Skip to main content
Top
Published in: Advances in Therapy 8/2014

Open Access 01-08-2014 | Original Research

Cost-Effectiveness of Asenapine in the Treatment of Patients with Bipolar I Disorder with Mixed Episodes in an Italian Context

Authors: Chiara Caresano, Guido Di Sciascio, Andrea Fagiolini, Giuseppe Maina, Giulio Perugi, Claudio Ripellino, Claudio Vampini

Published in: Advances in Therapy | Issue 8/2014

Login to get access

Abstract

Introduction

Bipolar disorder is a chronic disease characterized by periods of mania or hypomania, depression, or a combination of both (mixed state). Because bipolar disorder is one of the leading causes of disability, it represents an important economic burden on society. Asenapine (ASE) is a new second-generation antipsychotic developed and approved for the treatment of manic or mixed episodes associated with bipolar disorder. The objective of the present study was to assess the cost-effectiveness of ASE compared to olanzapine (OLA) in the treatment of patients experiencing mixed episodes associated with bipolar I disorder in the context of the Italian National Health Service (NHS).

Methods

A pharmacoeconomic model was developed to simulate the management of Italian bipolar I patients with mixed episodes over a 5-year time horizon by combining clinical parameters with resource utilization. An expert panel of Italian psychiatrists and health economists was responsible for adapting a UK model to the Italian context. The primary outcome measure of the economic evaluation was the incremental cost effectiveness ratio, where effectiveness is measured in terms of quality adjusted life-years gained. Scenario analyses, sensitivity analyses, and a probabilistic sensitivity analysis were performed to test the robustness of the model.

Results

This pharmacoeconomic model showed that ASE resulted to be dominant over OLA; in fact, ASE was associated with lower direct costs (derived largely by the savings from hospitalizations avoided) and also generated a better quality of life. Results were robust to changes in key parameters; both scenario analyses and sensitivity analyses demonstrated model reliability.

