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Medical Device Reimbursement Process
Mediclever Ltd. provides regulatory, quality, reimbursement, and clinical research consulting services to life science start-ups in Europe and the USA. Their services include regulatory landscape reports, quality management system implementation, clinical study planning and execution, reimbursement strategy development, and applications for regulatory approval and reimbursement. They work in collaboration with partners who can coordinate and manage the provision of these services.
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Medical Device Reimbursement Process
- 1. Service Package forLife Science Start-Ups Regulatory, Reimbursement, Quality and Clinical Research In Europe and the USA Amir Inbar, UK Office: Israel Office: CEO 27 Old Gloucester St., 6 Ha-Teena St., Mediclever Ltd. London WC1N 3AX Modiin 71799 amir@mediclever.com uk@mediclever.com il@mediclever.com www.mediclever.com +44.208.099.7435 +972.50.837.1711 1/16
- 2. Reimbursement In a nut shell… 1. Reimbursement 4. Evidence Planning 9. Implementation Landscape Report Main Decision • Value story • Establish user base, • Relevant, Makers • Economic model Obtain stakeholders’ codes, • Reimbursement support coverage & Healthcare issues for clinical • Utilize existing payment Providers study protocol reimbursement • Reimbursement • Stakeholders’ mechanisms or: strategy feedback Payers • Apply for new reimbursement mechanisms More Info / Pricing More Info / Pricing 2. Regulatory EU 8. Prep. / App. and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Technical file • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical 6.Perform 7.Quality indications for Control • Design dossier Class III Study Clinical Manag. use procedures Protocol Study System • Regulatory • Other QS route US • Review • Clinical • FDA aspects Eval. QSR / and/or Class III essential Report ISO write • PMA for US and protocol 13485 Class II EU pre- • 510(k) study Class I compliance 2/16
- 3. Reimbursement In a nut shell… Mediclever provides Reimbursement consulting services in Europe and the USA. and Clinical Research Regulatory, Quality Our partners coordinate and manage the provision of Regulatory, Quality, and Clinical Research services in Europe and the USA, in collaboration with Mediclever. 3/16
- 4. Reimbursement Landscape Report • In order to define the existing reimbursement scenario for a new Reimbursement 1. Reimbursement Landscape Report product (drug or device), we start with the Reimbursement • Relevant, Landscape Report. codes, coverage & payment In the Reimbursement Landscape Report we: • Reimbursement strategy • Analyze the relevant market/s, providing numbers of currently conducted procedures, type of Payers (insurance companies) that finance them and overall More Info / Pricing 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. 4/16
- 5. Decision Makers andInitial Strategy This enables us to: Reimbursement 1. Reimbursement Landscape Report Main Decision • Relevant, Makers • Define the most relevant Decision Makers for the codes, reimbursement of your new product. coverage & Healthcare Providers payment • Formulate an initial reimbursement strategy for your • Reimbursement strategy new product in the selected markets (Europe, US). Payers More Info / Pricing 5/16
- 6. Regulatory Landscape Report • In parallel, or immediately after the Reimbursement Reimbursement 1. Reimbursement Landscape Report Main Decision Landscape Report is submitted, our partners Makers • Relevant, provide the Regulatory Landscape Report to codes, coverage & Healthcare determine the product’s classification, intended use, payment Providers indications for use and the anticipated regulatory • Reimbursement strategy route. Payers • Sometimes regulatory status and classification are different between EU and US, and this needs to be More Info / Pricing taken into account when formulating regulatory, reimbursement and marketing strategies. 2. Regulatory EU and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Regulatory status Class I (S/M) • Device Class IIa classification • Intended use & Class IIb indications for Class III use • Regulatory route US Class III Class II Class I 6/16
- 7. Preparations for ClinicalStudy At the next stage, when the company prepares for its Reimbursement 1. Reimbursement Landscape Report Main Decision clinical study (if needed, see chart below), it typically: • Relevant, Makers codes, • Implements the relevant parts of its Quality coverage & Healthcare payment Providers Management System (e.g., Design Controls and • Reimbursement other QS aspects essential for US and EU pre-study strategy compliance). Payers • Writes its clinical study protocol. More Info / Pricing 2. Regulatory EU and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical indications for Control Class III Study use procedures Protocol • Regulatory • Other QS route US • Review aspects and/or Class III essential write for US and protocol Class II EU pre- study Class I compliance 7/16
- 8. Evidence Planning At this stage, long before the clinical Reimbursement 1. Reimbursement 4. Evidence Planning Landscape Report Main Decision • Value story study actually begins, we will plan the • Relevant, Makers • Economic model required ‘evidence’ for the codes, • Reimbursement reimbursement of your new product: coverage & Healthcare issues for clinical payment Providers study protocol • Value Story: Lay out the clinical AND • Reimbursement • Stakeholders’ economic benefits of using your new strategy feedback product, from the identified Decision Payers Makers’ perspective. More Info / Pricing More Info / Pricing • Economic Model: Quantify the economic benefit, allow for sensitivity analysis and later on, use it as a 2. Regulatory EU sales tool. and Clinical Research Landscape Report • Reimbursement Related Parameters: Regulatory, Quality Class I (NS/M) • Regulatory Integrate in the study protocol. status Class I (S/M) 3. Quality Management • Stakeholders’ Feedback: Don’t • Device Class IIa System classification gamble. Verify with our network • Intended use & Class IIb • Design 5. Clinical partners, representing relevant indications for Control use Class III procedures Study Decision Makers, that they will indeed Protocol • Regulatory • Other QS finance the use of your new product if route US • Review aspects and/or the claims in the Value Story are Class III essential proven according to the presented write for US and protocol Class II EU pre- clinical study protocol. study Class I compliance 8/16
