Abstract
Background
The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control as part of managing this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements.
Objectives
To estimate the budget impact of point-of-care HbA1c testing to replace laboratory HbA1c measurement for monitoring glycemic control in patients with diabetes in 2013/2014.
Review Methods
This analysis compared the average testing cost of 3 point-of-care HbA1c devices licensed by Health Canada and available on the market in Canada (Bayer's A1cNow+, Siemens's DCA Vantage, and Bio Rad's In2it), with that of the laboratory HbA1c reference method. The cost difference between point-of-care HbA1c testing and laboratory HbA1c measurement was calculated. Costs and the corresponding range of net impact were estimated in sensitivity analyses.
Results
The total annual costs of laboratory HbA1c measurement and point-of-care HbA1c testing for 2013/2014 were $91.5 million and $86.8 million, respectively. Replacing all laboratory HbA1c measurements with point-of-care HbA1c testing would save approximately $4.7 million over the next year. Savings could be realized by the health care system at each level that point-of-care HbA1c testing is substituted for laboratory HbA1c measurement. If physician fees were excluded from the analysis, the health care system would incur a net impact from using point-of-care HbA1c testing instead of laboratory A1c measurement.
Limitations
Point-of-care HbA1c technology is already in use in the Ontario health care system, but the current uptake is unclear. Knowing the adoption rate and market share of point-of-care HbA1c technology would allow for a more accurate estimate of budget impact.
Conclusions
Replacing laboratory HbA1c measurement with point-of-care HbA1c testing or using point-of-care HbA1c testing in combination with laboratory HbA1c measurement to monitor glycemic control in patients with diabetes could have saved the province $1,175,620 to $4,702,481 in 2013/2014.
Plain Language Summary
Diabetes occurs when the body cannot use glucose normally. It happens because either the pancreas does not make enough insulin (a hormone that controls the level of glucose in the blood) or the body does not respond well to the insulin it makes. High blood glucose levels over a long time cause damage to the heart, eyes, kidneys, and nerves. Checking blood glucose levels often can help doctors choose the right treatment to help keep diabetes in control.
Hemoglobin A1c (HbA1c) is a test that measures the amount of glucose that has stuck to red blood cells over a 3-month period. It is directly related to a patient's average blood glucose levels. People with diabetes usually go to a laboratory to have their HbA1c tested. However, testing HbA1c in diabetes education centres or doctor's offices may save money for the health care system.
Background
Overuse, underuse, and misuse of interventions are important concerns in health care and lead to individuals receiving unnecessary or inappropriate care. In April 2012, under the guidance of the Ontario Health Technology Advisory Committee's Appropriateness Working Group, Health Quality Ontario (HQO) launched its Appropriateness Initiative. The objective of this initiative is to develop a systematic framework for the ongoing identification, prioritization, and assessment of health interventions in Ontario for which there is possible misuse, overuse, or underuse.
For more information on HQO's Appropriateness Initiative, visit our website at www.hqontario.ca.
The Programs for the Assessment of Technology in Health (PATH) Research Institute was commissioned by Health Quality Ontario to evaluate the budget impact and predict the costs of point-of-care testing for hemoglobin A1c for the management of diabetes. The budget impact of implementing each intervention is estimated.
Health Quality Ontario conducts full evidence-based analyses, including economic analyses, of health technologies being considered for use in Ontario. These analyses are then presented to the Ontario Health Technology Advisory Committee, whose mandate it is to examine proposed health technologies in the context of available evidence and existing clinical practice, and to provide advice and recommendations to Ontario health care practitioners, the broader health care system, and the Ontario Ministry of Health and Long-Term Care.
DISCLAIMER: Health Quality Ontario uses a standardized costing method for its economic analyses. The main cost categories and associated methods of retrieval from the province's perspective are described below.