Conclusions

Results from this study suggest that the management of bipolar I patients with mixed episodes using ASE as alternative to OLA can lead to cost saving for the Italian NHS and improve patients quality of life.
Appendix
Available only for authorised users
Literature
1.
go back to reference American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, D.C., USA, 2000. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, D.C., USA, 2000.
2.
go back to reference Fagiolini A, Forgione R, Maccari M, et al. Prevalence, chronicity, burden and borders of bipolar disorder. J Affect Disord. 2013;148(2–3):161–9.PubMedCrossRef Fagiolini A, Forgione R, Maccari M, et al. Prevalence, chronicity, burden and borders of bipolar disorder. J Affect Disord. 2013;148(2–3):161–9.PubMedCrossRef
3.
go back to reference Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: global Burden of Disease Study. Lancet. 1997;349(9063):1436–42.PubMedCrossRef Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: global Burden of Disease Study. Lancet. 1997;349(9063):1436–42.PubMedCrossRef
4.
go back to reference Das Gupta R, Guest JF. Annual cost of bipolar disorder to UK society. Br J Psychiatry. 2002;180:227–33.PubMedCrossRef Das Gupta R, Guest JF. Annual cost of bipolar disorder to UK society. Br J Psychiatry. 2002;180:227–33.PubMedCrossRef
5.
go back to reference Fountoulakis KN, Kontis D, Gonda X, Siamouli M, Yatham LN. Treatment of mixed bipolar states. Int J Neuropsychopharmacol. 2012;15(7):1015–26.PubMedCrossRef Fountoulakis KN, Kontis D, Gonda X, Siamouli M, Yatham LN. Treatment of mixed bipolar states. Int J Neuropsychopharmacol. 2012;15(7):1015–26.PubMedCrossRef
6.
go back to reference Zajecka JM. Calming the bipolar storm: treating acute mania and mixed episodes in patients with bipolar disorder. CNS Spectr. 2005;11(Suppl 13):1–16. Zajecka JM. Calming the bipolar storm: treating acute mania and mixed episodes in patients with bipolar disorder. CNS Spectr. 2005;11(Suppl 13):1–16.
7.
go back to reference Perugi G, Akiskal HS, Micheli C, et al. Clinical subtypes of bipolar mixed states: validating a broader European definition in 143 cases. J Affect Disord. 1997;43(3):169–80.PubMedCrossRef Perugi G, Akiskal HS, Micheli C, et al. Clinical subtypes of bipolar mixed states: validating a broader European definition in 143 cases. J Affect Disord. 1997;43(3):169–80.PubMedCrossRef
8.
go back to reference Akiskal HS, Benazzi F. Psychopathologic correlates of suicidal ideation in major depressive outpatients: is it all due to unrecognized (bipolar) depressive mixed states? Psychopathology. 2005;38(5):273–80.PubMedCrossRef Akiskal HS, Benazzi F. Psychopathologic correlates of suicidal ideation in major depressive outpatients: is it all due to unrecognized (bipolar) depressive mixed states? Psychopathology. 2005;38(5):273–80.PubMedCrossRef
9.
go back to reference Akiskal HS, Benazzi F, Perugi G, Rihmer Z. Agitated, “unipolar” depression re-conceptualized as a depressive mixed state: implications for the antidepressant-suicide controversy. J Affect Disord. 2005;85(3):245–58.PubMedCrossRef Akiskal HS, Benazzi F, Perugi G, Rihmer Z. Agitated, “unipolar” depression re-conceptualized as a depressive mixed state: implications for the antidepressant-suicide controversy. J Affect Disord. 2005;85(3):245–58.PubMedCrossRef
10.
go back to reference Zarate CA, Tohen MF. Bipolar disorder and comorbid substance use disorders, in Substance abuse in the mentally and physically disabled, Chap. 4. New York: Marcel Dekker Inc; 2005. p. 64. Zarate CA, Tohen MF. Bipolar disorder and comorbid substance use disorders, in Substance abuse in the mentally and physically disabled, Chap. 4. New York: Marcel Dekker Inc; 2005. p. 64.
11.
go back to reference Swann AC, Lafer B, Perugi G, et al. Bipolar mixed states: an international society for bipolar disorders task force report of symptom structure, course of illness, and diagnosis. Am J Psychiatry. 2013;170(1):31–42.PubMedCrossRef Swann AC, Lafer B, Perugi G, et al. Bipolar mixed states: an international society for bipolar disorders task force report of symptom structure, course of illness, and diagnosis. Am J Psychiatry. 2013;170(1):31–42.PubMedCrossRef
