Abstract
Objective
Methods
Results
Conclusions
Keywords
Introduction
- Keeling N.J.
- Rosenthal M.M.
- West-Strum D.
- Patel A.S.
- Haidar C.E.
- Hoffman J.M.
Methods
Model Structure

Model Cohort
Model Input Parameters
Parameter | Base case | One-way sensitivity analysis values: min, max | Distribution (parameters) | Ref. | |
---|---|---|---|---|---|
Annual Prescription Proportion Breakdown | |||||
Antiplatelet Therapy | |||||
Clopidogrel | 0.75 | — | — | 17 | |
Prasugrel | 0.10 | — | — | 17 | |
Ticagrelor | 0.15 | — | — | 17 | |
New statin start | 0.46 | — | — | 18 | |
Statin Therapy | |||||
Simvastatin | 0.13 | — | — | 18 | |
Other statins | 0.87 | — | — | 18 | |
Warfarin Prescription | 0.30 | — | — | 10 | |
Disease State Probabilities, 30 days | |||||
Myalgia | |||||
SLCO1B1-induced | 0.0426 | 0.0347, 0.0486 | Beta (α = 182, β = 4222) | 16 , 19 , 20 | |
Non-SLCO1B1-induced | 0.0284 | 0.0223, 0.0338 | Beta (α = 122, β = 4282) | 16 , 19 , 20 | |
Myopathy | |||||
SLCO1B1-induced | 0.00111 | 0.00048, 0.00203 | Beta (α = 11.1, β = 9989) | 20 , 21 | |
Non-SLCO1B1-induced | 0.00074 | 0.00044, 0.00104 | Beta (α = 7.4, β = 9992.6) | 20 , 21 | |
Atrial fibrillation, 12 months | 0.0274 | 0.0168, 0.0408 | Beta (α = 27.4, β = 972.6) | 22 | |
Antiplatelet Therapy Event Probabilities, 12 months | |||||
Stroke | |||||
Clopidogrel, no variants in CYP2C19 | 0.0029 | 0.0014, 0.0051 | Beta (α = 14, β = 4743) | 23 ,24 ,25 | |
Clopidogrel, variants in CYP2C19 | 0.017 | 0.011, 0.024 | Beta (α = 34, β = 2005) | 23 ,24 ,25 | |
Prasugrel | 0.0072 | 0.0050, 0.0098 | Beta (α = 49, β = 6746) | 23 | |
Ticagrelor | 0.0082 | 0.0059, 0.011 | Beta (α = 56, β = 6739) | 24 | |
Myocardial Infarction | |||||
Clopidogrel, no variants in CYP2C19 | 0.059 | 0.053, 0.069 | Beta (α = 288, β = 4469) | 23 ,24 ,25 | |
Clopidogrel, variants in CYP2C19 | 0.097 | 0.087, 0.118 | Beta (α = 208, β = 1831) | 23 ,24 ,25 | |
Prasugrel | 0.054 | 0.049, 0.062 | Beta (α = 377, β = 6418) | 23 | |
Ticagrelor | 0.060 | 0.055, 0.068 | Beta (α = 417, β = 6378) | 24 | |
Major bleed | |||||
Clopidogrel, no variants in CYP2C19 | 0.013 | 0.0099, 0.018 | Beta (α = 89, β = 6627) | 23 ,24 | |
Clopidogrel, variants in CYP2C19 | 0.013 | 0.0099, 0.018 | Beta (α = 89, β = 6627) | 23 ,24 | |
Prasugrel | 0.017 | 0.014, 0.02 | Beta (α = 117, β = 6678) | 23 | |
Ticagrelor | 0.016 | 0.013, 0.02 | Beta (α = 111, β = 6795) | 24 | |
CV-related death | |||||
Clopidogrel, no variants in CYP2C19 | 0.013 | 0.0099, 0.018 | Beta (α = 64, β = 4693) | 23 ,24 ,25 | |
Clopidogrel, variants in CYP2C19 | 0.027 | 0.020, 0.037 | Beta (α = 56, β = 1983) | 23 ,24 ,25 | |
Prasugrel | 0.016 | 0.012, 0.019 | Beta (α = 107, β = 6688) | 23 | |
Ticagrelor | 0.014 | 0.011, 0.018 | Beta (α = 96, β = 6699) | 24 | |
Non-CV-related death | |||||
Clopidogrel, no variants in CYP2C19 | 0.0045 | 0.0025, 0.0070 | Beta (α = 21, β = 4736) | 23 ,24 ,26 | |
Clopidogrel, variants in CYP2C19 | 0.0080 | 0.0040, 0.013 | Beta (α = 16, β = 2023) | 23 ,24 ,26 | |
Prasugrel | 0.0063 | 0.0043, 0.0088 | Beta (α = 43, β = 6752) | 23 | |
Ticagrelor | 0.0039 | 0.0024, 0.0060 | Beta (α = 27, β = 6768) | 24 | |
