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在加拿大,达拉非尼作为BRAF V600突变阳性不可切除或转移性黑色素瘤患者一线治疗的成本效益。

Cost effectiveness of dabrafenib as a first-line treatment in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma in Canada.

作者信息

Delea Thomas E, Amdahl Jordan, Wang Alice, Amonkar Mayur M, Thabane Marroon

机构信息

Policy Analysis Inc. (PAI), Four Davis Court, Brookline, MA, 02445, USA,

出版信息

Pharmacoeconomics. 2015 Apr;33(4):367-80. doi: 10.1007/s40273-014-0241-z.

Abstract

OBJECTIVE

To evaluate the cost effectiveness of dabrafenib versus dacarbazine and vemurafenib as first-line treatments in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma from a Canadian healthcare system perspective.

METHODS

A partitioned-survival analysis model with three mutually exclusive health states (pre-progression, post-progression, and dead) was used. The proportion of patients in each state was calculated using survival distributions for progression-free and overall survival derived from pivotal trials of dabrafenib and vemurafenib. For each treatment, expected progression-free, post-progression, overall, and quality-adjusted life-years (QALYs), and costs were calculated. Costs were based on list prices, a clinician survey, and published sources. A 5-year time horizon was used in the base case. Costs (in 2012 Canadian dollars [CA$]) and QALYs were discounted at 5% annually. Deterministic and probabilistic sensitivity analyses were conducted.

RESULTS

Dabrafenib was estimated to yield 0.2055 more QALYs at higher cost than dacarbazine. The incremental cost-effectiveness ratio was CA$363,136/QALY. In probabilistic sensitivity analyses, at a threshold of CA$200,000/QALY, there was an 8.2% probability that dabrafenib is cost effective versus dacarbazine. In deterministic sensitivity analyses, cost effectiveness was sensitive to survival distributions, utilities, and time horizon, with the hazard ratio for overall survival for dabrafenib versus dacarbazine being the most sensitive parameter. Assuming a class effect for efficacy of BRAF inhibitors, dabrafenib was dominant versus vemurafenib (less costly, equally effective), reflecting its assumed lower daily cost. Assuming no class effect, dabrafenib yielded 0.0486 more QALYs than vemurafenib.

CONCLUSIONS

At a threshold of CA$200,000/QALY, dabrafenib is unlikely to be cost effective compared with dacarbazine. It is not possible to make reliable conclusions regarding the relative cost effectiveness of dabrafenib versus vemurafenib based on available information.

摘要

目的

从加拿大医疗保健系统的角度,评估达拉非尼与达卡巴嗪及维莫非尼作为一线治疗药物,用于治疗BRAF V600突变阳性不可切除或转移性黑色素瘤患者的成本效益。

方法

采用具有三种互斥健康状态(进展前、进展后和死亡)的分区生存分析模型。使用从达拉非尼和维莫非尼的关键试验得出的无进展生存期和总生存期的生存分布,计算每种状态下的患者比例。对于每种治疗方法,计算预期的无进展生存期、进展后生存期、总生存期和质量调整生命年(QALY)以及成本。成本基于标价、临床医生调查和已发表的资料。基础病例采用5年的时间范围。成本(以2012年加元[CA$]计)和QALY每年按5%进行贴现。进行了确定性和概率敏感性分析。

结果

据估计,与达卡巴嗪相比,达拉非尼成本更高,但可多产生0.2055个QALY。增量成本效益比为363,136加元/QALY。在概率敏感性分析中,在每QALY 200,000加元的阈值下,达拉非尼相对于达卡巴嗪具有成本效益的概率为8.2%。在确定性敏感性分析中,成本效益对生存分布、效用和时间范围敏感,达拉非尼与达卡巴嗪的总生存期风险比是最敏感的参数。假设BRAF抑制剂具有类效应,达拉非尼相对于维莫非尼具有优势(成本更低,效果相同),这反映了其假定的每日成本较低。假设无类效应,达拉非尼比维莫非尼多产生0.0486个QALY。

结论

在每QALY 200,000加元的阈值下,与达卡巴嗪相比,达拉非尼不太可能具有成本效益。基于现有信息,无法就达拉非尼与维莫非尼的相对成本效益得出可靠结论。

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