Cost effectiveness of paliperidone palmitate versus risperidone long-acting injectable and olanzapine pamoate for the treatment of patients with schizophrenia in Sweden.

OBJECTIVE: To model the cost effectiveness of paliperidone palmitate (paliperidone long-acting injectable; PLAI), a new once-monthly long-acting antipsychotic therapy, compared with risperidone long-acting injectable (RLAI) and olanzapine pamoate (OLAI), in multi-episode patients (two or more relapses) with schizophrenia in Sweden. METHODS: A Markov decision analytic model was developed to simulate the history of a cohort of multi-episode patients transitioning through different health states on a monthly basis over a 5-year time horizon from the perspective of the Swedish healthcare system. Therapeutic strategies consisted of starting treatment with RLAI (mean dose 37.5 mg every 2 weeks), PLAI (mean dose 75 mg equivalent (eq.) every month) or OLAI (150 mg every 2 weeks or 300 mg every 4 weeks). Probability of relapse, level of adherence, side-effects (extrapyramidal symptoms, tardive dyskinesia, weight gain and diabetes) and treatment discontinuation (switch) were derived from long-term observational data when feasible. Incremental cost-effectiveness outcomes, discounted at 3% annually, included cost per quality-adjusted life-year (QALY) and cost per relapse avoided (expressed in 2009 Swedish Krona SEK). RESULTS: Relative to RLAI and OLAI, PLAI is economically dominant: more effective (additional QALYs, less relapses) and less costly treatment option over a 5-year time horizon. The results were robust when tested in sensitivity analysis. LIMITATIONS: The impact of once-monthly treatment on adherence levels is not yet known, and not all variables that could impact on real-world outcomes and costs were included in this model. CONCLUSION: PLAI was cost saving from a Swedish payer perspective compared with RLAI and OLAI in the long-term treatment of multi-episode (two or more relapses) schizophrenia patients.

The burden of chronic low back pain with and without a neuropathic component: a healthcare resource use and cost analysis.

BACKGROUND: This research addresses the need for population-based studies on the burden of chronic low back pain (CLBP) by examining healthcare service use and costs for patients with and without neuropathic components in the US population. METHODS: Data were analyzed from PharMetrics IMS LifeLink™ US Claims Database (2006-2008). Patients (≥18 years) with 36 months continuous enrollment, ICD-9 code for low back pain, and claims in 3 out of 4 consecutive months in the 12-month prospective period were included and classified with CLBP. Patients were further classified with a neuropathic component (wNP) and without a neuropathic component (woNP) based on ICD-9 codes. Healthcare resources, physical therapy, prescription medication use, and associated costs were assessed for the period January 1-December 31, 2008. RESULTS: A number of patients (39,425) were identified with CLBP (90.4% wNP). Patients wNP included more women, were older and more likely to have clinically diagnosed depression, and made significantly greater use of any prescription medication at index event, opioids (particularly schedule II), and healthcare resources. Total direct costs of CLBP-related resource use were ∼US$96 million over a 12-month follow-up. CLBP wNP accounted for 96% of total costs and mean annual cost of care/patient was ∼160% higher than CLBP patients woNP (US$ 2577 vs US$ 1007, p < 0.0001). LIMITATIONS: This study was descriptive and was not designed to demonstrate causality between diagnosis, treatment, and outcomes. Resource use and costs for reasons other than LBP were not included. Patients with neuropathic pain are more likely to seek treatment; therefore CLBP patients with a non-neuropathic component may be under-represented. CONCLUSIONS: The disproportionately high share of interventional resource use in CLBP wNP suggests greater need for new treatment options that more comprehensively manage the range of pain symptoms and signaling mechanisms involved, to help improve patient outcomes and reduce the burden on healthcare systems.

Personal and social functioning in schizophrenia: defining a clinically meaningful measure of maintenance in relapse prevention.

