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Reimbursement in EU/USA for

Reimbursement in EU/USA for. Pharmaceuticals and Medical Devices. A Step By Step Checklist. Amir Inbar, CEO Mediclever Reimbursement Consultants amir@mediclever.com www.mediclever.com. UK Office : 27 Old Gloucester St., London WC1N 3AX uk@mediclever.com +44.208.099.7435. US Office :

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Reimbursement in EU/USA for

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  1. Reimbursement in EU/USA for Pharmaceuticals and Medical Devices A Step By Step Checklist Amir Inbar, CEO MedicleverReimbursement Consultants amir@mediclever.com www.mediclever.com • UK Office: • 27 Old Gloucester St., • London WC1N 3AX • uk@mediclever.com • +44.208.099.7435 • US Office: • 616 Corporate Way, Suite 2-4683, • Valley Cottage, NY 10989 • us@mediclever.com • +1.845.570.2910 • Israel Office: • 6 Te’ena St., • Modiin 71799 • il@mediclever.com • +972.50.837.1711

  2. Reimbursement In Europe and The USAChecklist • In order to define the existing reimbursement scenario for a new product (drug or device), we start with the Reimbursement Landscape Report. Checklist 1. Reimbursement Landscape: Timing a. Seek existing/ relevant reimbursement mechanisms • In the Reimbursement Landscape Report we: • Analyze the relevant market/s, providing numbers of currently conducted procedures, type of Payers (insurance companies) that finance them and overall spending. Costs Clients b. Define Decision Makers • Find out whether there are any existing codes, coverage policies and payment mechanisms that could be utilized or compared to, the new medical product. c. Formulate initial reimbursement strategy • Define the most relevant Decision Makers for the reimbursement of the new medical product. More Info / Pricing • Formulate an initial reimbursement strategy for the new medical product.

  3. Reimbursement In Europe and The USAChecklist Before the company initiates any clinical studies, we carefully plan the required ‘evidence’ for the reimbursement of the new medical product: Checklist 1. Reimbursement Landscape: 2. Evidence Planning: Timing a. Seek existing/ relevant reimbursement mechanisms a. Value Story Costs a. Value Story: Lays out the clinical AND economic benefits of using the new medical product, from the identified Decision Makers’ perspective. b. Economic Model: Quantifies the economic benefit, allows for sensitivity analysis and later on, used as a sales tool. c. Reimbursement Related Parameters: Integrated in the clinical study protocol. d. Stakeholders’ Feedback: Verifies, in advance, the willingness of the actual Decision Makers to finance the use of the new medical product if the claims in the Value Story are proven according to the presented clinical study protocol. b. Economic Model Clients b. Define Decision Makers c. Study Protocol d. Stake-holders’ feedback c. Formulate initial reimbursement strategy More Info / Pricing More Info / Pricing

  4. Reimbursement In Europe and The USAChecklist Checklist 3. Generate Evidence: 1. Reimbursement Landscape: 2. Evidence Planning: Timing • Perform study (if needed) • Publish data • c. Dossier a. Seek existing/ relevant reimbursement mechanisms a. Value Story Costs b. Economic Model Clients b. Define Decision Makers c. Study Protocol d. Stake-holders’ feedback c. Formulate initial reimbursement strategy More Info / Pricing More Info / Pricing • Now, the clinical study may be conducted (if needed). • The resulting ‘evidence’, substantiating the claims in the Value Story, should be published • Compile Value Story, Economic Model, and published clinical data to a dossier

  5. Reimbursement In Europe and The USAChecklist Checklist 3. Generate Evidence: 4. Implementation 1. Reimbursement Landscape: 2. Evidence Planning: Timing Use this dossier to: a. Establish an initial user base b. Harness local medical community’s support c. Utilize intermediate reimbursement mechanisms d. If needed, develop new mechanisms • Perform study (if needed) • Publish data • c. Dossier a. Seek existing/ relevant reimbursement mechanisms a. Value Story Costs b. Economic Model Clients b. Define Decision Makers c. Study Protocol d. Stake-holders’ feedback c. Formulate initial reimbursement strategy More Info / Pricing More Info / Pricing More Info / Pricing • The developed dossier is used to facilitate the conditions for intermediate and long-term reimbursement applications.

  6. Reimbursement In Europe and The USATiming Checklist Timing Costs Clients When?

  7. Reimbursement In Europe and The USATiming Checklist 3. Generate Evidence: 4. Implementation 1. Reimbursement Landscape: 2. Evidence Planning: Start early! The outcome of this Reimbursement Landscape report could impact product development, relevant applications and the targeted markets Timing Use this dossier to: a. Establish an initial user base b. Harness local medical community’s support c. Utilize intermediate reimbursement mechanisms d. If needed, develop new mechanisms • Perform study (if needed) • Publish data • c. Dossier a. Seek existing/ relevant reimbursement mechanisms a. Value Story Costs b. Economic Model Clients b. Define Decision Makers c. Study Protocol d. Stake-holders’ feedback c. Formulate initial reimbursement strategy More Info / Pricing More Info / Pricing More Info / Pricing Prior to finalizing first clinical study protocol

  8. Reimbursement In Europe and The USACosts Checklist Timing Costs Clients Costs?

  9. Reimbursement In Europe and The USACosts Checklist 3. Generate Evidence: 4. Implementation 1. Reimbursement Landscape: 2. Evidence Planning: To receive our quote, kindly click on the appropriate “More Info / Pricing” link in one of the relevant boxes below. Timing • Perform study (if needed) • Publish data • c. Dossier a. Seek existing/ relevant reimbursement mechanisms Use this dossier to: a. Establish an initial user base b. Harness local medical community’s support c. Utilize intermediate reimbursement mechanisms d. If needed, develop new mechanisms a. Value Story Costs b. Economic Model Clients b. Define Decision Makers c. Study Protocol d. Stake-holders’ feedback c. Formulate initial reimbursement strategy More Info / Pricing More Info / Pricing More Info / Pricing

  10. Reimbursement In Europe and The USASome of our Clients Checklist Timing Costs Clients

  11. Reimbursement In Europe and The USAChecklist Thank You For Listening Amir Inbar, CEO http://www.mediclever.com amir@mediclever.com http://twitter.com/mediclever 050.837.1711 http://mediclever.com/blog • UK Office: • 27 Old Gloucester St., • London WC1N 3AX • uk@mediclever.com • +44.208.099.7435 • US Office: • 616 Corporate Way, Suite 2-4683, • Valley Cottage, NY 10989 • us@mediclever.com • +1.845.570.2910 • Israel Office: • 6 Te’ena St., • Modiin 71799 • il@mediclever.com • +972.50.837.1711

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