Pharmacoeconomic analysis of paliperidone palmitate for treating schizophrenia in Greece
- Thomas R Einarson1Email author,
- Maria Geitona2,
- Alexandros Chaidemenos3,
- Vasiliki Karpouza4,
- Theodoros Mougiakos5,
- Periklis Paterakis6,
- Dimitrios Ploumpidis7, 8,
- Dionyssios Potamitis-Komis9,
- Roman Zilbershtein10,
- Colin Vicente10,
- Charles Piwko10,
- Panagiotis Kakkavas11,
- Konstantina Paparouni12,
- Rasmus C D Jensen13 and
- Michiel E H Hemels13
© Einarson et al.; licensee BioMed Central Ltd. 2012
Received: 26 March 2012
Accepted: 15 May 2012
Published: 2 July 2012
Patients having chronic schizophrenia with frequent relapses and hospitalizations represent a great challenge, both clinically and financially. Risperidone long-acting injection (RIS-LAI) has been the main LAI atypical antipsychotic treatment in Greece. Paliperidone palmitate (PP-LAI) has recently been approved. It is dosed monthly, as opposed to biweekly for RIS-LAI, but such advantages have not yet been analysed in terms of economic evaluation.
To compare costs and outcomes of PP-LAI versus RIS-LAI in Greece.
A cost-utility analysis was performed using a previously validated decision tree to model clinical pathways and costs over 1 year for stable patients started on either medication. Rates were taken from the literature. A local expert panel provided feedback on treatment patterns. All direct costs incurred by the national healthcare system were obtained from the literature and standard price lists; all were inflated to 2011 costs. Patient outcomes analyzed included average days with stable disease, numbers of hospitalizations, emergency room visits, and quality-adjusted life-years (QALYs).
The total annual healthcare cost with PP-LAI was €3529; patients experienced 325 days in remission and 0.840 QALY; 28% were hospitalized and 15% received emergency room treatment. With RIS-LAI, the cost was €3695, patients experienced 318.6 days in remission and 0.815 QALY; 33% were hospitalized and 17% received emergency room treatment. Thus, PP-LAI dominated RIS-LAI. Results were generally robust in sensitivity analyses with PP-LAI dominating in 74.6% of simulations. Results were sensitive to the price of PP-LAI.
PP-LAI appears to be a cost-effective option for treating chronic schizophrenia in Greece compared with RIS-LAI since it results in savings to the health care system along with better patient outcomes.
KeywordsPaliperidone palmitate Risperidone Long-acting injectables Schizophrenia Pharmacoeconomic analysis Greece
Glazer and Ereshefsky  were the first to conduct a pharmacoeconomic analysis on patients affected with so-called “revolving door” schizophrenia. The label was adopted to describe persons suffering from chronic disease with multiple relapses, frequent hospitalizations, and problems with adherence to prescribed medications. These patients have many problems and obstacles preventing them from living a normal life. They are also responsible for increased expenditures for healthcare, social services, and the justice system .
Antipsychotic drugs can help many revolving door patients to remain in a stable condition; however, a major problem for them is adherence to these prescribed drugs [1, 3]. The adherence of patients with schizophrenia is reduced over time. In fact, it has been demonstrated that partial adherence (i.e. missing 25-50% of doses) can reach 50% in 1 year and 75% in 2 years . An important advance in enhancing adherence has been the depot form of these drugs, also referred to as long-acting injectables (LAIs). They have become a mainstay in treatment because of their prolonged effect and consequent prevention of much of the intentional and non-intentional non-adherence that results in treatment failures and hospitalizations . The clinically meaningful superiority of depot medication compared to oral antipsychotic drugs in outpatients with schizophrenia has also been confirmed by the findings of a recent meta-analysis which demonstrated that depot formulations significantly reduced relapses from an average of 33.2% to 21.5% .
