Study Details

Study Code: CA209-901

Short Name: CHECKMATE901
Drug / Compound: BMS-936558
Title: "A Phase 3, Open-label, Randomized Study of
Nivolumab Combined with Ipilimumab versus Standard
of Care Chemotherapy in Participants with Previously
Untreated Unresectable or Metastatic Urothelial
Cancer."

Budget Type: Complete

Phase: III
Patient Type: Mixed, inpatient and outpatient
Study Type: Open
Study Population Type: - Oncology

Single Patient Duration: 5Years

Visits: 16
Payment Terms:

Average Period Between Visits: 4 Weeks

Indications
(1)
ICD Code Indication Primary
Malignant Neoplasm of Urothelium, Urothelium Cancer;
189.91 (ICD9)
oncology a

Visit Description (17) Study: ARM A- Nivolomab+Ipililumab-HIGH

Description Short Name AMOUNT

Screening Visit SV 1,744.00
C01
Cycle1 Day1 Week1(N+I) C1D1W1 1,811.00
Cycle2 D1 Wk4 (N+I) C2D1W4 1,811.00 C02
Cycle3 D1 Wk7(N+I) C3D1W7 1,775.00 C03
Cycle4 D1 Wk10(N+I) C4D1W10 1,703.00 C04
Cycle5 D1 Wk16 C5D1W16 1,535.00 D01
Cycle6 D1 Wk20 C6D1W20 1,463.00 D02
Cycle7 D1 Wk24 C7D1W24 1,372.00 D03
Cycle8 D1 Wk28 C8D1W28 1,372.00 D04
Cycle9 D1 Wk32 C9D1W32 1,463.00 D05
Cycle10 D1 Wk36 C10D1W36 1,372.00 D06
Cycle11 D1 Wk40 C11D1W40 1,372.00 D07
Cycle12 D1 Wk44 C12D1W44 1,372.00 D08
Cycle13 D1 Wk48 C13D1W48 1,463.00 D09
Safety Follow-up Visit 1 FUV1 1,159.00 X01
Safety Follow-up Visit 2 FUV2 765.00 X02
Survival Follow-up Visit 1 SFUV1 274.00 Y01
TOTAL 23,826.00

Visit Schedule Study: ARM A- Nivolomab+Ipililumab-HIGH

Cost Per Procedure View

Code Procedure Qty OH Budget SV C1D1W1 C2D1W4 C3D1W7 C4D1W10 C5D1W16 C6D1W20 C7D1W24 C8D1W28 C9D1W32 C10D1W36 C11D1W40 C12D1W44 C13D1W48 FUV1 FUV2 SFUV1
INCON Informed consent 1 a 100 100
INCEX Inclusion/Exclusion criteria 1 a 150 150

Medical History & Initial Physical Exam (incl. Vital

99205
Signs, ECOG, Assessment of Signs & Symptoms, etc)
1 a 30 30

99212 Targeted Physical Exam (Vital Signs, ECOG, etc) 15 a 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20

ADEVT Adverse events, SAE 17 a 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
CONMD Concomitant medications 16 a 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45

Blood count; hemogram and platelet count, automated

85025 and automated complete differential WBC count (CBC), 16 a 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 INV
haemogram, hematology, haematology

Comprehensive metabolic panel, chemistry,

chemistries, SMAC: Includes Albumin, Bilirubin, total,
Calcium , Carbon Dioxide (bicarbonate), Chloride,
80053 Creatinine , Glucose, Phosphatase, alkaline, 14 a 120 120 120 120 120 120 120 120 120 120 120 120 120 120 120
Potassium, Protein total, Sodium, Transferase, alanine
amino (ALT) (SGPT), Transferase, aspartate amino
(AST) (SGOT), Urea Nitrogen (BUN)

Hepatic function panel: Includes Albumin, Bilirubin,

Phosphatase, alkaline, Protein total, Transferase,
80076
alanine amino (ALT) (SGPT), Transferase, aspartate
1 a 150 150 INV
amino (AST) (SGOT) ; Liver Function Test

