Pharmaco-Economic Consequences of Losartan Therapy in Patients Undergoing Diabetic End Stage Renal Disease in EU and USA

Abstract

Diabetic nephropathy is the most frequent cause of end stage renal disease (ESRD). As ESRD incidence increases continuously, more resources are needed for treatment. The objective was to evaluate the economic impact of losartan added to the standard care administered to diabetic subjects with ESRD. The analysis has involved more than 500 million inhabitants. Standard methods have been used in order to conduct an economic evaluation comparing the economic outcomes deriving from the administration of losartan added to standard care versus standard care alone in patients with type 2 diabetes mellitus (DM) and nephropathy over 3.4 years. The study was hence conducted from the perspective of the third-party payer. The clinical outcome data were based on the results from the Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan (RENAAL) trial. Direct medical costs are referred to the purchase costs of losartan and to the costs of hospitalization. The costs were discounted back at an annual rate of 3%. Also sensitivity analysis was performed. The RENAAL study showed that losartan confers strong renal protection in patients with DM and nephropathy. Losartan results into cost saving in all countries considered: 3,602.98€/Italy, 4,531.35€/France, 3,019.66€/Germany, 3,949.50€/Switzer-land, and 3,855.50€/US per patient. Results are not sensitive to both clinical and economic variables. In addition to the medical benefits, this analysis demonstrates the economic relevance of the treatment with losartan in DM patients affected by nephropathy.

Full text

A294 13th Euro Abstracts
PDB55
COMPARISON OF RESOURCE USE AND COSTS IN TYPE 1 DIABETES
PATIENTS TREATED WITH DIFFERENT LONG ACTING INSULINS IN A
BASAL-BOLUS REGIMEN IN GERMANY
Bierwirth RA1, Kostev K2, Dippel FW3, Fuchs S4, Kotowa W4
1Ambulantes Diabteszentrum am Elisabeth-Krankenhaus, Essen, Germany; 2IMS Health
GmbH & Co. OHG, Frankfur t am Main, Germany; 3Sanofi -Aventis Deutschland GmbH,
Berlin, Germany; 4IMS Health GmbH & Co. OHG, Nürnberg, Germany
OBJECTIVES: Compare resource utilization and treatment costs with three different
basal insulins in type-1-diabetics (T1D). METHODS: A cohort study based on a repre-
sentative database (IMS® Disease Analyzer) included T1D who had started an intensi-
fi ed conventional therapy (ICT) with NPH-insulin (NPH), insulin glargine (GLA) or
insulin detemir (DET) between July 2000 and February 2008 and whose data were
continuously documented at least 12 months before and 18 months after ICT initiation.
The variables age, gender, diabetes duration, HbA1c, Body Mass Index (BMI), insurance
status, geographical region and specifi cation of the practice were collected. Diabetes-
related resource utilization (insulin, test strips, lancets, pens, needles, glucose i.v., glu-
cagon, physician visits and hospitalization) and associated direct treatment costs
(excluding physicians visits and hospitalization) were determined for a time period of
12 months for patients receiving NPH, GLA and DET, respectively. The results were
adjusted applying a multivariate regression model. RESULTS: A total of 1218 T1D
received an ICT with NPH, 1079 with GLA and 443 with DET, respectively. The
unadjusted annual direct treatment costs were c1308 for NPH, c1512 for GLA and
c1729 for DET. After adjusting ICT with GLA showed economic advantages compared
to NPH (−c234/year; P < 0.0001) or DET (−c425/year; P = 0.2800). The consumption
of basal insulin and test strips was lower in patients treated with GLA compared to
NPH (−6.00 U/day; P = 0.3514 and −0.31 strips/day; P = 0.8291) or DET (−3.23 U/
day; P < 0.0001 and −0.59 strips/day; P = 0.0235). CONCLUSIONS: After adjustment
this analysis of German real-life data showed that ICT with GLA is related to lower
annual treatment costs than ICT with NPH or DET. In view of the equal clinical effi cacy
as reported in several randomized clinical trials [1, 2] and the economic advantages,
GLA should be regarded as the favored therapeutic option in ICT for T1D in Germany.