Event-free | |||||
Clopidogrel, no variants in CYP2C19 | 0.91 | 0.88, 0.93 | — | — | |
Clopidogrel, variants in CYP2C19 | 0.84 | 0.80, 0.89 | — | — | |
Prasugrel | 0.90 | 0.89, 0.92 | — | — | |
Ticagrelor | 0.90 | 0.89, 0.92 | — | — | |
Statin-Associated Cardiovascular Event Probabilities, 24 months | |||||
Discontinue statin long-term after myalgia | 0.266 | — | — | 16 | |
Discontinue statin long-term after myopathy | 0.403 | — | — | 16 | |
Myocardial infarction | |||||
Adherent to statin | 0.064 | 0.055, 0.079 | Beta (α = 151, β = 2114) | 27 | |
Nonadherent to statin | 0.067 | — | — | 27 | |
Stroke | |||||
Adherent to statin | 0.012 | 0.008, 0.018 | Beta (α = 28, β = 2237) | 27 | |
Nonadherent to statin | 0.016 | — | — | 27 | |
CV-related death | Beta (α = 83, β = 2182) | ||||
Adherent to statin | 0.036 | 0.028, 0.046 | 27 | ||
Nonadherent to statin | 0.048 | — | 27 | ||
Non-CV-related death | |||||
Adherent to statin | 0.009 | 0.005, 0.015 | Beta (α = 21, β = 2244) | 27 | |
Nonadherent to statin | 0.009 | — | — | 27 | |
Event-free | |||||
Adherent to statin | 0.88 | 0.84, 0.91 | — | — | |
Nonadherent to statin | 0.86 | — | — | — | |
Atrial Fibrillation Event Probabilities for Warfarin, 3 months | |||||
Major bleed | |||||
Pharmacogenetic intervention | 0.006 | 0.002, 0.013 | Beta (α = 6, β = 982) | 28 | |
Standard dosing | 0.017 | — | — | 28 | |
Thromboembolic events | |||||
Pharmacogenetic intervention | 0.006 | 0.002, 0.013 | Beta (α = 6, β = 1012) | 29 | |
Standard dosing | 0.019 | — | — | 29 | |
All-cause mortality | |||||
Pharmacogenetic intervention | 0.011 | 0.005, 0.021 | Beta (α = 10, β = 894) | 28 | |
Standard dosing | 0.011 | 0.005, 0.021 | Beta (α = 10, β = 894) | 28 | |
Event-free | |||||
Pharmacogenetic intervention | 0.98 | 0.94, 0.99 | — | — | |
Standard dosing | 0.95 | 0.94, 0.96 | — | — | |
Prescription Cost, Annual (2016 USD) | |||||
Antiplatelet Therapy | |||||
Clopidogrel, maintenance dose, 75 mg per day | $108 | $80, $142 | Gamma (location = 0, scale = 1.63, shape = 66.3) | ||
Prasugrel, maintenance dose, 10 mg per day | $474 | $468, $480 | Gamma (location = 0, scale = 0.015, shape = 31888) | ||
Ticagrelor, maintenance dose, 90 mg twice a day | $4080 | $4007, $4153 | Gamma (location = 0, scale = 0.24, shape = 16785.9) | ||
Statin Therapy | |||||
Statin initiators | $89 | $76, $104 | Gamma (location = 0, scale = 0.43, shape = 209) | ||
Simvastatin, long-term dose, 20 to 40 mg per day | $133 | $107, $189 | Gamma (location = 0, scale = 2.13, shape = 68.04) | ||
Other statins (atorvastatin, rosuvastatin, pravastatin, lovastatin), long-term dose, doses vary by agent | $116 | $102, $132 | Gamma (location = 0, scale = 0.36, shape = 327.55) | ||
On pre-existing statin (simvastatin, atorvastatin, rosuvastatin, pravastatin, lovastatin), long-term dose, doses vary by agent | |||||
Anticoagulant | |||||
Warfarin, maintenance dose, 5 mg per day | $112 | $109, $115 | Gamma (location = 0, scale = 0.013, shape = 8649) | ||
Genetic Testing Costs (2016 USD) | |||||
Single-gene testing (CYP2C19) | $292 | $162, $465 | Gamma (location = 0, scale = 14.6, shape = 20) | 31 , 32 | |
