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Applied Health Economics and Health Policy
Published in: Applied Health Economics and Health Policy 6/2011

01-11-2011 | Original Research Article

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

Author: Dr Sandra L. Tunis, PhD

Published in: Applied Health Economics and Health Policy | Issue 6/2011

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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 [HbA1c] 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. HbA1c 8.4%), SMBG HbA1c advantage (−0.25%) and costs were retained. As with the COMPUS analysis, UKPDS HbA1c decay curves were incorporated into SMBG and no-SMBG pathways. An important difference was that SMBG HbA1c benefits in the current study could extend beyond the initial simulation period. Sensitivity analyses examined SMBG HbA1c 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) $Can39231 and $Can54349 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 HbA1c 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 HbA1c 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.
Appendix
Available only for authorised users
Footnotes
1
Please see the COMPUS Report[7] for a complete list of sensitivity and subgroup analyses.
 
2
A meta-analysis by Poolsup et al.,[49] using a standardized scale, rated three RCTs[35,36,39] as having ‘good’ quality based on reporting of adherence levels. These three had received a ‘poor’ quality rating in the COMPUS review.[40]
 
3
Complication history had not been reported in the RCTs from which the SMBG clinical effect was derived. However, for Canadian patients in primary-care settings with type 2 diabetes of 3–5 years’ duration, prevalence rates have been reported as follows: IHD (8–10%), MI (9%), heart failure (4%), stroke (2–4%), atrial fibrillation (4%), PVD (2–3%), amputation (1%), blindness (1%) and renal failure (1%).[6] Prevalence rates for neuropathy (4%) and for cataract (8%) have also been published;[6] however, the current version of the UKPDS model does not include these two diabetes-related complications.
 
4
SMBG effects have repeatedly been found to be more pronounced for patients on OADs, than for those on a regimen of just diet and exercise.[17,21] Only two of the seven RCTs included patients exclusively on OADs; others included both patients on orals and those on no pharmacotherapy. Analyses that combine the two treatment cohorts are likely to mask the stronger effects of SMBG for patients on OADs. Results of the COMPUS cost-effectiveness study were, in fact, sensitive to treatment modality. In subgroup analyses that included only patients on OADs (other assumptions: baseline HbA1c 8.3%; SMBG HbA1c effect −0.24%; no complication history; strip use 1.08 per day), the incremental cost per QALY associated with SMBG decreased by approximately $Can22 000 from base-case results.
 
5
The impact of reducing baseline HbA1c can be illustrated by results of the COMPUS meta-analysis, revealing greater SMBG effects on HbA1c (−0.30%) in the six of seven RCTs with baseline HbA1c= 8.0–10.5%.
 
6
The COMPUS source was a 2006 report on the development of the Ontario Diabetes Economic Model (ODEM).[32] Estimates for average annual per patient costs of diabetes and complications were based on patient prototypes (e.g. male, aged 63 years), and were used for an economic evaluation of a primary-care diabetes programme. Costs used in the evaluation had been inflated to year 2004 values. For the COMPUS economic evaluation of SMBG, these values were again inflated. Complication costs were increased by approximately 5–6% to represent cost increases from 2004 to 2008 in Canada.
 
7
Despite the use of these parameters, closely replicating COMPUS base-case results was not possible. Details of several aspects of the COMPUS analysis had not been provided: (i) duration of post-trial HbA1c effect was not described beyond the statement that the simulation followed UKPDS trajectories; (ii) not explained was whether the mean change assumed for each group (−0.25% for SMBG; 0% for no SMBG) was based on all hypothetical patients within the group having the exact post-trial HbA1c change. If variance was assumed (e.g. through a SD of 0.10%), and patient-level data randomly generated, the type of distribution (e.g. Normal) assumed would need to be described and justified; (iii) the duration of strip costs was not explained; it would appear that SMBG effectiveness was assumed to diminish following the initial effect, but that strip costs were allowed to continue throughout the 40-year simulation; (iv) there was not a clear listing of assumed SMBG frequency and strip cost corresponding to each RCT, nor were exact figures provided on assumed annual costs of strips input into the model. When different HbA1c effect durations and distributions were applied in the current analyses, the difference in costs over 40 years was found to be within approximately $Can200.00 of that reported by COMPUS. However, it could not be determined how the difference in HbA1c effects reported by COMPUS could be replicated with any of the plausible scenarios explored.
 
8
These rates were used in COMPUS sensitivity analyses of adherence. The rate of 66% also approximates the adherence level for SMBG reported by Vincze et al.[57] for a similar population of patients with type 2 diabetes. This adherence level has also been modelled in other economic evaluations of SMBG.[22]
 
9
The ODEM report described in Footnote 6 also provided an estimate of costs for a proto-typical patient with type 2 diabetes but with no complications.[32] The current author’s reading is that the value was reported to be $Can1733. This value and the smaller one used in the COMPUS reference case ($Can1507) can be considered conservative in that both represent costs reported for 2004 and were not inflated.
 
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Metadata
Title
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
Author
Dr Sandra L. Tunis, PhD
Publication date
01-11-2011
Publisher
Springer International Publishing
Published in
Applied Health Economics and Health Policy / Issue 6/2011
Print ISSN: 1175-5652
Electronic ISSN: 1179-1896
DOI
https://doi.org/10.2165/11594270-000000000-00000

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Acknowledgments

Acknowledgement