Transcript Slide 1
Reimbursement in EU/USA for Pharmaceuticals and Medical Devices A Step By Step Checklist Amir Inbar, CEO Mediclever Reimbursement Consultants [email protected] www.mediclever.com UK Office: • 27 Old Gloucester St., London WC1N 3AX • [email protected] /241 1 / •9 +44.208.099.7435 US Office: Israel Office: • 616 Corporate Way, Suite 2-4683, • 3b Lubetkin St., Herzliya 4640903 Valley Cottage, NY 10989 • [email protected] • [email protected] • +972.50.837.1711 • +1.845.570.2910 Copyright © 2014 Mediclever Ltd. Checklist 1. Reimbursement Landscape: a. Seek existing/ relevant reimbursement mechanisms b. Define Decision Makers c. Formulate initial reimbursement strategy More Info / Pricing Timing Costs Clients In order to define the existing reimbursement scenario for a new product (drug or device), we start with the Reimbursement Landscape Report. 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. • Find out whether there are any existing codes, coverage policies and payment mechanisms that could be utilized or compared to, the new medical product. • Define the most relevant Decision Makers for the reimbursement of the new medical product. • Formulate an initial reimbursement strategy for the new medical product. 2/9 Copyright © 2014 Mediclever Ltd. Checklist 1. Reimbursement Landscape: Costs 2. Evidence Planning: a. Seek existing/ relevant reimbursement mechanisms a. Value Story b. Define Decision Makers c. Study Protocol c. Formulate initial reimbursement strategy More Info / Pricing 3/9 Timing b. Economic Model d. Stake-holders’ feedback Clients Before the company initiates any clinical studies, we carefully plan the required ‘evidence’ for the reimbursement of the new medical product: 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. More Info / Pricing 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. Copyright © 2014 Mediclever Ltd. Checklist 1. Reimbursement Landscape: Timing Costs 2. Evidence Planning: a. Seek existing/ relevant reimbursement mechanisms a. Value Story b. Define Decision Makers c. Study Protocol c. Formulate initial reimbursement strategy More Info / Pricing b. Economic Model d. Stake-holders’ feedback Clients 3. Generate Evidence: a. Perform study (if needed) b. Publish data c. Dossier 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 4/9 Copyright © 2014 Mediclever Ltd. Checklist 1. Reimbursement Landscape: Timing Costs 2. Evidence Planning: a. Seek existing/ relevant reimbursement mechanisms a. Value Story b. Define Decision Makers c. Study Protocol c. Formulate initial reimbursement strategy More Info / Pricing b. Economic Model d. Stake-holders’ feedback Clients 3. Generate Evidence: a. Perform study (if needed) b. Publish data c. Dossier 4. Implementation 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 More Info / Pricing • The developed dossier is used to facilitate the conditions for intermediate and long-term reimbursement applications. 5/9 Copyright © 2014 Mediclever Ltd. More Info / Pricing Checklist Timing Costs Clients Start early! The outcome of this Reimbursement Landscape report could impact product development, relevant applications and the targeted markets 1. Reimbursement Landscape: 2. Evidence Planning: a. Seek existing/ relevant reimbursement mechanisms a. Value Story b. Define Decision Makers c. Study Protocol c. Formulate initial reimbursement strategy More Info / Pricing b. Economic Model d. Stake-holders’ feedback 3. Generate Evidence: a. Perform study (if needed) b. Publish data c. Dossier More Info / Pricing Prior to finalizing first clinical study protocol 6/9 Copyright © 2014 Mediclever Ltd. 4. Implementation 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 More Info / Pricing Checklist Timing Costs Clients To receive our quote, kindly click on the appropriate “More Info / Pricing” link in one of the relevant boxes below. 1. Reimbursement Landscape: a. Seek existing/ relevant reimbursement mechanisms a. Value Story b. Define Decision Makers c. Study Protocol c. Formulate initial reimbursement strategy More Info / Pricing 7/9 2. Evidence Planning: b. Economic Model d. Stake-holders’ feedback 3. Generate Evidence: a. Perform study (if needed) b. Publish data c. Dossier More Info / Pricing Copyright © 2014 Mediclever Ltd. 4. Implementation 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 More Info / Pricing Checklist 8/9 Timing Costs Clients Copyright © 2014 Mediclever Ltd. Checklist Timing Costs Clients Thank You For Your Attention UK Office: • 27 Old Gloucester St., London WC1N 3AX • [email protected] • +44.208.099.7435 9/9 Amir Inbar, CEO http://www.mediclever.com [email protected] http://twitter.com/mediclever +44.208.099.7435 http://mediclever.com/blog US Office: • 616 Corporate Way, Suite 2-4683, Valley Cottage, NY 10989 • [email protected] • +1.845.570.2910 Israel Office: • 3b Lubetkin St., Herzliya 4640903 • [email protected] • +972.50.837.1711 Copyright © 2014 Mediclever Ltd.