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Antibiotic Incentives For Global
HealthWHO CEWG 2011
Kevin OuttersonBoston University Schools of Law & Public
Health Harvard Center for Communicable Disease
DynamicsPapers at www.ssrn.com
Public Health Implications of
Antimicrobial Drug RegulationKevin Outterson, JD, LLM (Project Co-Director)
Boston University School of LawRosa Rodriguez-Monguio, PhD (Project Co-Director)University of Massachusetts, School of Public Health
Enrique Seoane-Vazquez, PhDMassachusetts College of Pharmacy
Aaron S. Kesselheim, MD, JD, MPH, Brigham & Women’s Hospital, Harvard Medical School
Marc Lipsitch, PhDHarvard School of Public Health
John H. Powers, MDGeorge Washington University School of Medicine
Funded by the Boston University School of Law & the Robert Wood Johnson Foundation
World Health Day7 April 2011
Coordination•Abx = common pool resource•No real global coordination on new production or use (withdrawals)
•Hospitals, physicians, patients, payors, drug companies & drug sellers all lack financial incentives to conserve
See R. Laxminarayan; K. Outterson; E. Kades; A.S. Kesselheim; A. Malani; R. Saver; S. Mechoulan; Sage & Hyman
Patent Holder Waste
•Sub-therapeutic animal uses•Label extensions to CAP/cSSSI/AOM
•Narrow v. broad spectrum•Dx•Resistance within & across classes
Outterson K, et al., LID 2007; 7:559-566; Outterson K, Cardozo L Rev 2010; Kesselheim AS, Outterson K, Health Affairs 2010; 29(9):1689-96.
Conservation•Commercial incentives
undermine conservation•Poor incentives at patient, provider & industry levels
•Complex delivery, cultural & infrastructure issues, esp. globally
Kesselheim AS, Outterson K, 11 YJHPLE 2011
Production•New molecules are needed, else class and sector exhaustion
•Stewardship and infection control diminish market incentives
•Declining returns to R&D observedKesselheim AS, Outterson K, 11 YJHPLE 2011
Systemic Antibacterial NMEs Approved by the FDA (1980-2009)
MarketedPriority Review
Approved
NMEs
Marketed = Products still in the market in August 1, 2010.
Discontinued NMEs and BLAs.Approved by the FDA (1980-1999)
% NMEs & BLAs Discontinued from Market
Systemic Antibacterials Approved by the FDA (1980-2009).
Marketed Drugs, Linear Trend
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Bayh-Dole Act
CAFCODA
CUSFTA TRIPS
OB Ped Excl.
Bioshield
TRIPS India + AUSFTA
Sec.505
Marketed NMEs and BLAs Approved by the FDA by Selected Therapeutic Classes
as a % Total Approvals (1980-2009)
% Total NMEs & BLAs
1980s1990s2000s
Cardiovascular System Drugs Approved by the FDA (1980-2009). Marketed Drugs, Linear
Trend & 5 Year Moving Average
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Antineoplastic & Immunomodulating Agents Approved by the FDA (1980-2009). Marketed Drugs,
Linear Trend & 5 Year Moving Average
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1 1
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Proposal 1• Value-based rbx for social value
of abx• Financing mechanism is OECD
health system rbx• Contingent on meeting global
conservation & health targets• Scalable globally
Kesselheim AS & Outterson K, Improving Antibiotic Markets, 11 YJHPLE (2011); Kesselheim AS & Outterson K, Health Affairs Sept. 8, 2010.
Contingent P4P
•Current metric: Ability to pay•With de-linkage: –Cost of resistant infections?–Cost of current ID burden?–Cost of avoided infections?
•Room for adjustment if SV>PV by an order of magnitude
Contingent P4P
Social Value of the ABX gap
DALY Value US & CAN HI Europe
$50k $73.3 $66.3
$75k $110.0 $99.5
$100k $146.7 $132.6
$125k $183.3 $165.8
In billions of US Dollars at various DALY value levels. Underlying data on burden of disease from WHO 2008. Estimates by Outterson (2009)
Further Issues
•OECD willingness to rbx•Setting & measuring realistic global conservation targets–Industry capture–Top down bias
•Voluntary contracts with companies (no change to IP rules)
Proposal 2•$$ for conservation, not use•Voluntary, science-driven•Significant $$ demonstration•Complete de-linkage for 1-2 especially valuable molecules
Kesselheim AS & Outterson K, Improving Antibiotic Markets,11 YJHPLE (2011); Kesselheim AS, Outterson K, Health Affairs 2010; 29(9):1689-96; Love J, Prizes, not patents, to stimulate antibiotic R&D, SciDev.Net (26 March 2008); So AS, et al. Drug Resistance Updates 2011
Strategic ABX Reserve
Further Issues
•Funding•Access/price to patients•Industry capture/targets•Informational problems with value & efficacy)
•IP coordination
Invitation•Harvard Center for Communicable Disease Dynamics Conference, Boston
•Oct. 3-4, 2011•2.5 hour program on abx incentives on Oct. 4
Antibiotic Incentives For Global
HealthWHO CEWG 2011
Kevin OuttersonBoston University Schools of Law & Public
Health Harvard Center for Communicable Disease
DynamicsPapers at www.ssrn.com
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