Hospital costs: Ontario Case Costing Initiative cost data are used for in-hospital stay, emergency department visit, and day procedure costs for the designated International Classification of Diseases diagnosis codes and Canadian Classification of Health Interventions procedure codes. Adjustments may be required to reflect accuracy in the estimated costs of the diagnoses and procedures under consideration. Due to difficulties in estimating indirect costs in hospitals associated with a particular diagnosis or procedure, Health Quality Ontario normally defaults to a consideration of direct treatment costs only.
Non-hospital costs: These include physician services costs obtained from the Ontario Schedule of Physician Benefits, laboratory fees from the Ontario Schedule of Laboratory Fees, drug costs from the Ontario Drug Benefit Formulary, and device costs from the perspective of local health care institutions whenever possible, or from the device manufacturer.
Discounting: For cost-effectiveness analyses, a discount rate of 5% is applied (to both costs and effects/QALYs), as recommended by economic guidelines.
Downstream costs: All reported downstream costs are based on assumptions of population trends (i.e., incidence, prevalence, and mortality rates), time horizon, resource utilization, patient compliance, health care patterns, market trends (i.e., rates of intervention uptake or trends in current programs in place in the province), and estimates of funding and prices. These may or may not be realized by the Ontario health care system or individual institutions and are often based on evidence from the medical literature, standard listing references, and educated hypotheses from expert panels. In cases where a deviation from this standard is used, an explanation is offered as to the reasons, the assumptions, and the revised approach.
The economic analysis represents an estimate only, based on the assumptions and costing methods explicitly stated above. These estimates will change if different assumptions and costing methods are applied to the analysis.
NOTE: Numbers may be rounded to the nearest decimal point, as they may be reported from an Excel spreadsheet.
Objective of Analysis
The objective of this analysis was to estimate the budget impact (2013/2014) of point-of-care hemoglobin A1c (POC HbA1c) testing to replace laboratory hemoglobin A1c (lab HbA1c) measurement for monitoring glycemic control in patients with diabetes.
Clinical Need and Target Population
Description of Disease/Condition
Diabetes is a metabolic disorder resulting from defective insulin production and/or action. There are 2 major types of diabetes: type 1 and type 2. Type 1 diabetes is an autoimmune disease in which the body's defence system attacks its own insulin-producing cells; type 2 diabetes is characterized by insulin resistance and inadequate insulin production. Type 2 diabetes accounts for over 90% of the diabetes population. Left uncontrolled, the chronic hyperglycemia associated with diabetes contributes to cardiovascular disease and microvascular complications affecting the eyes, kidneys, and nerves. (1) Classic diabetes trials, including the Diabetes Control and Complications Trial for type 1 diabetes and the United Kingdom Prospective Diabetes Study for type 2 diabetes, have demonstrated that optimal glycemic control slows the onset and progression of diabetes-related complications. (2–4)
Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control, and it has been widely used to guide treatment decisions in clinical practice. Its value reflects average blood glucose concentration over the preceding 3 months. (5) It is recommended that patients with diabetes have HbA1c tested every 3 to 6 months to assess glycemic control. (6)
Ontario Prevalence
In 2012, Statistics Canada reported a prevalent diabetes population of 770,410 in Ontario. (7) This figure is expected to increase in parallel with the upward trend of obesity and the aging population.
Technology/Technique
Point-of-care testing refers to diagnostic testing at or near the site of patient care. (8) POC HbA1c testing is an alternative to lab HbA1c measurement, and it has several potential advantages. First, it provides rapid test results following blood collection, to expedite medical decision-making. Second, it may improve health system efficiency and be convenient for patients, because fewer visits to laboratories or physician's offices would be needed. Third, it may improve access to HbA1c measurement for patients in underserved populations (e.g., rural or remote communities).
Ontario Context
The current standard of care in Ontario is that patients with diabetes go to community laboratories or hospitals for HbA1c measurement, usually prior to their physician visit. POC HbA1c devices are being used in selected diabetes education centres, community health centres, and doctor's offices, funded by their operating budgets.
