populations, viable protocol designs, endpoint sensitivity, or recruitment strategies) 13
  15. 15. Key market Strategy Registry Plan: Design, Execution, and Communication REPORTS LEGAL, REGULATORY, IRB REVIEW MATERIALS PRODUCTION AND DISTRIBUTION SITE RECRUITMENT AND TRAINING PATIENT ENROLLMENT, OUTCOMES TRACKING, DATA COLLECTION SITE SUPPORT ANALYSES NEWSLETTERS PUBLICATIONS ABSTRACTS, PRESENTATIONS MEETINGS STRATEGY ANALYSIS PLAN COMMUNICATIONS PLAN DATA COLLECTION FORMS, PROCESSES, AND LOGISTICS SCIENTIFIC ADVISORY PANEL SITE IDENTIFICATION (FIELD INVOLVEMENT)
  16. 16. Methodological Considerations: Patient Selection, Size & Scope Target Population Assessable Population Intended Population The population to which the study findings are meant to apply Subset of the target population available for the study Subset of the population sampled according to the registry design Patients who actually participate in the registry Identification of the target population All patients Actual Population Defining Registry Size & Scope: Design Considerations • Duration of the registry o Time needed to assess outcomes o Plan for evolution? • How many patients per site? o Size of overall patient population o Enrollment timeframe expectations o Level of ‘engagement’ o Not too many to bias analysis, but enough to be interesting to sites o 5-10 is generally the rule
  17. 17. 16 Patient registry success primarily hinges on a well-reasoned design and good data collection practices Success Factors for Patient Registries Broad entry criteria • Make sure entry criteria is not limited to specific treatments to facilitate comparisons Ideal ration of incident vs. prevalent cases • It is key to strike the right balance between methodological purity (only newly diagnosed) vs. practicality (more eligible patients, if you allow previously diagnosed) Targeted data collection • While you may have the ability to collect large amounts of data, sometimes it is a good idea to collect only what you know you plan to analyze • However, often very interesting questions can be addressed when collecting “extra” information (the drawback is that you risk losing sites and/or patients) • It is important to get both clinical data and patient-reported data, because neither can substitute for the other Data collection automation • Get objective medical information (e.g. labs, utilization information, Rx refill information, etc.) in an automated way, because it will greatly enhance your registry at a relatively low cost Address known biases • Address all known biases at the design stage, including Patient selection within sites and systematic differences between sites (academic/community), because these may subsequently affect interpretation of the results Data control • Control access to the data by having a single team of analysts – this guards against misinterpretation of the data and poor-quality analyses
  18. 18. Costs are Accelerating – Best Practices for Management Post-Market surveillance budgets rival clearance/approval budgets ─ Build an evidence generation roadmap ─ Consider all stakeholders’ needs are considered ─ Leverage Payer and Market Access available data 17
  19. 19. Opportunities to Increase Cost Effectiveness ─ Operational differences for post-market data collection ─ Site selection • Use of networks and EMR ─ Enrollment ─ Site management • Continual training ─ Monitoring 18
  20. 20. Opportunities to Increase Cost Effectiveness ─ Technology ─ Site training ─ Risk based monitoring ─ Ease the burden of patient participation • Truly informed consent/eConsent • Better informed participants ─ Reduce visits with mobile, cloud and wearables • Types of sensors • Data gathering Apps • Patients vs healthy individuals what is available ─ Outsourcing – is it a solution for your program? 19
  21. 21. Evidence Generation Roadmap: The role of real world data in the product lifecycle 20 LIFECYCLE POST MARKET NO PHASE RESEARCH CONCEPT PRECLINICAL & PHASE I PRE-CLINICAL & FEASIBILITY PHASE II FIRST IN MAN PHASE III PILOT REGISTRATION PIVOTAL Strategy Development Strategy Development Clinical Outcomes Assessment Peri-Approval & Observational Research / Medical Device & Diagnostic Research Health Economics & Epidemiology PRODUCT LIFECYCLE Patient / Physician surveys Observational studies Preference Studies (DCE / WTP) Select or develop PROs / ClinROs / ObsROs, including linguistic validation PRO measurement strategy - Efficacy endpoints and labelling Regulatory interactions / submissions - Dossier development PRO dissemination strategy Regulated and non regulated clinical studies Phase IIIB/IV Prospective Trials Directed Use Programs Registries (pharma /device/ commercial strategy) Interventional / Non-Interventional Research PASS, PAES Comparative Effectiveness Research Burden of Illness Resource Use Studies Epidemiology – Characterisation of Disease & Treatment Patterns Dynamic Transition Modelling Economic Modelling Meta-Analysis, NMA PERI-POST APPROVAL POST-APPROVAL PHARMA: DEVICE:
  22. 22. Case Study: Seamless Transition from PMA to Post-Market Study
  23. 23. Case Study: Rapid Post-Market Study Start-up
  24. 24. Accelerating Time to Market and Eliminating $5 Million in Development Costs through Adaptive Design
  25. 25. Your New Prescription for Commercial Success Peri-Approval & Observational Research Global Pricing & Market Access Healthcare Communications Medical Device and Diagnostics Research Clinical Outcomes Assessment Market Research Creative Digital Language Services Content Call Center ICON Commercialisation & Outcomes Health Economics & Epidemiology Real World Evidence

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