A further advance has been the development of atypical antipsychotics. They have advantages over the traditional drugs in that they improve both the positive and negative symptoms of the disease . A depot form of atypical antipsychotic was not available until 2002, the first of which was risperidone (RIS-LAI) [7, 8]. In a review of the clinical research, Möller concluded that RIS-LAI displayed clinical efficacy and a reasonable degree of tolerability . Moreover, based on the results of a recent multi-centre cohort study across 15 French regions that accounted for 77.6% of the French population in 2005, RIS-LAI use compared to all other LAIs and first or second generation per os antipsychotics was associated with a 34% reduced rate of hospitalization . A clinical disadvantage is that, although clinically effective, it must be administered every two weeks, usually by a specially trained psychiatric nurse or physician .
More recently, paliperidone palmitate (PP-LAI) has been developed and approved by the European Medicines Agency . Among the other advantages that it shares with existing drugs, this new product has an added advantage in that it may be administered monthly . PP-LAI is already marketed in several European markets, most often at a higher acquisition price than RIS-LAI.
Although the clinical use of PP-LAI has been investigated in a number of randomized controlled trials [13–17], few economic evaluations have yet been conducted. A search of the international peer reviewed literature revealed one study from the USA that included PP-LAI . However, that study did not use data inputs generated by PP-LAI, but rather they used data from RIS-LAI studies and assumed the two drugs to be exactly equal. Considering differences in dosing regimens, such assumptions and associated cost outcomes may not be valid. Several pharmacoeconomic studies have compared RIS-LAI with other drugs, mainly oral atypicals and traditional depots. In his review of those studies, Haycox found that RIS-LAI was the dominant strategy in all eight different countries, using different analytical models .
In Greece, a single pharmacoeconomic study by Geitona and associates  was published which focused on paliperidone extended release oral tablets. That study demonstrated that paliperidone was cost-effective over all other oral drugs tested, including risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole. Paliperidone had the lowest overall cost and the highest number of days with stable disease. No other similar studies from Greece could be located.
Given that PP-LAI has a higher acquisition price than RIS-LAI and taking into consideration the scarcity of resources health care systems are faced with, economic evaluation of new technologies is important for decision making purposes. The aim of this paper is to compare costs and outcomes of PP-LAI versus RIS-LAI for the treatment of persons with chronic schizophrenia in Greece.
Unlike a clinical trial, patients are not recruited into this research. Rather, a decision model was used to represent the average patient being treated using standard approaches.
Therefore, it is necessary to define the population to whom results would apply. The population of interest consisted of patients having chronic schizophrenia with multiple relapses, frequent hospitalizations, and problems with adherence to prescribed medications. At initiation of the analysis, all patients were stable and treated as outpatients with maintenance doses of their LAIs. For the purposes of this analysis, comorbidities were not considered even though they are common in this population .
Drugs of interest
The primary drug of interest was PP-LAI, which was compared against RIS-LAI. Long term use of PP-LAI has been investigated in a number of randomized controlled trials [13–17]; one of these trials involved a comparison with RIS-LAI . As previously mentioned, the European Medicines Agency has approved PP-LAI for monthly dosing , while RIS-LAI is administered every two weeks . It should be noted that at the time of this analysis PP-LAI was not marketed in Greece and there was no local clinical experience.
