Eco 1

Just Accepted by Journal of Medical Economics
Epidemiology
An analysis of the cost-effectiveness of switching from biphasic
human insulin 30, insulin glargine or neutral protamine Hagedorn to
biphasic insulin aspart 30 in people with type 2 diabetes
Vishal Gupta, MD, MRCP, Asrul Akmal Shafie, PhD, Ranya Baabbad,
BPharmSci, Eva Hammerby, MSc, Annie Nikolajsen, MSc
doi: 10.3111/13696998.2014.991791
Abstract
Aims: The aim of this analysis was to assess the cost-effectiveness of
switching from biphasic human insulin 30 (BHI), insulin glargine (IGlar) or
neutral protamine Hagedorn (NPH) insulin (all ± oral glucose-lowing drugs
[OGLDs]) to biphasic insulin aspart 30 (BIAsp 30) in people with type 2
Journal of Medical Economics Downloaded from informahealthcare.com by Cornell University on 12/27/14
diabetes in India, Indonesia, and Saudi Arabia.

Methods: The IMS CORE Diabetes Model was used to determine the
clinical outcome, costs, and cost-effectiveness of switching from treatment
with BHI, IGlar, or NPH to BIAsp 30 over a 30-year time horizon. A 1-year
analysis was also performed based on quality-of-life data and treatment
costs. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of gross domestic product
(GDP) per capita, and cost-effectiveness was defined as ICER <3 times GDP per capita.
Results: Switching treatment from BHI, IGlar, or NPH to BIAsp 30 was associated with an increase in life
expectancy of >0.7 years, reduction in all diabetes-related complications, and was considered as cost-effective
or highly cost-effective in India, Indonesia, and Saudi Arabia (BHI to BIAsp 30, 0.26 in India, 1.25 in Indonesia,
For personal use only.
0.01 in Saudi Arabia; IGlar to BIAsp 30, −0.68 in India, −0.21 in Saudi Arabia; NPH to BIAsp 30, 0.15 in India,
−0.07 in Saudi Arabia; GDP per head per annum/quality-adjusted life-year). Cost-effectiveness was
maintained in the 1-year analyses.
Conclusions: Switching from treatment with BHI, IGlar, or NPH to BIAsp 30 (all ± OGLDs) was found to be
cost-effective in India, Indonesia, and Saudi Arabia, both in the long and short term.
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An analysis of the cost-effectiveness of switching from biphasic human insulin 30, insulin
glargine or neutral protamine Hagedorn to biphasic insulin aspart 30 in people with type 2
diabetes
Vishal Gupta, MD, MRCP (UK)a, Asrul Akmal Shafie, PhDb, Ranya Baabbad, BPharmScic, Eva
Hammerby, MScd, Annie Nikolajsen, MScd
a
Jaslok Hospital and Research Centre, Mumbai, India
b
Universiti Sains Malaysia, Penang, Malaysia
c
Pharmacoeconomics Centre of KSMC, Riyadh, Saudi Arabia
d
Novo Nordisk A/S, Søborg, Denmark
Article type: Epidemiology
Word count: 3445 (5000 limit)
Corresponding author: Vishal Gupta, Jaslok Hospital and Research Centre, 15 Dr Deshmukh
Marg, Pedder Road, Mumbai 400 026, India
Telephone: +91 22 6657 3333; Email: vishal.drvishgmd@gmail.com
ClinicalTrials.gov trial identifier: NCT00869908

Abstract
Aims: The aim of this analysis was to assess the cost-effectiveness of switching from biphasic
human insulin 30 (BHI), insulin glargine (IGlar) or neutral protamine Hagedorn (NPH) insulin
(all ± oral glucose-lowing drugs [OGLDs]) to biphasic insulin aspart 30 (BIAsp 30) in people
with type 2 diabetes in India, Indonesia, and Saudi Arabia.
Methods: The IMS CORE Diabetes Model was used to determine the clinical outcome, costs,
and cost-effectiveness of switching from treatment with BHI, IGlar, or NPH to BIAsp 30 over a
30-year time horizon. A 1-year analysis was also performed based on quality-of-life data and
treatment costs. Incremental cost-effectiveness ratios (ICERs) were expressed as a fraction of
gross domestic product (GDP) per capita, and cost-effectiveness was defined as ICER <3 times
GDP per capita.
Results: Switching treatment from BHI, IGlar, or NPH to BIAsp 30 was associated with an
increase in life expectancy of >0.7 years, reduction in all diabetes-related complications, and was
considered as cost-effective or highly cost-effective in India, Indonesia, and Saudi Arabia (BHI
to BIAsp 30, 0.26 in India, 1.25 in Indonesia, 0.01 in Saudi Arabia; IGlar to BIAsp 30, −0.68 in
India, −0.21 in Saudi Arabia; NPH to BIAsp 30, 0.15 in India, −0.07 in Saudi Arabia; GDP per
head per annum/quality-adjusted life-year). Cost-effectiveness was maintained in the 1-year
analyses.
Conclusions: Switching from treatment with BHI, IGlar, or NPH to BIAsp 30 (all ± OGLDs)
was found to be cost-effective in India, Indonesia, and Saudi Arabia, both in the long and short
term.
Key words: A1chieve; type 2 diabetes mellitus; cost-effectiveness; Saudi Arabia; India;
Indonesia; biphasic insulin aspart 30
Introduction
The International Diabetes Federation estimates that, globally, 382 million people currently have
diabetes, and this is projected to increase over the coming years, resulting in 592 million people
having diabetes by 2035 [1]. The long-term health consequences of diabetes caused by poor
glycaemic control include complications such as amputations, renal disease, blindness, blood
pressure problems, kidney problems, and cardiovascular disease, which may lead to a premature
death [2]. Currently, glycaemic targets are not being met worldwide [3–6], leading to an
increased incidence of diabetes-related complications, which translates into greater overall
diabetes management costs [2].
The total global health expenditure on treating people with diabetes was
USD 548 billion in 2013 [1]. Type 2 diabetes has been growing at a particularly high rate in low-
and middle-income countries, where a disproportionally small amount of the global expenditure
spent on treatment can be expected [1,2,7]. The estimated health expenditure on diabetes is
predicted to more than double from 2010 to 2030, from USD 2.8 million to USD 4.8 million in
India, from USD 287 million to USD 502 million in Indonesia, and from USD 1.4 billion to
USD 3 billion in Saudi Arabia, respectively [7].
Biphasic insulin aspart 30 (BIAsp 30) is a simple-to-use insulin regimen that

