Four Practical Approaches To Managing A More Effective Device Trial


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Four Practical Approaches To Managing A More Effective Device Trial

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