Abacus International, Bicester, UK.
Pharmacoeconomics. 2011 Dec;29(12):1075-91. doi: 10.2165/11589260-000000000-00000.
Previous research has demonstrated that tenofovir disoproxil fumarate (DF) is the most cost-effective nucleos(t)ide treatment for chronic hepatitis B (CHB) in the UK, Spain, Italy and France. However, to our knowledge, no published studies have yet evaluated the cost effectiveness of any treatments for CHB in a Canadian setting, where relative prices and management of CHB differ from those in Europe.
Our objective was to determine the cost effectiveness of tenofovir DF compared with other nucleos(t)ide therapies licensed for CHB in Canada from the perspective of publicly funded healthcare payers.
A Markov model was used to calculate the costs and benefits of nucleos(t)ide therapy in three groups of patients with hepatitis B e antigen (HBeAg)-positive and -negative CHB: nucleos(t)ide-naive patients without cirrhosis; nucleos(t)ide-naive patients with compensated cirrhosis; and lamivudine-resistant patients. Disease progression was modelled as annual transitions between 18 disease states. Transition probabilities, quality of life and costs were based on published studies. Health benefits were measured in QALYs. The reference year for costs was 2007 and costs and outcomes were discounted at 5% per annum.
First-line tenofovir DF was the most effective nucleos(t)ide strategy for managing CHB, generating 6.85-9.39 QALYs per patient. First-line tenofovir DF was also the most cost-effective strategy in all patient subgroups investigated, costing between $Can43,758 and $Can48,015 per QALY gained compared with lamivudine then tenofovir. First-line tenofovir DF strongly dominated first-line entecavir. Giving tenofovir DF monotherapy immediately after lamivudine resistance developed was less costly and more effective than any other active treatment strategy investigated for lamivudine-resistant CHB, including second-line use of adefovir or adefovir + lamivudine. Probabilistic sensitivity analysis demonstrated 50% confidence that first-line tenofovir DF is the most cost-effective nucleos(t)ide strategy for treatment-naive patients with CHB, at a $Can50,000 per QALY threshold, and confirmed that first-line tenofovir DF has the highest expected net benefits.
First-line tenofovir DF appears to be the most cost-effective nucleos(t)ide treatment for both cirrhotic and non-cirrhotic CHB patients in Canada, providing that society is willing to pay at least $Can48,015 per QALY gained, although sensitivity analyses highlighted uncertainty around the results.
先前的研究表明，替诺福韦二吡呋酯（DF）是英国、西班牙、意大利和法国慢性乙型肝炎（CHB）最具成本效益的核苷（酸）治疗药物。然而，据我们所知，在加拿大，还没有发表的研究评估过任何 CHB 治疗方法的成本效益，因为那里的相对价格和 CHB 的管理与欧洲不同。
我们的目的是从公共资助的医疗保健支付者的角度，确定替诺福韦 DF 与在加拿大获得 CHB 许可的其他核苷（酸）治疗药物相比的成本效益。
使用 Markov 模型计算了三组 HBeAg 阳性和阴性 CHB 患者（无肝硬化的核苷（酸）初治患者；代偿性肝硬化的核苷（酸）初治患者；以及拉米夫定耐药患者）的核苷（酸）治疗的成本和效益。疾病进展每年在 18 种疾病状态之间进行转换。转移概率、生活质量和成本基于已发表的研究。健康效益以 QALYs 衡量。参考年度为 2007 年，成本和结果按每年 5%贴现。
一线替诺福韦 DF 是管理 CHB 的最有效核苷（酸）策略，为每位患者带来 6.85-9.39 个 QALYs。一线替诺福韦 DF 也是所有研究患者亚组中最具成本效益的策略，与拉米夫定相比，每获得一个 QALY 的成本为 43758 加元至 48015 加元。一线替诺福韦 DF 强烈优于一线恩替卡韦。在拉米夫定耐药后立即给予替诺福韦 DF 单药治疗，比任何其他用于拉米夫定耐药 CHB 的活性治疗策略都更具成本效益，包括阿德福韦或阿德福韦+拉米夫定的二线使用。概率敏感性分析表明，在 50000 加元/QALY 的阈值下，一线替诺福韦 DF 是治疗初治 CHB 患者的最具成本效益的核苷（酸）治疗策略，有 50%的置信度，并证实一线替诺福韦 DF 具有最高的预期净效益。
在加拿大，一线替诺福韦 DF 似乎是肝硬化和非肝硬化 CHB 患者最具成本效益的核苷（酸）治疗药物，前提是社会愿意为每获得一个 QALY 支付至少 48015 加元，但敏感性分析突出了结果的不确定性。
