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Reimbursement Process Checklist

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Download Mediclever's proven, step-by-step, cost-effective method for obtaining reimbursement for a medical technology product in Europe or the US.

Download Mediclever's proven, step-by-step, cost-effective method for obtaining reimbursement for a medical technology product in Europe or the US.

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Reimbursement Process Checklist Presentation Transcript

  • 1. Reimbursement in EU/USA for Pharmaceuticals and Medical Devices A Step By Step Checklist UK Office : 27 Old Gloucester St., London WC1N 3AX [email_address] +44.208.099.7435 Israel Office : 6 Ha-Teena St., Modiin 71799 [email_address] +972.50.837.1711 Amir Inbar, CEO Mediclever Ltd. [email_address] www.mediclever.com
  • 2. Reimbursement In Europe and The USA Why Reimbursement
    • Decision Makers for a market launch
    • Following FDA/CE
    • Planning for reimbursement
    Past Reimbursement is ‘ given ’ Just prior to launch Healthcare Providers
    • Healthcare costs
    Containable
    • Reimbursement strategy
    Not important Why Reimbursement Reimbursement Checklist Timing Costs
  • 3. Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
  • 4. Reimbursement In Europe and The USA Why Reimbursement So, what has changed? Why Reimbursement Reimbursement Checklist Timing Costs
  • 5. Reimbursement In Europe and The USA Why Reimbursement
    • Decision Makers for a market launch
    • Following FDA/CE
    • Planning for reimbursement
    Past Present Healthcare Providers + Payers Reimbursement is ‘ given ’ Reimbursement only if there’s clinical + economic Value Just prior to launch At an early stage Healthcare Providers
    • Healthcare costs
    Containable Soaring Required by Investors, inc. resources and timelines
    • Reimbursement strategy
    Not important Why Reimbursement Reimbursement Checklist Timing Costs
  • 6. Reimbursement In Europe and The USA Why Reimbursement
    • Wrong features : Product’s features impede reimbursement
    Not addressing reimbursement issues early:
    • Unnecessary trials : Conducted post FDA/CE to convince Payers
    • Wrong applications : Targeting indications/settings/population that inhibit reimbursement – Check in advance.
    => Addressing reimbursement issues early on will result in more revenues, sooner .
    • Problematic FDA/CE applications : Preventing reimbursement
    Short regulatory path ≠ Optimal reimbursement Add reimbursement related issues to initial FDA/CE trial. ! Why Reimbursement Reimbursement Checklist Timing Costs
  • 7.
    • So, how should vendors prepare for the launch of their new Medical Device or Drug in this new era?
    Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
  • 8. Reimbursement In Europe and The USA Checklist Checklist Why Reimbursement Reimbursement Checklist Timing Costs
  • 9. Reimbursement In Europe and The USA Checklist
    • Step 1 :
    • Find out whether there are any existing Codes, Coverage policies and Payment mechanisms that could be utilized or compared to by the new Drug/Device.
    • Define the most relevant Decision Makers for the reimbursement of the new Drug/Device.
    • Formulate an initial reimbursement strategy for the new Drug/Device
    Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy
  • 10. In case all the required reimbursement mechanisms are available, there is no need to contact the RDMs (Reimbursement Decision Makers). The relevant Decision Makers are the Healthcare Providers and the Patients. Reimbursement In Europe and The USA Checklist Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy
  • 11. Reimbursement In Europe and The USA Checklist In case all or any of the required reimbursement mechanisms are NOT available, the relevant Decision Makers are the RDMs (Reimbursement Decision makers). Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs
  • 12. Reimbursement In Europe and The USA Checklist a. Value Story: Indicate the clinical AND economic benefits for the identified Decision Maker b. Economic Model: Use for sensitivity analysis and as a sales tool c. Study protocol: Include reimbursement related parameters d. Stakeholders’ feedback: Obtain before initiating the trial Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing
  • 13. Reimbursement In Europe and The USA Checklist
    • Perform the clinical study and publish its results
    • Make sure that the published article establishes the ‘claims’ in the Value Story
    Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence
  • 14. Reimbursement In Europe and The USA Checklist
    • If the main Decision Makers are the Healthcare Providers, immediately after obtaining FDA clearance / CE Mark, use the Value Story, Economic Model and published articles to initiate sales
    Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales
  • 15. Reimbursement In Europe and The USA Checklist
    • If the main Decision Makers are the Reimbursement Decision Makers, make sure your product has been used by “many physicians or practitioners” in the designated country
    Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales Achieve a minimal user base
  • 16. Reimbursement In Europe and The USA Checklist
    • Verify support from the relevant physicians, Key Opinion Leaders and medical societies
    3. Verify stakeholders support Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales Achieve a minimal user base
  • 17. Reimbursement In Europe and The USA Checklist
    • After obtaining FDA clearance / CE Mark, apply for Codes, Coverage and Payment
    3. Verify stakeholders support 4. Apply for codes, coverage, payment Main Decision Makers are Healthcare Providers Why Reimbursement Reimbursement Checklist Timing Costs More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales Achieve a minimal user base
  • 18. When? Reimbursement In Europe and The USA Timing Why Reimbursement Reimbursement Checklist Timing Costs
  • 19. Reimbursement In Europe and The USA Timing Start early! The outcome of this Reimbursement Landscape report could impact product development, relevant applications and the targeted markets Prior to initiating clinical studies Why Reimbursement Reimbursement Checklist Timing Costs Main Decision Makers are Healthcare Providers More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales Achieve a minimal user base
  • 20. Reimbursement In Europe and The USA Timing Start Now ! Why Reimbursement Reimbursement Checklist Timing Costs
  • 21. Costs? Reimbursement In Europe and The USA Costs Why Reimbursement Reimbursement Checklist Timing Costs
  • 22. Reimbursement In Europe and The USA Costs To receive our quote, kindly click on the appropriate “More Info / Pricing” link in one of the relevant boxes below. Why Reimbursement Reimbursement Checklist Timing Costs Main Decision Makers are Healthcare Providers More Info / Pricing 1. Reimbursement Landscape : a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy Main Decision Makers are the RDMs 2. Evidence Planning : a. Value Story b. Economic Model c. Study Protocol d. Stake-holders’ feedback More Info / Pricing Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales Achieve a minimal user base
  • 23. Some of Our Clients 0
  • 24. Thank You
    • UK Office :
    • 27 Old Gloucester St.,
    • London WC1N 3AX
    • [email_address]
    • +44.208.099.7435
    • Israel Office :
    • 6 Ha-Teena St.,
    • Modiin 71799
    • [email_address]
    • +972.50.837.1711
    • Amir Inbar, CEO
    • Mediclever Ltd.
    • [email_address]
    • www.mediclever.com