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A Systems View Across Time and Space

Table 3 Costs for full development used for modelling (numbers in millions of USD)

From: A novel valuation model for medical intervention development based on progressive dynamic changes that integrates Health Technology Assessment outcomes with early-stage innovation and indication-specific clinical success rates

 

DiMasi OOP-CE (high)

Sertkaya CP-CE (low)

DiMasi OOP-Bio (high)

Sertkaya CP-Bio (low)

a. Abbreviated cost estimate

Registration

1.3

1.3

1.3

1.3

Phase III

255.4

25

255.4

25

Phase II

58.6

7

58.6

7

Phase I

25.3

2

25.3

2

Preclinical

110

7

159

10

Discovery

119

6

119

6

Total cost

569.6

48.3

618.6

51.3

b. FEC cost estimate

Manufacturing costs

400

400

400

400

Facility costs

65

65

350

350

Launch/post-market R&D

350

350

350

350

Registration

1.3

1.3

1.3

1.3

Add. HTA CTs

510.8

50

510.8

50

Phase III

255.4

25

255.4

25

Phase II

58.6

7

58.6

7

Phase I

25.3

2

25.3

2

Preclinical

110

7

159

10

Discovery

119

6

119

6

Total

1895.4

913.3

2229.4

1201.3

  1. a. Low cost estimates corresponding to values obtained from 3 independent sources in which costs end at the registration phase for both chemical entity and biologic-based medical interventions
  2. b. High cost estimates corresponding to values obtained from 3 independent sources in which costs end at the registration phase for both chemical entity and biologic-based medical interventions