The Real World Costs of Asenapine in Manic Episodes in the Manacor Study

Background Asenapine is the most recent compound that hasbeen FDA- and EMA-approved for treatment of mania. Its efficacy and safety havebeen assessed in placebo-controlled trials, but little is known about itsperformance in routine clinical conditions. The MANACOR study assessed costsassociated with treatment of mania in several hospital settings acrossCatalonia, Spain. As part of the protocol, we compared cost-effectiveness ofasenapine versus other treatment options. Methods A combined prospective and retrospective datacollection and analysis was conducted from January 2011 to December 2013following a clinical interview and assessment of manic and depressive symptoms(YMRS, HDRS-17), clinical state (CGI-BP-M), psychosocial functioning (FAST),sexual dysfunction (PRSexDQ) and health resource costs associated withtreatment with asenapine versus other antipsychotics. Results 152 patients from different university hospitalswere included. 53 patients received asenapine and 99 received otherantipsychotics. Considering inpatients (N=117), those treated with asenapinepresented a significantly less severe manic episode (p=0.001), less psychoticsymptoms (p=0.030) and, more comorbid personality disorder (p=0.002). Regardingoutpatients, those treated with asenapine showed significantly less severemanic episode (p=0.046), more previous mixed episodes (p= 0.013) and, moresexual dysfunction at baseline (p=0.036). No significant differences were foundin mean total costs per day. Limitations Non-randomized study design. Conclusion Clinicians tended to use asenapine in patientswith less severe manic symptoms but more complex clinical profile, includingmore mixed episodes in the past, concomitant personality disorder, and sexualproblems. Treatment with asenapine was not associated with higher costs when comparedto other options.