In 2009, RE-LY1 trial introduced a new oral anticoagulant that changed the anticoagulation world. Dabigatran (Pradaxa®), the first oral direct thrombin inhibitor, was introduced as a safer alternative to warfarin for the management of patients with non-valvular atrial fibrillation (NVAF). However, its associated cost was a major limitation for its use.
A recent critical review2 aimed to assess the quality-adjusted survival, costs, and cost effectiveness of dabigatran compared with adjusted-dose warfarin for ischemic stroke prevention in patients 65 years of age or older with rate-controlled NVAF has been published with promising results. The review used data mainly from study done by Freeman et al. which was a comprehensive societal cost-effectiveness analysis (CEA) that used a Markov decision model to compare dabigatran with adjusted dose warfarin by following a hypothetical cohort of NVAF patients 65 years of age or older and CHADS2 ≥1 over their lifetime. The main outcome measures were quality-adjusted life year (QALY), costs (in 2008 US dollars), and incremental cost-effectiveness ratios (ICERs). The willingness-to-pay threshold was set at $50,000 per additional QALY. Of note, however, despite the “societal” design, many direct and indirect costs and opportunity costs remained unaccounted for.
The study reported that in their case-based model, quality-adjusted life expectancy was 10.28 QALYs for warfarin, 10.70 QALYs with low-dose dabigatran, and 10.84 QALYs with high dose dabigatran. The total costs were $143,193, $164,576, and $168,398, respectively. Compared with warfarin, low-dose dabigatran and high-dose dabigatran ICERs were respectively $51,229 and $45,372 per QALY gained. However, the price of dabigatran was based on United Kingdom price estimate which valued dabigatran at a cost of $ (U.S dollar) 13/day. After adjusting for a dabigatran cost closer to the actual US market price ($8/day), the ICER for high-dose dabigatran was reduced to roughly $12,000 per additional QALY gained. The results favored high-dose (150mg bid) dabigatran ($12,286 per QALY) as a cost-effective alternative to warfarin for the prevention of ischemic stroke in patients 65 years of age or older with NVAF. Sensitivity analysis asserted that the cost effectiveness of dabigatran improved if it was used in populations with high risk of stroke or intracranial hemorrhage.
1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2010;361:1139-1151.
2. Adcock AK, Lee-Iannotti JK, Aguilar MI, et al. Is dabigatran cost effective compared with warfarin for stroke prevention in atrial fibrillation? A critically appraised topic. Neurologist. 2012 Mar;18(2):102-7.
3. Sonnenberg F, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making