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1/16 Service Package for Life Science Start-Ups Regulatory, Reimbursement, Quality and Clinical Research In Europe and the USA UK Office: 27 Old Gloucester.

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Presentation on theme: "1/16 Service Package for Life Science Start-Ups Regulatory, Reimbursement, Quality and Clinical Research In Europe and the USA UK Office: 27 Old Gloucester."— Presentation transcript:

1 1/16 Service Package for Life Science Start-Ups Regulatory, Reimbursement, Quality and Clinical Research In Europe and the USA UK Office: 27 Old Gloucester St., London WC1N 3AX Israel Office: 6 Ha-Teena St., Modiin Amir Inbar, CEO Mediclever Ltd.

2 2/16 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route 8.Prep. / App. Design dossier Technical file PMA 510(k) In a nut shell… Main Decision Makers Healthcare Providers Payers Establish user base, Obtain stakeholders’ support Utilize existing reimbursement mechanisms or: Apply for new reimbursement mechanisms 9.Implementation1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 6.Perform Clinical Study Clinical Eval. Report 7.Quality Manag. System Regulatory, Quality and Clinical Research Reimbursement FDA QSR / ISO Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Review and/or write protocol

3 3/16 In a nut shell… Regulatory, Quality and Clinical Research Reimbursement Mediclever provides Reimbursement consulting services in Europe and the USA. Our partners coordinate and manage the provision of Regulatory, Quality, and Clinical Research services in Europe and the USA, in collaboration with Mediclever.

4 4/16 Reimbursement Landscape Report 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Reimbursement 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, by the new medical product.

5 5/16 Main Decision Makers Healthcare Providers Payers Decision Makers and Initial Strategy 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Reimbursement This enables us to: Define the most relevant Decision Makers for the reimbursement of your new product. Formulate an initial reimbursement strategy for your new product in the selected markets (Europe, US).

6 6/16 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Regulatory Landscape Report 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement In parallel, or immediately after the Reimbursement Landscape Report is submitted, our partners provide the Regulatory Landscape Report to determine the product’s classification, intended use, indications for use and the anticipated regulatory route. Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU Sometimes regulatory status and classification are different between EU and US, and this needs to be taken into account when formulating regulatory, reimbursement and marketing strategies. Main Decision Makers Healthcare Providers Payers

7 7/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Preparations for Clinical Study 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement At the next stage, when the company prepares for its clinical study (if needed, see chart below), it typically: Implements the relevant parts of its Quality Management System (e.g., Design Controls and other QS aspects essential for US and EU pre-study compliance). Writes its clinical study protocol. Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Review and/or write protocol

8 8/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Evidence Planning 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing At this stage, long before the clinical study actually begins, we will plan the required ‘evidence’ for the reimbursement of your new product: Value Story: Lay out the clinical AND economic benefits of using your new product, from the identified Decision Makers’ perspective. Economic Model: Quantify the economic benefit, allow for sensitivity analysis and later on, use it as a sales tool. Reimbursement Related Parameters: Integrate in the study protocol. Stakeholders’ Feedback: Don’t gamble. Verify with our network partners, representing relevant Decision Makers, that they will indeed finance the use of your new product if the claims in the Value Story are proven according to the presented clinical study protocol. Review and/or write protocol

9 9/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Evidence Planning 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing Review and/or write protocol Raise funding: At this stage, in order to finance their clinical trial, many companies raise their growth funding round (also referred as Series A round). Seed Funding Round A

10 10/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Clinical Study 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing 6.Perform Clinical Study Clinical Eval. Report Now, the clinical trial may be conducted and the resulting ‘evidence’, substantiating the claims in the Value Story, should be published. The Clinical Evaluation Report (CER) should now be prepared, based on official European guidance. CER may also be useful for US submissions. Review and/or write protocol Seed Funding Round A

11 11/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Completion of Quality Management System 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing 6.Perform Clinical Study Clinical Eval. Report Completion of QMS At this stage, if the company has not already done so, the quality management system can be completed to ensure it complies with US and/or European requirements. 7.Quality Manag. System FDA QSR / ISO Review and/or write protocol Seed Funding Round A

12 12/16 Main Decision Makers Healthcare Providers Payers 2.Regulatory Landscape Report Regulatory status Device classification Intended use & indications for use Regulatory route Regulatory Application 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement Class III Class II Class I US Class I (NS/M) Class I (S/M) Class IIa Class IIb Class III EU 5.Clinical Study Protocol 3.Quality Management System Design Control procedures Other QS aspects essential for US and EU pre- study compliance Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing 6.Perform Clinical Study Clinical Eval. Report 7.Quality Manag. System FDA QSR / ISO Prep. / App. Design dossier Technical file PMA 510(k) At this point the company may submit the Technical File or the Design Dossier (in Europe) or apply for FDA Clearance / Approval (in the US). If granted, it could start selling its products. To obtain reimbursement, see the next slide… Review and/or write protocol Seed Funding Round A

13 13/16 Establish user base, Obtain stakeholders’ support Utilize existing reimbursement mechanisms or: Apply for new reimbursement mechanisms 9.Implementation Main Decision Makers Healthcare Providers Payers Reimbursement Application 1.Reimbursement Landscape Report Relevant, codes, coverage & payment Reimbursement strategy More Info / Pricing Regulatory, Quality and Clinical Research Reimbursement 5.Clinical Study Protocol Value story Economic model Reimbursement issues for clinical study protocol Stakeholders’ feedback 4.Evidence Planning More Info / Pricing 6.Perform Clinical Study Clinical Eval. Report 7.Quality Manag. System FDA QSR / ISO Prep. / App. Design dossier Technical file PMA 510(k) In case existing reimbursement mechanisms (Codes, Coverage, Payment) were allocated in the Reimbursement Landscape Report, we will Compile the Value Story, Economic Model and the published ‘evidence’ into a dossier that would be used to convince Healthcare Providers to purchase your new product. Otherwise: After verifying a sufficient user-base and support from the medical community, we will apply for new codes, coverage policies and favorable payment rates. Review and/or write protocol Seed Funding Round A

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