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Table 1. Model Parameters.

From: Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer

Base Min Max Range Reference
Prevalence
EGFR 0.53 0.424 0.636 ±20％ (10)
ALK 0.038 0.030 0.046 ±20％
ROS1 0.009 0.007 0.011 ±20％
BRAF 0.003 0.002 0.004 ±20％
MET ex14 skipping 0.028 0.022 0.034 ±20％
RET 0.019 0.015 0.023 ±20％
NTRK 0.002 0.002 0.002 ±20％
Other 0.371
Test success rate
Oncomine™ DxTT 0.917 0.7336 1 ±20％
(Max 1)		 (21)
CobasⓇ EGFR Mutation Test v2 0.994 0.7952 1 ±20％
(Max 1)
Histofine ALK iAEPⓇ Kit 1 0.8 1 ±20％
(Max 1)
AmoyDxⓇ ROS1 Gene Fusions Detection Kit 1 0.8 1 ±20％
(Max 1)
ArcherⓇ MET Companion Diagnostic System 0.9388 - - - (22)
FoundationOneⓇ CDx 1 - - - (23)
Test performance
Sensitivity Oncomine™ Dx TT 0.900 1.000 ±20％
(Max 1)		 (24)
Specificity Oncomine™ Dx TT 0.991 1.000 ±20％
(Max 1)
Sensitivity CobasⓇ EGFR Mutation Test v2 0.808 1.000 ±20％
(Max 1)		 (25)
Specificity CobasⓇ EGFR Mutation Test v2 0.987 1.000 ±20％
(Max 1)
Sensitivity Histofine ALK iAEPⓇ Kit 0.980 1.000 ±20％
(Max 1)		 (26)
Specificity Histofine ALK iAEPⓇ Kit 0.990 1.000 ±20％
(Max 1)
Sensitivity AmoyDxⓇ ROS1 Gene Fusions Detection Kit 1.00 1.000 ±20％
(Max 1)		 (27)
Specificity AmoyDxⓇ ROS1 Gene Fusions Detection Kit 1.00 1.000 ±20％
(Max 1)
Sensitivity ArcherⓇ MET Companion Diagnostic System 0.939 0.751 1.000 ±20％
(Max 1)		 (22)
Specificity ArcherⓇ MET Companion Diagnostic System 0.983 0.786 1.000 ±20％
(Max 1)
Sensitivity FoundationOneⓇ CDx 0.737 0.590 0.884 ±20％ (23)
Specificity FoundationOneⓇ CDx 1.000 0.800 1.000 ±20％
(Max 1)
Utility
First-line PF 0.71 0.67 0.76 95%CI (13)
First-line PD 0.67 0.59 0.75 95%CI
Osimertinib（EGFR）
mPFS 18.9 15.2 21.4 95% CI (28), (29)
mOS 38.6 34.5 41.8 95% CI
Alectinib（ALK）
mPFS 34.1 22.1 NR 95% CI (30)
mOS 69.6 55.68 83.52 ±20％
Crizotinib（ROS1）
mPFS 15.9 12.9 24 95% CI (31)
mOS 32.5 26 39 ±20％
Dabrafenib + trametinib（BRAF）
mPFS 10.9 7 16.6 95% CI (32)
mOS 24.6 12.3 NE 95% CI
Tepotinib（MET）
mPFS 11.0 1.4 NR 95% CI (33), (34)
mOS 19.1 7.9 NR 95% CI
Selpercatinib（RET）
mPFS 22 13.8 NR 95% CI (35)
mOS 25.2 20.16 30.24 ±20％
Entrectinib（NTRK）
mPFS 14.9 11.9 17.9 ±20％ (36), (37)
mOS 21 14.9 NE 95% CI
Pembrolizumab + chemotherapy
mPFS 9.0 8.1 10.4 95% CI (38)
mOS 22 19.5 24.5 95% CI
Drug cost (per month)
Osimeltinib ¥621,582 ¥497,266 ¥745,898 ±20％ (14)
Alectinib ¥808,452 ¥646,762 ¥970,142 ±20％
Crizotinib ¥700,176 ¥560,141 ¥840,211 ±20％
Dabrafenib + trametinib ¥1,761,432 ¥1,409,146 ¥2,113,718 ±20％
Tepotinib ¥863,940 ¥691,152 ¥1,036,728 ±20％
Selpercatinib ¥838,140 ¥670,512 ¥1,005,768 ±20％
Entrectinib ¥906,570 ¥725,256 ¥1,087,884 ±20％
Pembrolizumab + chemotherapy ¥910,163 ¥728,130 ¥1,092,195 ±20％
Test cost（per one time)
Oncomine™ Dx TT ¥140,000 ¥112,000 ¥168,000 ±20％ (6)
EGFR/ALK/ROS1 (CobasⓇ EGFR, Histofine ALK, AmoyDxⓇ ROS1) ¥60,000 ¥48,000 ¥72,000 ±20％ (39)
EGFR/ALK ¥40,000 - - -
EGFR ¥25,000 - - -
ArcherⓇ MET Companion Diagnostic System ¥50,000 ¥40,000 ¥60,000 ±20％ (40)
FoundationOneⓇ CDx ¥50,000 ¥40,000 ¥60,000 ±20％ (41)
Other cost
Outpatient chemotherapy - - - - -
　Outpatient service fee ¥740 - - - (14), (42)
　Prescription fee ¥420 - - -
　Prescription fee for anticancer drug ¥680 - - -
　Outpatient chemotherapy ¥7,000 - - -
　Intravenous drip fee (/day) ¥990 - - -
　Preparation in sterile environment ¥450 - - -
Disease monitoring - - - -
　Blood-drawing fee (/day) ¥370 - - -
　Peripheral blood test fee ¥210 - - -
　Peripheral blood test diagnostic fee ¥1,250 - - -
　Biochemical test fee ¥1,060 - - -
　Biochemical test diagnostic fee ¥1,450 - - -
　Tumor marker test fee ¥4,080 - - -
　CT scan with a contrast medium ¥10,200 - - -
　CT scan diagnostic fee ¥4,500 - - -
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Table 2. Base Case Results.