The prevalence of POC HbA1c testing in Ontario is unclear. However, considering the increasing prevalence of diabetes, there will be a growing need for HbA1c testing to monitor glycemic control. POC HbA1c testing may improve system efficiency if the results from point-of-care devices are comparable to those from laboratory assays. Therefore, Health Quality Ontario chose to compare the correlation between POC HbA1c and lab HbA1c measurement in clinical settings.
Interventions Under Evaluation
Six POC HbA1c devices are licensed by Health Canada as class-3 devices for quantitative determination of HbA1c from capillary or venous whole blood. The manufacturer information for these devices is presented in Table 1.
Table 1:
Manufacturer Information for POC HbA1c Devices Licensed for Use in Canada
| Manufacturer Information | A1c Now Self-Check at Home A1c System | A1c Now+ | DCA 2000 Analyzer System | DCA Vantage Analyzer | In2it (I) System | Smart Direct HbA1c Analyzer |
|---|---|---|---|---|---|---|
| Manufacturer | Bayer Healthcare LLC | Bayer Healthcare LLC | Siemens Healthcare Diagnostics Inc | Siemens Healthcare Diagnostics Inc | Bio-Rad Laboratories Deeside | Diazyme Laboratories |
| Licence number | 84541 | 65484 | 1990 | 76034 | 80662 | 88752 |
| Issue date | November 2010 | July 2008 | March 1999 | January 2008 | September 2009 | April 2012 |
| Remark | — | — | Unavailable in Canada | — | — | Unavailable in Canada |
Abbreviation: POC HbA1c, point-of-care hemoglobin A1c.
The operating characteristics of the 3 POC HbA1c devices that are available for use in Canada are summarized in Table 2.
Table 2:
Characteristics of POC HbA1c Devices Available for Use in Canada
| Characteristic | A1c Now+ | DCA Vantage Analyzer | In2it (I) System |
|---|---|---|---|
| Manufacturer | Bayer Healthcare LLC | Siemens Healthcare Diagnostics Inc | Bio-Rad Laboratories Deeside |
| Method | Immunoassay | Latex agglutination inhibition immunoassay | Boronate-affinity chromatography |
| Blood sample | 5 μL (capillary or venous) | 1 μL (capillary or venous) | 10 μL (capillary or venous) |
| Time for results | 5 minutes | 6 minutes | 10 minutes |
| Interference with abnormal hemoglobin variants (15) | HbC, HbS, HbF − 10–15% | HbC, HbE, HbF − 10–15% | HbF − 10% |
| NGSP-certified (16) | Yes | Yes | Yes |
| CLIA waived | Yes | Yes | Yes |
| Other characteristics | Same device as A1c Now, with more test cartridges in the kit | Successor of DCA 2000 | N/A |
Abbreviation: CLIA, Clinical Laboratory Improvement Amendments; HbC, hemoglobin C; HbE, hemoglobin E; HbF, hemoglobin F; HbS, hemoglobin S; NGSP, National Glycohemoglobin Standardization Program; POC HbA1c, point-of-care hemoglobin A1c.
Economic Analysis
Research Question
What is the estimated budget impact (2013/2014) of POC HbA1c testing to replace lab HbA1c measurement for monitoring glycemic control in patients with diabetes?
Budget Impact Analysis
A budget impact analysis was conducted from the perspective of the Ontario Ministry of Health and Long-Term Care to determine the estimated cost burden of replacing lab HbA1c measurements performed in community laboratories with POC HbA1c testing to monitor glycemic control in Ontario patients with diabetes. All costs are reported in 2013 Canadian dollars.
Research Methods
Prevalent Population
The population of Ontario was estimated using data from Statistics Canada (Table 3). (9) The overall prevalent population with diabetes was estimated using prevalence rates and constant rate projection with data from the Institute for Clinical Evaluative Sciences and the Canadian Diabetes Association. (10) However, the overall prevalence of diabetes includes both diagnosed and undiagnosed populations. Because only those diagnosed with diabetes receive HbA1c testing, the population of those with diagnosed diabetes was also determined.
