York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.
National Institute for Health and Care Excellence, Level 1A, City Tower, Piccadilly Plaza, Manchester, M1 4BT, UK.
Appl Health Econ Health Policy. 2018 Aug;16(4):445-464. doi: 10.1007/s40258-018-0389-3.
Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath-051 to double-J stents. Results indicated that Memokath-051 generated cost savings of £4156 per patient over 2.5 years. The External Assessment Centre (EAC) critiqued the company's submission and completed substantial additional work. Sixteen studies were identified assessing Memokath-051 and all listed comparators in the scope (double-J stents, reconstructive surgery and metallic and alloy stents) except nephrostomy. Similar success rates were reported for Memokath-051 compared with double-J and Resonance stents and worse outcomes compared with other options with evidence available. The EAC updated the company's cost model structure and modified several inputs. The EAC's model estimated that Memokath-051 generated savings of at least £1619 per patient over 5 years compared with double-J stents, was cost neutral compared with other metallic stents and was cost saving compared with surgery up to month 55. Overall, Memokath-051 is likely to be cost saving in patients not indicated for reconstructive surgery and those expected to require a ureteral stent for at least 30 months. The Medical Technologies Advisory Committee (MTAC) reviewed the evidence and supported the case for adoption, issuing partially supportive recommendations published after public consultation as Medical Technologies Guidance 35.
Memokath-051 是一种热可膨胀的镍钛合金螺旋支架,用于治疗因恶性或良性狭窄引起的输尿管梗阻。国家卫生与保健卓越研究所(NICE)选择了 Memokath-051 进行评估。PNN Medical 公司声称,与双 J 支架相比,Memokath-051 具有临床优势和成本节约。它确定了五项报告 Memokath-051 临床证据的研究,并构建了一个新的成本模型,比较了 Memokath-051 与双 J 支架。结果表明,Memokath-051 在 2.5 年内为每位患者节省了 4156 英镑的成本。外部评估中心(EAC)对公司的提交内容进行了批评,并完成了大量额外的工作。确定了 16 项评估 Memokath-051 的研究,所有研究都在范围内列出了比较器(双 J 支架、重建手术以及金属和合金支架),除了经皮肾造口术。与双 J 和 Resonance 支架相比,Memokath-051 报告的成功率相似,而与其他可用证据的选择相比,结果较差。EAC 更新了公司的成本模型结构,并修改了几个输入。EAC 的模型估计,与双 J 支架相比,Memokath-051 在 5 年内为每位患者至少节省 1619 英镑,与其他金属支架相比成本中性,与手术相比在第 55 个月前节省成本。总体而言,Memokath-051 可能在不适合重建手术的患者和预计需要输尿管支架至少 30 个月的患者中具有成本效益。医疗技术咨询委员会(MTAC)审查了证据,并支持采用该技术,在公开咨询后发布了部分支持的建议,作为医疗技术指南 35。