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首页> 外文期刊>PharmacoEconomics >Nalmefene for Reducing Alcohol Consumption in People with Alcohol Dependence: An Evidence Review Group Perspective of a NICE Single Technology Appraisal
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Nalmefene for Reducing Alcohol Consumption in People with Alcohol Dependence: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

机译：纳美芬用于减少酒精依赖者的酒精消耗：NICE单一技术评估的证据审查小组观点

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As part of its single technology appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company (Lundbeck) marketing nalmefene (Selincro) to submit evidence of its clinical and cost effectiveness for reducing alcohol consumption in people with alcohol dependence. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG) and to produce a critical review of the company's submission to NICE. The clinical evidence was derived from three phase III, company-sponsored, randomised, double-blind, placebo-controlled trials in adults with a diagnosis of alcohol dependence comparing nalmefene, taken on an as-needed basis, in conjunction with psychosocial support with placebo in conjunction with psychosocial support. Psychosocial support was provided in the form of BRENDA, an intervention of lower intensity than that recommended in NICE Clinical Guideline 115 (NICE CG115). Post-hoc subgroup analyses were conducted in people who were drinking at high or very high risk levels at baseline and maintained this level of drinking during the screening phase prior to randomisation. This subgroup forms the licensed population. There were a number of limitations and uncertainties in the clinical evidence base which warrant caution in its interpretation. In particular, the post-hoc subgroup analyses and high dropout rates in the three nalmefene studies meant that the inference of treatment effects might be confounded. The company's economic evaluation showed that use of nalmefene in conjunction with psychosocial support in the form of BRENDA dominated the use of BRENDA in conjunction with placebo, providing more quality-adjusted life-years (QALYs) at a reduced cost. However, this evaluation did not meet the final scope issued by NICE, which specified that the comparator should be psychological intervention as defined in NICE CG115. The ERG produced alternative cost per QALY values for the comparison undertaken by the company and suggested three further comparisons deemed relevant: (1) nalmefene with psychological intervention as defined in NICE CG115; (2) delayed use of nalmefene in those who did not respond to psychological intervention as recommended in NICE CG115 alone; and (3) use of naltrexone outside of its marketing authorisation. The ERG thought it probable that using nalmefene in only those people who do not respond to psychological intervention alone was likely to be more cost effective compared with its immediate use in the entire licensed population. The Appraisal Committee accepted the comparison with psychosocial support in the form of BRENDA and believed that the most plausible cost per QALY was likely to be below A 5100 pound. Therefore, the Appraisal Committee concluded that nalmefene in conjunction with psychosocial support was a cost effective use of NHS resources compared with psychosocial support alone for treating people with alcohol dependence drinking at a high risk level, without physical withdrawal symptoms and not requiring immediate assisted withdrawal from alcohol.
机译：作为其单一技术评估过程的一部分，美国国家卫生与医疗保健研究院（NICE）邀请该公司（伦德贝克）营销纳美芬（Selincro）提交其减少酒精依赖人群饮酒的临床和成本效益证据。谢菲尔德大学卫生与相关研究技术评估小组受委托担任独立的证据审查小组（ERG），并对公司提交给NICE的文件进行严格审查。临床证据来自三项公司共同资助的，成人双盲，安慰剂对照的三阶段临床试验，该试验在成年人中对酒精依赖的诊断与纳美芬进行了比较，并根据需要与安慰剂的社会心理支持相结合结合社会心理支持。以BRENDA的形式提供社会心理支持，其干预强度低于NICE临床指南115（NICE CG115）中建议的强度。事后亚组分析是在基线时处于高或极高危险水平饮酒的人群中进行的，并在随机分组之前的筛查阶段中保持这一饮酒水平。该子组构成了许可人口。临床证据库存在许多局限性和不确定性，因此在解释时应谨慎行事。特别是，三项纳美芬研究中的事后亚组分析和高辍学率意味着治疗效果的推论可能会混淆。该公司的经济评估表明，将纳美芬与以BRENDA形式提供的社会心理支持相结合，主要是将BRENDA与安慰剂结合使用，从而以更低的成本提供了更多的质量调整寿命（QALY）。但是，此评估不符合NICE发布的最终范围，该最终范围指定比较器应为NICE CG115中定义的心理干预。 ERG为公司进行的比较得出了每个QALY值的替代成本，并建议了三个被认为相关的进一步比较：（1）纳美芬与NICE CG115中定义的心理干预; （2）仅对NICE CG115建议的对心理干预无反应的人群延迟使用纳美芬; （3）在其营销授权范围之外使用纳曲酮。 ERG认为，仅在那些对心理干预没有反应的人中使用纳美芬可能比在整个许可人群中立即使用纳美芬更具成本效益。评估委员会接受了BRENDA形式与心理支持的比较，并认为每个QALY的最合理的成本可能低于5100磅。因此，评估委员会的结论是，与单独的心理支持相比，纳美芬与社会心理支持相结合可以有效地利用NHS资源来治疗高风险水平，无身体戒断症状且不需要立即协助戒断的酒精依赖人群醇。

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