provides postprandial glucose regulation in addition to basal insulin coverage [8,9]. Randomised
controlled trials have demonstrated the efficacy and safety of switching from biphasic human
insulin 30 (BHI) to BIAsp 30 [10–12], switching from neutral protamine Hagedorn (NPH)
insulin to BIAsp 30 [13] and greater efficacy of starting therapy with BIAsp 30 versus insulin
glargine (IGlar) [8,14]. In addition, observational studies complement randomised controlled
trials and provide a more representative profile of complications as they account for broader
populations and allow for longer follow-up [15]. A number of observational studies have
reported positive efficacy and safety outcomes associated with switching from BHI to treatment
with BIAsp 30 [6,16,17].
A1chieve was a global observational study designed to evaluate the safety and
clinical effectiveness of insulin analogues in routine clinical practice in people with type 2
diabetes. The aim of this analysis was to assess the cost-effectiveness of switching from BHI ±
(with or without) oral glucose-lowering drugs (OGLDs), IGlar ± OGLDs, or NPH ± OGLDs to
BIAsp 30 ± OGLDs, in countries in different economic circumstances, based on clinical
outcomes and health-related quality of life (HRQoL) values from the A1chieve study.
Methods
A1chieve study
The A1chieve study was a 24-week observational study in 28 countries across Asia, Africa,
Eastern Europe, and Latin America. The study was designed to evaluate the safety and clinical
effectiveness of starting treatment with BIAsp 30, insulin detemir, or insulin aspart (all Novo
Nordisk, Copenhagen, Denmark) with or without OGLDs in 66,726 people (44,872 insulin-naïve
and 21,854 insulin-experienced) with type 2 diabetes in routine clinical practice. Details of the
study design and primary data have been presented previously [5,18]. Briefly, the study showed
that, in routine clinical practice in all of the regions studied, people starting treatment with
BIAsp 30, insulin detemir, or insulin aspart experienced clinically useful improvements in blood
glucose without clinically significant problems associated with hypoglycaemia or weight gain, as
well as increased HRQoL [19].
Simulation cohort and assumptions
The cost-effectiveness analysis was performed using data from insulin-experienced people in the
A1chieve study who switched from treatment with BHI, IGlar, or NPH to BIAsp 30 (all ±
OGLDs). Baseline characteristics and the clinical changes associated with switching to BIAsp 30
are shown in Table 1; data include change in HbA1c, body mass index (BMI), EQ-5D based
HRQoL, systolic blood pressure, lipid content, and hypoglycaemia. Study populations for
switching from BHI ± OGLDs to BIAsp 30 ± OGLDs were from India (n = 866), Indonesia
(n = 175), and Saudi Arabia (n = 401); switching from IGlar ± OGLDs to BIAsp 30 ± OGLDs
were from India (n = 191) and Saudi Arabia (n = 103); switching from NPH ± OGLDs to
BIAsp 30 ± OGLDs were also from India (n = 113) and Saudi Arabia (n = 176). Data were only
included in the cost-effectiveness analysis if HbA1c measurements at baseline and at week 24
were available. Data were collected on the costs associated with the management of diabetes,
such as annual costs for medications and screening tests in all of the individual countries. In
addition, the costs of treating relevant co-morbidities, such as cardiovascular and renal
complications, eye disease, foot ulcers, and neuropathy were collected for each country (specific
data on costs were collected independently of the investigators for the analysis model) [20–22].
For the base-case scenario, the clinical and economic impact of switching from BHI, IGlar, or
NPH to BIAsp 30 (all ± OGLDs) in each of the countries was projected over a 30-year time
horizon.
An analysis of the incremental cost of treatment and the incremental change in

