Hemostatic Agents: Cost-Effectiveness Issues

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Hemostatic Agents Cost-Effectiveness Issues

• Peter K. Smith, MD
• Professor and Chief
• Thoracic Surgery
• Duke University

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Tranexamic RCT Cardiac Surgery (n163) 10 mg/kg
(incision) ? 1 mg/kg/hr
Horrow et al. Circulation 1991 842063
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Aprotinin vs EACA Efficacy - Demographics
Bennett-Guerrero et al. Anesthesiology
1997871373
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Aprotinin vs EACA Efficacy
Bennett-Guerrero et al. Anesthesiology
1997871373
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High-Dose Aprotinin
Original Administration Regimen
Royston et al Lancet 1987 Dec 521289-91
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Aprotinin Dosing
Mossinger et al, ATS 199865S45-51
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Aprotinin Dosing

• Half-dose FDA Regimen B
• 1 ml (10,000 KIU) test dose
• 100 ml (1,000,000 KIU) loading dose
• 100 ml (1,000,000 KIU) pump prime
• 25 ml (250,000 KIU) per hour CPB

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Aprotinin Dosing
Mossinger et al, ATS 199865S45-51
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Aprotinin Effect on Survival
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Aprotinin and Myocardial Infarction
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Aprotinin and Stroke Incidence


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Cost of Therapy

• Drug cost
• Cost of storage and administration
• Indirect costs
• Cost of complications related to the drug
• In-Hospital
• Lifetime

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Cost Savings

• Reduction of blood products and their
  complications
• Reduced OR time and incidence of return
• Reduction of inflammatory syndrome
• Reduction of complications related to the drug
• Cardiac team satisfaction
• Patient satisfaction

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Aprotinin vs EACA - Efficacy/Cost

• Prospective randomized double-blind trial
• Repeat median sternotomy- CABG, valve, or both
• n 204
• High dose EACA or Aprotinin (on incision)
• Efficacy analysis
• Cost/benefit analysis (bleeding related costs)

Bennett-Guerrero et al. Anesthesiology
1997871373
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Aprotinin vs EACA Cost/Benefit

• Perspective of the hospital
• Bleeding related costs (not charges), e.g. drug,
  direct indirect blood product costs, OR time
• No differences in other outcomes expected or seen
• Costs Aprotinin Rx higher (1,813 vs 1,088)
• Sensitivity analysis w/ half dose aprotinin- no
  chg
• Threshold value for aprotinin 486

Bennett-Guerrero et al. Anesthesiology
1997871373
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Lifetime Cost of Therapy

• Myocardial Infarction Lifetime Costs
• 25,000 more than matched (age, gender) patients
  without MI
• With an incidence of 1, 1 of 100 patients would
  generate 25,000 in total cost or
• 250 per patient per percent MI change
• Stroke Lifetime Costs
• 100,000 more than matched patients without
  stroke
• With an incidence of 1, 1 of 100 patients would
  generate 100,000 total cost or
• 1000 per patient per percent stroke change

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Cost Effectiveness of Aprotinin

• Drug cost is dose dependent and linear
• Effects are dose dependent and non-linear
• Effects are only well known at the three doses
  tested in double-blind trials

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Aprotinin Dose vs Hemostatic Factors Given
Data from US Multicenter Studies for Repeat CABG
Surgery
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Aprotinin Dose vs Hemostatic Factors vs Cost
1200
600
Data from US Multicenter Studies for Repeat CABG
Surgery
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Aprotinin Dose vs Definite MI
10
5
Data from US Multicenter Studies for All CABG
Surgery
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Aprotinin Dose vs Mortality
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2.5
Data from US Multicenter Studies for All CABG
Surgery
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Aprotinin Dose vs Stroke Outcome
3
2
1
Data from US Multicenter Studies for All CABG
Surgery
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Randomized Trial Analysis

• Resources used (OR time, blood tx, ICU LOS, Total
  LOS, etc, etc) as well as age, gender and
  complication rate were analyzed from the
  randomized patients.
• Model developed on Duke 1300 CABG patients with
  same resources related multivariably to actual
  cost.
• Adjusted model R20.74

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Randomized Trial Composition
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Cost Model Coefficients
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Itemized Resources-Primary CABG
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Complications-Primary CABG
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Randomized Trial Resource Use Data Primary
CABG Transformed to Cost Through Duke Data Model
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Cost-Primary CABG
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Itemized Resources-Redo CABG
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Complications-Redo CABG
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Randomized Trial Resource Use Data Redo
CABG Transformed to Cost Through Duke Data Model
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Cost-Redo CABG