reimbursement process checklist
DESCRIPTION
Download Mediclever's proven, step-by-step, cost-effective method for obtaining reimbursement for a medical technology product in Europe or the US.TRANSCRIPT
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Reimbursement in EU/USA for
Pharmaceuticals and Medical Devices
A Step By Step Checklist
UK Office:27 Old Gloucester St.,London WC1N [email protected]+44.208.099.7435
Israel Office:6 Ha-Teena St.,Modiin [email protected]+972.50.837.1711
Amir Inbar, CEOMediclever [email protected]
2/24
Decision Makers for a market launch
Following FDA/CE
Planning for reimbursement
Past
Reimbursement is ‘given’
Just prior to launch
Healthcare Providers
Healthcare costs Containable
Reimbursement strategy
Not important
Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
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Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
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So, what has changed?
Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
5/24
Decision Makers for a market launch
Following FDA/CE
Planning for reimbursement
Past Present
Healthcare Providers + Payers
Reimbursement is ‘given’
Reimbursement only if there’s clinical + economic Value
Just prior to launch At an early stage
Healthcare Providers
Healthcare costs Containable Soaring
Required by Investors, inc. resources and timelines
Reimbursement strategy
Not important
Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
6/24
• Wrong features: Product’s features impede reimbursement
Not addressing reimbursement issues early:
• Unnecessary trials: Conducted post FDA/CE to convince Payers
• Wrong applications: Targeting indications/settings/population that inhibit reimbursement – Check in advance.
=> Addressing reimbursement issues early on will result in more revenues, sooner.
!
• Problematic FDA/CE applications: Preventing reimbursementShort regulatory path ≠ Optimal reimbursement
Add reimbursement related issues to initial FDA/CE trial.
Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
7/24
So, how should vendors prepare for the launch of their new Medical Device or
Drug in this new era?
Reimbursement In Europe and The USAWhy Reimbursement
Why Reimbursement
Reimbursement Checklist
Timing
Costs
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Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
9/24
Reimbursement In Europe and The USAChecklist
Step 1:
• Find out whether there are any existing Codes, Coverage policies and Payment mechanisms that could be utilized or compared to by the new Drug/Device.
• Define the most relevant Decision Makers for the reimbursement of the new Drug/Device.
• Formulate an initial reimbursement strategy for the new Drug/Device
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
10/24
Main Decision Makers are Healthcare Providers
In case all the required reimbursement mechanisms are available, there is no need to contact the RDMs (Reimbursement Decision Makers). The relevant Decision Makers are the Healthcare Providers and the Patients.
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
11/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
In case all or any of the required reimbursement mechanisms are NOT available, the relevant Decision Makers are the RDMs (Reimbursement Decision makers).
Main Decision Makers are the RDMs
12/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
a. Value Story: Indicate the clinical AND economic benefits for the identified Decision Maker
b. Economic Model: Use for sensitivity analysis and as a sales tool
c. Study protocol: Include reimbursement related parameters
d. Stakeholders’ feedback: Obtain before initiating the trial
13/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
• Perform the clinical study and publish its results
• Make sure that the published article establishes the ‘claims’ in the Value Story
Conduct Clinical Study
Publish evidence
14/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
• If the main Decision Makers are the Healthcare Providers, immediately after obtaining FDA clearance / CE Mark, use the Value Story, Economic Model and published articles to initiate sales
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
15/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
• If the main Decision Makers are the Reimbursement Decision Makers, make sure your product has been used by “many physicians or practitioners” in the designated country
Achieve a minimal user base
16/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
• Verify support from the relevant physicians, Key Opinion Leaders and medical societies
Achieve a minimal user base
3.Verify stakeholders support
17/24
Main Decision Makers are Healthcare Providers
Reimbursement In Europe and The USAChecklist
Why Reimbursement
Reimbursement Checklist
Timing
Costs
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
• After obtaining FDA clearance / CE Mark, apply for Codes, Coverage and Payment
Achieve a minimal user base
3.Verify stakeholders support
4. Apply for codes, coverage, payment
18/24
Reimbursement In Europe and The USATiming
Why Reimbursement
Reimbursement Checklist
Timing
Costs
19/24
Start early! The outcome of this Reimbursement Landscape report could impact product development, relevant applications and the targeted markets
Prior to initiating clinical studies
Reimbursement In Europe and The USATiming
Why Reimbursement
Reimbursement Checklist
Timing
CostsMain Decision Makers are Healthcare Providers
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
Achieve a minimal user base
20/24
Start Now !
Reimbursement In Europe and The USATiming
Why Reimbursement
Reimbursement Checklist
Timing
Costs
21/24
Reimbursement In Europe and The USACosts
Why Reimbursement
Reimbursement Checklist
Timing
Costs
22/24
Reimbursement In Europe and The USACosts
To receive our quote, kindly click on the appropriate “More Info / Pricing” link in one of the relevant boxes below.
Why Reimbursement
Reimbursement Checklist
Timing
Costs
Main Decision Makers are Healthcare Providers
More Info / Pricing
1.Reimbursement Landscape:
a.Seek existing/ relevant reimbursement mechanisms
b.Define Decision Makers
c. Formulate initial reimbursement strategy
Main Decision Makers are the RDMs
2.Evidence Planning:
a.Value Story
b.Economic Model
c. Study Protocol
d.Stake-holders’ feedback
More Info / Pricing
Conduct Clinical Study
Publish evidence
After FDA/CE => Initiate sales
Achieve a minimal user base
24/24
Thank You
• 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