Dabigatran versus warfarin under standard or pharmacogenetic-guided management for the prevention of stroke and systemic thromboembolism in patients with atrial fibrillation: a cost/utility analysis using an analytic decision model

Nshimyumukiza, Léon; Duplantie, Julie; Gagnon, Mathieu; Douville, Xavier; Fournier, Diane; Lindsay, Carmen; Parent, Marc; Milot, Alain; Giguère, Yves; Gagné, Christian; Rousseau, François; Reinharz, Daniel

doi:10.1186/1477-9560-11-14

Table 1 Model input parameters

From: Dabigatran versus warfarin under standard or pharmacogenetic-guided management for the prevention of stroke and systemic thromboembolism in patients with atrial fibrillation: a cost/utility analysis using an analytic decision model

Parameter				Baseline	Range for sensitivity analysis	Distribution	Reference(s)
Event probabilities
Percentage of INR time in therapeutic range (2-3) in warfarin usual standard dosing				64%	55-69%	Beta	[16]
Proportion of INR time range below therapeutic range (<2)				54%	45-60%		[13]
Percentage of increasing of TTR by warfarin pharmacogenetic guided dosing				7.3%	0-30%		[13]
Risk of major bleedings INR in therapeutic range				1.4%	0.9-2.3%		[32, 33]
Relative risk of major bleedings INR above therapeutic range				1	-	Fixed (reference)
Relative risk of major bleedings INR below therapeutic range				4.7	3.57-10	Log-normal
Relative risk of major hemorrhagic event dabigatran 150 mg vs warfarin				0.93	0.81-1.07	Log-normal	[16, 17, 28, 29]
Major hemorrhagic events (warfarin treatment)		Proportion intracranial		42%	20-45%	Beta	[24, 31]
Major hemorrhagic events (warfarin treatment)		Proportion extracranial		58%	55-80%		[31]
Proportion major hemorrhagic events Dabigatran 150 mg		% Intracranial		12.6%	6.3-13.4%		[14, 18–20]
Proportion major hemorrhagic events Dabigatran 150 mg		% Extracranial		90.4%	86.6-93.7		[14, 18–20]
Risk of major thromboembolic events INR in therapeutic range				2.4%	1.2-4.9		[32, 34]
Relative risk of major thromboembolic events INR above therapeutic range				3.5	2.8-44	Log normal
Relative risk of major thromboembolic events INR below therapeutic range				0.9	0.6-1.3
Relative risk of major thromboembolic events dabigatran 150 vs warfarin		Stroke and systemic embolism		0.66	0.53-0.82		[16]
		MI		1.38	1-1.91
		PE		1.61	0.76-3.42
Major thromboembolic events (warfarin treatment)		% Stroke		52.5%		Fixed	[35]
		% Myocardial infarctus (MI)		12.5%
		% Pulmonary embolism (PE)		30%
		% Deep venous thrombosis (DVT)		5%
Complications	Major hemorrhagic event	intracranial	No deficit	8%			[31, 36]
			Mild deficit	16%
			Severe deficit	34%
			Death	42% (first month)
		Extracranial		2%			[31]
	Major thromboembolismevent	Stroke		Month 1 : 8.3%			[24, 36, 37]
		Death		Months 2 and 3 : 5.6% per month
		Severe deficit		40.2%
		Mild deficit		42.5%
		No deficit		9.1%
		Death PE		12%			[38, 39]
		Death DVT		6%			[38, 40]
		Death IM		7%			[24]
Treatment discontinuation after a major event		Intracranial hemorrhage		100% during the entire period			[26] and expert opinion
Treatment discontinuation after a major event		Extracranial hemorrhage		100% during 30 days			[26] and expert opinion
Costs (CAD$)
Drug costs		Dabigatran 150 mg		3.20/day	1-5	Gamma	[41]
		Warfarin 5 mg		0.074/day	0.03-0.1	Gamma
		LMWH		27.90/5 days	-	Fixed
INR monitoring (first year)		SD-W		8.06/month	5-12	Gamma	[42]
INR monitoring (first year)		GT-W		5/month	2-8		Assumption
INR monitoring (subsequent years)				4.03/month	2-6		Assumption
Genetic tests (CYP2C9 and VKORC1)				615	100-1000		[43, 44]
One-time event treatment costs		Ischemic stroke, no deficit		845	500-100		[43, 44]
		Ischemic stroke, mild deficit		23772	15000-40000		[43–45]
		Ischemic stroke, severe deficit		42620	30000-60000		[43–46]
		Intracranial hemorrhage (ICH), non deficit		1067	25000-50000		[43–45]
		ICH mild deficit		21218	15000-25000		[43–45]
		ICH severe deficit		36451	25000-50000		[43–45]
		Subdural hematoma		31942	20000-45000		[43–45]
		Extra cranial hemorrhage		8146	5000-12000		[43, 44]
		DVT		2576	1500-4000		[43, 44]
		PE		8799	5000-9000		[43, 45]
		MI		7177	5000-15000		[43, 45]
Post-event cost		Severe disability stroke/ICH		6259/month	3000-10000		[44–46]
Post-event cost		Mild disability stroke/ICH		1855/month	1000-3000		[44–46]
Health utilities
Warfarin no event				0.95	0.95-0.98	Beta	[21, 47, 48]
Dabigatran no event				0.95	0.95-0.98		[21, 47, 48]
Major bleeding		ICH	No deficit	0.51	0.15-0.60		[21, 47, 48]
			Mild deficit	0.75	0.70-0.90
			Severe deficit	0.95	0.90-0.95
		Extracranial		0.80	0.75-0.85
Stroke		No deficit		0.95	0.90-0.95		[21, 47, 48]
		Minor		0.75	0.70-0.90
		Severe		0.39	0.15-0.50
MI				0.84	0.80-0.90		[21, 47, 48]
PE				0.76	0.70-0.90		[21, 47, 48]
DVT				0.84	0.80-0.90		[21, 47, 48]

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