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Four Practical Approaches To Managing A More Effective Device Trial
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Four Practical Approaches To Managing A More Effective Device Trial


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  • 1. Four practical approaches to managing a more effective device trial Blair Keagy, MD, CEO, Medical Products Analytics David Levin, Vice President, Clinipace June 10, 2009
  • 2. Sponsors Commercial Feasibility Analysis | Clinical Development Digital Clinical Research Organization (dCRO)
  • 3. Device and drug trials are not all alike
    • Will the clinical development plan limit the use of the product to a sub-segment of the TAM?
    • Will FDA approval limit the market to a sub-segment of the TAM?
    • Will payers require an initial use of an alternative therapy form before approving payment?
    • Is there potential for marketing directly to patients?
    • Are there strong potential competitors?
    • Can competitors rapidly develop a competing or identical product?
    • Is this a quantum leap forward in technology?
  • 4.
    • Scientific basis not sound
    • Overestimation of clinically relevant market
    • Poor reimbursement strategy
    • Poorly designed or executed clinical studies that fail to convince payers
    Reasons devices fail to achieve commercial success
  • 5. Objects in the mirror are farther than they appear
    • Good engineering doesn’t guarantee clinical trial and/or commercial success
    • When planning your next clinical trial you must consider…
      • Select the appropriate regulatory path
      • Incorporate a reimbursement strategy to maximize your trial and product success
      • Understand your patient population and customer setting
      • Ensure complete trial visibility with technology-driven processes
  • 6. FDA approval doesn’t guarantee reimbursement Pre-IDE meeting is very important
  • 7. {Great} reimbursement ideas from the government Prospective Payment System Inpatient Outpatient
  • 8. HCPCS (Healthcare Common Procedure Coding System) Level I
    • CPT codes (managed by AMA)
    • T-code for new technology
    • Determine physician payment
    Level II
    • Alphanumeric system
    • Determine where product will fit
    • Under contract to CMS
    • Guidance to manufacturers
    • Durable medical equipment
    • Large part of level II codes
  • 9. 2,800 Level II HCPCS Codes A Codes Miscellaneous services and supplies B Codes Enteral or parenteral treatment C Codes Drugs and biologics (pass-through) D Codes Dental codes E Codes Durable medical equipment H Codes Alcohol and drug abuse treatment J Codes Drugs that cannot be self-administered Q Codes Biologics such as dermagraft
  • 10.
    • How difficult will it be to obtain reimbursement codes?
    • Will hospitals realize a cost savings?
    • Will the device add patient benefit?
    • Will physicians be reimbursed for use of the device?
    • What is potential for favorable AHRQ and BC/BS TEC determination?
    • Will the device have patient appeal?
    Reimbursement considerations when designing a trial
  • 11. Product use impacts trial design and operations Hospitals
    • Purchase products at MD request
    • Facing budget constraints
    Physician Offices
    • Increase office efficiency
    • Allow global fee reimbursement
    • Covered under DRG (CMS)
    • Private carriers use global payment
    • Covered under APCS
    • Some pass through products
    • Fee schedules
    • Cross walking
  • 12.
    • Final approval from appropriate government bodies
    • Scientific evidence must permit conclusions concerning effect on outcomes
    • Improve net health outcomes
    • As beneficial as any established alternative
    • Attainable results outside investigational setting
    • CMS is relying on AHRQ for payment decisions
    Clinical efficacy must be proven
  • 13. AHRQ Analysis of Aortic Endografts
  • 14. Hospitals make purchasing decisions
  • 15. Yet, device and drug trials are alike
    • Are the case report forms user-friendly?
    • Are key safety measures included in the protocol?
    • Are statistical parameters valid?
    • Is the protocol powered properly?
    • Does the market potential justify the cost of the trial?
    • Can the protocol be adequately funded?
    • Are the objectives achievable?
    • Does the trial include gathering economic data?
    • Will patient enrollment be prohibitive?
  • 16. Clinical trials are a major investment
    • Clinical trial protocol development
    • Statistical analysis
    • Standard project management
    • University overhead (28%)
    • IRB review fee
    • IRB administrative fee
    • Site/Patient recruitment
    • Data management 
    • Clinical monitoring (e.g. 4 visits x 15 sites)
    • Costs for non standard of care studies
    • Regulatory document management
    • Site  management (including site payment) 
    • Regulatory submission
  • 17. Technology is more efficient, but requires more planning Technology-Driven Trials [1997 - ] Design Conduct Analysis Low High Cost 30% Reduction
  • 18. Successful technology deployment requires focus on process Management Operations Strategy & Planning Design Enrollment Data Capture/Mgt Analysis Regulatory Modeling/Simulation Site/Patient Recruitment Submission Protocol Design Electronic Data Capture [EDC] IVRS PRO Study/Project Management Reporting / Analytics CDM Clinical Trial Portfolio Management IIR / Grants Management
  • 19. Visibility is king Management Operations Strategy & Planning Start - Up Conduct Close - Out Project Milestones Queries Patient Accrual CRF Status Monitoring Activities
  • 20. Questions & Answers Commercial Feasibility Analysis | Clinical Development Blair Keagy, MD [email_address] Digital Clinical Research Organization (dCRO) David Levin [email_address]