and $11 respectively (Figure 1). ⢠Total (direct and indirect) expected annual hypoglycaemia costs for different levels of glucose control were expected at $338, ...
Quantifying the direct and indirect costs associated with severe and non-severe hypoglycaemia in subjects with type-2 diabetes who are treated with insulin Volker Foos1, David Grant2, James Palmer1, Nebibe Varol3, Bradley Curtis4, Kristina S. Boye4, Phil McEwan5 1
IMS Health, Basel, Switzerland; 2 IMS Health, London, UK; 3 Eli Lilly and Company, Windlesham, Surrey, UK; 4 Eli Lilly and Company, Indianapolis, USA; 5 Centre for Health Economics, Swansea University, Wales.
INTRODUCTION
Table 1: Unit costs and frequency of medical resources required to treat NSHE, SHE1 and SHE2
There have been a number of studies quantifying the direct and indirect resource implications associated with severe hypoglycaemia episodes (SHE). Although non-severe hypoglycaemia episodes (NSHEs) are more frequent, research has focused on the evaluation of the economic and clinical impact of SHEs; the health economic implications of NSHEs are less well understood. The objective of this study was to identify the direct and indirect costs of NSHE and SHE in insulin-treated patients with type 2 diabetes in the US setting.
Resource Type
1) The first literature review assessed frequency and costs of resource consumption (primary and secondary care and treatment related) and productivity loss associated with NSHE and SHE. •
For costing purposes, SHEs were further sub-classified into events requiring medical assistance (SHE2) and events requiring non-medical assistance (SHE1).
•
Following data from a self-administered questionnaire to collect retrospective data on hypoglycaemia frequency (7) we assumed that 11.8% of all SHE are attributable to SHE2 (i.e. require medical assistance) and the remaining percentage to SHE1.
•
Direct costs of hypoglycemic episodes were derived based on frequency of service items required to treat hypoglycaemia multiplied with the related unit costs of the resource (Table 1).
•
Based on the human capital approach, indirect costs were estimated from the expected productivity loss (PL) associated with daytime or nocturnal hypoglycaemic episodes (Table 2), (1, 4, 5)
•
Period specific PL was subsequently weighted according to the expected frequencies of hypoglycaemia events occurring during particular time periods to yield the overall expected loss in productivity for NSHE, SHE1 and SHE2.
•
PL was finally converted to monetary units assuming an annual income of $27,915; 40 work hours during the week and 48 working weeks in one year.
2) The second literature review established the frequency of NSHE and SHE in insulin-based clinical trials where sulfonylurea usage was also reported in T2DM. •
•
•
Multivariate linear regression was used to determine the contributions to hypoglycaemia risk from a series of significant risk factors including HbA1c, insulin regimen, age, duration of diabetes, sulfonylurea usage, and other potential determinants.
An economic module was developed in Microsoft Excel to collate findings from [1] and [2] and predict the expected annual per-patient hypoglycaemia event cost (using 2011 US costs) and costs associated with different levels of glucose control (HbA1c range between 6% and 9%) (Figure 1).
Source
$43.67
Medicare 2012 Physician Fee Schedule
$139.14
Addendum B Medicare “Outpatient Prospective Payment System” (OPPS) for hospital outpatient services
$182.81
Total
$214.47
SHE1
SHE2
0%
0%
17%
(2) for SHE2
Medicare ambulance fee schedule
0%
0%
21.32%
(6) for SHE2
Medicare IPPS (inpatient prospective payment system) FY2012 FR Table 5 Weights;
0%
0%
26%
(2) for SHE2
(3)
0%
0%
20%
(2) for SHE2
Medicare 2012 Physician Fee Schedule
13.7%
13.7%
26%
(2) for SHE2 and (1) for NSHE and SHE1
$43.41
Medicare 2012 Physician Fee Schedule (85% of 99213 – physician visit for medium, established patient)
0%
0%
13%
(2) for SHE2
Self Monitoring of Blood Glucose (SMBG)
$0.98
(8)
Non HCP treatment (third-party assitance)
$55.02
US net effective sales price of replacement vials
no
yes
no
Non HCP treatment (self Tx)
$9.23
(1)
yes
no
no
ER visit
Ambulance
$7,354.00 (W MCC) $4,171.00 (W CC)
Inpatient with ER
$2,811.00 (W/O CC/ MCC) Outpatient
$285.00
Primary Care $76.23 (new patient) Visit to GP
$51.07 (established patient)
Nurse
Other
•
Episodes requiring assistance from a health care practitioner were identified as particularly costly and amounted to $ 1,150 per episode (direct costs) compared to episode costs of $66 and $11 for events requiring third-party (non-medical) assistance and events resolvable by self-treatment, respectively (Figure 1).