HRQoL was conducted for the first year after the switch from BHI, IGlar, or NPH to BIAsp 30
(all ± OGLDs) assessing the cost per quality-adjusted life-year (QALY) in the short-term. The
direct effect of change in clinical measures, such as HbA1c, BMI, and hypoglycaemia on costs
were excluded from the 1-year analysis. However, the change in clinical measures would
indirectly be reflected in the change in HRQoL.
CORE Diabetes Model
The Centre for Outcomes Research (CORE) Diabetes Model is used to determine the long-term
clinical outcome, costs, and cost-effectiveness of clinical interventions for the treatment of type 1
and type 2 diabetes. In this analysis, the CORE model was used to determine the long-term
health and cost outcomes of switching from treatment with BHI, IGlar, or NPH to BIAsp 30 (all
± OGLDs). The interactive computer model is based on a number of Markov sub-models that use
published sources to incorporate time, state, time-in state, and diabetes type-dependent
probabilities. These sub-models are used to simulate the complications experienced by patients
with diabetes (including eye disease, cardiovascular disease, neuropathy, nephropathy, foot
ulcers, stroke, amputation, lactic acidosis, ketoacidosis, and mortality) [23]. Analyses can be
performed on groups of people with type 1 or type 2 diabetes based on specific pre-existing
baseline complications, known risk factors, age, or gender. The economic and clinical data used
in the model are editable, which enables the inclusion of new data as they become available and
the ability to perform long-term analyses on a country-specific basis. The current analysis of the
A1chieve study-specific change in EQ-5D HRQoL scores from the participating countries [19]
replaced the default CORE values in the current analysis.
Statistics
Non-parametric bootstrapping was used in each simulation. The incremental cost-effectiveness

ratio (ICER) is expressed in both USD and local currency (exchange rates as of November 2013
unless stated) as cost per QALY. The ICER is also presented for each country in the analysis as a
fraction of the gross domestic product (GDP) per capita. GDP data were taken from the World
Bank for 2011 [24]. The relative cost-effectiveness of an intervention was based on the World
Health Organisation (WHO) CHOosing Interventions that are Cost Effective (CHOICE)
programme, which recommends a threshold based on GDP per capita [25]. An intervention is
considered as non-cost-effective if the cost of an additional health benefit gained (i.e., QALY) is
>3 times GDP per capita, cost-effective at 1–3 times GDP per capita, highly cost-effective at
<1 times GDP per capita, or cost-saving (more effective and less costly i.e., dominant) if
estimated cost per QALY gained is below zero.
A series of sensitivity analyses were conducted to assess the robustness of the

results, including an extension of the time horizon to 50 years. The impact of treatment-
associated change was assessed by assuming that there was no deterioration in HbA1c over time
compared with deterioration by −0.15% (−1.6 mmol/mol) each year (excluding the first year) in
the base-case scenario. In addition, the median HbA1c treatment effect was used instead of the
mean effect and the first quartile distribution of the HbA1c treatment effect (i.e., HbA1c change
in the lowest 25% of the study population) was used instead of the mean effect.
In addition, in an analysis of the switch from IGlar to BIAsp 30, the incremental
treatment costs assumed the following: 1) that two self-measured plasma glucose (SMPG) strips
were used per day versus the one strip that was used in the base case (it was assumed that BHI,
NPH, and BIAsp 30 would all use the same amount of strips per day and, therefore, the switch
from BHI or NPH to BIAsp 30 was not included in the analysis); 2) that in the first year after the
switch to BIAsp 30, an additional four visits to a healthcare practitioner were assumed to be
required (based on public sector prices with one specialist consultation and three subsequent
consultations with a general practitioner [GP]; the highest price of a GP/specialist visit for each
country was used in order to be conservative); 3) two visits would be required to a GP every year
after the switch to BIAsp 30 (based on public sector prices to a non-specialist); 4) the average
overall switch specific EQ-5D change could be used from the A1chieve study population (BHI to
BIAsp 30 [± OGLDs, 0.143; + OGLDs, 0.182]; IGlar to BIAsp 30, 0.123; NPH to BIAsp 30,
0.117), rather than individual EQ-5D scores specific for each country.
A short-term analysis (1 year) was performed where sensitivity analyses were

conducted for the costs of additional SMPG strips (IGlar to BIAsp 30 only) and four medical
consultations with GPs after the switch to BIAsp 30.
An analysis was also conducted to project the maximum total costs (assuming the same
clinical outcome) where BIAsp 30 would still be considered cost-effective as defined by an
ICER of three times GDP per capita for each country to allow for potential costs not included in
the cost-effectiveness analyses.
Results
Life expectancy, diabetes-related complications, costs, and cost-effectiveness

