medical device reimbursement process

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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

[email protected]

+44.208.099.7435

Israel Office:

6 Ha-Teena St.,

Modiin 71799

[email protected]

+972.50.837.1711

Amir Inbar,

CEO

Mediclever Ltd.

[email protected]

www.mediclever.com

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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

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•FDA QSR / ISO 13485

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

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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.

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Reimbursement Landscape Report

1.Reimbursement Landscape Report



More Info / Pricing

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t • 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.

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Payers

Decision Makers and Initial Strategy




More Info / Pricing

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t 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).

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Regulatory Landscape Report




More Info / Pricing

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t • 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.



Payers

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Payers






Preparations for Clinical Study




More Info / Pricing

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t 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






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Payers






Evidence Planning




More Info / Pricing

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Class III

Class II

Class I

US

Class I (NS/M)

Class I (S/M)

Class IIa

Class IIb

Class III

EU





• Value story

• Economic model



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.


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Payers






Evidence Planning




More Info / Pricing

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Class III

Class II

Class I

US

Class I (NS/M)

Class I (S/M)

Class IIa

Class IIb

Class III

EU





• Value story

• Economic model



4.Evidence Planning

More Info / Pricing


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

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Payers






Clinical Study




More Info / Pricing

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Class III

Class II

Class I

US

Class I (NS/M)

Class I (S/M)

Class IIa

Class IIb

Class III

EU





• Value story

• Economic model



4.Evidence Planning

More Info / Pricing



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.



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Payers






Completion of Quality Management System




More Info / Pricing

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Class III

Class II

Class I

US

Class I (NS/M)

Class I (S/M)

Class IIa

Class IIb

Class III

EU





• Value story

• Economic model



4.Evidence Planning

More Info / Pricing



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.





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Payers






Regulatory Application




More Info / Pricing

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Class III

Class II

Class I

US

Class I (NS/M)

Class I (S/M)

Class IIa

Class IIb

Class III

EU





• Value story

• Economic model



4.Evidence Planning

More Info / Pricing





8.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…



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• Establish user base, Obtain stakeholders’ support

• Utilize existing reimbursement mechanisms or:

• Apply for new reimbursement mechanisms

9.Implementation



Payers

Reimbursement Application




More Info / Pricing

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• Value story

• Economic model



4.Evidence Planning

More Info / Pricing





8.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.



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Costs

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medical device reimbursement process

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