Using QALYs to Using QALYs to Evaluate Chronic Evaluate Chronic

Sequelae: The Case Sequelae: The Case of Reactive of Reactive Arthritis Arthritis David ZornDavid Zorn

CFSAN-FDACFSAN-FDA

David.Zorn@fda.hhs.govDavid.Zorn@fda.hhs.gov

Background on Valuing Background on Valuing Chronic SequelaeChronic Sequelae

Buzby, Roberts, Lin, and MacDonald, Buzby, Roberts, Lin, and MacDonald, 19961996 Hemolitic Uremic Syndrome (HUS)Hemolitic Uremic Syndrome (HUS) ListeriosisListeriosis

Zorn and Klontz, 1998Zorn and Klontz, 1998 Reactive Arthritis (ReA)Reactive Arthritis (ReA)

Scharff and Jessup, 2007Scharff and Jessup, 2007 ReAReA

Apologies to othersApologies to others

Regulatory Analyses Regulatory Analyses including Valuations of including Valuations of

Chronic Sequelae Chronic Sequelae Food Safety & Inspection Service Food Safety & Inspection Service

Meat & Poultry HACCP Rule Meat & Poultry HACCP Rule (unpublished 1996)(unpublished 1996)

FDA Juice Labeling and HACCP FDA Juice Labeling and HACCP Rules (1998, 2001)Rules (1998, 2001)

FDA Egg Refrigeration & Labeling FDA Egg Refrigeration & Labeling Rule (1999, 2000)Rule (1999, 2000)

FDA Egg Production Rule (2004)FDA Egg Production Rule (2004)

Secondary Complications of Campylobacteriosis Health LossSecondary Complications of Campylobacteriosis Health Loss

SymptomSymptom MobilityMobility PhysicalPhysical SocialSocial Well-beingWell-beingQALDs QALDs

LostLost

Guillain Guillain Barre Barre SyndromeSyndrome -0.333-0.333 -0.09-0.09 -0.077-0.077

--0.1060.106 0.390.39 0.610.61

GBS GBS perm perm disabilitydisability -0.299-0.299 -0.062-0.062 -0.06-0.06

--0.0610.061 0.520.52 0.480.48

ReAReA -0.144-0.144 0.0000.000 -0.06-0.06 0.0000.000 0.800.80 0.200.20

Previous IllustrationPrevious Illustration

Simple Method for Simple Method for Valuation of Chronic Valuation of Chronic

SequelaeSequelae Adaptation of FDA’s method for acute Adaptation of FDA’s method for acute

illnessillness Monetized QALYs + Medical CostsMonetized QALYs + Medical Costs

Duration of symptoms is lengthenedDuration of symptoms is lengthened

(QALD loss/symptom) x (days) x ($ of (QALD loss/symptom) x (days) x ($ of QALD)QALD)

++

Medical CostsMedical Costs

QALY Valuation of Reactive QALY Valuation of Reactive ArthritisArthritis

DaysDays QALDs QALDs LostLost

Value of Value of QALDs QALDs Lost Lost (QALD (QALD = $630)= $630)

MedicMedical al CostsCosts

Total Total Valuation Valuation per Case per Case ReAReA

ShorShort-t-term term ReAReA

2525 10.810.8 $6,800$6,800 $100$100 $7,000$7,000

LongLong-term -term ReAReA

18,2518,2500

5,223.25,223.2 $970,00$970,0000

$5,860$5,860 $976,000$976,000