Table 3:
Ontario Population and Estimated Prevalence of Diabetes
The population with diagnosed diabetes was selected for the budget impact analysis, and patients were divided into 2 groups: those with optimal glycemic control (HbA1c ≤ 7.0%) and those with suboptimal glycemic control (HbA1c − 7.0%). (6) The Diabetes in Canada Evaluation study (2002/2003) reported that approximately 49% of patients with diagnosed diabetes had suboptimal glycemic control. (12) Using this estimate, the number of patients in each subgroup was projected for 2013/2014 (Table 4).
Table 4:
Prevalent Population: Glycemic Control
| Glycemic Control | %a | n |
|---|---|---|
| Optimal (HbA1c ≤ 7.0%) | 51.0% | 418,409 |
| Suboptimal (HbA1c − 7.0%) | 49.0% | 402,001 |
Abbreviation: HbA1c, hemoglobin A1c.
Diabetes in Canada Evaluation study. (12)
Resources
Patients with diabetes should have their HbA1c levels tested twice yearly if their glycemic control is optimal, or 4 times yearly if their glycemic control is suboptimal (Table 5). (6) For patients with suboptimal glycemic control, an additional 2 physician visits were assumed for follow-up treatment changes after lab HbA1c measurement, totalling 6 visits. According to administrative data from the Institute for Clinical Evaluative Sciences, approximately 64% of patients with diagnosed diabetes (N = 525,062) receive HbA1c testing according to the guidelines. (13)
Table 5:
Physician Visits per Year for Lab HbA1c Measurement and POC HbA1c Testing
| Population | Lab HbA1c | POC HbA1c | ||
|---|---|---|---|---|
| Physician Visits per Patient per Year | Total Physician Visits | Physician Visits per Patient per Year | Total Physician Visits | |
| Patients with optimal glycemic control (HbA1c ≤ 7.0%) (n = 267,781) | 2 | 836,818 | 2 | 836,818 |
| Patients with suboptimal glycemic control (HbA1c − 7.0%) (n = 257,281) | 6 | 2,412,005 | 4 | 1,608,004 |
| All patients (N = 525,062) | — | 3,248,824 | — | 2,444,822 |
Abbreviation: lab HbA1c, laboratory hemoglobin A1c; POC HbA1c, point-of-care hemoglobin A1c.
Canadian Costs
The average Canadian costs for HbA1c testing are presented in Table 6.
Table 6:
Per Procedure Cost
| Procedure | Average Cost |
|---|---|
| POC HbA1c testing | $16.26a |
| Bayer A1C Now + | $16.45b |
| DCA Vantage | $9.74c |
| In2it | $22.50d |
| Lancets | $0.03e |
| Lab HbA1c measurement | $8.81f |
| Physician visit (diabetes management assessment) | $39.20 (fee code K030)g |
| Additional physician visit for patients with suboptimal glycemic control | $33.70 (fee code A007)h |
Abbreviations: lab HbA1c, laboratory hemoglobin A1c; POC HbA1c, point-of-care hemoglobin A1c.
Total cost for a POC HbA1c test includes the average cost of the 3 reviewed devices plus the cost of a lancet.
Manufacturer list price from McKesson, based on a 10-test MD kit. Cost includes a wholesale markup.
Price for DCA 2000 kit reagent 10TST/PK. Personal communication, Manthamed distributor, September 1, 2013.
Personal communication, product manager, Bio-Rad Laboratories (Canada) Ltd., September 19, 2013.
Manufacturer list price from McKesson, based on a 100 lancets per box (Medi+Sure Soft Twist Lancet). Cost includes a wholesale markup.
Cost for a lab HbA1c test is based on the Ontario Schedule of Benefits for Laboratory Services, (14) assuming that the cap per test is 77.5% (average of 75% to 80%) of the total of $11.37 (average cost of $8.81).
