Olivares JM, Rodriguez-Martinez A, Burón JA, et al. Cost-effectiveness analysis of switching antipsychotic medication to long-acting injectable risperidone in patients with schizophrenia: A 12- and 24-month followup from the e-STAR database in Spain

Department of Psychiatry, Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Applied Health Economics and Health Policy 02/2008; 6(1):41-53. DOI: 10.2165/00148365-200806010-00004
Source: PubMed

ABSTRACT The availability of long-acting injectable risperidone may increase adherence to antipsychotic treatment and lead to improved clinical and economic outcomes for patients with schizophrenia.
To investigate the cost effectiveness of treatment with long-acting injectable risperidone compared with previous antipsychotic regimens in patients with schizophrenia enrolled in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) in Spain.
e-STAR is an international, long-term, ongoing, observational study of schizophrenia patients who, during their routine course of clinical practice, are started on a new antipsychotic treatment. In e-STAR, data are collected at baseline, retrospectively over a minimum period of 12 months and up to a maximum of 24 months, and prospectively at 3-month intervals for 24 months after the start of a new antipsychotic drug. For the purpose of this study, patients who started treatment with long-acting injectable risperidone during their routine clinical management and were enrolled in the e-STAR study in Spain were eligible. The effectiveness of long-acting injectable risperidone compared with previous antipsychotic treatment, defined as the absence of hospitalizations or relapses, was assessed at 12 and 24 months of treatment. Acquisition costs of antipsychotic drug therapy were based on the official registered price. Drug prices from source were in euro, year 2005 values; hospital costs from source were in euro, year 2001 values, and were inflated to reflect 2005 costs. Complete follow-up data were available for 788 patients at 12 months after starting long-acting injectable risperidone and for 757 patients at 24 months.
In terms of effectiveness, at 12 months after switching to long-acting injectable risperidone, there was a higher percentage of patients who did not require hospitalization (89.1%), did not relapse (85.4%) or neither required hospitalization nor relapsed (82.4%) as compared retrospectively with the same period for the previous treatment (67%, 47.8% and 59.8%, respectively). The corresponding figures at 24 months also favoured treatment with long-acting injectable risperidone (85.2% vs 60%, 88.5% vs 47.4% and 77% vs 53.6%, respectively). Treatment with long-acting injectable risperidone was associated with higher medication costs per month compared with previous antipsychotic medication after 12 (euro 405.80 vs euro 128.16) and 24 months (euro 407.33 vs euro 142.77) of follow-up. Cost effectiveness per month per patient was lower for risperidone than previous antipsychotic medication in the three patient scenarios: without hospitalization (euro 539.82 vs euro 982.13), without relapse (euro 519.67 vs euro 1242.03) and without hospitalization and without relapse (euro 597.22 vs euro 1059.39).
Treatment with long-acting injectable risperidone compared with previous antipsychotic medications resulted in a higher number of patients not requiring hospitalization, not relapsing, and not requiring hospitalization and not showing relapse, resulting in risperidone being more cost effective per month per patient.It is important to note that real-world variations in adherence would automatically be controlled from within a randomized control trial, and hence, any evaluation of variations in adherence inevitably requires a real-world focus. On the basis of these findings, which were obtained in real-world clinical practice, long-acting injectable risperidone is predicted to be the dominant strategy because it results in effective symptom control and direct medical cost savings. However, because of limitations in methodology, any conclusions should, at this stage, be treated as tentative, and confirmation in more detailed follow-up studies is required. Cost-effectiveness comparisons based on experimental evaluations of relapse minimization strategies are also required. In order to avoid estimation biases in the future, a prospectively designed study is needed.

