Cost-Utility Analysis of Dabigatran and Warfarin for Stroke Prevention Among Patients With Nonvalvular Atrial Fibrillation in India

• Published in: Value in health regional issues Vol. 31; pp. 119 - 126
• Main Authors: Aghoram, Rajeswari, Kumar, S. Mathan, Rajasulochana, Subramania Raju, Kar, Sitanshu Sekhar, Aggarwal, Rakesh
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2022
• Subjects: Economic analysis; Low-middle Income country; Stroke prevention; Economic analysis; Low-middle Income country; Stroke prevention
• ISSN: 2212-1099; 2212-1102
• DOI: 10.1016/j.vhri.2022.04.007

Dabigatran has a better safety profile and requires less monitoring, but is costlier than warfarin. This study evaluated the cost-utility of dabigatran relative to warfarin for preventing stroke in nonvalvular atrial fibrillation (NVAF) in India. A Markov decision analysis model was developed to compare dabigatran (110 or 150 mg twice a day) to warfarin titrated to target prothrombin time in patients with NVAF at high risk of stroke. Model utilities and transition probabilities were based on literature and costs on market prices. Data on out-of-pocket expenses and income lost were taken from a nationally representative survey. We adopted a societal perspective and discounted both costs and outcomes at 3%. Ischemic stroke, intracranial bleed, other major bleeds, and death were outcomes of NVAF. The model projected the costs, life-years, and quality-adjusted life-years (QALYs) for each intervention over a lifetime. We used gross domestic product per capita of India (US dollars [US$]1889) as the cost-effectiveness threshold. Sensitivity analyses were conducted. Treatment with either dose of dabigatran was associated with gain in life-years and QALYs compared with warfarin. The discounted incremental cost-effectiveness ratios/QALYs for both doses of dabigatran (110 mg US$7519; 150 mg US$6634) were above the cost-effectiveness threshold, and the probability of being cost-effective at this threshold was low. Cost of dabigatran was an important factor in determining incremental cost-effectiveness ratio. Price reduction of 150 mg dose by 49% will make it cost-effective. Dabigatran is not cost-effective in the Indian societal context. Reducing the price of dabigatran 150 mg by half will make it cost-effective. •The burden of nonvalvular atrial fibrillation (NVAF) and stroke is increasing in lower middle–income countries like India. Oral anticoagulants prevent stroke and reduce the morbidity and mortality associated with NVAF. Dabigatran is safer and requires less monitoring, but is costlier than warfarin. Evidence from high-income countries suggests that dabigatran is cost-effective in NVAF. Nevertheless, there is no evidence from low- and middle-income countries.•This study found that, at the current threshold for India, dabigatran was not cost-effective. Price reduction of dabigatran 150 mg by 49% would make it cost-effective, and further reduction to 68% will make it cost neutral (no net cost for the added benefit).•The recent expiry of patent for dabigatran and inclusion of dabigatran in the National List of Essential Medicines of India have provided an opportunity to determine appropriate price caps for dabigatran to make it available as a cost-effective alternative to Indian patients.