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

0

2

0

1

2

3 3

1

0

1 1

3

1 1

0

1

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2

1

2

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1 1

0

1

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1

0

1

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5

1980

1981

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1989

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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

0

7

3

2

4 4

2

4

3

2 2

8

3

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0

5

4

3

2

1 1

2

3

1 1 1 1

3

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3

0

1

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1980

1981

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Antineoplastic & Immunomodulating Agents Approved by the FDA (1980-2009). Marketed Drugs,

Linear Trend & 5 Year Moving Average

0

1 1

2

0

1

2

1 1

3 3

5

3

2

3

4

7

5

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2

4

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7

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5 5 5

8

0

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1980

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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