Understanding the real-world cost and burden of mania: the MANACOR study Hidalgo-Mazzei D., M.D. 1; Undurraga J., M.D., Ph.D.1 2 ; Bonnin C.M., Psy., Ph.D. 1; Reinares M., Psy., Ph.D. 1 , Saez C., M.D 3, Mur M., M.D., Ph.D.4, Nieto E., M.D., Ph.D. 5; Vieta E., M.D., Ph.D.1 * 1 Bipolar Disorders Program, Department of Psychiatry, Hospital Clinic, University of , IDIBAPS, CIBERSAM, Barcelona, . 2 Department of Psychiatry, Clínica Alemana, Universidad del Desarrollo, Santiago, Chile. 3 University Psychiatric Hospital, Institut Pere Mata, CIBERSAM, , , Spain 4 Mental Health Service, Santa Maria Hospital, IRB LLeida, University of LLeida, Catalonia, Spain. 5 Althaia, Xarxa Assistencial Universitária de Manresa, Catalonia, Spain.

Background and Aims Baseline Even though the results of clinical trials show a high efficacy 40 6 months of antipsychotics and mood stabilizers on the treatment of 35 -26% mania1, few observational studies have reported the 30 effectiveness, security and burden of the disease of manic 25 patients in naturalistic conditions2. 20 15 The main objective of this study was to describe the general -75% 10 -3% burden and direct costs associated with manic episodes both -52% 5 in inpatients and outpatients in four University Hospitals in 0 Catalonia (Spain). YMRS HDRS-17 FAST SCIP Fig.3 Score change of the assessment scales at follow-up Methods The effectiveness of the treatment prescribed was acceptable We combined retrospective-prospective data and collected as expected. Mean days of hospitalization were 19.8 (11.6). information from medical records regarding Furthermore,11.9% of patients were readmitted during the sociodemographic and diagnostic variables. Clinical study for a mean of 88.3 (55.9) days. Finally, at six-month variables of 169 bipolar disorder type I patients with an acute 23% of the previously employed were still on sick leave. The manic episode were collected during the six following mean total cost per treatment day for outpatients was 16.58 € months after the episode. (67.9% of it from pharmacological treatment) while for Any other inpatients was 43.47 € (73.5% of it from hospitalization disorder charges). 386 €; 8% 50 €; 1% Substance use 684 €; 14% disorder Outpatient visits

Personality Emergency room visits disorder Total direct mean cost: 4771 € Anxiety disorder Hospitalization

3.651 €; 77% 0% 20% 40% 60% 80% 100% Pharmacological Yes No treatment Fig.1 Comorbid psychiatric disorders Results The mean age of the sample was 42.5 years and there Fig. 4 Mean total direct costs distribution associated with the manic episode was a greater percentage of males (53.8%) comparing to An initial FAST (Functional assessment short test) score >41 females (46.2%). 14.2 were the mean years since the significantly 7.000 bipolar disorder was first diagnosed among the patients. predicted There was a high proportion of patients with anxiety 6.000 a higher (15.1%), mixed symptoms (27.2%), and psychosis 5.000 direct cost. (56.8%). 4.000 The most commonly prescribed drug was lithium (43.8%), 3.000 followed by valproic acid (36.1%). The vast majority of patients (98.2%) were treated with antipsychotics including 2.000 aripiprazole, asenapine, olanzapine, 1.000 aripiprazole quetiapine and risperidone, clotiapine 7% asenapine 8% 27% 0 and most of them were in olanzapine FAST <29 FAST 30 to 40 FAST >41 19% combination with mood Outpatient cost Emergency Room cost Inpatient cost Pharmacological cost risperidone Fig. 5. Distribution and total direct healthcare costs between initial FAST score categories stabilizers. quetiapine 20% 19% Conclusions •Our results show the high cost and burden associated with Bipolar disorder(BD) and the need to design more cost- efficient strategies in the prevention and management of 180

160 relapses in order to avoid hospital admissions as this is the

140 main cost driver.

120 •Poor baseline functioning predicted high costs, indicating the 100 importance of functional assessment in BD.

80 98% 84% Fig.2 References 60 63% Pharmacological 1 Yildiz A, Vieta E, Leucht S, Baldessarini RJ. Efficacy of antimanic treatments: meta-analysis of 40 treatment randomized, controlled trials. Neuropsychopharmacology. 2011 Jan;36(2):375-89. 2 20 Rosa AR, Reinares M, Michalak EE, Bonnin CM, Sole B, Franco C, Comes M,Torrent C, Kapczinski F, 12% prescribed 6% Vieta E. Functional impairment and disability across mood states in bipolar disorder. Value Health. 0 Antidepressant Biperidene Benzodiazepine Mood stabilizer Antipsychotic 2010 Dec;13(8):984-8.