Multigene testing (CYP2C19, SLCO1B1, CYP2C9, VKORC1) | $250 | $146, $386 | Gamma (location = 0, scale = 10.7, shape = 23.4) | Expert opinion, 6 , 14
Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers. Genet Med. October 2017; https://doi.org/10.1038/gim.2017.181 | |
Events (2016 USD) | |||||
Myopathy/myalgia | $398 | $236, $606 | Gamma (location = 0, scale = 15.9, shape = 25) | 33 | |
Nonfatal stroke | $13 874 | $6770, $23 398 | Gamma (location = 0, scale = 974.1, shape = 14.2) | 34 Centers for Medicare and Medicaid Services. Inpatient Charge Data FY 2015. Medicare Provider Utilization and Payment Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Inpatient2015.html. Accessed May 24, 2018. | |
Nonfatal myocardial infarction | $8518 | $3306, $16 504 | Gamma (location = 0, scale = 953.1, shape = 8.9) | 34 Centers for Medicare and Medicaid Services. Inpatient Charge Data FY 2015. Medicare Provider Utilization and Payment Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Inpatient2015.html. Accessed May 24, 2018. | |
Nonfatal major bleed | $7785 | $2570, $16 264 | Gamma (location = 0, scale = 1125.6, shape = 6.9) | 34 Centers for Medicare and Medicaid Services. Inpatient Charge Data FY 2015. Medicare Provider Utilization and Payment Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Inpatient2015.html. Accessed May 24, 2018. | |
Thromboembolic events | $8339 | $4954, $12 700 | Gamma (location = 0, scale = 333.5, shape = 25) | 35 | |
CV-related mortality | $15 181 | $8856, $23 398 | Gamma (location = 0, scale = 645.9, shape = 23.5) | 36 | |
Non-CV-related mortality | $14 019 | $8329, $21 353 | Gamma (location = 0, scale = 560.8, shape = 25) | 36 | |
All-cause mortality (average of CV-related and non-CV-related mortality) | $14 600 | $8674, $22 237 | Gamma (location = 0, scale = 584, shape = 25) | 36 | |
Health State Utilities (12 months) | |||||
Antiplatelet-associated and statin-associated CVD outcomes | |||||
Acute coronary syndrome, event-free survival, 65 to 74 years old | 0.88 | — | — | 37 | |
Acute coronary syndrome, event-free survival, 75 to 84 years old | 0.84 | — | — | 37 | |
Acute coronary syndrome, event-free survival, ≥85 years old | 0.80 | — | — | 37 | |
Nonfatal stroke | 0.77 | 0.74, 0.80 | Beta (α = 776.87, β = 234.68) | 15 | |
Nonfatal myocardial infarction | 0.70 | 0.52, 0.85 | Beta (α = 28.11, β = 12.05) | 38 | |
Nonfatal major bleed | 0.63 | 0.55, 0.70 | Beta (α = 141.23, β = 84.38) | 39 | |
Atrial fibrillation | |||||
No event | 0.75 | 0.66, 0.82 | Beta (α = 127.94, β = 43.79) | 40 | |
Thromboembolic events | 0.62 | 0.55, 0.69 | Beta (α = 155.26, β = 95.16) | 35 | |
Major bleed | 0.60 | 0.53, 0.67 | Beta (α = 153.06, β = 102.04) | 41 | |
Death | |||||
CV-related mortality | 0 | — | — | 42 | |
Non-CV-related mortality | 0 | — | — | 42 | |
All-cause mortality | 0 | — | — | 42 | |
Health State Disutility (12 months) | |||||
Myopathy/myalgia | 0.017 | 0.0033, 0.043 | Beta (α = 3.76, β = 217.38) | 43 |
Antiplatelet therapy selection and associated events
Statin therapy selection and associated events
Warfarin use for atrial fibrillation and associated events
Costs
- Keeling N.J.
