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Table 1 The input parameters for current and early timing of price negotiations

From: The impact of early phase price agreements on prices of orphan drugs

Model parameter

  

Remarks

Cost of development (US$ million)

US$701 million

€660 million

Not specific for orphan disease or orphan drugs in oncology

Cost pre-clinical

US$217 million

€205 million

 

Phase I

US$84 million

€79 million

 

Phase II

US$142 million

€134 million

 

Phase III

US$190 million

€168 million

 

Phase IV

US$68 million

€64 million

 

Years of development & approval

8 years

  

Net patent life

12 years

  

Population

Western markets: 947.1 million

  
 

Larger global market: 1743.4 million

  

Period between registration and reimbursement

1.5 years

 

Based on increasing hurdles, especially for high priced orphan drugs (reimbursement) + pricing negotiations

Net patent life

12 years

  

Uptake

80% from first year

 

Uptake is higher in orphan diseases than other drugs

Cost of revenue

40%

  

Probability success

 Phase I to II

70%

  

 Phase II to III

39%

  

 Phase III to approval (FDA/EMA)

69%

  

 Reimbursement

90%

 

Based on increasing hurdles, especially for high priced orphan drugs (reimbursement) + pricing negotiations

 Cost of capital

12%