long-acting risperidone adds value in schizophrenia

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Inpharma 1418 - 20 Dec 2003 Long-acting risperidone adds value in schizophrenia Laura Hunt Atypical antipsychotics are the mainstay of therapy in the treatment of schizophrenia, due to their effective management of both positive and negative symptoms. However, relapses resulting from partial compliance with therapy can limit the clinical success of these agents. Treatment options in schizophrenia have been further limited by a lack of long-acting atypical antipsychotics. Researchers at the 6th European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) [Barcelona, Spain; November 2003] presented data that showed the potential for improved outcomes and cost savings following treatment with the first long-acting injectable atypical antipsychotic risperidone [Risperdal Consta] in patients with schizophrenia, schizoaffective disorder or other psychotic disorders. 1,2 Researchers from Janssen-Ortho and Syreon Health inpatient setting than recipients of either haloperidol Corporation, Canada, performed an exploratory analysis depot therapy or oral olanzapine therapy, note the of the outcomes associated with Risperdal Consta investigators. In addition, Risperdal Consta had the therapy among a subgroup of patients participating in lowest Positive and Negative Symptom Scale (PANSS) the ongoing, prospective, population-based CNOMSS * score between relapses (77 vs 80 and 82 for Risperdal study involving 32 academic and community sites Consta vs oral olanzapine and haloperidol depot) and across Canada. 1 ** Patients (n = 21) who were treated during relapses (113 vs 117 and 119, respectively). with Risperdal Consta under the conditions of routine Furthermore, it was estimated that treatment with clinical practice and who completed 1 year of follow- Risperdal Consta would lead to the avoidance of 0.21 up were assessed. Patient outcomes were assessed relapses per patient compared with conventional depot using the Clinical Global Impression (CGI) instrument, therapy, while saving 131 euros per patient. Compared the Social and Occupational Functional Assessment with oral atypical antipsychotic therapy, Risperdal Scale (SOFAS) and the Brief Psychiatric Rating Scale Consta would result in the avoidance of 0.32 relapses (BPRS). and lead to per-patient savings of 2192 euros. Significant improvement despite ’mild’ Outcomes and costs of Risperdal Consta vs other disease . . . antipsychotic therapy over 5 years In the previous 2 years, almost half of patients (47.6%) Patients initiated on treated with Risperdal Consta had been hospitalised. The researchers observed a significant improvement haloperidol Risperdal olanzapine over the 2-year observation period, compared with Consta baseline, despite the fact that 57.1% of patients were Patients with < 4 23.2 32.1 18.3 considered ‘mild’ according to the CGI rating scale. relapses (%) Moreover, patients showed significant improvement Patients with > 4 35.9 28.1 40.2 compared with baseline over the first and second years relapses (%) of observation according to the BPRS. At baseline, Average number of 3.97 3.75 4.07 relapses patients’ mean score on the SOFAS was 62.4, which Patients remaining on 9.4 11 8 improved to 76 over the 2-year period. In addition, first-line therapy (%) patients’ mean monthly cost of care "appeared to be Relapse-free years 2.08 2.20 2.01 relatively stable", with small reductions in all cost Cumulative QALYs a 1.70 1.78 1.72 sources, although these were not significant, say the Total discounted costs 95 467 95 336 97 528 researchers. (euros) b "The addition of a long-acting atypical antipsychotic to a quality-adjusted life-years the psychiatrist’s armamentarium may have the potential b Costs included those associated with drug acquisition, psychiatrist to substantially improve outcomes in persons with visits and setting (e.g. private practice, day care, sheltered living). schizophrenia in Canada", they conclude. . . . "at no extra cost" Added benefit likely among high-risk Investigators from Germany and The Netherlands patients conducted a discrete-event model to evaluate the The trend was similar among a subgroup of high-risk, outcomes and costs associated with Risperdal Consta noncompliant patients, although the clinical benefits compared with conventional depot or oral atypical and savings associated with Risperdal Consta were even therapy, and found that Risperdal Consta provided greater. Risperdal Consta would result in the avoidance "added value . . . at no extra cost". 2‡ Using data obtained of 0.22 and 0.46 relapses per patient, leading to savings from an expert panel and published literature, the of 1442 euros and 9082 euros per patient, compared investigators compared the following three treatment with haloperidol depot therapy and oral olanzapine scenarios over a 5-year period in Germany: therapy, respectively. patients initiated on haloperidol depot therapy; may Sensitivity analysis showed the results to be "relatively be switched to olanzapine followed by clozapine robust", note the investigators. The effect of the atypical patients initiated on Risperdal Consta; may be and conventional formulations on symptom scores, and switched to olanzapine followed by clozapine estimates about Risperdal Consta compliance when patients initiated on olanzapine; may be switched to compared with oral atypical antipsychotic therapy, were oral risperidone followed by clozapine. the key variables determining the results. Additional Recipients of Risperdal Consta would spend more benefits may be expected when Risperdal Consta "is time in the outpatient setting and less time in the 1 Inpharma 20 Dec 2003 No. 1418 1173-8324/10/1418-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1418 - 20 Dec 2003

Long-acting risperidone adds value in schizophrenia– Laura Hunt –

Atypical antipsychotics are the mainstay of therapy in the treatment of schizophrenia, due to their effectivemanagement of both positive and negative symptoms. However, relapses resulting from partial compliance withtherapy can limit the clinical success of these agents. Treatment options in schizophrenia have been furtherlimited by a lack of long-acting atypical antipsychotics. Researchers at the 6th European Congress of theInternational Society for Pharmacoeconomics and Outcomes Research (ISPOR) [Barcelona, Spain; November2003] presented data that showed the potential for improved outcomes and cost savings following treatmentwith the first long-acting injectable atypical antipsychotic risperidone [Risperdal Consta] in patients withschizophrenia, schizoaffective disorder or other psychotic disorders.1,2

