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.
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Reimbursement Process Checklist
- 1. 1/24 Reimbursement in EU/USA for Pharmaceuticals and Medical Devices A Step By Step Checklist UK Office: 27 Old Gloucester St., London WC1N 3AX uk@mediclever.com +44.208.099.7435 Israel Office: 6 Ha-Teena St., Modiin 71799 il@mediclever.com +972.50.837.1711 Amir Inbar, CEO Mediclever Ltd. amir@mediclever.com www.mediclever.com
- 2. 2/24 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 Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
- 3. 3/24 Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
- 4. 4/24 So, what has changed? Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
- 5. 5/24 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 Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
- 6. 6/24 • 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. Reimbursement In Europe and The USA Why Reimbursement Why Reimbursement Reimbursement Checklist Timing Costs
- 7. 7/24 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. 8/24 Reimbursement In Europe and The USA Checklist Why Reimbursement Reimbursement Checklist Timing Costs
- 9. 9/24 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. 10/24 Main Decision Makers are Healthcare Providers 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 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. 11/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 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 the RDMs
- 12. 12/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 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
- 13. 13/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 • Perform the clinical study and publish its results • Make sure that the published article establishes the ‘claims’ in the Value Story Conduct Clinical Study Publish evidence
- 14. 14/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 • 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 Conduct Clinical Study Publish evidence After FDA/CE => Initiate sales
- 15. 15/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 • 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 Achieve a minimal user base
- 16. 16/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 • Verify support from the relevant physicians, Key Opinion Leaders and medical societies Achieve a minimal user base 3.Verify stakeholders support
- 17. 17/24 Main Decision Makers are Healthcare Providers Reimbursement In Europe and The USA Checklist 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 • After obtaining FDA clearance / CE Mark, apply for Codes, Coverage and Payment Achieve a minimal user base 3.Verify stakeholders support 4. Apply for codes, coverage, payment
- 18. 18/24 Reimbursement In Europe and The USA Timing Why Reimbursement Reimbursement Checklist Timing Costs
- 19. 19/24 Start early! The outcome of this Reimbursement Landscape report could impact product development, relevant applications and the targeted markets Prior to initiating clinical studies Reimbursement In Europe and The USA Timing 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. 20/24 Start Now ! Reimbursement In Europe and The USA Timing Why Reimbursement Reimbursement Checklist Timing Costs
- 21. 21/24 Reimbursement In Europe and The USA Costs Why Reimbursement Reimbursement Checklist Timing Costs
- 22. 22/24 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. 23/24 Some of Our Clients 0
- 24. 24/24 Thank You • UK Office: • 27 Old Gloucester St., • London WC1N 3AX • uk@mediclever.com • +44.208.099.7435 • Israel Office: • 6 Ha-Teena St., • Modiin 71799 • il@mediclever.com • +972.50.837.1711 • Amir Inbar, CEO • Mediclever Ltd. • amir@mediclever.com • www.mediclever.com