82565 Creatinine; blood 1 a 15 15 INV

84520 Urea nitrogen (BUN); blood, serum; quantitative 1 a 25 25 INV
83735 Magnesium (Mg) 14 a 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20
83615 Lactate dehydrogenase (LD) (LDH) 14 a 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50

84100 Phosphorus inorganic (phosphate) (PO4); blood, serum 14 a 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25

82150 Amylase 1 a 12
83690 Lipase 1 a 12
84443 Thyroid stimulating hormone (TSH) 15 a 33 33 33 33 33 33 33 33 33 33 33 33 33 33 33 33 INV

84481 Triiodothyronine; free (FT3) (free T-3) (T-3 Uptake) 1 a 50 50 INV INV INV INV INV INV INV INV INV INV INV INV INV INV INV

84439 Thyroxine; free (FT4) (FT-4) (Free T-4) 1 a 50 50 INV INV INV INV INV INV INV INV INV INV INV INV INV INV INV
Infectious agent antigen detection; hepatitis B surface
87340
antigen (HBsAg)
1 a 60 60

86803 Hepatitis C antibody (HCVab) (anti-HCV) 1 a 40 40

Infectious agent detection by nucleic acid (DNA or
87522 RNA); hepatitis C quantification; HCV RNA, 0 a 325 INV
quantification

Infectious agent detection by nucleic acid (DNA or

87535 RNA); HIV-1, HIV-2, amplified probe technique, 0 a 330 INV
uncludes reverse transcription when performed

36415 Phlebotomy: Lab samples Collection and Processing 15 a 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 INV

Central Lab samples Handling and Shipping to Central

99000
Lab
10 a 46 46 46 46 46 46 46 46 46 46 46

Collection of samples, any method including blood,

T0299 serum, plasma; Serum Biomarker, PBMC, Whole Blood 22 a 30 120 120 90 30 90 30 30 30 60 60
Biomarker; PK/IG drug level samples

93000 12-lead ECG: Includes tracing, interpretation and report 1 a 50 50

Intravenous (IV) infusion for therapy / Daily facility

96365
charge
13 a 150 150 150 150 150 150 150 150 150 150 150 150 150 150

96366 Intravenous (IV) infusion for therapy 4 a 150 150 150 150 150
96409 Chemotherapy administration, intravenous (IV) 0 a 200
96411 Chemotherapy administration; intravenous, 0 a 200
Procedures Sub Total 1,028 984 984 954 894 804 744 668 668 744 668 668 668 744 599 271 145

Code Non Procedure Qty OH Budget SV C1D1W1 C2D1W4 C3D1W7 C4D1W10 C5D1W16 C6D1W20 C7D1W24 C8D1W28 C9D1W32 C10D1W36 C11D1W40 C12D1W44 C13D1W48 FUV1 FUV2 SFUV1

NP015 Pharmacy, Complex (e.g. infusions); dispense drug 17 60 120 120 120 120 60 60 60 60 60 60 60 60 60

NP021 Study Coordinator and CRF Completion Fee 16 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90

Patient Reimbursement 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40
NP025 Physician Fee 16 310 380 310 310 310 310 310 310 310 310 310 310 310 310 310 310 310
NP002 Nurse Fee, Per Hour (Lab samples, Infusion) 13 70 70 70 70 70 70 70 70 70 70 70 70 70 70
NP001 Study Coordinator - Per Hour 1 100 100
Non Procedures Sub Total 510 630 630 630 630 570 570 570 570 570 570 570 570 570 440 440 100

Overhead (all procedure costs) 20% 206 197 197 191 179 161 149 134 134 149 134 134 134 149 120 54 29

Total Cost Per Visit with Overhead 1,744 1,811 1,811 1,775 1,703 1,535 1,463 1,372 1,372 1,463 1,372 1,372 1,372 1,463 1,159 765 274

Total Cost Per Patient 23,826

Planned Number of Patients 1

Total Cost for All Patients 23,826

Total Site Costs 5,000

Total Cost Per Site 28,826

Notes
Study Details

Study Code: CA209-901

Short Name: CHECKMATE901
Drug / Compound: BMS-936558
Title: "A Phase 3, Open-label, Randomized Study of
Nivolumab Combined with Ipilimumab versus Standard
of Care Chemotherapy in Participants with Previously
Untreated Unresectable or Metastatic Urothelial
Cancer."