BACKGROUND: Relapse prevention and maintenance of social functioning are important treatment objectives in the long-term management of schizophrenia. However, relatively little is known about measuring maintenance of social functioning to assess treatment benefit in relapse prevention clinical trials or as a tool to predict relapse in clinical practice. This study aims (1) to define a clinically meaningful decrease in the Personal and Social Performance scale (PSP) to assess antipsychotic treatment benefit in terms of maintenance of functioning and (2) to explore the threshold value of PSP decline as a useful tool to predict relapse in clinical practice. METHODS: This post hoc analysis of two similar placebo-controlled relapse prevention clinical trials consisted of an exploration of change in PSP that would represent a clinically important decrement to measure treatment benefit in terms of time to PSP decrement (ITT analysis set; Study 1: n = 205) and an assessment of predictive value of PSP decrement and relapse status (ITT analysis set; Study 2: n = 408). RESULTS: A 10-point decrement in PSP score was the threshold value for a clinically meaningful decline in personal and social functioning in a relapse prevention trial (Study 1). A strong association was found with relapse status: 61% of subjects with at least a 10-point decrease in PSP experienced the decrement prior to (between start of double-blind phase and before day of relapse) or on the day of relapse (Study 2). Kaplan-Meier survival analysis of time to at least a 10-point decrement in PSP showed that the proportion of subjects who did not experience at least a 10-point PSP decrease was statistically significantly greater in the paliperidone palmitate group than in the placebo group (p = 0.0014) (Study 2). CONCLUSIONS: Findings suggest a 10-point PSP decrement is a clinically relevant measure of maintenance of functioning in patients stabilized with antipsychotic therapy. Paliperidone palmitate demonstrated a statistically significant treatment benefit in terms of maintenance of functioning versus placebo. Furthermore, measuring a clinically relevant PSP decrement may be useful as an early functional indicator of relapse in clinical practice. LIMITATIONS: The exploration and validation of the threshold value of change in the PSP was designed and conducted post hoc. Predictive value is limited by the frequency in which PSP assessments were carried out in these trials, underscoring the importance of regular assessment.

Burden of schizophrenia in recently diagnosed patients: healthcare utilisation and cost perspective.

BACKGROUND: Inpatient care to manage relapse of patients with schizophrenia contributes greatly to the overall financial burden of treatment. The present study explores to what extent this is influenced by duration of illness. METHODS: Medical and pharmaceutical claims data for patients diagnosed with schizophrenia (ICD-9 295.xx) were obtained from the PharMetrics Integrated Database, a large, regionally representative US insurance claims database, for the period 1998-2007. Recently diagnosed (n = 970) and chronic patients (n = 2996) were distinguished based on ICD-9 295.xx classification, age and claims history relative to the first year (recently diagnosed) and the third year onwards (chronic) after the first index schizophrenia event. RESULTS: The medical resource use and costs during the year following the index schizophrenia event differed significantly between cohorts. A higher proportion of recently diagnosed patients were hospitalised compared with chronic patients (22.3% vs 12.4%; p < 0.0001), spending a greater mean number of days in hospital (5.1 days vs 3.0 days; p = 0.0065) as well as making more frequent use of emergency room (ER) resources during this time. The mean annual healthcare costs of recently diagnosed patients were also greater ($20,654 vs $15,489; p < 0.0001) with inpatient costs making up a higher proportion of total costs (62.9%) compared with chronic patients (38.5%). CONCLUSIONS: There is a considerably higher overall economic burden in the year following their first schizophrenia event in the treatment of recently diagnosed schizophrenia patients compared with chronic patients. Since hospitalisations and ER visits are the most significant components contributing to this finding, efforts that focus on measures to reduce the risk of relapse, particularly amongst recently diagnosed patients, such as improved adherence programs, may lead to better clinical and economic outcomes in the management of schizophrenia. LIMITATIONS: Only commercially insured patients and direct medical costs were included, therefore, results may underestimate the economic burden of schizophrenia.