- Rosenthal M.M.
- West-Strum D.
- Patel A.S.
- Haidar C.E.
- Hoffman J.M.
Centers for Medicare and Medicaid Services. Inpatient Charge Data FY 2015. Medicare Provider Utilization and Payment Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Inpatient2015.html. Accessed May 24, 2018.
- United States Department of Labor Bureau of Labor Statistics
- United States Department of Labor Bureau of Labor Statistics
Quality of life estimates
Life expectancy
Base-Case and Sensitivity Analyses
Results
Base-Case Scenario
Myalgia and myopathy | Discontinue statin long-term | Stroke | MI | Major bleed | TE | Deaths | Total life years | Average life years per person | |
---|---|---|---|---|---|---|---|---|---|
12 months | |||||||||
Standard of care | 4774 | 1287 | 2165 | 20 096 | 4219 | NA | 6645 | 296 678 | 0.989 |
Multigene testing | 4579 | 1234 | 1527 | 17 181 | 4498 | NA | 5741 | 297 129 | 0.990 |
Single-gene testing | 4774 | 1287 | 1527 | 17 181 | 4498 | NA | 5741 | 297 129 | 0.990 |
24 months | |||||||||
Standard of care | 4774 | 1287 | 5773 | 39 018 | 4260 | 45 | 19 948 | 583 381 | 1.945 |
Multigene testing | 4579 | 1234 | 5146 | 36 161 | 4513 | 14 | 19 085 | 584 716 | 1.949 |
Single-gene testing | 4774 | 1287 | 5146 | 36 161 | 4540 | 45 | 19 086 | 584 716 | 1.949 |
Lifetime | |||||||||
Standard of care | 4774 | 1287 | 5773 | 39 018 | 4900 | 737 | NA | 6 438 455 | 21.46 |
Multigene testing | 4579 | 1234 | 5146 | 36 161 | 4738 | 233 | NA | 6 462 435 | 21.54 |
Single-gene testing | 4774 | 1287 | 5146 | 36 161 | 5182 | 739 | NA | 6 461 650 | 21.54 |
Total cost (2016 USD) | Cost per person (2016 USD) | Total Outcome (QALY) (n) | Outcome (QALY) per person (n) | Incremental total cost (2016 USD) | Incremental total QALYs (n) | ICER (Incremental total cost [2016 USD]/ Incremental total QALY [n]) | |
---|---|---|---|---|---|---|---|
12 months | |||||||
Standard of care | 590 844 110 | 1969 | 254 983 | 0.850 | — | — | — |
Multigene testing | 645 404 459 | 2151 | 255 894 | 0.853 | 54 560 349 | 911 | 59 876 |
Single-gene testing | 657 885 201 | 2193 | 255 891 | 0.853 | 12 480 742 | −3 | Dominated |
24 months | |||||||
Standard of care | 1 023 694 372 | 3412 | 497 265 | 1.658 | — | — | — |
Multigene testing | 1 079 307 542 | 3598 | 498 925 | 1.663 | 55 613 171 | 1659 | 33 512 |
Single-gene testing | 1 092 068 491 | 3640 | 498 919 | 1.663 | 12 760 948 | −5 | Dominated |
Lifetime | |||||||
Standard of care | 1 574 907 720 | 5250 | 3 949 926 | 13.166 | — | — | — |
Multigene testing | 1 630 140 791 | 5434 | 3 964 538 | 13.215 | 55 233 072 | 14 612 | 3780 |
Single-gene testing | 1 645 260 453 | 5484 | 3 963 752 | 13.213 | 15 119 662 | −786 | Dominated |
Twelve-month outcomes
Twenty-four-month outcomes
Lifetime outcomes
One-Way Sensitivity Analysis
Probabilistic Sensitivity Analysis




Alternate Scenario
Discussion
Conclusions
Acknowledgments
Supplemental Material
- Supplementary Materials
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