Model and base case
Clinical inputs into the model and sources of information
RIS rate adjusted via Mehnert 
Adherent, stable disease
Calculation [1 - (ER exacerbation rate + hospitalization rate)]
Calculation [1 - (ER exacerbation rate + hospitalization rate)]
Adherent, exacerbation requiring ER visit
Ratio of ER vists: hospitalizations Ascher-Svanum 
Ratio of ER vists: hospitalizations Ascher-Svanum 
Calculation [1 - (Stable rate + hospitalization rate)]
Calculation [1 - (Stable rate + hospitalization rate)]
Assumption; PP rate adjusted based on calculations by Mehnert & Diels 
40.3 mg biweekly
69.3 mg monthly
Dose after relapse
50 mg biweekly*
Risperdal Consta® Approved Summary of Product Characteristics  maximum dose
84.9 mg monthly
Dose after discontinuation
50 mg biweekly*
Risperdal Consta® Approved Summary of Product Characteristics  maximum dose
150 mg week 1, 100 mg week 2, then 84.9 mg every 4 weeks
Clozapine maintenance after failing both drugs
450 mg daily
Clozapine maximum dose
750 mg daily
Cost inputs into the economic model (2011€)
hospital bed acute care
€ 146 for the first 21 days
hospital bed acute care
€ 45.00/day after 21 days
Analysis and outputs
For each drug, we calculated the average cost per patient treated. Patient outcomes analyzed included average days with stable disease, numbers of hospitalizations, emergency room visits, and quality-adjusted life-years (QALYs). To derive utilities (i.e., the quality weights) for this quality adjustment, preference based estimates were obtained from the literature [45–49]. Each of the three primary health states (i.e., stable disease, exacerbation requiring emergency room treatment, and hospitalization) were weighted using the average of the reported utility scores. QALYs were then estimated for each drug by multiplying the amount of time in each health state by the quality value assigned to that health state. Therefore, a cost-utility analysis was conducted, which involves calculating the incremental treatment cost per QALY as the pharmacoeconomic outcome. In addition, a cost-effectiveness analysis was performed in order to assess other important clinical outcomes, such as the number of stable and relapse days as well as rates of hospitalisation and emergency room visits.
Several sensitivity analyses were performed to determine if alterations in clinical or cost inputs would influence outputs. One-way sensitivity analyses were done to identify break-even points, that is, what the values would have to be in order for PP-LAI to cost more than RIS-LAI. We conducted one-way sensitivity analyses on important parameters such as rates of adherence, hospitalization, and emergency room visits as well as drug acquisition costs. Finally, all variables were varied over plausible ranges in a probabilistic sensitivity analysis (also called a Monte Carlo simulation) with 10,000 iterations. That analysis reproduces results for a large group of patients and gives a projection of what average costs and outcomes would be.
Cost-utility analysis results from comparing paliperidone and risperidone long acting injections for chronic schizophrenia in Greece
Total cost per patient*
Total QALYs per patient
Incremental cost per patient
Incremental QALYs per patient
The primary pharmacoeconomic analysis was cost-utility, which simultaneously compares costs and QALYs. Along with costs, Table 3 also lists the numbers of QALYs associated with the use of each drug. In the base case, patients treated with PP-LAI have a higher QALY score, meaning that they experience more time with a higher quality of life. Because PP-LAI has a lower cost and a greater number of QALYs, it is considered dominant over RIS-LAI. That means it is the preferred treatment and should be adopted, providing it is affordable.
Cost-effectiveness analysis results
Stable days per patient
Days in relapse per patient
Average visits to the emergency room per patient
Average number of hospitalizations per patient
To test the robustness of the model and its results, an array of different sensitivity analyses were conducted. In one-way sensitivity analyses, the model was insensitive to variations in rates of hospitalization or emergency room visits. That means results would not change and favour RIS-LAI regardless of how many patients were hospitalized or treated in the emergency room. As well, for cost equality between drugs, the adherence rate for PP-LAI would have to decrease by 28.5% (while that of RIS-LAI remained the same), which is not a reasonable scenario.
This pharmacoeconomic analysis aims to assess the clinical and economic value of PP-LAI as a new treatment option in schizophrenia and to support decision making with respect to efficient allocation of resources within the Greek health care setting. Decision analytic modelling was used to estimate and compare the costs and effects of PP-LAI and RIS-LAI in outpatients with chronic schizophrenia within a 1 year time horizon. In this analysis, PP-LAI was the dominant treatment option as it was associated with improved outcomes and a lower average total treatment cost per year.
