Background
Diabetes mellitus is an important public health issue [
1]. The increasing prevalence, extensive morbidity, and associated high health care expenditures of diabetes pose an increasing burden on affected individuals, the health care system, and society as a whole [
1]. Nova Scotia has one of the highest prevalences of diabetes in Canada [
2] as approximately five percent of the population aged 20 years and above and fourteen percent of the population aged 65 years and above have diabetes [
3]. With the increasing trend in diabetes prevalence, the total healthcare cost for individuals with diabetes in Canada is expected to increase by 75 % from $4.7 billion in 2000 to more than $8.1 billion in 2016[
4]. The direct healthcare cost associated with diabetes in Nova Scotia is projected to increase from $175.5 million in 2005 to $249.3 million in 2016 [
4].
Diabetes testing supplies are integral to SMBG which contributes substantial costs to the provincial health care plans. The provincial government drug benefit programs of Nova Scotia spent $2.66 million on insulin products, $4.10 million on oral antihyperglycemic agents (OAA) and $6.72 million on self-monitoring of blood glucose (SMBG) test strips in the fiscal year 2004/05 [Personal communication by Jianxiang Huang, M.D., Information and Statistics Officer, Nova Scotia Department of Health and Mike Joyce, BA., MBA, Senior Economic Advisor, Pharmaceutical Services, Nova Scotia Department of Health, March 19, 2008].
In the province of Nova Scotia, Canada, the Seniors' Pharmacare program (NSSPP) is a publicly funded drug insurance plan that reimburses drugs and medical supplies listed in the Nova Scotia Formulary for eligible seniors in the province. The beneficiaries of this program are Nova Scotia residents with a minimum age of 65 years who enroll by paying the required insurance premium and who pay the required per prescription co-payment. The NSSPP does not provide coverage for senior residents who have private drug insurance, or coverage with another public sector plan, e.g. with Veterans Affairs Canada or with First Nations and Inuit Health. The beneficiary co-payment during the study period was 33% of the total prescription cost to a maximum of $30 with a minimum of $3 per prescription. The annual maximum co-payment was $360. Once beneficiaries reached a total annual co-payment of $360, the plan covered 100% of eligible prescription costs. Co-payment is calculated according to the government fiscal year [
5]. According to the NSSPP's cost sharing policy, a maximum allowable cost (MAC) of Canadian $0.74 was reimbursed for each test strip in the fiscal year 2004/05. Patients who wish to use test strips which cost more than the MAC, are required to pay the difference [
5]. This cost sharing policy is intended to both reduce financial barriers to the practice of SMBG, while encouraging cost-effective SMBG through beneficiary contribution for the more expensive test strip brands.
Diabetes is associated with many complications, and inappropriate management can increase the risk of cardiovascular disorders, neurological disorders, foot sores and wounds, retinopathy, and nephropathy. Reducing hyperglycemia has shown to be an important factor in the prevention of diabetes-related complications [
1]. Owing to the complex manifestations associated with diabetes, effective management of diabetes needs to be multifaceted with strategies which include: (1) educating patients about the signs and symptoms of the disease and how to assess their condition; (2) lifestyle interventions such as regular physical activity, appropriate diet, weight management, and reduced stress levels; and (3) medications when required [
6,
7]. Currently two methods, SMBG and laboratory monitoring of A1c are used to assess glycemic control in patients with diabetes. SMBG shows a patient's blood glucose levels at a particular time point whereas A1c shows a patient's blood glucose control in the past two or three months [
8].
SMBG is considered to be a cornerstone of diabetes self-management to monitor blood glucose levels and guide patients in making adjustments to therapy or lifestyle to achieve glycemic control [
1,
8‐
12]. SMBG helps in avoiding episodes of high or low blood glucose levels among patients [
13]. SMBG also allows physicians to gather data for appropriate clinical decision-making [
14]. Qualitative studies have revealed patients' views on the advantages and disadvantages of SMBG. Patients report SMBG enhances awareness of lifestyle modifications needing adoption and raises the sense of success or failure to achieve target blood glucose levels [
10,
15]. Patients have also expressed the lack of interest shown by health professionals for the results of SMBG, compared to A1c levels, which discouraged them to continue with SMBG. This highlights the crucial role played by health professionals in educating patients on how to respond to testing results and in continuously reinforcing this information [
10,
15].