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    • "A total of 1,659 patients completed the study.25 At 12 months after switching from oral to LAI antipsychotics, the percentage of patients who did not require hospitalization (89.1% vs 67.0%) and did not relapse (85.4% vs 47.8%) was higher with LAIs than with oral antipsychotics.26 Cost-effectiveness per month per patient was lower for LAIs than for previous antipsychotic medication among patients who were defined as without hospitalization, without relapse, or without hospitalization and without relapse. "
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    ABSTRACT: Schizophrenia is a debilitating chronic disease that requires lifelong medical care and supervision. Even with treatment, the majority of patients relapse within 5 years, and suicide may occur in up to 10% of patients. Poor adherence to oral antipsychotics is the most common cause of relapse. The discontinuation rate for oral antipsychotics in schizophrenia ranges from 26% to 44%, and as many as two-thirds of patients are at least partially nonadherent, resulting in increased risk of hospitalization. A very helpful approach to improve adherence in schizophrenia is the use of long-acting injectable (LAI) antipsychotics, although only a minority of patients receive these. Reasons for underutilization may include negative attitudes, perceptions, and beliefs of both patients and health care professionals. Research shows, however, significant improvements in adherence with LAIs compared with oral drugs, and this is accompanied by lower rates of discontinuation, relapse, and hospitalization. In addition, LAIs are associated with better functioning, quality of life, and patient satisfaction. A need exists to encourage broader LAI use, especially among patients with a history of nonadherence with oral antipsychotics. This paper reviews the impact of nonadherence with antipsychotic drug therapy overall, as well as specific outcomes of the schizophrenia patient, and highlights the potential benefits of LAIs.
    Patient Preference and Adherence 11/2013; 7:1171-1180. DOI:10.2147/PPA.S53795 · 1.68 Impact Factor
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    • "Reported components of the definition for relapse. Hospitalization [11,15-59]; Positive and Negative Syndrome Scale (PANSS) [7,15,17,18,60-72]; Clinical Global Impression (CGI) scale [17,18,26,30,52,57,60-62,65],[66,68,71,73,74]; exacerbation/re-emergence of symptoms [7,27,29,34,38,43,63,67],[75-81]; deliberate self-harm or violent behaviour, suicidal or homicidal ideation, arrest [18,23,27,43,49,50,57,65],[66,71,74,82-84]; Brief Psychiatric Rating Scale (BPRS) [28,43,71,76,84-91]; change of medication or patient management [18,27,38,41,56,66,75,92]; exacerbation/re-emergence of symptoms leading to hospitalization [20,66,92-96]; clinical assessment of patient notes [38,57,88]; International Classification of Diseases (ICD) criteria [70,89,97]; Global Assessment of Functioning (GAF) [64,72]; physician interview and/or assessment [86,98]; Present State Examination (PSE) [84]; Global Assessment Scale (GAS) [84]; Target Symptoms Ratings Scale (TSRS) [76]; Psychiatric Assessment Scale (PAS) [99]; scale for the assessment of positive symptoms [86]; social functioning [75]; Social and Occupational Functioning Assessment Scale (SOFAS) [60]. "
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    ABSTRACT: Relapse in patients with schizophrenia has devastating repercussions, including worsening symptoms, impaired functioning, cognitive deterioration and reduced quality of life. This progressive decline exacerbates the burden of illness on patients and their families. Relapse prevention is identified as a key therapeutic aim; however, the absence of widely accepted relapse definition criteria considerably hampers achieving this goal. We conducted a literature review in order to investigate the reporting of relapses and the validity of hospitalization as a proxy for relapse in patients with schizophrenia. The primary aim was to assess the range and validity of methods used to define relapse in observational or naturalistic settings. The secondary aim was to capture information on factors that predicted or influenced the risk of relapse. A structured search of the PubMed database identified articles that discussed relapse, and hospitalization as a proxy of relapse, in patients with schizophrenia. National and international guidelines were also reviewed. Of the 150 publications and guidelines identified, 87 defined relapse and 62% of these discussed hospitalization. Where hospitalization was discussed, this was as a proxy for, or a component of, relapse in the majority of cases. However, hospitalization duration and type varied and were not always well defined. Scales were used to define relapse in 53 instances; 10 different scales were used and multiple scales often appeared within the same definition. There were 95 references to factors that may drive relapse, including non-adherence to antipsychotic medication (21/95), stress/depression (11/95) and substance abuse (9/95). Twenty-five publications discussed the potential of antipsychotic therapy to reduce relapse rates---continuous antipsychotic therapy was associated with reduced frequency and duration of hospitalization. Non-pharmacological interventions, such as psychoeducation and cognitive behavioural therapy, were also commonly reported as factors that may reduce relapse. In conclusion, this review identified numerous factors used to define relapse. Hospitalization was the factor most frequently used and represents a useful proxy for relapse when reporting in a naturalistic setting. Several factors were reported to increase the risk of relapse, and observation of these may aid the identification of at-risk patients.
    Annals of General Psychiatry 10/2013; 12(1):32. DOI:10.1186/1744-859X-12-32 · 1.40 Impact Factor
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    • "Similar analyses have confirmed that patients initiating long-acting injectable anti-psychotics incur less healthcare costs in comparison to patients initiating oral anti-psychotics19. Therefore, the greater initial acquisition costs of long-acting injectable anti-psychotics compared with their oral formulations is likely to be offset by reduced health-resource utilisation19–22. "
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    ABSTRACT: Abstract Objective: To report the design and preliminary results of a mirror-image study comparing total psychiatric hospitalization rates pre- and post-switch to aripiprazole once-monthly, an extended release injectable solution. Methods: A multicenter, open-label mirror-image study of patients (18-65 years) with schizophrenia to compare total psychiatric hospitalization rates between retrospective treatment with oral standard-of-care (SOC) antipsychotics and prospective treatment with aripiprazole once-monthly in a naturalistic community setting in North America. Total psychiatric hospitalization rates were assessed between retrospective (Months -4 to -1) and prospective treatment periods (Months 4 to 6) for patients who completed ≥3 months aripiprazole once-monthly. Results: 183 patients entered the prospective phase. After switching to aripiprazole once-monthly, total psychiatric hospitalization rates for the 3-month prospective period were significantly lower (p<0.0001, Exact McNemar's test) compared with the retrospective 3-month period when the same patients received SOC antipsychotics (6.6% [n=8/121] vs. 28.1%; [n=34/121], respectively; rate ratio=0.23). Similarly, total psychiatric hospitalization rates for all patients who entered the prospective treatment phase were significantly lower (p<0.0001, Exact McNemar's test) for the prospective 6 months following switch to aripiprazole once-monthly, compared with the retrospective 6-month SOC period (14.2% [n=26/183] vs. 41.5% [n=76/183], respectively; rate ratio=0.34). Common treatment-emergent adverse events (occurring in ≥5% of patients) were psychotic disorder (7.7%), akathisia (7.2%), and insomnia (7.2%). Discontinuation (all causes) during the prospective phase was 44.8% (n=82/183). Limitations: Mirror-image studies do not include a parallel active control; as each patient serves as their own control, it cannot be determined whether other treatments may have similar effects. Treatment and trial effects may be difficult to separate. Independent factors such as admission patterns, insurance coverage, availability of hospital beds and community support may influence rates of hospitalization. Conclusions: Switching to aripiprazole once-monthly substantially reduced total psychiatric hospitalization rates compared with retrospective rates in the same patients taking oral SOC.
    Journal of Medical Economics 05/2013; 16(7). DOI:10.3111/13696998.2013.804411 · 1.58 Impact Factor
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