Researchers from Janssen-Ortho and Syreon Health inpatient setting than recipients of either haloperidolCorporation, Canada, performed an exploratory analysis depot therapy or oral olanzapine therapy, note theof the outcomes associated with Risperdal Consta investigators. In addition, Risperdal Consta had thetherapy among a subgroup of patients participating in lowest Positive and Negative Symptom Scale (PANSS)the ongoing, prospective, population-based CNOMSS* score between relapses (77 vs 80 and 82 for Risperdalstudy involving 32 academic and community sites Consta vs oral olanzapine and haloperidol depot) andacross Canada.1** Patients (n = 21) who were treated during relapses (113 vs 117 and 119, respectively).with Risperdal Consta under the conditions of routine Furthermore, it was estimated that treatment withclinical practice and who completed ≥ 1 year of follow- Risperdal Consta would lead to the avoidance of 0.21up were assessed. Patient outcomes were assessed relapses per patient compared with conventional depotusing the Clinical Global Impression (CGI) instrument, therapy, while saving 131 euros per patient. Comparedthe Social and Occupational Functional Assessment with oral atypical antipsychotic therapy, RisperdalScale (SOFAS) and the Brief Psychiatric Rating Scale Consta would result in the avoidance of 0.32 relapses(BPRS). and lead to per-patient savings of 2192 euros.

Significant improvement despite ’mild’Outcomes and costs of Risperdal Consta vs otherdisease . . .antipsychotic therapy over 5 yearsIn the previous 2 years, almost half of patients (47.6%)

Patients initiated ontreated with Risperdal Consta had been hospitalised.The researchers observed a significant improvement haloperidol Risperdal olanzapineover the 2-year observation period, compared with Constabaseline, despite the fact that 57.1% of patients were Patients with < 4 23.2 32.1 18.3considered ‘mild’ according to the CGI rating scale. relapses (%)Moreover, patients showed significant improvement Patients with > 4 35.9 28.1 40.2compared with baseline over the first and second years relapses (%)of observation according to the BPRS. At baseline, Average number of 3.97 3.75 4.07

relapsespatients’ mean score on the SOFAS was 62.4, whichPatients remaining on 9.4 11 8improved to 76 over the 2-year period. In addition,first-line therapy (%)patients’ mean monthly cost of care "appeared to be

Relapse-free years 2.08 2.20 2.01relatively stable", with small reductions in all costCumulative QALYsa 1.70 1.78 1.72sources,† although these were not significant, say theTotal discounted costs 95 467 95 336 97 528researchers.(euros)b

"The addition of a long-acting atypical antipsychotic toa quality-adjusted life-yearsthe psychiatrist’s armamentarium may have the potentialb Costs included those associated with drug acquisition, psychiatristto substantially improve outcomes in persons withvisits and setting (e.g. private practice, day care, sheltered living).schizophrenia in Canada", they conclude.

. . . "at no extra cost"Added benefit likely among high-riskInvestigators from Germany and The Netherlandspatientsconducted a discrete-event model to evaluate the

The trend was similar among a subgroup of high-risk,outcomes and costs associated with Risperdal Constanoncompliant patients, although the clinical benefitscompared with conventional depot or oral atypicaland savings associated with Risperdal Consta were eventherapy, and found that Risperdal Consta providedgreater. Risperdal Consta would result in the avoidance"added value . . . at no extra cost".2‡ Using data obtainedof 0.22 and 0.46 relapses per patient, leading to savingsfrom an expert panel and published literature, theof 1442 euros and 9082 euros per patient, comparedinvestigators compared the following three treatmentwith haloperidol depot therapy and oral olanzapinescenarios over a 5-year period in Germany:therapy, respectively.• patients initiated on haloperidol depot therapy; may

Sensitivity analysis showed the results to be "relativelybe switched to olanzapine followed by clozapinerobust", note the investigators. The effect of the atypical• patients initiated on Risperdal Consta; may beand conventional formulations on symptom scores, andswitched to olanzapine followed by clozapineestimates about Risperdal Consta compliance when• patients initiated on olanzapine; may be switched tocompared with oral atypical antipsychotic therapy, wereoral risperidone followed by clozapine.the key variables determining the results. AdditionalRecipients of Risperdal Consta would spend morebenefits may be expected when Risperdal Consta "istime in the outpatient setting and less time in the

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Inpharma 20 Dec 2003 No. 14181173-8324/10/1418-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Single Article

Long-acting risperidone adds value in schizophrenia – continued‡ One of the researchers was affiliated with Janssen-Cilag GmbH,aimed at patients with a high-risk of being non-compliantGermany, which provided funding for the study.and at patients in whom further deterioration is1. Trakas K, et al. 2-Year outcomes of Risperdal (Rm) Consta (TM) - the firstexpected", the researchers conclude.

atypical long acting injectable antipsychotic: results from the Canadian National* Canadian National Outcomes Measurement Study in Schizophrenia Outcomes Measurement Study in Schizophrenia. Value in Health 6: 689 (plus

poster) abstr. PMH4, No. 6, Nov-Dec 2003.** The study received financial support from Janssen-Ortho, Inc.,2. Heeg BM, et al. Costs and effects of Risperdal Consta (TM) in comparison toCanada. conventional depot and short-acting atypical formulations in Germany. Value in

Health 6: 692 (plus poster) abstr. PMH10, No. 6, Nov-Dec 2003.† Costs included those related to drug acquisition, inpatient and800969256outpatient services, as well as nonmedical and indirect costs.

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1173-8324/10/1418-0002/$14.95 Adis © 2010 Springer International Publishing AG. All rights reservedInpharma 20 Dec 2003 No. 1418