From: Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer

Strategy Cost per patient
(JPJPY)		 Incremental cost
(JPJPY)		 Effectiveness
(QALY)		 Incremental effectiveness
(QALY)		 ICER
(ΔCost/ΔQALY)
Strategy B: Three single-gene tests (EGFR/ALK/ROS1) ¥12,083,034 - 21.68 - Dominant
Strategy A: Oncomine™ Dx TT ¥12,298,099 ¥215,064 21.52 −0.16
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Table 3. Base Case Results (Cost, Effectiveness of Each Strategy).

From: Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer

Cost per patient
(JPJPY)		 Effectiveness
(QALY)		 ICER
(ΔCost/ΔQALY)
Strategy D: No genetic testing ¥10,236,314 15.10 -
Strategy C: One single-gene test
　　　　　 (EGFR)		 ¥11,172,603 20.07 ¥188,281
Strategy B: Three single-gene tests
　　　　　 (EGFR/ALK/ROS1)		 ¥12,083,034 21.68 ¥566,433
Strategy A: Oncomine™ Dx TT ¥12,298,099 21.52 Dominated
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Table 4. Sensitivity Analysis Results.

From: Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer

Min Max
Parameters Base Min Max Range ΔQALY ΔCost ICER ΔQALY ΔCost ICER
Prevalence: EGFR 0.53 0.424 0.636 ±20％ −0.43 ¥195,140 Dominated −0.60 ¥149,581 Dominated
Prevalence: ALK 0.038 0.0304 0.0456 ±20％ −0.49 ¥185,972 Dominated −0.54 ¥158,749 Dominated
Prevalence: ROS1 0.009 0.0072 0.0108 ±20％ −0.51 ¥172,633 Dominated −0.51 ¥172,088 Dominated
Prevalence: BRAF 0.003 0.0024 0.0036 ±20％ −0.51 ¥167,346 Dominated −0.51 ¥177,375 Dominated
Prevalence: MET ex14 0.028 0.0224 0.0336 ±20％ −0.50 ¥178,290 Dominated −0.53 ¥166,431 Dominated
Prevalence: RET 0.019 0.0152 0.0228 ±20％ −0.52 ¥142,014 Dominated −0.50 ¥202,707 Dominated
Prevalence: NTRK 0.002 0.0016 0.0024 ±20％ −0.51 ¥172,336 Dominated −0.51 ¥172,385 Dominated
Utility: First line Progression-free 0.71 0.67 0.76 95%CI −0.51 ¥172,361 Dominated −0.52 ¥172,361 Dominated
Utility: First line Progressive disease 0.67 0.59 0.75 95%CI −0.46 ¥172,361 Dominated −0.56 ¥172,361 Dominated
mPFS: Osimeltinib (EGFR) 18.9 15.2 21.4 95% CI −0.51 ¥269,850 Dominated −0.52 ¥106,490 Dominated
mOS: Osimeltinib (EGFR) 38.6 34.5 41.8 95% CI −0.40 ¥172,361 Dominated −0.60 ¥172,361 Dominated
mPFS: Alectinib (ALK) 34.1 22.1 NR 95% CI −0.51 ¥207,672 Dominated −0.51 ¥152,292 Dominated
mOS: Alectinib (ALK) 69.6 55.68 83.52 ±20％ −0.48 ¥172,361 Dominated −0.55 ¥172,361 Dominated
mPFS: Crizotinib (ROS1) 15.9 12.9 24 95% CI −0.51 ¥179,761 Dominated −0.51 ¥152,379 Dominated