The cost per physician visit for patients with diabetes was obtained from the Ontario Schedule of Benefits for Physician Services, using the fee code K030 for Diabetic Management Assessment, up to a maximum of 4 visits per year. (15)
The cost for the 2 additional physician visits for patients with suboptimal glycemic control was applied using the fee code A007. (15)
Results of Budget Impact Analysis
The total estimated annual cost of POC HbA1c testing and lab HbA1c measurement in 2013/2014 is presented in Table 7. Replacing lab HbA1c test with POC HbA1c would result in cost savings.
Table 7:
Budget Impact of POC HbA1c Testing
| 2013/2014 | |
|---|---|
| Total annual cost of lab HbA1c testing | $91,482,155 |
| Total annual cost of POC HbA1c testinga | $86,779,673 |
| Net budget impact | − $4,702,481 |
Abbreviations: lab HbA1c, laboratory hemoglobin A1c; POC HbA1c, point-of-care hemoglobin A1c.
Total annual cost of POC HbA1c testing if being used instead of lab HbA1c testing in patients with diabetes.
Sensitivity Analyses
Sensitivity analyses were conducted on the prevalence of both diagnosed and undiagnosed diabetes; the rate of HbA1c testing; the percentage of patients with diabetes and suboptimal glycemic control; increases in the volume of POC HbA1c testing (with a corresponding decrease in lab HbA1c testing); and the exclusion of physicians’ visits. Table 8 outlines the results of these sensitivity analyses and their net budget impact. All but 1 of the sensitivity analyses indicated that the use of of POC HbA1c testing to monitor glycemic control would result in savings in 2013/2014. If physicians’ visits were excluded from the analysis, there would an increase in spending with the full-scale introduction of POC HbA1c testing.
Table 8:
Results of Sensitivity Analyses
| Net Budget Impact, 2013/2014 | |
|---|---|
| Prevalence of diagnosed diabetes in Ontario increased by 50% | − $7,053,722 |
| HbA1c testing increased by 25% | − $5,878,102 |
| HbA1c testing decreased by 25% | − $3,526,861 |
| Percentage of patients with suboptimal glycemic control increased by 25% | − $8,315,175 |
| Percentage of patients with suboptimal glycemic control increased by 50% | − $11,927,868 |
| Impact of increasing POC HbA1c testing by 25% | − $1,175,620 |
| Impact of increasing POC HbA1c testing by 50% | − $2,351,241 |
| Impact of increasing POC HbA1c testing by 75% | − $3,526,861 |
| Physicians’ visits excluded | $11,656,363 |
Abbreviations: HbA1c, hemoglobin A1c; POC HbA1c, point-of-care hemoglobin A1c.
Limitations
Although POC HbA1c technology is already in use in the Ontario health care system, the current uptake is unclear. Knowing the adoption rate and market share of POC HbA1c technology would allow for a more accurate estimate of budget impact.
Conclusions
Replacing lab HbA1c measurement with POC HbA1c testing or using POC HbA1c testing in combination with lab HbA1c measurement to monitor glycemic control in patients with diabetes could have saved the province between $1,175,620 and $4,702,481 in 2013/2014.