The change in clinical outcomes after 24 weeks of treatment reported in the A1chieve study for
patients switching from BHI, IGlar, or NPH to BIAsp 30 (all ± OGLDs) are shown in Table 1.
Switching from BHI, IGlar, or NPH to BIAsp 30 (all ± OGLDs) was consistently associated with
a projected increase in life expectancy and an estimated reduction in all diabetes-related
complications over 30 years, compared with remaining on BHI ± OGLDs, IGlar ± OGLDs, or
NPH ± OGLDs, in India, Indonesia, and Saudi Arabia (Table 2). Overall, the simulated risk
reduction in myocardial infarction over 30 years from switching to BIAsp 30 ± OGLDs ranged
between 12% and 24%; switching from BHI ± OGLDs to BIAsp 30 ± OGLDs resulted in a 15%
(India), 12% (Indonesia), and 17% (Saudi Arabia) reduction; switching from IGlar ± OGLDs to
BIAsp 30 ± OGLDs resulted in a 14% (India) and 17% (Saudi Arabia) reduction; switching from
NPH ± OGLDs to BIAsp 30 ± OGLDs resulted in a 14% (India) and 24% (Saudi Arabia)
reduction.
The direct total costs of diabetes care, including treatment costs, management costs,
and complication costs are shown in Table 3. The total costs of switching to BIAsp 30 ± OGLDs
or remaining on BHI ± OGLDs were similar in Saudi Arabia (USD 53,575 and USD 53,128,
respectively). However, in India and Indonesia, the cost of switching from BHI ± OGLDs to
BIAsp 30 ± OGLDs was greater than remaining on BHI ± OGLDs (USD 6970 and USD 6094,
respectively, in India; USD 30,676 and USD 26,856, respectively, in Indonesia), but still well
below the cost-effectiveness threshold. The total cost of switching from IGlar ± OGLDs to
BIAsp 30 ± OGLDs was less than remaining on IGlar treatment in India (USD 7571 and USD
10,114, respectively) and Saudi Arabia (USD 52,849 and USD 61,569, respectively). The total
costs associated with remaining on NPH ± OGLDs or switching to BIAsp 30 ± OGLDs were
USD 6705 and USD 6174 in India and USD 47,865 and USD 50,199 in Saudi Arabia,
respectively (Table 3). In addition, the long-term ICERs per QALY gained from the base-case
analysis (calculated from the incremental cost and the incremental QALY) were projected over
30 years and presented as a fraction of GDP per QALY. In Indonesia, switching from BHI ±
OGLDs to BIAsp 30 ± OGLDs was cost-effective with GDP per capita of 1.25, whereas in India
and Saudi Arabia, the switch was highly cost-effective (0.26 and 0.01, respectively). Switching
from IGlar ± OGLDs to BIAsp 30 ± OGLDs was cost-neutral or potentially cost-saving in both
India (−0.68) and Saudia Arabia (−0.21), and switching from NPH ± OGLDs was highly cost-
effective in India (0.15) and cost-neutral or potentially cost-saving in Saudi Arabia (−0.07)
(Table 4).
In the short-term analysis, when the 1-year ICER was expressed as GDP fractional cost per
QALY gained, switching to BIAsp 30 ± OGLDs was highly cost-effective (≤1 GDP per capita)
in all countries, with the exception of switching from BHI ± OGLDs to BIAsp 30 ± OGLDs in
Indonesia, which was determined as being cost-effective (≥1 and ≤3 GDP per capita) (Table 4).
Sensitivity analysis
The sensitivity analysis showed that the ICERs did not change greatly by extending the analysis
over a 50-year time horizon, or having no deterioration in HbA1c compared with the base case,
where switching from BHI ± OGLDs to BIAsp 30 ± OGLDs in people with type 2 diabetes
remained cost-effective (Indonesia) or highly cost-effective (India and Saudi Arabia). In
addition, switching from IGlar ± OGLDs or NPH ± OGLDs to BIAsp 30 ± OGLDs remained
highly cost-effective regardless of the modified outcome in India and Saudi Arabia (Figure 1).
The addition of two clinic visits every year after the switch and the cost of SMPG strips affected
ICER but did not change the cost-effectiveness of switching insulin treatment to BIAsp 30
(Figure 1).
The increase in total current costs that would still deliver an ICER of 3.0 GDP/capita/QALY
gained (i.e., which would be on the cost-effectiveness limit) was estimated to be 131% for India,
17% for Indonesia, and 229% for Saudi Arabia when switching from BHI ± OGLDs to BIAsp 30
± OGLDs; 182% for India and 257% for Saudi Arabia when switching from IGlar ± OGLDs to
BIAsp 30 ± OGLDs; 155% for India and 226% for Saudi Arabia when switching from NPH ±
OGLDs to BIAsp 30 ± OGLDs in Indonesia).
Discussion
In this analysis, switching therapy from BHI ± OGLDs, IGlar ± OGLDs, or NPH ± OGLDs to
BIAsp 30 ± OGLDs in patients with type 2 diabetes was found to be highly cost-effective or
cost-effective over a 30-year time horizon in India, Indonesia, and Saudi Arabia using the CORE
Diabetes Model. In each case, local baseline clinical characteristics and costs for the treatment
and management of diabetes were used for the analysis to ensure local validity.
The long-term analysis showed a projected reduction in the incidence of serious
diabetes-related complications by switching from BHI, IGlar, or NPH ± OGLDs to BIAsp 30 ±
OGLDs over a 30-year time horizon. In all countries analysed (India, Indonesia, and Saudi
Arabia), there was an expected reduction in the incidence of severe vision loss, end-stage renal
disease, myocardial infarction, and ulcer when treatment was switched to BIAsp 30, resulting in
HbA1c levels closer to the recommended targets. In addition, as would be expected with a
reduction in the incidence of serious complications, there was an increase in life expectancy in
patients who switched to BIAsp 30 ± OGLDs in all countries.
The 30-year time horizon was judged to be a suitable length of time for the
analysis, as the majority of patients would be expected to have died within that period of time,
given the mean age range at baseline (Table 1). The analysis was actually extended over a 50-