mOS: Crizotinib (ROS1) 32.5 26 39 ±20％ −0.50 ¥172,361 Dominated −0.53 ¥172,361 Dominated
mPFS: Dabrafenib + trametinib (BRAF) 10.9 7 16.6 95% CI −0.51 ¥153,315 Dominated −0.51 ¥200,197 Dominated
mOS: Dabrafenib + trametinib (BRAF) 24.6 12.3 NE 95% CI −0.53 ¥172,361 Dominated −0.50 ¥172,361 Dominated
mPFS: Tepotinib (MET) 11 1.4 NR 95% CI −0.53 ¥−165,178 ¥313,162 −0.51 ¥249,713 Dominated
mOS: Tepotinib (MET) 19.1 7.9 NR 95% CI −0.81 ¥172,361 Dominated −0.41 ¥172,361 Dominated
mPFS: Selpercatinib (RET) 22 13.8 NR 95% CI −0.52 ¥49,330 Dominated −0.51 ¥238,377 Dominated
mOS: Selpercatinib (RET) 25.2 20.16 30.24 ±20％ −0.57 ¥172,361 Dominated −0.45 ¥172,361 Dominated
mPFS: Entrectinib (NTRK) 14.9 11.92 17.88 ±20％ −0.51 ¥168,581 Dominated −0.51 ¥176,140 Dominated
mOS: Entrectinib (NTRK) 21 14.9 NE 95% CI −0.52 ¥172,361 Dominated −0.51 ¥172,361 Dominated
mPFS: Pembrolizumab + chemotherapy 9.0 8.1 10.4 95% CI −0.51 ¥172,361 Dominated −0.51 ¥172,361 Dominated
mOS: Pembrolizumab + Chemotherapy 22 19.5 24.5 95% CI −0.51 ¥172,361 Dominated −0.51 ¥172,361 Dominated
Test Success Rate: Oncomine™ DxTT 0.917 0.7336 1 ±20％
(Max 1)		 −1.88 ¥−209,422 ¥111,509 0.11 ¥345,141 ¥3,265,726
Test Success Rate: CobasⓇ EGFR Mutation Test v2 0.994 0.7952 1 ±20％
(Max 1)		 0.69 ¥392,501 ¥569,742 −0.55 ¥165,716 Dominated
Test Success Rate: Histofine ALK iAEPⓇ Kit 1 0.8 1 ±20％
(Max 1)		 −0.26 ¥312,298 Dominated −0.51 ¥172,361 Dominated
Test Success Rate: AmoyDxⓇ ROS1 Gene Fusions Detection Kit 1 0.8 1 ±20％
(Max 1)		 −0.50 ¥175,593 Dominated −0.51 ¥172,361 Dominated
Test Performance: Sensitivity Oncomine™ DxTT 0.900 0.72 1 ±20％
(Max 1)		 −2.89 ¥−1,131,752 ¥391,610 −0.36 ¥247,184 Dominated
Test Performance: Specificity Oncomine™ DxTT 0.991 0.793 1 ±20％
(Max 1)		 20.77 ¥15,328,4557 ¥738,009 −0.51 ¥172,361 Dominated
Test Performance: Sensitivity ArcherⓇ MET Companion Diagnostic System 0.939 0.75104 1 ±20％
(Max 1)		 −0.58 ¥124,865 ¥−216,707 −0.49 ¥187,842 Dominated
Test Performance: Specificity ArcherⓇ MET Companion Diagnostic System 0.983 0.7864 1 ±20％
(Max 1)		 1.81 ¥1,898,776 ¥1,050,673 −0.71 ¥23,077 Dominated
Test Performance: Sensitivity FoundationOneⓇ CDx 0.737 0.5896 0.8844 ±20％ −0.52 ¥168,581 Dominated −0.51 ¥176,140 Dominated
Test Performance: Specificity FoundationOneⓇ CDx 1.000 0.8 1 ±20％
(Max 1)		 2.17 ¥2,731,206 ¥1,257,468 −0.51 ¥172,361 Dominated