12.
go back to reference Filaković P, Petek Erić A, Požgain I. New strategies in the treatment of bipolar disorder. Psychiatria Danubina. 2011;23(3):293–9.PubMed Filaković P, Petek Erić A, Požgain I. New strategies in the treatment of bipolar disorder. Psychiatria Danubina. 2011;23(3):293–9.PubMed
13.
go back to reference Grunze H, Azorin JM. Clinical decision making in the treatment of mixed states. World J Biol Psychiatry. 2014 (Epub ahead of print). Grunze H, Azorin JM. Clinical decision making in the treatment of mixed states. World J Biol Psychiatry. 2014 (Epub ahead of print).
14.
go back to reference Muralidharan K, Ali M, Silveira LE, et al. Efficacy of second generation antipsychotics in treating acute mixed episodes in bipolar disorder: a meta-analysis of placebo-controlled trials. J Affect Disord. 2013;150(2):408–14.PubMedCrossRef Muralidharan K, Ali M, Silveira LE, et al. Efficacy of second generation antipsychotics in treating acute mixed episodes in bipolar disorder: a meta-analysis of placebo-controlled trials. J Affect Disord. 2013;150(2):408–14.PubMedCrossRef
15.
go back to reference McIntyre RS, Tohen M, Berk M, Zhao J, Weiller E. DSM-5 mixed specifier for manic episodes: evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data. J Affect Disord. 2013;150(2):378–83.PubMedCrossRef McIntyre RS, Tohen M, Berk M, Zhao J, Weiller E. DSM-5 mixed specifier for manic episodes: evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data. J Affect Disord. 2013;150(2):378–83.PubMedCrossRef
17.
go back to reference Azorin JM, Sapin C, Weiller E. Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord. 2013;145(1):62–9.PubMedCrossRef Azorin JM, Sapin C, Weiller E. Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord. 2013;145(1):62–9.PubMedCrossRef
18.
go back to reference McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord. 2009;11(7):673–86.PubMedCrossRef McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord. 2009;11(7):673–86.PubMedCrossRef
19.
go back to reference McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010;122(1):27–38.PubMedCrossRef McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010;122(1):27–38.PubMedCrossRef
20.
go back to reference McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009;11(8):815–26.PubMedCrossRef McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009;11(8):815–26.PubMedCrossRef
21.
go back to reference All Wales Medicines Strategy Group (AWMSG). Aripiprazole tablets for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole. AWMSG Secretariat Assessment Report Advice, no. 1209, 2009. All Wales Medicines Strategy Group (AWMSG). Aripiprazole tablets for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole. AWMSG Secretariat Assessment Report Advice, no. 1209, 2009.
22.
go back to reference Klok RM, Al Hadithy AF, van Schayk NP, et al. Pharmacoeconomics of quetiapine for the management of acute mania in bipolar I disorder. Expert Rev Pharmacoecon Outcomes Res. 2007;7(5):459–67.PubMedCrossRef Klok RM, Al Hadithy AF, van Schayk NP, et al. Pharmacoeconomics of quetiapine for the management of acute mania in bipolar I disorder. Expert Rev Pharmacoecon Outcomes Res. 2007;7(5):459–67.PubMedCrossRef
23.
go back to reference McKendrick J, Cerri KH, Lloyd A, D’Ausilio A, Dando S, Chinn C. Cost effectiveness of olanzapine in prevention of affective episodes in bipolar disorder in the United Kingdom. J Psychopharmacol. 2007;21(6):588–96.PubMedCrossRef McKendrick J, Cerri KH, Lloyd A, D’Ausilio A, Dando S, Chinn C. Cost effectiveness of olanzapine in prevention of affective episodes in bipolar disorder in the United Kingdom. J Psychopharmacol. 2007;21(6):588–96.PubMedCrossRef
24.
go back to reference Ramirez de Arellano A, Rubio-Terres C, Baca E, et al. Economic evaluation analysis in the treatment of bipolar disorder with aripiprazole and other atypical antipsychotic drugs in Spain. Presented at ISPOR 13th Annual European Congress, Prague, 2010. Ramirez de Arellano A, Rubio-Terres C, Baca E, et al. Economic evaluation analysis in the treatment of bipolar disorder with aripiprazole and other atypical antipsychotic drugs in Spain. Presented at ISPOR 13th Annual European Congress, Prague, 2010.
