Deliverable-based reimbursement process and timeline

Reimbursement Process and Guidance

Activity	Description	Phase	May Impact
Reimbursement Landscape	Money flows and financial incentives Reimbursement mechanisms Decision makers and their requirements Drug or medical device reimbursement strategy	R&D	Features and applications Predicate device / intended use Fundraising The results of Activity 1 may help choose either one of the following stories to tell potential investors: 1. The company could commercialize its product under existing reimbursement mechanisms. Thus, it would need to convince physicians and/or hospitals (but not payers) in the clinical and economic benefits of its product compared to the currently utilized alternatives. This is a relatively short and inexpensive process; or 2. The company will need to develop new reimbursement mechanisms. Thus, it would need to convince payers (rather than physicians and/or hospitals) in the clinical and economic benefits of its product compared to the currently utilized alternatives. This is a much longer and more expensive process. » These are very different stories, requiring different investments. > More on Reimbursement Strategy ...
Reimbursement Planning	Value story Economic model Support of clinical data Decision makers' feedback Parallel review of regulatory and reimbursement entities Funding of clinical study by payers	Pre Clinical	Market size Price Clinical study protocol Fundraising The results of Activity 2 may help tell potential investors that after we clarified the reimbursement strategy in Activity 1, we also validated it with the actual decision makers (physician/hospitals or Payers) down to the required end points in the company's clinical study. This is like receiving the client's pre-approval to pay for a future product, if only we prove that it works as we say it will. » This substantially reduces the associated risk and may impact valuation. > More on Reimbursement Planning ...
Implementation	Billing guide/Dossier Support of local medical community Prior authorizations and denial appeals Pilot projects with individual payors New reimbursement mechanisms	Pre Sales	Time to market Revenue > More on Reimbursement Implementation ...

Activity

Description

Phase

May Impact

Reimbursement Landscape

Money flows and financial incentives
Reimbursement mechanisms
Decision makers and their requirements
Drug or medical device reimbursement strategy

Features and applications
Predicate device / intended use
Fundraising
The results of Activity 1 may help choose either one of the following stories to tell potential investors:

1. The company could commercialize its product under existing reimbursement mechanisms. Thus, it would need to convince physicians and/or hospitals (but not payers) in the clinical and economic benefits of its product compared to the currently utilized alternatives. This is a relatively short and inexpensive process; or

2. The company will need to develop new reimbursement mechanisms. Thus, it would need to convince payers (rather than physicians and/or hospitals) in the clinical and economic benefits of its product compared to the currently utilized alternatives. This is a much longer and more expensive process.

» These are very different stories, requiring different investments.

> More on Reimbursement Strategy ...

Reimbursement Planning

Value story
Economic model
Support of clinical data
Decision makers' feedback
Parallel review of regulatory and reimbursement entities
Funding of clinical study by payers

Pre Clinical

Market size
Price
Clinical study protocol
Fundraising
The results of Activity 2 may help tell potential investors that after we clarified the reimbursement strategy in Activity 1, we also validated it with the actual decision makers (physician/hospitals or Payers) down to the required end points in the company's clinical study.

This is like receiving the client's pre-approval to pay for a future product, if only we prove that it works as we say it will.

» This substantially reduces the associated risk and may impact valuation.

> More on Reimbursement Planning ...