Overall, the cost of treatment was slightly lower for the healthcare system when PP-LAI was used, despite a higher acquisition cost. It appears that the price of the drug is more than offset by savings accrued from less frequent drug administration and higher adherence rates, as used in our model.
The only other pharmacoeconomic analysis of schizophrenia in Greece was that of Geitona and colleagues who investigated paliperidone extended release tablets . Their calculated cost was just over €7,030 for both paliperidone and risperidone oral tablets, with drugs comprising €1,541 (21.9%) and €1,293 (18.4%) of the totals, respectively. Our overall costs were lower, possibly reflecting the different patient population, i.e.. the analysis by Geitona and colleagues focused on patients with acute exacerbation, or some of it might be attributed to the improved efficacy (i.e., via higher adherence rates) and the reduced hospitalisation rates associated with LAI formulations . In our analysis, drugs accounted for 61% and 56% of the total costs, respectively, which reflect the higher acquisition costs of the LAIs. Nonetheless, the final results were somewhat similar, with paliperidone dominating risperidone.
While reviewing these results it is important to keep in mind the potential limitations of this analysis. An apparent limitation was the fact that local expert panel was used for estimating specific input parameters to the model, namely, those associated with resource utilization in the Greek setting. Although this approach has been followed before in other similar studies [19, 20], it could lead to potentially biased estimates. However, in the light of the absence of real life resource utilization data the expert panel could give a picture of the actual clinical setting. Furthermore, in our model we did not include the costs for treating adverse events. One reason was that the drugs are closely related, with paliperidone being a metabolite of risperidone . Therefore, one might expect the efficacy and safety profiles to be quite similar. In fact, that assumption of equal side effect rates was made in a recently published pharmacoeconomic analysis in the USA that included both of these drugs . Geitona and associates  did include some of these events, but found that the associated cost was trivial and had no impact on the model. Similar results have been reported by Vera-Llonch and coworkers , who estimated the monthly cost associated with side effect management for risperidone and olanzapine. It should be noted that our model captured the discontinuation and switching rates, which are also attributed to adverse events.
Health policy implications
Efficient resource allocation has become a priority for policy makers across Europe and in Greece in particular. That applies to healthcare as well and to the management of patients with chronic schizophrenia. Health economic studies could provide significant tools for well documented and rational decision making given the scarcity of resources and the increasing control on health care and pharmaceutical expenditure. Pharmacoeconomic analyses, like the one presented, give quantitative estimates of the costs of care and identify the preferred choices for drug treatment. In the case of PP-LAI, its adoption would actually lead to savings for the system, since the overall cost of care would decrease. Both clinicians and managers within the system need to become aware of these analyses and use them to the advantage of both themselves and patients.
In Greece, PP-LAI should be preferred to RIS-LAI for treating patients with chronic relapsing schizophrenia because it has both clinical and economic advantages. The analysis showed that PP-LAI has a lower overall cost to the health care system and greater clinical benefits in terms of QALYs, days in remission, hospitalizations, and visits to the emergency room for exacerbations of schizophrenia. If adopted, it should result in net savings to the system of €166 per patient treated per year, along with better quality patient care. These findings could be further validated when PP-LAI becomes commercially available in Greece and clinical experience is accumulated. Future research efforts, could focus on conducting economic evaluations based on “real-life” data with respect to clinical outcomes and resource utilization in the local setting, providing this way deeper analysis of the cost-effectiveness of PP-LAI.
Paliperidone palmitate long-acting injectable
Quality adjusted life-year
Risperidone long-acting injectable.
Supported by Janssen Pharmaceutica NV, Beerse, Belgium. The authors would like to thank the members of the experts‘‘ panel: Alexandros Chaidemenos, Vasiliki Karpouza, Theodoros Mougiakos, Periklis Paterakis, Dimitrios Ploumpidis, Dionyssios Potamitis, for providing advice on local treatment patterns and resource utilization and for reviewing the draft manuscript, and also Prof. Maria Geitona for participating in the experts’ panel and for reviewing the manuscript.
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