25.
go back to reference Chisholm D, van Ommeren M, Ayuso-Mateos JL, Saxena S. Cost-effectiveness of clinical interventions for reducing the global burden of bipolar disorder. Br J Psychiatry. 2005;187:559–67.PubMedCrossRef Chisholm D, van Ommeren M, Ayuso-Mateos JL, Saxena S. Cost-effectiveness of clinical interventions for reducing the global burden of bipolar disorder. Br J Psychiatry. 2005;187:559–67.PubMedCrossRef
26.
go back to reference Fajutrao L, Paulsson B, Liu S, Locklear J. Cost-effectiveness of quetiapine plus mood stabilizers compared with mood stabilizers alone in the maintenance therapy of bipolar I disorder: results of a Markov model analysis. Clin Ther. 2009;31(1):1456–68.PubMedCrossRef Fajutrao L, Paulsson B, Liu S, Locklear J. Cost-effectiveness of quetiapine plus mood stabilizers compared with mood stabilizers alone in the maintenance therapy of bipolar I disorder: results of a Markov model analysis. Clin Ther. 2009;31(1):1456–68.PubMedCrossRef
27.
go back to reference Sawyer L, Azorin JM, Chang S, et al. Cost-effectiveness of asenapine in the treatment of bipolar I disorder patients with mixed episodes. J Med Econ. 2014;17(7):508–19.PubMedCrossRef Sawyer L, Azorin JM, Chang S, et al. Cost-effectiveness of asenapine in the treatment of bipolar I disorder patients with mixed episodes. J Med Econ. 2014;17(7):508–19.PubMedCrossRef
28.
go back to reference Lachaine J, Beauchemin C, Mathurin K, Gilbert D, Beillat M. Cost-effectiveness of asenapine in the treatment of bipolar disorder in Canada. BMC Psychiatry. 2014;14:16.PubMedCentralPubMedCrossRef Lachaine J, Beauchemin C, Mathurin K, Gilbert D, Beillat M. Cost-effectiveness of asenapine in the treatment of bipolar disorder in Canada. BMC Psychiatry. 2014;14:16.PubMedCentralPubMedCrossRef
29.
go back to reference Ekman M, Lindgren P, Miltenburger C, Meier G, Locklear JC, Chatterton ML. Cost effectiveness of quetiapine in patients with acute bipolar depression and in maintenance treatment after an acute depressive episode. Pharmacoeconomics. 2012;30(6):513–30.PubMedCrossRef Ekman M, Lindgren P, Miltenburger C, Meier G, Locklear JC, Chatterton ML. Cost effectiveness of quetiapine in patients with acute bipolar depression and in maintenance treatment after an acute depressive episode. Pharmacoeconomics. 2012;30(6):513–30.PubMedCrossRef
30.
go back to reference Soares-Weiser K, Bravo Vergel Y, Beynon S, et al. A systematic review and economic model of the clinical effectiveness and cost-effectiveness of interventions for preventing relapse in people with bipolar disorder. 2007;11(39):iii-iv, ix-206. Soares-Weiser K, Bravo Vergel Y, Beynon S, et al. A systematic review and economic model of the clinical effectiveness and cost-effectiveness of interventions for preventing relapse in people with bipolar disorder. 2007;11(39):iii-iv, ix-206.
31.
go back to reference Nivoli AM, Colom F, Murru A, et al. New treatment guidelines for acute bipolar depression: a systematic review. J Affect Disord. 2011;129(1–3):14–26.PubMedCrossRef Nivoli AM, Colom F, Murru A, et al. New treatment guidelines for acute bipolar depression: a systematic review. J Affect Disord. 2011;129(1–3):14–26.PubMedCrossRef
32.
go back to reference Szegedi A, Calabrese JR, Stet L, et al. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012;32(1):46–55.PubMedCrossRef Szegedi A, Calabrese JR, Stet L, et al. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012;32(1):46–55.PubMedCrossRef
33.
go back to reference Vieta E, Suppes T, Ekholm B, Udd M, Gustafsson U. Long-term efficacy of quetiapine in combination with lithium or divalproex on mixed symptoms in bipolar I disorder. J Affect Disord. 2012;142(1–3):36–44.PubMedCrossRef Vieta E, Suppes T, Ekholm B, Udd M, Gustafsson U. Long-term efficacy of quetiapine in combination with lithium or divalproex on mixed symptoms in bipolar I disorder. J Affect Disord. 2012;142(1–3):36–44.PubMedCrossRef
34.
