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% |