year time horizon and the increase in duration of treatment was shown to have very little effect
on the overall cost-effectiveness in any of the countries in this analysis. In addition, in the 1-year
analysis, the cost-effectiveness of switching to BIAsp 30 was similar, but not as great as in the
30-year analysis (long term), where switching from BHI, IGlar, or NPH ± OGLDs to BIAsp 30 ±
OGLDs remained highly cost-effective or cost-effective in India, Indonesia, or Saudi Arabia.
This is to be expected as the 30-year analysis provides cost-saving information on the long-term
benefits and reduction in costs of treating diabetes-related complications, whereas the 1-year
analysis only provides information on the short-term costs, which relate only to direct-treatment
costs. These analyses demonstrating the cost-effectiveness of switching from BHI, IGlar, or NPH
± OGLDs to BIAsp 30 ± OGLDs complement the finding that switching to BIAsp 30 improves
glycaemic control in patients with type 2 diabetes [17,26–30].
With the predicted increase in the number of people with diabetes, and therefore
diabetes-related complications, over the next 20 years, the long- and short-term cost-
effectiveness of different treatments for type 2 diabetes will become increasingly important.
Currently, policy-makers regard randomised control trials as the ‘gold standard’ for evidence [2],
whereas the data presented in this analysis are generated from the observational A1chieve study.
Observational studies have the benefit of providing information that is representative of what
actually happens in routine clinical practice in the real world [31].
Cost-effectiveness analyses are inherently comparative, evaluating one treatment
type versus another. In this analysis, it is assumed that the comparator group remained on BHI ±
OGLDs, IGlar ± OGLDs, or NPH ± OGLDs indefinitely and did not switch to another type of
therapy at any stage during the projected 30-year time horizon. As diabetes is a progressive
disease, the majority of patients would switch insulin or increase their dose and dosing frequency
of insulin during the 30-year time horizon. In an effort to address this potential limitation of the
study, we conducted several sensitivity analyses using median and first quartile distribution of
HbA1c treatment effect as well as assuming no deterioration in HbA1c over time, which showed
no significant effect on the cost-effectiveness measure. A further limitation of the study is the
lack of published cost studies that are specific to the Indian, Indonesian, and Saudi Arabian
populations. However, estimates were obtained from three local experts in each country where
data were lacking [20–22]. The findings of high cost-effectiveness in all three countries included
in the analyses were robust in the sensitivity analyses, including the threshold analyses of insulin
cost, and so the variance in cost would not appear to be an issue in this instance.
An advantage of the current study is that specific country and treatment QoL data
were used for each of the countries included in the analysis. Results of the cost-effectiveness of
switching from BHI, IGlar, or NPH to BIAsp 30 are not transferable between regions. However,
a previous study has demonstrated the cost-effectiveness of switching to BIAsp 30 ± OGLDs in
other countries [32]. In addition, in South Korea, switching to BIAsp 30 in patients with poorly
controlled type 2 diabetes with NPH improved life expectancy and quality-adjusted life
expectancy, and was a cost-effective treatment option [15]. In the USA, switching to BIAsp 30
from human premixed insulin in patients with poor glycaemic control or hypoglycaemia was
shown to be a cost-effective treatment option [33]. In addition, switching from BHI to BIAsp 30
in China was projected to substantially improve clinical outcomes in patients with type 2
diabetes while increasing lifetime medical costs. However, BIAsp 30 would be considered a
cost-effective treatment option in China in patients with type 2 diabetes poorly controlled with
BHI [34].
Direct treatment costs with IGlar are higher than with BIAsp 30, so switching from
IGlar to BIAsp 30 provides a direct cost saving from the time of the switch. However, many of
the healthcare costs associated with diabetes relate to the treatment of diabetes-related
complications rather than treatment of the disease itself. The present analysis demonstrates that,
even if the initial direct cost of switching the treatment is higher than remaining on the current
insulin (as in the case of switching from BHI to BIAsp 30), the treatment can still be cost-
effective over a longer period of time when the effect of treatment on long-term complications is
taken into account (30-year time horizon). If a patient has poorly controlled type 2 diabetes with
a basal insulin ± OGLDs, switching to BIAsp 30 ± OGLDs can offset the cost of treatment with
the reduction in the cost of management of serious diabetes-related complications. However, a
problem for funders and policy-makers is justifying the increased upfront costs of diabetes
treatments to achieve savings in the future. This analysis shows BIAsp 30 to be good value for
money by demonstrating that, in India, Indonesia, and Saudi Arabia, switching from BHI ±
OGLDs, IGlar ± OGLDs, or NPH ± OGLDs to BIAsp 30 ± OGLDs was cost-effective over the
short term with a 1-year time horizon, where only cost of medication was considered and costs
saved on reduction in diabetes related complications were not included.
In conclusion, switching from BHI ± OGLDs, IGlar ± OGLDs, or NPH ± OGLDs
to BIAsp 30 ± OGLDs was found to be cost-effective, based on data from the A1chieve study, in
India, Indonesia, and Saudi Arabia, both in the long and short term.
Transparency
Declaration of financial/other relationships