go back to reference Vieta E, Günther O, Locklear J, et al. Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2011;14(8):1029–49.PubMedCrossRef Vieta E, Günther O, Locklear J, et al. Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2011;14(8):1029–49.PubMedCrossRef
36.
go back to reference Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34–38 years. J Affect Disord. 2002;668(2–3):167–81.CrossRef Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34–38 years. J Affect Disord. 2002;668(2–3):167–81.CrossRef
37.
go back to reference Tohen M, Baker RW, Altshuler LL, et al. Olanzapine versus divalproex in the treatment of acute mania. Am J Psychiatry. 2002;159(6):1011–7.PubMedCrossRef Tohen M, Baker RW, Altshuler LL, et al. Olanzapine versus divalproex in the treatment of acute mania. Am J Psychiatry. 2002;159(6):1011–7.PubMedCrossRef
38.
go back to reference Niufan G, Tohen M, Qiuqing A, et al. Olanzapine versus lithium in the acute treatment of bipolar mania: a double-blind, randomized, controlled trial. J Affect Disord. 2008;105(1–3):101–8.PubMedCrossRef Niufan G, Tohen M, Qiuqing A, et al. Olanzapine versus lithium in the acute treatment of bipolar mania: a double-blind, randomized, controlled trial. J Affect Disord. 2008;105(1–3):101–8.PubMedCrossRef
39.
go back to reference Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health. 2010;13(5):509–18.PubMedCrossRef Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health. 2010;13(5):509–18.PubMedCrossRef
43.
go back to reference Brunelle J, Consoli A, Tanguy ML, et al. Phenomenology, socio-demographic factors and outcome upon discharge of manic and mixed episodes in hospitalized adolescents: a chart review. Eur Child Adolesc Psychiatry. 2009;18(3):185–93.PubMedCrossRef Brunelle J, Consoli A, Tanguy ML, et al. Phenomenology, socio-demographic factors and outcome upon discharge of manic and mixed episodes in hospitalized adolescents: a chart review. Eur Child Adolesc Psychiatry. 2009;18(3):185–93.PubMedCrossRef
44.
go back to reference Ouanes S, Chenoufi L, Cheour M. An update on the treatment of mixed bipolar states: what is new in 2013? J Affect Disord. 2014;158:53–5.PubMedCrossRef Ouanes S, Chenoufi L, Cheour M. An update on the treatment of mixed bipolar states: what is new in 2013? J Affect Disord. 2014;158:53–5.PubMedCrossRef
45.
go back to reference Kemp DE, Zhao J, Cazorla P, et al. Weight change and metabolic effects of asenapine in patients with schizophrenia and bipolar disorder. J Clin Psychiatry. 2014;75(3):238–45.PubMedCrossRef Kemp DE, Zhao J, Cazorla P, et al. Weight change and metabolic effects of asenapine in patients with schizophrenia and bipolar disorder. J Clin Psychiatry. 2014;75(3):238–45.PubMedCrossRef
46.
go back to reference Hayhurst H, Palmer S, Abbott R, Johnson T, Scott J. Measuring health-related quality of life in bipolar disorder: relationship of the EuroQol (EQ-5D) to condition-specific measures. Qual Life Res. 2006;15(7):1271–80.PubMedCrossRef Hayhurst H, Palmer S, Abbott R, Johnson T, Scott J. Measuring health-related quality of life in bipolar disorder: relationship of the EuroQol (EQ-5D) to condition-specific measures. Qual Life Res. 2006;15(7):1271–80.PubMedCrossRef
47.
go back to reference Briggs A, Wild D, Lees M, et al. Impact of schizophrenia and schizophrenia treatment-related adverse events on quality of life: direct utility elicitation. Health Qual Life Outcomes. 2008;6:105.PubMedCentralPubMedCrossRef Briggs A, Wild D, Lees M, et al. Impact of schizophrenia and schizophrenia treatment-related adverse events on quality of life: direct utility elicitation. Health Qual Life Outcomes. 2008;6:105.PubMedCentralPubMedCrossRef
Metadata
Title
Cost-Effectiveness of Asenapine in the Treatment of Patients with Bipolar I Disorder with Mixed Episodes in an Italian Context
Authors
Chiara Caresano
Guido Di Sciascio
Andrea Fagiolini
Giuseppe Maina
Giulio Perugi
Claudio Ripellino
Claudio Vampini
Publication date
01-08-2014
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 8/2014
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-014-0139-3

Other articles of this Issue 8/2014

Advances in Therapy 8/2014 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine