Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
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3/15/13%<br />
High Visibility & Political Pressure<br />
Average Cost <strong>of</strong> Drug Development<br />
INTERVAL<br />
Spending<br />
($m)<br />
Time to<br />
Core<br />
Launch<br />
Capitalized<br />
Spend/<br />
Successful Med<br />
($m)<br />
1- Pre-1 tox dose 76.5 9.6 207.4<br />
2- 1 st tox dose to 1 st human dose 86.8 7.2 184.1<br />
3- 1 st human dose to 1 st patient<br />
dose<br />
4- 1 st patient dose to 1 st pivotal<br />
dose<br />
5 – 1 st pivotal dose to 1 st core<br />
submission<br />
149.5 6.2 284.0<br />
316.9 4.4 501.6<br />
235.9 2.1 293.8<br />
6 – 1 st core submission to 1 st core 33.3 0.5 34.9<br />
launch<br />
TOTAL<br />
Mestre-Ferrandiz J: The R&D Cost <strong>of</strong> a <strong>New</strong> Medicine . Dec 2012.<br />
<strong>Off</strong>ice <strong>of</strong> Health Economics based 899 on Center for Medicines 1,506 Research<br />
US Growth in Health Expenditures<br />
$5,000,000<br />
$4,500,000<br />
Projection<br />
15.00%<br />
$4,000,000<br />
$3,500,000<br />
Millions<br />
$3,000,000<br />
$2,500,000<br />
$2,000,000<br />
$1,500,000<br />
$1,000,000<br />
Source: CMS, <strong>Off</strong>ice <strong>of</strong> the Actuary, National Health Statistics Group.<br />
10.00%<br />
5.00%<br />
% <strong>of</strong> Total Health Expenditure<br />
$500,000<br />
$0<br />
0.00%<br />
1982<br />
1983<br />
1984<br />
1985<br />
1986<br />
1987<br />
1988<br />
1989<br />
1990<br />
1991<br />
1992<br />
1993<br />
1994<br />
1995<br />
1996<br />
1997<br />
1998<br />
1999<br />
2000<br />
2001<br />
2002<br />
2003<br />
2004<br />
2005<br />
2006<br />
2007<br />
2008<br />
2009<br />
2010<br />
2011<br />
2012<br />
2013<br />
2014<br />
2015<br />
2016<br />
2017<br />
2018<br />
2019<br />
2020<br />
Health Expenditures<br />
Prescription Drugs<br />
14%
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