PDB56
PHARMACOECONOMIC CONSEQUENCES OF LOSARTAN THERAPY IN
PATIENTS UNDERGOING DIABETIC END-STAGE RENAL DISEASE IN EU
AND USA
Citarella A, de Portu S, Cammarota S, Menditto E, Mantovani LG
CIRFF, Federico II University, Naples, Italy
OBJECTIVES: Diabetic nephropathy is the most frequent cause of End Stage Renal
Disease (ESRD). As ESRD incidence continuously increases, more resources are needed
for treatment. The objective was to evaluate the economic impact of losartan added to
the standard care administered to diabetic subjects with ESRD. The analysis has involved
more than 500 million inhabitants. METHODS: We used standard methods to conduct
an economic evaluation comparing the economic outcomes deriving from the adminis-
tration of losartan added to standard care versus standard care alone in patients with
type 2 diabetes mellitus (DM) and nephropathy over 3.4 years. The study was conducted
from the perspective of the third-party payer hence. The clinical outcome data were
based on the results from the RENAAL trial. Direct medical costs are referred to the
purchase costs of losartan and the cost of hospitalizations. The costs were discounted
back at an annual rate of 3%. Also sensitivity analysis was performed. RESULTS:
RENAAL study established that losartan confers strong renal protection in patients with
DM and nephropathy. Losartan results into a cost saving in all countries considered: 3
c602.98/Italy, c4531.35/France, c3019.66/Germany, c3949.50/Switzerland and
c3855.50/USA per patient. Results are not sensitive to both clinical and economic
variables. CONCLUSIONS: In addition to the medical benefi t, this analysis demon-
strates the economic relevance of treatment with losartan in DM patients with
nephropathy.
PDB57
LOWER TREATMENT COSTS WITH INSULIN GLARGINE COMPARED
TO INSULIN DETEMIR IN
TYPE 1 DIABETES PATIENTS TREATED WITH
A BASAL-BOLUS REGIMEN IN GERMANY
Wiesner T1, Schädlich PK2, Dippel FW3, Koltermann K2, Hagenmeyer EG2
1MVZ Stoffwechselmedizin Leipzig, Leipzig, Germany; 2IGES Institut GmbH, Berlin, Germany;
3Sanofi -Aventis Deutschland GmbH, Berlin, Germany
OBJECTIVES: To compare, from the perspective of Statutory Health Insurance (SHI)
in Germany, direct diabetes-related treatment costs in patients with type 1 diabetes
mellitus (T1DM) during the fi rst year after the switch from Neutral Protamin Hage-
dorn insulin (NPH) to the respective long acting insulin in the course of a basal-bolus
insulin regimen (ICT) with insulin glargine or insulin detemir as the basal insulin
component. METHODS: Natural units of resource consumption incurred by basal
and bolus insulin, needles, lancets, and test strips were modelled over a period of 1
year in each of the two cost-minimization analyses, based on the results of two con-
trolled clinical trials [1, 2]. Resources were valued in prices of 15 January 2010 rel-
evant to SHI in the outpatient sector. In the base-case analyses, average values of all
the model parameters were applied. In comprehensive sensitivity analyses (impact
analysis, analysis of extremes, Monte Carlo simulation), the robustness of the base-
case results was tested. RESULTS: In the base-case analyses, there were savings of
c378 or 15% and c311 or 14%, respectively, per patient and year obtained by insulin
glargine compared to insulin detemir. Savings in favour of GLA turned out to be
robust in the sensitivity analyses. Even in the analyses of extremes, there were always
savings obtained by insulin glargine, irrespective of insulin detemir being given once,
once to twice, or twice daily. When simulating real-life conditions the savings obtained
by insulin glargine instead of insulin detemir were maintained. CONCLUSIONS:
Treatment of T1DM patients with insulin glargine as the basal insulin component of
an ICT may lead to substantial savings from the German SHI perspective as compared
to insulin detemir. [1] Pieber et al. Diabet Med 2007;24:635–42; [2] Heller et al. Clin
Ther 2009;31:2086–97.