Budget Type: Complete

Phase: III
Patient Type: Mixed, inpatient and outpatient
Study Type: Open
Study Population Type: - Oncology

Single Patient Duration: 5Years

Visits: 16
Payment Terms:

Average Period Between Visits: 4 Weeks

Indications
(1)
ICD Code Indication Primary
Malignant Neoplasm of Urothelium, Urothelium Cancer;
189.91 (ICD9)
oncology
a

Visit Description (16) Study: Arm B- Chemotherapy-HIGH

Description Short Name AMOUNT

Screening Visit SV 1,674.00
Cycle1 Day1 Week1 C1D1W1 E01
2,946.00
Cycle 1 Day 8 Wk2 C1D8W2
Cycle2 D1 Wk4 C2D1W4
2,946.00 E02
Cycle 2 Day 8 Wk5 C2D8W5
Cycle3 D1 Wk7 C3D1W7
2,855.00 E03
Cycle 3 Day 8 Wk8 C3D8W8
Cycle4 D1 Wk10 C4D1W10
2,946.00 E04
Cycle 4 Day 8 Wk11 C4D8W11
Cycle5 D1 Wk13 C5D1W13
2,946.00 E05
Cycle 5 Day 8 Wk14 C5D8W14
Cycle6 D1 Wk16 C6D1W16
2,946.00 E06
Cycle 6 Day 8 Wk17 C6D8W17
Safety Follow-up Visit 1 FUV1 1,152.00 X01
Safety Follow-up Visit 2 FUV2 729.00 X02
Survival Follow-up Visit 1 SFUV1 274.00 Y01
TOTAL 21,414.00

Visit Schedule Study: Arm B- Chemotherapy-HIGH

Cost Per Procedure View

Code Procedure Qty OH Budget SV C1D1W1 C1D8W2 C2D1W4 C2D8W5 C3D1W7 C3D8W8 C4D1W10 C4D8W11 C5D1W13 C5D8W14 C6D1W16 C6D8W17 FUV1 FUV2 SFUV1
INCON Informed consent 1 a 100 100
INCEX Inclusion/Exclusion criteria 1 a 150 150

Medical History & Initial Physical Exam (incl. Vital

99205
Signs, ECOG, Assessment of Signs & Symptoms, etc)
1 a 30 30

99212 Targeted Physical Exam (Vital Signs, ECOG, etc) 14 a 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20

ADEVT Adverse events, SAE 16 a 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
CONMD Concomitant medications 15 a 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45 45

Blood count; hemogram and platelet count, automated

85025 and automated complete differential WBC count (CBC), 15 a 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 INV
haemogram, hematology, haematology

Comprehensive metabolic panel, chemistry,

chemistries, SMAC: Includes Albumin, Bilirubin, total,
Calcium , Carbon Dioxide (bicarbonate), Chloride,
80053 Creatinine , Glucose, Phosphatase, alkaline, 7 a 120 120 120 120 120 120 120 120
Potassium, Protein total, Sodium, Transferase, alanine
amino (ALT) (SGPT), Transferase, aspartate amino
(AST) (SGOT), Urea Nitrogen (BUN)

Hepatic function panel: Includes Albumin (82040)

Bilirubin (82247) Phosphatase, alkaline (84075)
80076 Protein, total (84155) Transferase, alanine amino 1 a 150 150 INV
(ALT) (SGPT) (84460) Transferase, aspartate amino
(AST) (SGOT) (84450); Liver Function Test
82565 Creatinine; blood 1 a 15 15 INV
84520 Urea nitrogen (BUN); blood, serum; quantitative 1 a 25 25 INV
83735 Magnesium (Mg) 7 a 20 20 20 20 20 20 20 20
83615 Lactate dehydrogenase (LD) (LDH) 7 a 50 50 50 50 50 50 50 50

