Carter Marissa J, Myntti Matthew F
Strategic Solutions, Inc., Cody, WY, US.
J Wound Care. 2019 Jul 1;28(Sup7):S24-S38. doi: 10.12968/jowc.2019.28.Sup7.S24.
Analyse the cost-effectiveness and treatment outcomes of debridement (standard of care) plus BlastX, a biofilm-disrupting wound gel (group 1) or a triple-antibiotic, maximum-strength ointment (group 2), comparing a subset of patients who had not healed at four weeks using the ointment crossed-over to the biofilm-disrupting gel (group 3).
A series of Markov microsimulation models were built using health states of an unhealed non-infected ulcer, healed ulcer, and infected non-healed ulcer and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Complications and healing rates were based on a randomised controlled trial (RCT). Costs were incurred by patients for procedures at outpatient wound care clinics and hospitals (if complications occurred) and were in the form of Medicare allowable charges. Quality-adjusted life years (QALYs) were computed using literature utility values. Incremental cost-effectiveness ratios (ICERs) were calculated for group 1 versus group 2, and group 3 versus group 2. One-way, multi-way and probabilistic sensitivity analysis (PSA) was conducted.
After one year, the base case ICER was $8794 per QALY for group 1 versus group 2, and $21,566 per QALY for group 3 versus group 2. Product cost and amputation rates had the most influence in one-way sensitivity analysis. PSA showed that the majority of costs were higher for group 1 but effectiveness values were always higher than for group 2. Average product use of 3.1ml per application represented 9.4% of the total group 1 cost (average $24.52 per application/$822.50 per group 1 patient). The biofilm-disrupting gel group performed substantially better than the current cost-effectiveness benchmarks, $8794 versus $50,000, respectively. Furthermore, when biofilm-disrupting gel treatment was delayed, as in group 3, the ICER outcomes were less substantial but it did remain cost-effective, suggesting the added benefits of immediate use of biofilm-disrupting gel. Also, when product cost assumptions used in the study were halved (Wolcott study usage), the model indicates important reductions in ICER to $966/QALY when comparing group 1 with group 2. It should be noted that product cost can hypothetically be affected not only by direct product purchase costs, but also by application intervals and technique. This suggests additional opportunities exist to optimise these parameters, maximising wound healing efficacy while providing significant cost savings to the payer.
The addition of the biofilm-disrupting gel treatment to standard of care is likely to be cost-effective in the treatment of chronic wounds but when delayed by as little as 9-12 weeks the ICER is still far less than current cost-effectiveness benchmarks. The implication for payers and decision-makers is that biofilm-disrupting gel should be used as a first-line therapy at the first clinic visit rather than waiting as it substantially decreases cost-utility.
分析清创术（护理标准）联合BlastX（一种破坏生物膜的伤口凝胶，第1组）或三联抗生素最强效软膏（第2组）的成本效益和治疗结果，比较使用该软膏四周未愈合的部分患者转而使用破坏生物膜凝胶（第3组）的情况。
使用未愈合的非感染性溃疡、愈合的溃疡和感染的未愈合溃疡的健康状态以及死亡或截肢的吸收状态建立一系列马尔可夫微观模拟模型。所有患者在第0周期均以未愈合的非感染性溃疡开始。并发症和愈合率基于一项随机对照试验（RCT）。患者在门诊伤口护理诊所和医院进行手术（如果发生并发症）会产生费用，费用形式为医疗保险允许的收费。使用文献效用值计算质量调整生命年（QALY）。计算第1组与第2组、第3组与第2组的增量成本效益比（ICER）。进行了单因素、多因素和概率敏感性分析（PSA）。
一年后，第1组与第2组的基础病例ICER为每QALY 8794美元，第3组与第2组为每QALY 21,566美元。在单因素敏感性分析中，产品成本和截肢率影响最大。PSA显示，第1组的大多数成本较高，但效果值始终高于第2组。每次应用平均使用3.1毫升产品占第1组总成本的9.4%（每次应用平均24.52美元/第1组每位患者822.50美元）。破坏生物膜凝胶组的表现明显优于当前的成本效益基准，分别为8794美元和50,000美元。此外，如第3组那样延迟使用破坏生物膜凝胶治疗时，ICER结果不太显著，但仍具有成本效益，这表明立即使用破坏生物膜凝胶有额外益处。同样，当研究中使用的产品成本假设减半（沃尔科特研究用量）时，模型显示第1组与第2组比较时ICER大幅降至966美元/QALY。应当指出，产品成本理论上不仅会受到直接产品购买成本的影响，还会受到应用间隔和技术的影响。这表明存在优化这些参数的额外机会，在为支付方节省大量成本的同时最大限度提高伤口愈合疗效。
在慢性伤口治疗中，在护理标准基础上加用破坏生物膜凝胶治疗可能具有成本效益，但延迟使用9至12周时，ICER仍远低于当前成本效益基准。对支付方和决策者的启示是，破坏生物膜凝胶应在首次门诊就诊时作为一线治疗使用，而不是等待，因为这会大幅降低成本效用。