Test Performance: Sensitivity CobasⓇ EGFR Mutation Test 0.808 0.6464 0.9696 ±20％
(Max 1)		 0.82 ¥394,758 ¥481,412 −1.15 ¥35,730 Dominated
Test Performance: Specificity CobasⓇ EGFR Mutation Test 0.987 0.7896 1 ±20％
(Max 1)		 −1.24 ¥17,749 Dominated −0.46 ¥182,221 Dominated
Test Performance: Sensitivity Histofine ALK iAEPⓇ Kit 0.980 0.784 1 ±20％
(Max 1)		 0.08 ¥352,203 ¥4,402,538 −0.51 ¥172,361 Dominated
Test Performance: Specificity Histofine ALK iAEPⓇ Kit 0.990 0.792 1 ±20％
(Max 1)		 −6.43 ¥−3,292,145 ¥511,998 −0.51 ¥172,361 Dominated
Test Performance: Sensitivity AmoyDxⓇ ROS1 Gene 1.00 0.80 1 ±20％
(Max 1)		 −0.15 ¥217,585 Dominated −0.52 ¥171,756 Dominated
Test Performance: Specificity AmoyDxⓇ ROS1 Gene 1.00 0.80 1 ±20％
(Max 1)		 −1.61 ¥−62,518 ¥38,831 −0.49 ¥176,524 Dominated
Drug Cost: Osimeltinib ¥621,582 ¥497,266 ¥745,898 ±20％ −0.51 ¥267,125 Dominated −0.51 ¥77,597 Dominated
Drug Cost: Alectinib ¥808,452 ¥646,762 ¥970,142 ±20％ −0.51 ¥191,672 Dominated −0.51 ¥153,049 Dominated
Drug Cost: Crizotinib ¥700,176 ¥560,141 ¥840,211 ±20％ −0.51 ¥179,865 Dominated −0.51 ¥164,856 Dominated
Drug Cost: Dabrafenib + trametinib ¥1,761,432 ¥1,409,146 ¥2,113,718 ±20％ −0.51 ¥161,903 Dominated −0.51 ¥182,819 Dominated
Drug Cost: Tepotinib ¥863,940 ¥691,152 ¥1,036,728 ±20％ −0.51 ¥97,746 Dominated −0.51 ¥246,975 Dominated
Drug Cost: Selpercatinib ¥838,140 ¥670,512 ¥1,005,768 ±20％ −0.51 ¥108,750 Dominated −0.51 ¥235,971 Dominated
Drug Cost: Entrectinib ¥906,570 ¥725,256 ¥1,087,884 ±20％ −0.51 ¥168,709 Dominated −0.51 ¥176,012 Dominated
Drug Cost: Pembrolizumab plus Chemotherapy ¥1,092,195 ¥873,756 ¥1,310,634 ±20％ −0.51 ¥183,704 Dominated −0.51 ¥161,017 Dominated
Test Cost: Oncomine™ DxTT ¥140,000 ¥112,000 ¥168,000 ±20％ −0.51 ¥144,361 Dominated −0.51 ¥200,361 Dominated
Test Cost: EGFR/ALK/ROS1 ¥60,000 ¥48,000 ¥72,000 ±20％ −0.51 ¥184,361 Dominated −0.51 ¥160,361 Dominated
Test Cost: ArcherⓇ MET Companion Diagnostic System ¥50,000 ¥40,000 ¥60,000 ±20％ −0.51 ¥172,361 Dominated −0.51 ¥172,361 Dominated
Test Cost: FoundationOneⓇ CDx ¥50,000 ¥40,000 ¥60,000 ±20％ −0.51 ¥172,361 Dominated −0.51 ¥172,361 Dominated
Other Cost: Tyrosine kinase inhibitors ¥31,700 ¥25,360 ¥38,040 ±20％ −0.51 ¥172,831 Dominated −0.51 ¥171,890 Dominated
Other Cost: Pembrolizumab + chemotherapy ¥45,173 ¥36,138 ¥54,208 ±20％ −0.51 ¥172,830 Dominated −0.51 ¥171,891 Dominated
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Table 5. Scenario Analysis Results.