- 9. Evidence Planning Seed Funding Round A Raise funding: Reimbursement 1. Reimbursement 4. Evidence Planning Landscape Report Main Decision • Value story • At this stage, in order to finance • Relevant, Makers • Economic model their clinical trial, many codes, • Reimbursement coverage & Healthcare issues for clinical companies raise their growth payment Providers study protocol funding round (also referred as • Reimbursement • Stakeholders’ Series A round). strategy feedback Payers More Info / Pricing More Info / Pricing 2. Regulatory EU and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical indications for Control Class III Study use procedures Protocol • Regulatory • Other QS route US • Review aspects and/or Class III essential write for US and protocol Class II EU pre- study Class I compliance 9/16
- 10. Clinical Study Seed Funding Round A Now, the clinical trial may be Reimbursement 1. Reimbursement 4. Evidence Planning Landscape Report • Value story conducted and the resulting Main Decision • Relevant, Makers • Economic model ‘evidence’, substantiating the codes, • Reimbursement claims in the Value Story, should coverage & Healthcare issues for clinical Providers be published. payment study protocol • Reimbursement • Stakeholders’ The Clinical Evaluation Report strategy feedback (CER) should now be prepared, Payers based on official European guidance. CER may also be useful More Info / Pricing More Info / Pricing for US submissions. 2. Regulatory EU and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical 6.Perform indications for Control Class III Study Clinical use procedures Protocol Study • Regulatory • Other QS route US • Review • Clinical aspects Eval. and/or Class III essential Report write for US and protocol Class II EU pre- study Class I compliance 10/16
- 11. Completion of QualityManagement System Seed Funding Round A Completion of QMS Reimbursement 1. Reimbursement 4. Evidence Planning Landscape Report Main Decision • Value story At this stage, if the company has • Relevant, Makers • Economic model not already done so, the quality codes, • Reimbursement coverage & Healthcare issues for clinical management system can be payment Providers study protocol completed to ensure it complies • Reimbursement • Stakeholders’ with US and/or European strategy feedback requirements. Payers More Info / Pricing More Info / Pricing 2. Regulatory EU and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical 6.Perform 7.Quality indications for Control Class III Study Clinical Manag. use procedures Protocol Study System • Regulatory • Other QS route US • Review • Clinical • FDA aspects Eval. QSR / and/or Class III essential Report ISO write for US and protocol 13485 Class II EU pre- study Class I compliance 11/16
- 12. Regulatory Application Seed Funding Round A At this point the company may Reimbursement 1. Reimbursement 4. Evidence Planning Landscape Report Main Decision • Value story submit the Technical File or the • Relevant, Makers • Economic model Design Dossier (in Europe) or codes, • Reimbursement apply for FDA Clearance / coverage & Healthcare issues for clinical payment Providers Approval (in the US). study protocol • Reimbursement • Stakeholders’ If granted, it could start selling its strategy feedback products. Payers To obtain reimbursement, see the next slide… More Info / Pricing More Info / Pricing 2. Regulatory EU 8. Prep. / App. and Clinical Research Landscape Report Regulatory, Quality Class I (NS/M) • Technical file • Regulatory status Class I (S/M) 3. Quality Management • Device Class IIa System classification • Intended use & Class IIb • Design 5. Clinical 6.Perform 7.Quality indications for Control • Design dossier Class III Study Clinical Manag. use procedures Protocol Study System • Regulatory • Other QS route US • Review • Clinical • FDA aspects Eval. QSR / and/or Class III essential Report ISO • PMA write for US and protocol 13485 Class II EU pre- • 510(k) study Class I compliance 12/16
- 13. Reimbursement Application Seed Funding Round A Reimbursement 1. Reimbursement 4. Evidence Planning 9. Implementation Landscape Report Main Decision • Value story • Establish user base, • Relevant, Makers • Economic model Obtain stakeholders’ codes, • Reimbursement support coverage & Healthcare issues for clinical • Utilize existing payment Providers study protocol reimbursement • Reimbursement • Stakeholders’ mechanisms or: strategy feedback Payers • Apply for new reimbursement mechanisms More Info / Pricing More Info / Pricing In case existing reimbursement mechanisms 8. Prep. / App. and Clinical Research (Codes, Coverage, Payment) were allocated in Regulatory, Quality • Technical file 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 5. Clinical 6.Perform 7.Quality Providers to purchase your new product. Study Clinical Manag. • Design dossier Protocol Study System Otherwise: • Review • Clinical • FDA • After verifying a sufficient user-base and and/or Eval. QSR / support from the medical community, we will write Report ISO • PMA protocol 13485 apply for new codes, coverage policies and • 510(k) favorable payment rates. 13/16
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