84100 Phosphorus inorganic (phosphate) (PO4); blood, serum 7 a 25 25 25 25 25 25 25 25

82150 Amylase 6 a 12 12 12 12 12 12 12 12 INV

83690 Lipase 6 a 12 12 12 12 12 12 12 12 INV
84443 Thyroid stimulating hormone (TSH) 2 a 33 33 33 INV

84481 Triiodothyronine; free (FT3) (free T-3) (T-3 Uptake) 1 a 50 50 INV INV

84439 Thyroxine; free (FT4) (FT-4) (Free T-4) 1 a 50 50 INV INV

Infectious agent antigen detection; hepatitis B surface
87340
antigen (HBsAg)
1 a 60 60

86803 Hepatitis C antibody (HCVab) (anti-HCV) 1 a 40 40

Infectious agent detection by nucleic acid (DNA or
87522 RNA); hepatitis C quantification; HCV RNA, 0 a 325 INV
quantification

Infectious agent detection by nucleic acid (DNA or

87535 RNA); HIV-1, HIV-2, amplified probe technique, 0 a 330 INV
uncludes reverse transcription when performed

36415 Phlebotomy: Lab samples Collection and Processing 15 a 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 INV

Central Lab samples Handling and Shipping to Central

99000
Lab
7 a 46 46 46 46 46 46 46 46

Collection of samples, any method including blood,

T0299 serum, plasma; Serum Biomarker, PBMC, Whole Blood 7 a 30 30 30 30 30 30 30 30
Biomarker; PK/IG drug level samples

93000 12-lead ECG: Includes tracing, interpretation and report 1 a 50 50

Intravenous (IV) infusion for therapy/ Daily facility

96365
Charge
0 a 150

96366 Intravenous (IV) infusion for therapy 0 a 150

Chemotherapy administration, intravenous (IV); daily
96409
facility
12 a 200 200 200 200 200 200 200 200 200 200 200 200 200

96411 Chemotherapy administration; 6 a 200 200 200 200 200 200 200
Procedures Sub Total 1,028 985 470 985 470 909 470 985 470 985 470 985 470 593 241 145

Code Non Procedure Qty OH Budget SV C1D1W1 C1D8W2 C2D1W4 C2D8W5 C3D1W7 C3D8W8 C4D1W10 C4D8W11 C5D1W13 C5D8W14 C6D1W16 C6D8W17 FUV1 FUV2 SFUV1

NP015 Pharmacy, Complex (e.g. infusions); dispense drug 18 60 120 60 120 60 120 60 120 60 120 60 120 60

NP021 Study Coordinator and CRF Completion Fee 15 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90 90

Patient Reimbursement 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40
NP025 Physician Fee 15 310 310 310 310 310 310 310 310 310 310 310 310 310 310 310 310
NP002 Nurse Fee, Per Hour (Lab samples, Infusion) 12 70 70 70 70 70 70 70 70 70 70 70 70 70
NP001 Study Coordinator - Per Hour 1 100 100
Non Procedures Sub Total 440 630 570 630 570 630 570 630 570 630 570 630 570 440 440 100

Overhead (all procedure costs) 20% 206 197 94 197 94 182 94 197 94 197 94 197 94 119 48 29

Total Cost Per Visit with Overhead 1,674 1,812 1,134 1,812 1,134 1,721 1,134 1,812 1,134 1,812 1,134 1,812 1,134 1,152 729 274
2,946.00 2,946.00 2,855.00 2,946.00 2,946.00 2,946.00
Total Cost Per Patient 21,414

Planned Number of Patients 1

Total Cost for All Patients 21,414

Total Site Costs

Total Cost Per Site 21,414

Notes