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氢吗啡酮治疗严重阿片类药物使用障碍的成本效益:来自 SALOME 随机临床试验的结果。

Cost-effectiveness of hydromorphone for severe opioid use disorder: findings from the SALOME randomized clinical trial.

机构信息

Centre for Health Evaluation and Outcome Sciences, Providence Health Care, St Paul's Hospital, Vancouver, British Columbia, Canada.

School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, Canada.

出版信息

Addiction. 2018 Jul;113(7):1264-1273. doi: 10.1111/add.14171. Epub 2018 Mar 28.

Abstract

BACKGROUND AND AIMS

Previous research has found diacetylmorphine, delivered under supervision, to be cost-effective in the treatment of severe opioid use disorder, but diacetylmorphine is not available in many settings. The Study to Assess Long-term Opioid Maintenance Effectiveness (SALOME) randomized controlled trial provided evidence that injectable hydromorphone is non-inferior to diacetylmorphine. The current study aimed to compare the cost-effectiveness of hydromorphone directly with diacetylmorphine and indirectly with methadone maintenance treatment.

DESIGN

A within-trial analysis was conducted using the patient level data from the 6-month, double-blind, non-inferiority SALOME trial. A life-time analysis extrapolated costs and outcomes using a decision analytical cohort model. The model incorporated data from a previous trial to include an indirect comparison to methadone maintenance.

SETTING

A supervised clinic in Vancouver, British Columbia, Canada.

PARTICIPANTS

A total of 202 long-term street opioid injectors who had at least two attempts at treatment, including one with methadone (or other substitution), were randomized to hydromorphone (n = 100) or diacetylmorphine (n = 102).

MEASUREMENTS

We measured the utilization of drugs, visits to health professionals, hospitalizations, criminal activity, mortality and quality of life. This enabled us to estimate incremental costs, quality-adjusted life years (QALYs) and cost-effectiveness ratios from a societal perspective. Sensitivity analyses considered different sources of evidence, assumptions and perspectives.

FINDINGS

The within-trial analysis found hydromorphone provided similar QALYs to diacetylmorphine [0.377, 95% confidence interval (CI) = 0.361-0.393 versus 0.375, 95% CI = 0.357-0.391], but accumulated marginally greater costs [$49 830 ($28 401-73 637) versus $34 320 ($21 780-55 998)]. The life-time analysis suggested that both diacetylmorphine and hydromorphone provide more benefits than methadone [8.4 (7.4-9.5) and 8.3 (7.2-9.5) versus 7.4 (6.5-8.3) QALYs] at lower cost [$1.01 million ($0.6-1.59 million) and $1.02 million ($0.72-1.51 million) versus $1.15 million ($0.71-1.84 million)].

CONCLUSIONS

In patients with severe opioid use disorder enrolled into the SALOME trial, injectable hydromorphone provided similar outcomes to injectable diacetylmorphine. Modelling outcomes during a patient's life-time suggested that injectable hydromorphone might provide greater benefit than methadone alone and may be cost-saving, with drug costs being offset by costs saved from reduced involvement in criminal activity.

摘要

背景和目的

先前的研究发现,在治疗严重阿片类药物使用障碍方面,在监督下使用二乙酰吗啡具有成本效益,但在许多情况下都无法获得二乙酰吗啡。研究评估长效阿片类药物维持效果(SALOME)的随机对照试验提供了证据,表明注射用氢吗啡酮与二乙酰吗啡无差异。本研究旨在直接比较氢吗啡酮与二乙酰吗啡和间接比较与美沙酮维持治疗的成本效益。

设计

使用 6 个月、双盲、非劣效性 SALOME 试验的患者水平数据进行了试验内分析。终生分析使用决策分析队列模型推断成本和结果。该模型纳入了先前试验的数据,包括与美沙酮维持治疗的间接比较。

地点

加拿大不列颠哥伦比亚省温哥华的一家监督诊所。

参与者

共有 202 名长期街头阿片类药物注射者,他们至少有两次治疗尝试,包括一次美沙酮(或其他替代药物)治疗,随机分为氢吗啡酮组(n=100)或二乙酰吗啡组(n=102)。

测量

我们测量了药物使用、卫生专业人员就诊、住院、犯罪活动、死亡率和生活质量。这使我们能够从社会角度估计增量成本、质量调整生命年(QALY)和成本效益比。敏感性分析考虑了不同的证据来源、假设和观点。

发现

试验内分析发现,氢吗啡酮与二乙酰吗啡提供的 QALY 相似[0.377,95%置信区间(CI)=0.361-0.393 与 0.375,95% CI=0.357-0.391],但累计成本略高[49830 美元(28401-73637 美元)与 34320 美元(21780-55998 美元)]。终生分析表明,二乙酰吗啡和氢吗啡酮都比美沙酮提供更多的效益[8.4(7.4-9.5)和 8.3(7.2-9.5)与 7.4(6.5-8.3)QALY],成本更低[1010 万美元(0.6-1.59 百万美元)和 1020 万美元(0.72-1.51 百万美元)与 1150 万美元(0.71-1.84 百万美元)]。

结论

在参加 SALOME 试验的严重阿片类药物使用障碍患者中,注射用氢吗啡酮与注射用二乙酰吗啡的结果相似。对患者一生中的结果进行建模表明,注射用氢吗啡酮可能比单独使用美沙酮提供更大的益处,并且可能具有成本效益,药物成本可以通过减少犯罪活动的参与而节省的成本来抵消。

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