*Corresponding author: Eduard Vieta E-mail: [email protected] Disclosures: Prof. Vieta is a consultant or grant recipient with: Almirall, Astra-Zeneca, Bristol- Myers-Squibb, Elan, Eli Lilly, Ferrer, Forest Research Institute, Gedeon Richter, Glaxo-Smith- Kline, Janssen-Cilag, Jazz, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi, Servier, Schering-Plough, Shire, Sunovion, This poster was financially sponsored by an educational grant from Lundbeck. Takeda, Teva, and United Biosource Corporations. Dr. Undurraga has been speaker for Janssen. Acknowledgements: Supported by a Emili Letang Grant from the Hospital Clínic of Barcelona (to DH), by the Instituto de Salud Carlos III through the Centro para la Investigación Biomédica en Red de Salud Mental (CIBERSAM) (to EV). The other authors do not report any conflict of interest. P.2.d.021 Understanding the real-world cost and burden of mania: the MANACOR study D. Hidalgo-Mazzei1, J. Undurraga2, C.M. Bonnin1, M. Reinares1, C. Saez3, M. Mur4, E. Nieto5, E. Vieta1 1Neurosciencesa Bipolar Disorders Program Department of Psychiatry and Psychology Hospital Clínic IDIBAPS CIBERSAMa Barcelona Cataloniaa Spain 2Clinica Alemana Universidad del Desarrolloa Psychiatrya Santiagoa Chile 3Institut Pere Mata CIBERSAMa University Psychiatric Hospitala Reus Cataloniaa Spain 4Santa Maria Hospital IRB Lleida University of Lleidaa Mental Health Servicea Lleida Cataloniaa Spain 5Xarxa Assistencial Universitária de Manresaa Althaiaa Manresa Cataloniaa Spain

Introduction: Bipolar disorder is a disabling condition affecting approximately 1 to 2a of the population and considered the sixth most important cause of disability worldwide [1]. In general terms, it encom passes m anic and depressive mood episodes with sub-syndrom ic states and periods of stability. Even though theoretically the treatm ents available are effective, relapses are still very frequent and disabling in the real world [2]. Therefore, the healthcare resources used, direct cost and functional burden associated with every new episode of the disorder have relevant im plications in public health. Few studies had explored these issues in our setting [3].

Objective: The main objective of this study is to describe the general burden and cost associated with manic episodes both in inpatients and outpatients in four University Hospitals in Catalonia (Spain).

Method: 169 bipolar I disorder patients presenting an acute manic episode (based on DSM-IV criteria) were included. Demographic variables were collected as well as clinical variables during the last six m onths. We retrospectively assessed effectiveness (YMRS, HDRS-17), functionality (FAST) and health resource consumption, measured by means of days of hospitalization, re-hospitalizations, em ergency department and outpatient consultations.

Results: There was a greater percentage of males (53.8a) compared to females (46.2a) in the sample. The mean age was 42.5 years. 14.2 were the mean years since the bipolar disorder was first diagnosed among the patients. The majority of patients (78.7a) were hospitalized at the m oment of the first assessm ent. Up to 53.3a of patients had a comorbid substance use disorder.

The m ost commonly prescribed drug was lithium (43.8a), followed by valproic acid (36.1a). The vast majority of patients (98.2a) were treated with antipsychotics including aripiprazole, asenapine, olanzapine, quetiapine and risperidone, and most of them were in combination with m ood stabilizers. Regarding other mood stabilizers, they were prescribed in a far lesser extend as follows lam otrigine (7.7a), oxcarbamazepine (4.1a), topiramate (4.1a) and carbamazepine (1.8a). Among benzodiazepines, the most common prescribed were clonazepam (32a), lormetazepam (26.6a) and diazepam (8.3a).

Mean days of hospitalization were 19.8 (11.6). Furthermore, 9.2a of patients were readmitted during the study for a m ean of 68.1 (61.8) days. Thirty-six em ergency room visits were recorded during follow-up. Finally, at six-month 33.3a of the previously employed were still on sick leave. The mean total cost per treatment day for outpatients was 16.58€ (67.9a of it from pharmacological treatment) while for inpatients was 43.47€ (73.5a of it from hospitalization charges).

Conclusions: The results from the MANACOR study showed that the most prescribed drugs for the treatment of mania are mainly antipsychotics com bined with m ood stabilizers, lithium being the most used. The treatment was highly effective as shown by the reduction in severity scale scores. Although the functionality measured by FAST scale im proved, approximately one-third of the sam ple was still on sick leave at 6-month follow-up. The cost of treating manic episodes was almost three times higher for inpatients when com pared to outpatients.

1. Whiteford, H.A., Degenhardt, L., Rehm, J., Baxter, A.J., Ferrari, A.J., Erskine, H.E., Charlson, F.J., Norman, R.E., Flaxman, A.D., Johns, N., Burstein, R., Murray, C.J., Vos, T., 2013. Global burden of disease attributable to m ental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet 382, 1575–86.

2. Vieta, E., Langosch, J.M., Figueira, M.L., Souery, D., Blasco-Colmenares, E., Medina, E., Moreno-Manzanaro, M., Gonzalez, M.A., Bellivier, F., 2013. Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (W AVE-bd). Int J Neuropsychopharmacol 16, 1719–32.

3. Tafalla, M., Salvador-Carulla, L., Saiz-Ruiz, J., Diez, T., Cordero, L., 2010. Pattern of healthcare resource utilization and direct costs associated with manic episodes in Spain. BMC Psychiatry, 10:31.

Disclosure statement: Prof. Vieta is a consultant or grant recipient with: Almirall, Astra-Zeneca, Bristol-Myers Squibb, Elan, Eli Lilly, Ferrer, Forest Research Institute, Gedeon Richter, Glaxo-Smith-Kline, JanssenCilag, Jazz, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi, Servier, Schering-Plough, Shire, Sunovion, Takeda, Teva, and United Biosource Corporations. Dr. Undurraga has been speaker for Janssen. This work was supported in part by Lundbeck.

Citation: Eur Neuropsychopharmacol. 2014;24aSuppl 2):S425

Keywords Bipolar disorders Lithium and other mood stabilisers Neuroleptics & antipsychotics: clinical