PDB58
PHARMACOEPIDEMIOLOGICAL ASSAY AND COST-MINIMIZATION
ANALYSIS OF ORAL ANTIDIABETIC MEDICATIONS AND INSULINS IN
LITHUANIA
Kildonaviciute G, Stankunaite E, Kadusevicius E, Petraityte A
Kaunas Medical University, Kaunas, Lithuania
OBJECTIVES: To conduct pharmacoepidemiological research and cost-minimization
analysis of oral antidiabetic medications and insulins in Lithuania. METHODS: Medi-
cations were grouped according to the ATC classifi cation system. Our research results
were reported in DDDs per 1000 inhabitants per day (DDD/TID). Calculations of
drug prices and total expenditures on antidiabetic medications were made by using
data from National Patient Funds Price List in 2006–2009 years. Reference pricing
methodology was used to accomplish our cost-minimization analysis. RESULTS:
Total consumption of hypoglycaemic agents increased by 33% from 21.54 DDD/TID
in 2006 to 28.72 DDD/TID in 2009. Utilization of insulin increased by 30% reaching
the value 9.43 DDD/TID in 2009 and oral antidiabetic medications increased by
35%—19.29 DDD/TID in 2009. Total expenditures on hypoglycaemic agents
increased by 23% from LTL 57.138 mlln in 2006 to LTL 70.531 mlln in 2009 (1EUR
= 3.4528LTL). Single DDD prices ranged from 0.70 LTL/DDD to 5.01 LTL/DDD of
oral antidiabetics, and from 5.67 LTL/DDD to 2.97 LTL/DDD for insulins. With refer-
ence to meta-analysis and NICE recommendations, considering the similar effi cacy
and safety within drug classes, cost-minimization analysis using the reference-based
pricing could be implemented and total expenditures could be decreased by 27%
(saving LTL 19 mlln. yearly). CONCLUSIONS: Our fi ndings suggest that implementa-
tion of reference-based pricing could be a strong fi scal measure helping to rationalize
increasing direct health care expenditures by 27%.
PDB59
HEALTH ECONOMIC EVALUATIONS COMPARING THE BASAL INSULIN
ANALOGUE GLARGINE (GLA) WITH NEUTRAL PROTAMINE
HAGEDORN (NPH) INSULIN IN INTENSIFIED INSULIN THERAPY (ICT)
IN PATIENTS WITH TYPE 1 DIABETES: A SYSTEMATIC REVIEW
Hagenmeyer EG, Koltermann KC, Schädlich PK, Häussler B
IGES Institut GmbH, Berlin, Germany
OBJECTIVES: To perform a systematic literature review of health economic evalua-
tions comparing GLA with NPH as the basal component of an ICT in patients with
type 1 diabetes. METHODS: The search was performed between January 1, 2000 and
December 1, 2009 via Embase, Medline, the Cochrane Library, the databases of
German Medical Science and of DAHTA (Deutsche Agentur für Health Technology
Assessment), and abstract books of relevant scientifi c congresses. The inclusion of
retrieved studies was based on predefi ned criteria. The included studies were assessed
according to established methodological and quality aspects. RESULTS: A total of
seven health-economic evaluations from four different countries were included: six
modeling studies, all of them cost-utility analyses (CUA), and one cost-minimization
analysis (CMA) based on a claims data analysis. One CUA showed dominance of GLA
because of higher utilities and lower costs. The other fi ve CUAs varied in their addi-
tional costs per quality adjusted life-year (QALY) gained for treatment with GLA
between c3.859 and c57.002 (incremental cost-effectiveness ratio, ICER). The CMA
revealed about c160 higher diabetes-specifi c costs per year for GLA in the German
Statutory Health Insurance (SHI) setting. All the included studies showed good quality
despite a few constraints. Nevertheless, they all contained enough explanatory power
to evaluate the effectiveness of GLA in comparison to NPH. CONCLUSIONS: Despite
some differences concerning evaluation methods (CUA or CMA), data sources (ran-
domized controlled trial, claims data) and country specifi c conditions (pricing and
reimbursement situation) the identifi ed health economic analyses showed high confor-
mity concerning the main target parameter. Most of the studies (5 of 7) showed a
good to very good cost-effectiveness in favour of GLA compared to NPH depending
on the respective design of the health economic analysis chosen. ACKNOWLEDG-
MENT: This study was supported by Sanofi -Aventis Deutschland GmbH, Berlin,
Germany.
PDB60
HEALTH ECONOMIC EVALUATIONS COMPARING THE BASAL INSULIN
ANALOGUES INSULIN GLARGINE (GLA) AND INSULIN DETEMIR (DET)
IN INTENSIFIED INSULIN THERAPY (ICT) IN PATIENTS WITH TYPE 1
DIABETES: A SYSTEMATIC REVIEW
Hagenmeyer EG, Koltermann KC, Schädlich PK, Häussler B
IGES Institut GmbH, Berlin, Germany
OBJECTIVES: Due to limited health care resources economic evaluations of alterna-
tive drug treatment methods become more important, especially in chronic diseases
like diabetes mellitus. Therefore, a systematic literature review of health economic
evaluations comparing GLA with DET as the basal component of an ICT in patients