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“Doing Double Duty” Collecting Data for FDA and CMS in the Same Study

“Doing Double Duty” Collecting Data for FDA and CMS in the Same Study. Medical Device Regulatory & Compliance Congress March 30, 2006. Donald P. Conway, MD, MBA Director Healthcare Initiatives Tuck School of Business at Dartmouth. VIEW FROM 30,000 FEET.

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“Doing Double Duty” Collecting Data for FDA and CMS in the Same Study

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  1. “Doing Double Duty”Collecting Data for FDA and CMS in the Same Study Medical Device Regulatory & Compliance Congress March 30, 2006 Donald P. Conway, MD, MBA Director Healthcare Initiatives Tuck School of Business at Dartmouth

  2. VIEW FROM 30,000 FEET • Increase Utilization of Healthcare Services/Products • Constrained Budgets • Increased Scrutiny of Healthcare Costs

  3. DIFFERENCES IN PERSPECTIVE • FDA – Safety, Efficacy • CMS – Efficiency, Cost Effectiveness • Manufacturers – Timely Coverage and Adequate Reimbursement

  4. PERSPECTIVE: MANUFACTURERS Goal: To secure coverage and adequate reimbursement in a timely manner ASAP

  5. BUSINESS CASE “For Doing Double Duty” Having the right data In the right subpopulation With appropriate power At the right time.

  6. Additional Trial required Opportunity Cost-lost sales Competition even more entrenched Practice patterns established Never realizing true sales potential COST OF NOT OBTAINING COVERAGE

  7. DEMONSTRATING VALUE Peak Sales Potential Opportunity Cost Actual Sales $ Time

  8. WHAT MANUFACTURERS CAN DO • Model Reimbursement landscape • Incorporate economic “Value Proposition” in the Target Product Profile.

  9. Reimbursement systems are complex mechanisms. “Understanding reimbursement is absolutely critical. It is one of the key factors we evaluate in every market opportunity. If precedent for reimbursement exists we look at the level of reimbursement and determine what can be done to upgrade it. Creating a new reimbursement scheme is a significant undertaking. Reimbursement battles can go on for years post-approval. They can be the major obstacle to ramping up sales. It is essential that we understand a product’s reimbursement mechanism up front”. Ross Jaffee, MD, MBA Versant Ventures

  10. WHAT Manufacturers CAN DO • Anticipate CMS and Private Payers views • Dialogue early and often • Anticipate which competitive technologies will be disrupted • Anticipate competitions response

  11. WHAT Manufacturers CAN DO • Ensure pivotal trials include an adequate representation of Medicare eligible patients • Capture economic endpoints in pivotal trials both Direct and Indirect Costs • Model global economic impact from these endpoints

  12. WHAT Manufacturers CAN DO • Ongoing collection of patient level data via open label follow-up • Establish a Patient Registry to obtain patient level data – economic and patient reported outcomes

  13. PAYER COMMUNITY (CMS AND PRIVATE) • CMS sets precedent – Not Always • Demand effectiveness data/NIH • Comparative clinical effectiveness • Pay for Performance • Demand Cost/Effectiveness data • Increasingly Important role AHRQ

  14. PAYER COMMUNITY • An Eye to Other Healthcare Systems • National Institute of Clinical Excellence (NICE) www.nice.org.uk • PBAC - Australia • Provincial authorities - Canada • County councils – Sweden

  15. Questions / Answers

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