Acknowledgements
Editorial Staff
Jeanne McKane, CPE, ELS(D)
Expert Advisory Panel on Community-Based Care for Adult Patients With Type 2 Diabetes
| Panel Members | Affiliation(s) | Appointment(s) |
|---|---|---|
| Co-Chairs | ||
| Dr Baiju Shah | Sunnybrook Health Sciences Centre Institute for Clinical Evaluative Sciences University of Toronto | Staff Physician, Division of Endocrinology Scientist, ICES Associate Professor |
| Dr David Tannenbaum | Mount Sinai Hospital Ontario College of Family Physicians University of Toronto | Chief of Department of Family & Community Medicine Past-President, OCFP Associate Professor |
| Endocrinologist | ||
| Dr Harpreet Bajaj | Ontario Medical Association LMC Endocrinology Centre | Tariff Chairman, Section of Endocrinology |
| Dr Alice Cheng | Trillium Health Partners St. Michael's Hospital | Endocrinologist, Division of Endocrinology and Metabolism |
| Dr Janine Malcolm | Ottawa Hospital Ottawa Health Research Institute | |
| Nephrologist | ||
| Dr Sheldon Tobe | Sunnybrook Health Sciences Centre Canadian Cardiovascular Harmonized National Guidelines Endeavour | Associate Scientist Co-Chair, C-CHANGE |
| Family Physician | ||
| Dr Robert Algie | Fort Frances Family Health Team | Lead Physician |
| Dr J Robin Conway | Perth and Smiths Falls Community Hospitals Canadian Centre for Research on Diabetes | Family Physician (Diabetes Care) |
| Dr Lee Donohue | Ontario Medical Association | Health Policy Chair, Section of General and Family Practice |
| Dr Dan Eickmeier | Huron Community Family Health Team | |
| Dr Stewart B. Harris | Western University | Professor, Department of Family Medicine |
| Dr Warren McIsaac | Mount Sinai Hospital University of Toronto | |
| Nurse Practitioner | ||
| Betty Harvey | St. Joseph's Healthcare Hamilton | Clinical Nurse Specialist/Nurse Practitioner, Primary Care Diabetes Support Program |
| Registered Nurse | ||
| Brenda Dusek | Registered Nurses Association of Ontario | Program Manager, International Affairs & Best Practice Guideline Centre |
| Registered Nurse/Certified Diabetes Educator | ||
| Bo Fusek | Hamilton Health Sciences Centre | Diabetes Care and Research Program |
| Melissa Gehring | St. Joseph's Healthcare Hamilton | Diabetes Research Coordinator |
| Amanda Mikalachki | St. Joseph's Healthcare Hamilton | |
| Registered Dietitian/Certified Diabetes Educator | ||
| Pamela Colby | St. Joseph's Healthcare Hamilton Brescia University College, Western University | |
| Stephanie Conrad | Weeneebayko Diabetes Health Program | |
| Registered Dietitian | ||
| Stacey Horodezny | Trillium Health Partners | Team Leader, Diabetes Management Centre & Centre for Complex Diabetes Care |
| Lisa Satira | Mount Sinai Hospital | |
| Pharmacist | ||
| Lori MacCallum, PharmD | Banting and Best Diabetes Centre, University of Toronto | Program Director, Knowledge Translation and Optimizing Care Models Assistant Professor, Leslie Dan Faculty of Pharmacy |
| Clinical Pharmacist | ||
| Christine Papoushek, PharmD | Toronto Western Hospital University of Toronto | Pharmacotherapy Specialist, Department of Family Medicine |
| Community Pharmacist | ||
| Mike Cavanagh | Kawartha Lakes Pharmacy Ontario Pharmacists Association | |
| Economic Modelling Specialist | ||
| Meredith Vanstone, PhD | McMaster University | Post-doctoral Fellow, Centre for Health Economics and Policy Analysis |
| Epidemiologist/Scientist | ||
| Daria O'Reilly, PhD | McMaster University | Assistant Professor |
| Knowledge Translation/Delivery of Diabetes Self-Management Education | ||
| Enza Gucciardi, PhD | Ryerson University | Associate Professor, School of Nutrition |
| Bioethicist | ||
| Frank Wagner | Toronto Central CCAC University of Toronto | Assistant Professor, Department of Family and Community Medicine |
| Ontario Cardiac Care Network Representative | ||
| Kori Kingsbury | Cardiac Care Network | Chief Executive Officer |
| Heart and Stroke Foundation Representative/Registered Dietitian | ||
| Karen Trainoff | Ontario Heart and Stroke Foundation | Senior Manager, Health Partnerships |
| Centre for Complex Diabetes Care Representative/Registered Dietitian | ||
| Margaret Cheung | Trillium Health Partners Mississauga Hospital | Clinical Team Leader |
| Community Care Access Centre Representative | ||
| Dorota Azzopardi | Central West CCAC | Client Services Manager – Quality Improvement, Chronic – Complex and Short Stay |
| General Internal Medicine/Health Services Research | ||
| Dr Jan Hux | Canadian Diabetes Association | Chief Scientific Officer |
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