![Page 1: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/1.jpg)
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
[email protected]@fda.hhs.gov
![Page 2: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/2.jpg)
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
![Page 3: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/3.jpg)
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Meat & Poultry HACCP Rule Meat & Poultry HACCP Rule (unpublished 1996)(unpublished 1996)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)
![Page 4: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/4.jpg)
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
![Page 5: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/5.jpg)
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
![Page 6: Using QALYs to Evaluate Chronic Sequelae: The Case of Reactive Arthritis David Zorn CFSAN-FDADavid.Zorn@fda.hhs.gov](https://reader035.vdocuments.net/reader035/viewer/2022072016/56649ee15503460f94bf2196/html5/thumbnails/6.jpg)
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