Furthermore, the frequency of SMBG has been found to vary among patients with diabetes in different jurisdictions [
16‐
20]. An observational study evaluating insurance coverage policies for blood glucose devices and testing supplies found an increased rate of testing among patients once blood glucose monitors were provided free [
21], while a randomized controlled trial (RCT) found no effect in 6-month glycosylated hemoglobin (A1c) between patients with Type 2 diabetes receiving free SMBG test strips and control subjects [
22]. Patients with type 1 diabetes performing three or more self tests per day showed statistically and clinically significant association with A1c levels [
23]. However the optimal frequency of SMBG per day is uncertain in patients with type 2 diabetes who are recommended to follow lifestyle interventions alone or in combination with OAAs [
8,
23‐
26].
Clinical practice guidelines recommend SMBG to both insulin and non insulin treated diabetes patients. The Canadian clinical practice guideline issued by the Canadian Diabetes Association in the year 2003 with a recommendation to test three or more times a day in patients receiving insulin and at least once a day in patients receiving oral antihyperglycemic agents [
27]. These guidelines were synthesized by experts using standard criteria to assign levels of evidence from published studies.
The role of SMBG in patients with diabetes is widely debated [
24,
25,
28]. Previous studies have proven the beneficial effect of SMBG in patients with type 1 diabetes [
1,
23] and in patients with type 2 diabetes who use insulin [
8,
23]. Patients with type 2 diabetes, who do not use insulin, but self monitor blood glucose, have not shown significant reduction in A1c levels in many prospective studies and randomized controlled trials [
22,
24,
25,
29‐
33] and a small effect of 0.39% decrease in A1c levels compared to control in one systematic review [
30]. Studies assessing the effect of SMBG in non insulin treated patients have methodological issues, heterogeneity of the study population and variations in the interventions offered [
34,
35]. These studies lack homogeneity and the ability to measure the true impact of SMBG in non insulin treated patients [
34,
35]. Some experts support regular SMBG while others suggest that in non insulin treated patients, there is a need to weigh benefits with healthcare expenditures before advocating routine practice [
34,
35].
Objective
The purpose of this population based study was to assess the utilization of SMBG test strips within a Canadian provincial drug plan which incorporates both a copayment and a policy of paying up to a maximum amount per test strip. We were interested in the pattern of test strips claimed by both insulin and non insulin treated patients and the extent of their adherence to guidelines for SMBG. The specific objectives of this study were (1) to analyze the frequency of SMBG test strips claimed by the beneficiaries of NSSPP based on treatment category, sex and age group; and (2) to estimate the government and beneficiary expenditure on SMBG test strips in the NSSPP, which has both a beneficiary copayment and a policy of paying up to a maximum amount per test strip.
Acknowledgements
Ingrid Sketris holds a research chair in drug use management and policy funded by Canadian Health Services Research Foundation/Canadian Institutes of Health Research/Nova Scotia Health Research Foundation. Chiranjeev Sanyal was provided salary support under this chair and also from Drug Evaluation Alliance of Nova Scotia (DEANS), Nova Scotia Department of Health.
Nova Scotia Department of Health, through the DEANS, for providing funding to access the data from Population Health Research Unit, Dalhousie University.
Jill Casey, Senior Research Analyst, Population Health Research Unit, Dalhousie University, for technical assistance.
Ethel Langille Ingram and Jocelyn LeClerc for their assistance.
The observations and opinions are those of the investigators and do not represent the opinions of the Nova Scotia Department of Health, Canadian Health Services Research Foundation, Canadian Institutes of Health Research or Nova Scotia Health Research Foundation.
Competing interests
Charmaine Cooke and Chiranjeev Sanyal received salary support from an unconditional grant from the Nova Scotia Department of Health to Dalhousie University. Dr. Ingrid Sketris has received a grant from the Nova Scotia Department of Health.
Authors' contributions
CS was involved with study design, data analysis, disseminating results and preparing the manuscript. SDG designed the study, planned the analysis, coordinated the project and critically revised the manuscript. CC was involved with study design, coordinating the project and critically revising the manuscript. IS participated in the design of the study, coordinated the project and critically revised the manuscript. DMF conceived the project and brought in policy perspectives to the project. GF contributed statistical expertise and critically revised the manuscript. All authors have read and approved the final version.