VG, AS & RB, for themselves or institutions with which they are associated, receive funding from all
major international pharmaceutical companies for their advisory, lecturing, and research activities,
including from Novo Nordisk. EH and AN are employees of Novo Nordisk.
Contributions
All authors contributed to the preparation of the manuscript at all stages of development and have
approved the final article.
Acknowledgements
We thank all the participants and investigators who helped with the A1chieve study. The authors take full
responsibility for the data and analysis supporting this article, and the results and discussion presented,
but acknowledge editorial assistance from Kirsty Ratcliffe of Watermeadow Medical and Last Mile P/S
for assistance with analyses, funded by Novo Nordisk.
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Table 1. Baseline demographics and change in clinical outcomes after 24 weeks of treatment from the A1chieve study in people switching
from BHI ± OGLDs, IGlar ± OGLDs, or NPH ± OGLDs to BIAsp 30 ± OGLDs in people with type 2 diabetes.
BHI to BIAsp 30 IGlar to BIAsp 30 NPH to BIAsp 30

India Indonesia Saudi Arabia India Saudi Arabia India Saudi Arabia
N 866 175 401 191 103 113 176
Sex M/F, % 65.5/34.5 52.6/47.4 53.1/49.9 64.9/35.1 51.5/48.5 61.1/38.9 65.9/34.1
Age, years 55.6 (10.0) 56.0 (10.6) 54.1 (9.5) 54.7 (9.3) 52.3 (8.5) 55.9 (8.6) 56.3 (11.3)
Diabetes
11.0 (5.6) 10.9 (7.4) 12.2 (6.2) 9.3 (4.3) 11.2 (5.4) 8.9 (5.5) 12.8 (5.6)
duration, years
BMI, 26.1 (3.6)/−0.0 25.8 (5.1)/0.7 32.3 (5.2)/−0.2 27.4 (4.3)/−0.4 30.9 (5.7)/−0.1 27.9 (4.6)/0.1 29.5 (5.5)/−0.9
kg/m2/change (0.9) (1.3) (1.4) (1.1) (1.6) (2.0) (2.1)
HbA1c,
9.1 (1.4)/−1.6 9.4 (1.9)/−1.4 9.6 (1.8)/−2.1 9.5 (1.7)/−1.6 9.9 (1.6)/−2.5 9.2 (1.3)/−1.6 9.8 (1.6)/−2.8
%/change
HbA1c,
76 (15.4)/−18 79 (21)/−15 81 (20)/−23 80 (19)/−18 85 (18)/−28 77 (14)/−18 84 (18)/−31
mmol/mol/change
EQ-5D / change 0.595/0.214 0.849/0.041 0.681/0.143 0.587/0.240 0.685/0.123 0.617/0.229 0.701/0.117
Systolic blood
142.4 138.3
pressure, 136.3 (16.0)/−6.8 132.3 (16.4)/−2.9 133.4 (14.7)/−5.9 132.0 (18.3)/−6.5 136.5 (16.0)/−7.6
(14.3)/−10.5 (14.2)/−10.9
mmHg/change
Dose of insulin, 29.1 (12.3)/28.6 44.5 (21.3)/52.7 63.4 (23.4)/76.7 28.3 (14.7)/28.5 28.7 (11.3)/61.8 23.6 (15.9)/24.0 48.0 (25.4)/60.2
U/day/EOT (11.3) (20.7) (25.1) (10.2) (18.9) (10.2) (19.0)
Baseline complication, N (%)

Cardiovascular 327 (38.2) 53 (30.3) 146 (36.4) 80 (42.8) 32 (31.1) 39 (34.5) 70 (39.8)
Renal 314 (36.7) 59 (33.7) 226 (56.4) 89 (47.6) 64 (62.1) 46 (40.7) 88 (50.0)
Eye 249 (29.1) 51 (29.1) 193 (48.1) 71 (38.0) 51 (49.5) 33 (29.2) 74 (42.0)
Foot ulcer 59 ( 6.9) 12 (6.9) 25 (6.2) 10 (5.3) 11 (10.7) 4 (3.5) 30 (17.0)
Neuropathy 402 (47.0) 83 (47.4) 268 (66.8) 96 (51.3) 62 (60.2) 38 (33.6) 104 (59.1)
Lipids, mmol/L/change
Total cholesterol 5.0 (0.9)/−0.4 5.0 (1.7)/−0.2 5.1 (1.1)/−0.5 5.2 (1.0)/−0.4 5.2 (0.9)/−0.5 5.5 (0.7)/−0.4 6.1 (1.6)/−1.7
LDL cholesterol 2.8 (1.0)/−0.3 2.8 (1.1)/0.0 3.0 (0.9)/−0.3 3.1 (0.8)/−0.3 3.0 (0.8)/−0.4 3.2 (0.6)/−0.4 2.6 (1.4)/0.6
HDL cholesterol 1.0 (0.2)/0.0 1.2 (0.4)/0.1 1.1 (0.3)/0.0 1.0 (0.2)/−0.1 1.1 (0.2)/0.0 1.1 (0.2)/0.0 1.5 (0.9)/−0.4
Triglycerides 1.9 (0.7)/−0.2 1.8 (1.0)/−0.2 2.0 (1.0)/−0.3 2.2 (0.7)/−0.3 2.0 (0.8)/−0.3 2.1 (0.4)/−0.2 2.6 (1.2)/−0.9
Hypoglycaemia (events per 100 person years)/change
Daytime
Major 0.36/−0.36 0.67/−0.67 0.36/−0.36 0.14/−0.14 0/0 0.58/−0.58 0.07/−0.07
Minor 3.33/−2.68 2.67/−1.78 3.11/−1.29 0.61/−0.41 1.89/−0.38 1.04/−0.92 1.99/0.52
Nocturnal
Major 0.11/−0.11 0.22/−0.22 0.26/−0.26 0.14/−0.14 0/0 0.12/−0.12 0.07/−0.07
Minor 1.05/−0.84 2.15/−1.78 0.91/−0.10 0.41/−0.41 0.38/0.12 0.46/−0.46 0.52/0.14
Mean (SD or %).