•
When patients OOP costs following self treatment required to manage NSHE were considered, NSHE costs increased from $11 to $20.
•
Indirect costs associated with three severity grades of hypoglycaemia were predicted to be $579, $176 and $11 respectively (Figure 1).
•
Total (direct and indirect) expected annual hypoglycaemia costs for different levels of glucose control were expected at $338, $208 , $110 and $57 for HbA1c levels ranging from 6% to 9%, respectively (Figure 1).
CONCLUSION
(1)
(1)
Table 2: Indirect cost calculation NSHE PSF (NSHE)
PSPL
SHE1 WPL
PSF (SHE)
PSPL
SHE2 WPL
PSPL
WPL
Source
(1)
(1)
(5)
(4)
08:00-13:00
17.59%
0.14
0.024
16.00%
2.70
0.432
8.60
1.376
13:00-18:00
17.59%
0.14
0.024
9.00%
2.70
0.243
8.60
0.774
18:00-00:00
38.86%
0.12
0.046
35.00%
2.70
0.945
8.60
3.010
00:00-08:00
25.95%
0.25
0.066
40.00%
2.50
1.000
8.60
3.440
(4)
Average PL/episode
0.16
2.62
8.60
Indirect costs/episode ($ USD)
$11
$176
$579
PSF = period specific frequency; PSPL = period specific productivity loss (days); WPL = weighted productivity loss (day); WPL = PSF * PSPL; Average PL/episode = Σ WPL
Figure 1 : Annual direct, indirect and combined episode costs of hypoglycemia by different levels of glucose control and costs of hypoglycaemia per event HbA1c
6%
7%
8%
NSHE/yr
16.4
8.9
4.8
2.6
0.083
0.039
0.015
0.003
SHE/yr
9%
Direct health care costs Indirect costs
Combined (direct+indirect) 2000
• The results of this analysis show that SHEs and NSHEs are associated with considerable costs. Failure to account for this cost burden may underestimate the value of diabetes management strategies that minimize hypoglycaemia risk.
REFERENCES 5. Gold et al. Diabetes Care 17, 1994 6. Leese et al. Diabetes Care 26(4):1176-80, 2003 7. Leiter et al. Canad J of Diab 29(3):186-92, 2005 8. Yeaw et al. J Manag Care Pharm 18(1):21-32, 2012
$1'729
1800
Annual Hypoglycemai costs (USD)
• Limitations of this analysis include assumed glucagon injections following all cases of SHE1 and the application of productivity loss due to paid and non-paid activities in Davis et al. Sensitivity analyses were conducted to assess the impact of each assumption.
1. Brod et al. Value in Health 14: 665-671, 2011 2. Bullano et al. Am J Health Syst Pharm 15; 2473-82, 2006 3. Curkendall et al. J of Cl Outc Manag 18(10):455-62, 2011 4. Davis et al. Curr Med Res Opin 21(9):1477-83, 2005
3.9 extra tests per event
ER=emergency room; GP=general practitioner; HCP=health care practitioner; SMBG=self monitoring of blood glucose; W=with; W/O without; MCC=major complications and comorbidities; CC=complications and comorbidities
RESULTS Detailed evidence of the medical cost burden of hypoglycemic events was identified from eight US studies (1-8) of insulin-treated patients.
Source
NSHE
Direct medical episode costs were estimated from a payer perspective but patients out of pocket (OOP) expenses were considered in sensitivity analysis.
•
Required resource frequency
Secondary Care
METHODS We conducted two literature reviews of the MEDLINE database for studies published between 1st June 2002 and 1st June 2012.
Costs
1600 1400
$1'150
1200 1000 800
$579
600
388
400 200
194 195
$242 $176 $66
208 104 104
55 55
110
29 29 57
$11 $11 $22
0
A1c=6%
A1c=7%
A1c=8%
A1c=9%
c SHE2/event
c SHE1/event
c NSHE/event
cSHE2: cost of SHE2; cSHE1: cost of SHE1 ; cNSHE: cost of NSHE
PDB 32
Presented at the ISPOR 16th Annual European Congress, Dublin 2-6 November 2013
Supported by funding from Eli Lilly and Company
