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Reimbursement Process Checklist
1. 1/24
Reimbursement in EU/USA for
Pharmaceuticals and Medical Devices
A Step By Step Checklist
UK Office:
27 Old Gloucester St.,
London WC1N 3AX
uk@mediclever.com
+44.208.099.7435
Israel Office:
6 Ha-Teena St.,
Modiin 71799
il@mediclever.com
+972.50.837.1711
Amir Inbar,
CEO
Mediclever Ltd.
amir@mediclever.com
www.mediclever.com
2. 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 USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
3. 3/24
Reimbursement In Europe and The USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
4. 4/24
So, what has changed?
Reimbursement In Europe and The USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
5. 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 USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
6. 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 reimbursement
Short regulatory path ≠ Optimal reimbursement
Add reimbursement related issues to initial FDA/CE trial.
Reimbursement In Europe and The USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
7. 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 USA
Why Reimbursement
Why
Reimbursement
Reimbursement
Checklist
Timing
Costs
9. 9/24
Reimbursement In Europe and The USA
Checklist
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. 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 USA
Checklist
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. 11/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 12/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 13/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 14/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 15/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 16/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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. 17/24
Main
Decision
Makers are
Healthcare
Providers
Reimbursement In Europe and The USA
Checklist
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
19. 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 USA
Timing
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
22. 22/24
Reimbursement In Europe and The USA
Costs
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