BHI, biphasic human insulin 30; BIAsp 30, biphasic insulin aspart 30; HDL, high density lipoprotein; IGlar, insulin glargine; LDL, low density
lipoprotein; NPH, neutral protamine Hagedorn insulin; OGLD, oral glucose lowering drug; SD, standard deviation.
Table 2. Life expectancy, incidence of selected complications (percentage of people) and estimated time alive and free of complications
(years), and QALY gains over 30 years after switching from BHI ± OGLDs, IGlar ± OGLDs, or NPH ± OGLDs to BIAsp 30 ± OGLDs
compared with not switching insulin in people with type 2 diabetes.
BIAsp 30 BHI BIAsp 30 BHI BIAsp 30 BHI BIAsp 30 IGlar BIAsp 30 IGlar BIAsp 30 NPH BIAsp 30 NPH
Life expectancy, years 67.3 66.6 68.5 67.6 66.2 65.0 66.5 65.6 63.3 65.0 67.7 66.8 67.3 66.0
Any complication
Time to event, years 0.7 0.5 0.6 0.4 0.1 0.0 0.5 0.3 0.2 0.1 0.8 0.6 0.2 0.1
Severe vision loss
Incidence, % people 6.9 9.5 6.9 8.8 18.8 26.3 10.9 14.5 9.0 12.8 7.7 10.8 7.3 12.0
End-stage renal disease
Myocardial infarction
Ulcer
QALY gains
Estimated QALY gains 2.502 0.828 2.002 2.822 2.081 2.741 1.736
over 30 years
BHI, biphasic human insulin 30; BIAsp 30, biphasic insulin aspart 30; IGlar, insulin glargine; NPH, neutral protamine Hagedorn insulin; OGLD, oral
glucose lowering drug; SD, standard deviation.
Table 3. Direct costs of diabetes care are simulated over 30 years with switching to BIAsp 30 ± OGLDs or remaining on BHI ± OGLDs,
IGlar ± OGLDs, or NPH ± OGLDs in people with type 2 diabetes.
BIAsp 30 BHI BIAsp 30 BHI BIAsp 30 BHI BIAsp 30 IGlar BIAsp 30 IGlar BIAsp 30 NPH BIAsp 30 NPH
Total costs
Local currency 432,455 378,175 342,635,9 300,073,3 200,924 199,246 469,777 627,538 198,200 230,902 416,049 383,097 179,507 188,262
INR INR 51 IDR 43 IDR SAR SAR INR INR SAR SAR INR INR SAR SAR
USD 6970 6094 30,676 26,865 53,575 53,128 7571 10,114 52,849 61,569 6705 6174 47,865 50,199
Treatment costs
Local currency 216,450 133,633 130,844,0 75,795,22 42,820 22,238 221,642 345,152 38,295 46,673 189,310 123,693 30,318 17,928
USD 3488 2154 11,714 6786 11,418 5930 3572 5563 10,211 12,445 3051 1994 8084 4780
Management costs
Local currency 46,967 45,639 42,668,67 40,858,98 36,325 33,889 49,316 47,069 38,156 34,445 47,623 45,707 32,828 30,110
INR 0 IDR 6 IDR SAR SAR INR INR SAR SAR INR INR SAR SAR
INR
USD 757 736 3820 3658 9686 9036 795 759 10,174 9185 768 737 8753 8029
Complication costs
Local currency 169,039 198,903 169,123,2 183,419,1 121,778 143,118 198,819 235,318 121,749 149,784 179,116 213,698 116,362 140,225
USD 2724 3206 15,141 16,421 32,471 38,162 3204 3792 32,464 39,939 2887 3444 31,027 37,390
Currency conversions as of November 2013 (1 INR = 0.0161164 USD; 1 IDR = 0.0000895279 USD; 1 SAR = 0.266644 USD).
BHI, biphasic human insulin 30; BIAsp 30, biphasic insulin aspart 30; GDP, gross domestic product; IDR; Indonesian Rupiah; IGlar, insulin glargine;
INR, Indian Rupee; NPH, neutral protamine Hagedorn; OGLD, oral glucose lowering drug; SAR, Saudi Arabian Riyal.
Table 4. Long-term and short-term cost-effectiveness of switching from BHI ± OGLDs, IGlar ± OGLDs, or NPH ± OGLDs to BIAsp 30 ±
OGLDs in people with type 2 diabetes.
30-year ICER (cost per QALY gained) (base case)
Local
21,696 INR 51,416,659 IDR 838 SAR −55,914 INR −15,714 SAR 12,023 INR −5044 SAR
currency
USD 350 4603 224 −901 −4190 194 −1345

