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2 型糖尿病且未使用胰岛素的患者自我血糖监测(SMBG)的成本效益:建模假设对最近加拿大研究结果的影响。

Cost effectiveness of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes and not on insulin: impact of modelling assumptions on recent Canadian findings.

机构信息

Independent Health Economics Research Consultant, Indianapolis, IN, USA.

出版信息

Appl Health Econ Health Policy. 2011 Nov 1;9(6):351-65. doi: 10.2165/11594270-000000000-00000.

Abstract

BACKGROUND

Canadian patients, healthcare providers and payers share interest in assessing the value of self-monitoring of blood glucose (SMBG) for individuals with type 2 diabetes but not on insulin. Using the UKPDS (UK Prospective Diabetes Study) model, the Canadian Optimal Prescribing and Utilization Service (COMPUS) conducted an SMBG cost-effectiveness analysis. Based on the results, COMPUS does not recommend routine strip use for most adults with type 2 diabetes who are not on insulin. Cost-effectiveness studies require many assumptions regarding cohort, clinical effect, complication costs, etc. The COMPUS evaluation included several conservative assumptions that negatively impacted SMBG cost effectiveness.

OBJECTIVES

Current objectives were to (i) review key, impactful COMPUS assumptions; (ii) illustrate how alternative inputs can lead to more favourable results for SMBG cost effectiveness; and (iii) provide recommendations for assessing its long-term value.

METHODS

A summary of COMPUS methods and results was followed by a review of assumptions (for trial-based glycosylated haemoglobin [HbA(1c)] effect, patient characteristics, costs, simulation pathway) and their potential impact. The UKPDS model was used for a 40-year cost-effectiveness analysis of SMBG (1.29 strips per day) versus no SMBG in the Canadian payer setting. COMPUS assumptions for patient characteristics (e.g. HbA(1c) 8.4%), SMBG HbA(1c) advantage (-0.25%) and costs were retained. As with the COMPUS analysis, UKPDS HbA(1c) decay curves were incorporated into SMBG and no-SMBG pathways. An important difference was that SMBG HbA(1c) benefits in the current study could extend beyond the initial simulation period. Sensitivity analyses examined SMBG HbA(1c) advantage, adherence, complication history and cost inputs. Outcomes (discounted at 5%) included QALYs, complication rates, total costs (year 2008 values) and incremental cost-effectiveness ratios (ICERs).

RESULTS

The base-case ICER was $Can63 664 per QALY gained; approximately 56% of the COMPUS base-case ICER. SMBG was associated with modest risk reductions (0.10-0.70%) for six of seven complications. Assuming an SMBG advantage of -0.30% decreased the current base-case ICER by over $Can10 000 per QALY gained. With adherence of 66% and 87%, ICERs were (respectively) $Can39 231 and $Can54 349 per QALY gained. Incorporating a more representative complication history and 15% complication cost increase resulted in an ICER of $Can49 743 per QALY gained.

CONCLUSIONS

These results underscore the importance of modelling assumptions regarding the duration of HbA(1c) effect. The current study shares several COMPUS limitations relating to the UKPDS model being designed for newly diagnosed patients, and to randomized controlled trial monitoring rates. Neither study explicitly examined the impact of varying the duration of initial HbA(1c) effects, or of medication or other treatment changes. Because the COMPUS research will potentially influence clinical practice and reimbursement policy in Canada, understanding the impact of assumptions on cost-effectiveness results seems especially important. Demonstrating that COMPUS ICERs were greatly reduced through variations in a small number of inputs may encourage additional clinical research designed to measure SMBG effects within the context of optimal disease management. It may also encourage additional economic evaluations that incorporate lessons learned and best practices for assessing the overall value of SMBG for type 2 diabetes in insulin-naive patients.

摘要

背景

加拿大的患者、医疗保健提供者和支付者都对评估 2 型糖尿病患者自我血糖监测(SMBG)的价值感兴趣,但不包括使用胰岛素的患者。使用 UKPDS(英国前瞻性糖尿病研究)模型,加拿大最优处方和利用服务(COMPUS)进行了 SMBG 的成本效益分析。根据结果,COMPUS 不建议大多数未使用胰岛素的 2 型糖尿病成年人常规使用 Strip。成本效益研究需要对队列、临床效果、并发症成本等方面做出许多假设。COMPUS 评估包括了一些保守的假设,这些假设对 SMBG 的成本效益产生了负面影响。

目的

当前的目标是:(i)审查关键的、有影响力的 COMPUS 假设;(ii)说明如何使用替代输入来使 SMBG 的成本效益更有利;(iii)提供评估其长期价值的建议。

方法

总结了 COMPUS 的方法和结果,然后对假设(基于试验糖化血红蛋白[HbA1c]效果、患者特征、成本、模拟途径)及其潜在影响进行了审查。使用 UKPDS 模型对 SMBG(每天 1.29 条 Strip)与加拿大支付者环境中不进行 SMBG 的 40 年成本效益进行了分析。保留了 COMPUS 对患者特征(如 HbA1c 8.4%)、SMBG HbA1c 优势(-0.25%)和成本的假设。与 COMPUS 分析一样,将 UKPDS HbA1c 衰减曲线纳入 SMBG 和无 SMBG 途径。一个重要的区别是,当前研究中的 SMBG HbA1c 获益可以延长初始模拟期之外。灵敏度分析检查了 SMBG HbA1c 优势、依从性、并发症史和成本输入。结果(贴现率为 5%)包括 QALYs、并发症发生率、总费用(2008 年的价值)和增量成本效益比(ICERs)。

结果

基础病例的 ICER 为每获得一个 QALY 增加$Can63664;大约是 COMPUS 基础病例 ICER 的 56%。SMBG 与 7 种并发症中的 6 种风险降低相关(0.10%-0.70%)。假设 SMBG 优势为-0.30%,则当前基础病例的 ICER 将降低超过$Can10000 每获得一个 QALY。依从性为 66%和 87%时,ICER 分别为$Can39231 和$Can54349 每获得一个 QALY。纳入更具代表性的并发症史和 15%的并发症成本增加,ICER 为$Can49743 每获得一个 QALY。

结论

这些结果强调了建模关于 HbA1c 效果持续时间的假设的重要性。当前的研究与 UKPDS 模型共享几个 COMPUS 限制,这些限制与模型旨在针对新诊断的患者,以及随机对照试验监测率有关。两项研究都没有明确研究初始 HbA1c 效果持续时间变化,或药物或其他治疗变化的影响。由于 COMPUS 研究可能会影响加拿大的临床实践和报销政策,因此了解假设对成本效益结果的影响似乎尤为重要。通过对少数几个输入的变化来减少 COMPUS 的 ICER,可能会鼓励进行更多的临床研究,以在最佳疾病管理的背景下测量 SMBG 的效果。这也可能会鼓励进行更多的经济评估,以纳入 SMBG 在未使用胰岛素的 2 型糖尿病患者中的整体价值的经验教训和最佳实践。

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