From: Cost-effectiveness Analysis of the Oncomine™ Dx Target Test MultiCDx System Using Next-generation Sequencing and Single-gene Test in Advanced and Recurrent Nonsquamous Non-small-cell Lung Cancer

Scenario ΔQALY ΔCost ICER
(ΔCost/ΔQALY)
Scenario 1 The prevalence of gene mutations is based on overseas data (15) 0.220 ¥831,845 JPY3,781,114/QALY
Scenario 2 Treatment of CDDP + PEM for negative driver gene mutation 0.530 ¥−2,357,678 Dominant
Scenario 3 The effect of tepotinib (MET) is based on the results of all analyses (VISION study) instead of the Japanese subanalysis −0.220 ¥127,164 Dominated
Scenario 4 The effect of crizotinib (ROS1) is based on the results of all analyses (PROFILE1001) instead of Asian analysis −0.080 ¥231,504 Dominated
Scenario 5 The success rate for each genetic test is 100% 0.390 ¥383,509 JPY983,356/QALY
Scenario 6 The sensitivity/specificity of each genetic test is 100% −0.580 ¥112,417 Dominated
Scenario 7 Archer MET, FoundationOne test is not conducted after Oncomine DxTT −0.080 ¥244,589 Dominated
Scenario 8 The test success rate of Cobas EGFR is comparable to that of Oncomine DxTT (91.7%) 0.220 ¥285,657 JPY285,657/QALY
Scenario 9 The QALY of tepotinib (MET) and entrectinib (NTRK) is comparable to that of Crizotinib (ROS1) (QALY=22.4) 0.210 ¥215,064 JPY1,024,114/QALY
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