Tantai Narisa, Chaikledkaew Usa, Tanwandee Tawesak, Werayingyong Pitsaphun, Teerawattananon Yot
Social and Administrative Pharmacy Excellence Research (SAPER) Unit, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayudthaya Road, Payathai, Ratchathewi, Bangkok 10400, Thailand.
BMC Health Serv Res. 2014 Apr 14;14:170. doi: 10.1186/1472-6963-14-170.
Only lamivudine has been included for patients with chronic hepatitis B (CHB) in the National List of Essential Drugs (NLED), a pharmaceutical reimbursement list in Thailand. There have also been no economic evaluation studies of CHB drug treatments conducted in Thailand yet. In order to fill this gap in policy research, the objective of this study was to compare the cost-utility of each drug therapy (Figure 1) with palliative care in patients with HBeAg-positive CHB.
A cost-utility analysis using an economic evaluation model was performed to compare each drug treatment for HBeAg-positive CHB patients. A Markov model was used to estimate the relevant costs and health outcomes during a lifetime horizon based on a societal perspective. Direct medical costs, direct non-medical costs, and indirect costs were included, and health outcomes were denoted in life years (LYs) and quality-adjusted life years (QALYs). The results were presented as an incremental cost effectiveness ratio (ICER) in Thai baht (THB) per LY or QALY gained. One-way sensitivity and probabilistic sensitivity analyses were applied to investigate the effects of model parameter uncertainties.
The ICER values of providing generic lamivudine with the addition of tenofovir when drug resistance occurred, generic lamivudine with the addition of tenofovir based on the road map guideline, and tenofovir monotherapy were -14,000 (USD -467), -8,000 (USD -267) , and -5,000 (USD -167) THB per QALY gained, respectively. However, when taking into account all parameter uncertainties in the model, providing generic lamivudine with the addition of tenofovir when drug resistance occurred (78% and 75%) and tenofovir monotherapy (18% and 24%) would yield higher probabilities of being cost-effective at the societal willingness to pay thresholds of 100,000 (USD 3,333) and 300,000 (USD 10,000) THB per QALY gained in Thailand, respectively.
Based on the policy recommendations from this study, the Thai government decided to include tenofovir into the NLED in addition to generic lamivudine which is already on the list. Moreover, the results have shown that the preferred treatment regimen involves using generic lamivudine as the first-line drug with tenofovir added if drug resistance occurs in HBeAg-positive CHB patients.
在泰国的药品报销清单——《国家基本药物目录》(NLED)中,仅将拉米夫定纳入了慢性乙型肝炎(CHB)患者的治疗药物。泰国尚未开展过关于CHB药物治疗的经济学评估研究。为填补这一政策研究空白,本研究的目的是比较每种药物治疗(图1)与HBeAg阳性CHB患者姑息治疗的成本效用。
采用经济评估模型进行成本效用分析,以比较HBeAg阳性CHB患者的每种药物治疗方案。使用马尔可夫模型从社会角度估计终身范围内的相关成本和健康结果。纳入了直接医疗成本、直接非医疗成本和间接成本,健康结果以生命年(LYs)和质量调整生命年(QALYs)表示。结果以每获得一个LY或QALY所增加的成本效益比(ICER)来呈现,单位为泰铢(THB)。应用单向敏感性分析和概率敏感性分析来研究模型参数不确定性的影响。
在出现耐药时加用替诺福韦的普通拉米夫定、根据路线图指南加用替诺福韦的普通拉米夫定以及替诺福韦单药治疗的ICER值分别为每获得一个QALY -14,000泰铢(467美元)、-8,000泰铢(267美元)和 -5,000泰铢(167美元)。然而,考虑到模型中的所有参数不确定性,在泰国每获得一个QALY的社会支付意愿阈值为100,000泰铢(3,333美元)和300,000泰铢(10,000美元)时,在出现耐药时加用替诺福韦的普通拉米夫定(分别为78%和75%)以及替诺福韦单药治疗(分别为18%和24%)具有更高的成本效益概率。
基于本研究的政策建议,泰国政府决定除已列入清单的普通拉米夫定外,还将替诺福韦纳入《国家基本药物目录》。此外,结果表明,首选的治疗方案是将普通拉米夫定作为一线药物,HBeAg阳性CHB患者出现耐药时加用替诺福韦。