GDP
0.26 1.25 0.01 −0.68 −0.21 0.15 −0.07
fraction
Incremental
54,281 INR 42,562,608 IDR 1678 SAR –157,762 INR –32,703 SAR 32,952 INR –8754 SAR
cost
Incremental
2.52 0.83 2.00 2.82 2.08 2.74 1.74
QALY
1-year ICER (cost per QALY gained)
Local 120,507,713
36,001 INR 12,952 SAR −60,194 INR −10,445 SAR 25,652 INR 9624 SAR
currency IDR
USD
580 10,789 3454 −970 −2785 413 2566
GDP
0.44 2.92 0.17 −0.73 −0.14 0.31 0.13
fraction
Incremental
7704 INR 4,940,816 IDR 1852 SAR –14,447 INR −1285 SAR 5874 INR 1126 SAR
cost
Incremental
0.21 0.04 0.14 0.24 0.24 0.23 0.12
QALY
Currency conversions as of November 2013 (1 INR = 0.0161164 USD; 1 IDR = 0.0000895279 USD; 1 SAR = 0.266644 USD)
BHI, biphasic human insulin 30; BIAsp 30, biphasic insulin aspart 30; GDP, gross domestic product; IDR; Indonesian Rupiah; IGlar, insulin glargine;
INR, Indian Rupee; NPH, neutral protamine Hagedorn; OGLD, oral glucose lowering drug; SAR, Saudi Arabian Riyal.
Figure legend
Figure 1. Sensitivity analysis of switching from BHI ± OGLDs, IGlar ± OGLDs, or NPH ±
OGLDs to BIAsp 30 ± OGLDs in people with type 2 diabetes. Results presented as a
fraction of GDP per capita per QALY gained.
BHI, biphasic human insulin 30; BIAsp 30, biphasic insulin aspart 30; GP, general practitioner; IGlar, insulin
glargine; NPH, neutral protamine Hagedorn insulin; SMBG, self-measured blood glucose.

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Just Accepted by Journal of Medical Economics

diabetes in India, Indonesia, and Saudi Arabia.

Article type: Epidemiology

Word count: 3445 (5000 limit)

ClinicalTrials.gov trial identifier: NCT00869908

Biphasic insulin aspart 30 (BIAsp 30) is a simple-to-use insulin regimen that

Simulation cohort and assumptions

An analysis of the incremental cost of treatment and the incremental change in

CORE Diabetes Model

Non-parametric bootstrapping was used in each simulation. The incremental cost-effectiveness

A series of sensitivity analyses were conducted to assess the robustness of the

A short-term analysis (1 year) was performed where sensitivity analyses were

Life expectancy, diabetes-related complications, costs, and cost-effectiveness

Declaration of financial/other relationships

5. Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C, Chakkarwar P, et al. An

6. Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al; IMPROVE

7. Zhang P, Zhang X, Brown J, Vistisen D, Sicree R, Shaw J, et al. Global healthcare

9. Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, et al. Attainment of

12. Hermansen K, Colombo M, Storgaard H, ØStergaard A, Kølendorf K, Madsbad S. Improved

20. Hnoosh A, Vega-Hernández G, Jugrin A, Todorova L. PDB45 Direct medical costs of

29. Ohira M, Endo K, Oyama T, Yamaguchi T, Ban N, Kawana H, et al. Improvement of

BHI to BIAsp 30 IGlar to BIAsp 30 NPH to BIAsp 30

N 866 175 401 191 103 113 176

Sex M/F, % 65.5/34.5 52.6/47.4 53.1/49.9 64.9/35.1 51.5/48.5 61.1/38.9 65.9/34.1

EQ-5D / change 0.595/0.214 0.849/0.041 0.681/0.143 0.587/0.240 0.685/0.123 0.617/0.229 0.701/0.117

Baseline complication, N (%)

Foot ulcer 59 ( 6.9) 12 (6.9) 25 (6.2) 10 (5.3) 11 (10.7) 4 (3.5) 30 (17.0)

Hypoglycaemia (events per 100 person years)/change

Major 0.36/−0.36 0.67/−0.67 0.36/−0.36 0.14/−0.14 0/0 0.58/−0.58 0.07/−0.07

Minor 3.33/−2.68 2.67/−1.78 3.11/−1.29 0.61/−0.41 1.89/−0.38 1.04/−0.92 1.99/0.52

Major 0.11/−0.11 0.22/−0.22 0.26/−0.26 0.14/−0.14 0/0 0.12/−0.12 0.07/−0.07

Minor 1.05/−0.84 2.15/−1.78 0.91/−0.10 0.41/−0.41 0.38/0.12 0.46/−0.46 0.52/0.14

Mean (SD or %).

BHI to BIAsp 30 IGlar to BIAsp 30 NPH to BIAsp 30

Severe vision loss

End-stage renal disease

BHI to BIAsp 30 IGlar to BIAsp 30 NPH to BIAsp 30

BHI to BIAsp 30 IGlar to BIAsp 30 NPH to BIAsp 30

30-year ICER (cost per QALY gained) (base case)

USD 350 4603 224 −901 −4190 194 −1345

1-year ICER (cost per QALY gained)

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