CDX2 biomarker testing and adjuvant therapy for stage II colon cancer: An exploratory cost-effectiveness analysis

CDX2 biomarker testing and adjuvant therapy for stage II colon cancer: An exploratory cost-effectiveness analysis

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Disease Area (Primary)

Stage II Colon Cancer

Disease Area (Secondary)

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First Developed

07/28/2021

Last Developed

08/05/2021

Software Used

R (e.g., heemod, BCEA, dampack, hesim)

Model Sponsor

Academic institution

Intervention

other_adjuvant_chemotherapy

Model Validation Score

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Results

Testing for CDX2 followed by FOLFOX for CDX2-negative patients had an incremental cost-effectiveness ratio of $5,500/QALY compared to no CDX2 testing and no FOLFOX (6.874 vs. 6.838 discounted QALYs, and $89,991 vs. $89,797 discounted USD lifetime costs). In sensitivity analyses, considering a cost-effectiveness threshold of $100,000/QALY, testing for CDX2 followed by FOLFOX on CDX2-negative patients remains cost-effective for hazard ratios less than 0.975 of the effectiveness of FOLFOX in CDX2-negative patients in reducing the rate of developing a metastatic recurrence.

Conclusion

Testing stage II colon cancer patients’ tumor for CDX2 and administration of adjuvant treatment to the subgroup found CDX2-negative is a cost-effective and high-value management strategy across a broad range of plausible assumptions.

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Model Review

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Summary
Validation Score

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Internal Comments

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Full review

01 Model Built Reflective yes
02 Model Subgroups yes
03 Model Assesses all comparators yes
04 Model Incorporates costs yes
05 Model assesses all outcomes yes

06 Model structure validated by experts yes
07 Model aligns with or justifies deviation from previous models yes

08 Time in health states yes
09 Consistency with time in states yes
10 Clinical events extractable yes
11 Consistency with number of clinical events yes
12 Impact of adverse events yes
13 Consistency with adverse events yes
14 Life-years reported yes
15 Impact on mortality yes
16a Reasons for mortality differences yes
16b Reasons for mortality differences yes
16c Reasons for mortality differences yes
16d Reasons for mortality differences yes
17 Main driver of incremental life-years yes
18 Consistency with mortality rates yes
19 No technology-specific utilities used yes
20 Main driver of cost-effectiveness yes
21 Extrapolation methods identified yes
22 Adjustable time horizon yes
23 Double counting avoided yes
24 Surrogate vs final outcomes alignment yes
25 Flexibility for treatment effect waning yes

26 Access to deterministic and Monte Carlo results yes
27 Clear trace from inputs to outcomes yes
28 Macros used only for simulation/navigation (Excel) yes

29 QALY equivalence across technologies yes
30 Extreme effectiveness impact on QALY yes
31 Slight effectiveness impact on QALY yes
32 Increased mortality lowers QALYs yes
33 Reduced mortality increases QALYs yes
34 Increased baseline risk lowers QALYs yes
35 Reduced baseline risk increases QALYs yes
36 Zero mortality leads to equal life-years yes
37 Cost change affects only total costs yes
38 Utilities = 1 makes QALYs equal life-years yes
39 No discounting increases QALYs/costs yes
40 Higher discounting decreases QALYs/costs yes
41 Shorter time horizon lowers QALYs/costs yes
42 Inputs switchable across alternatives yes
43 Cost-QALY correlation across simulations yes
44 Strong cost correlation from Monte Carlo yes
45 Strong QALY correlation from Monte Carlo yes
46 Deterministic ≈ Probabilistic results yes

47 Backward trace from results to inputs yes
48 Backward trace from results to inputs yes

49 No use of non-transparent Excel functions yes
50 No hidden sheets, rows, or columns yes
51 No custom formulas inside VBA macros yes
52 Parameters persist after macros yes
53 Transparent input structure in single worksheet yes
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