Real-World Cost-analysis of Paliperidone Palmitate for Schizophrenia Management:A Retrospective Analysis in Xiamen, China

doi:10.21203/rs.3.rs-4260478/v1

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Real-World Cost-analysis of Paliperidone Palmitate for Schizophrenia Management:A Retrospective Analysis in Xiamen, China

https://doi.org/10.21203/rs.3.rs-4260478/v1

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Background: To perform a cost-analysis of one-year maintenance treatment in stable schizophrenic patients with paliperidone extended-release tablets (PPER) and paliperidone palmitate once-monthly (PP1M) and provide a reference for clinicians in patient selection.

Methods: A retrospective investigation and analysis were conducted on stable schizophrenic patients who had been on PPER or PP1M for at least one year between June 2014 and December 2019 in Xiamen City. Patient demographic data, direct medical and nonmedical costs, and other information were collected. The clinical efficacy data were obtained from published articles, and a cost-effectiveness analysis was conducted.

Results: The PPER and PP1M groups included data from 84 and 62 patients, respectively. The two groups had no significant difference in gender and age. The total effective rates of PPER and PP1M were 73.17 and 97.37%, respectively. The registration frequency in the PPER group was significantly higher than that in the PP1M group (P<0.001). The cost of medication and total treatment was significantly higher in the PP1M group than in the PPER group (P <0.001). The cost/effect value was slightly higher in the PP1M group than in the PPER group. The incremental cost-effect ratio of both treatments was 369.07 yuan, less than the per capita gross domestic product (GDP) value.

Conclusion: Both formulations of paliperidone were found to be suitable for the long-term management of schizophrenia, while PP1M has better pharmacoeconomic advantages.

Schizophrenia

Paliperidone

Long-acting injection

Medication compliance

Pharmacoeconomics

Schizophrenia (SZ), a serious mental disease, can lead to mental disability[1]. The long-term use of antipsychotic drugs is usually required to relieve the pain associated with symptoms and reduce the potential recurrence of SZ[2–3]. The increase in SZ recurrence and subsequent hospitalization leads to poorer treatment outcomes and increases economic burdens on such patients[4–5]. Prevention of SZ relapse is a key therapeutic goal, where antipsychotic drugs play an important role.

Notably, it is very common in SZ patients to avoid antipsychotic medications, which leads to a higher recurrence rate. Poor dosage compliance can also be a result of complex medication plans, irregular daily life, and/or a lack of awareness[6]. Many studies have shown that compared with oral antipsychotics, long-acting injections, such as paliperidone palmitate once-monthly (PP1M), can effectively improve compliance, reducing recurrence and readmission rates and therefore offer significant pharmacoeconomic advantages[7–9].

PP1M, a long-acting injection (LAI) with unique pharmacokinetics, delivers a sustained therapeutic effect. The effectiveness and safety of PP1M have been confirmed in the Chinese population, however, factors such as high treatment costs (medication and clinician fees) have been found to limit its use[10–11]. Pharmacoeconomics can provide a basis for the selection of clinical medication and health policy formulation. Although there are many pharmacoeconomics studies on antipsychotic drugs for SZ treatment in the Chinese population, there are few reports on the pharmacoeconomics of PP1M.

Real-world pharmacoeconomics data can objectively reflect the actual clinical characteristics of patients for practical decisions. Accordingly, this study used real-world data to evaluate the pharmacoeconomics of PPER and PP1M maintenance therapy in SZ patients. Our results provide options to clinicians for medication schemes in different SZ patients.

Subjects

Subject inclusion criteria were as follows: age 18–60 years old, regardless of gender. According to the recommended dose of PP1M, "150 mg of paliperidone palmitate (PP) is injected on the first day of the treatment, 100 mg is injected again a week later; after the second dose, PP is injected once a month". The PP1M group included patients who continuously had 13 ‘continuous’ doses of PP within one year, excluding those who did not. Additionally, patients who were excluded from treatment interruption should be injected at the original dose as soon as possible according to the drug instructions "only if the interval of administration is less than 6 weeks". Patients who did not receive PP within 6 weeks after the last injection were defined as treatment interruption. In the PPER group, patients who had PPER continuously for more than one year were included, and those who stopped PPER use for more than 14 days were excluded. Other exclusion criteria were: pregnant and lactating women; alcohol or drug abuse; patients with serious physical diseases; and organic brain diseases. None of the included subjects had any hospitalization or emergency treatment during the study period.

The eligible subjects' data were collected from the hospital information system (HIS) from June 1, 2014, to December 31, 2019, as the prices of the two target pharmaceutical were stable during this period. The data were collected for gender, age, frequency of registration, registration costs, and drug and other treatment costs. This study was retrospective and therefore did not require patients' consent. As the retrospective study was conducted using hospital information system records and the patients were not subjected to any intervention, informed consent was waived by the Medical Ethical Committee.

Cost estimation

The pharmacoeconomic analysis includes direct costs (both medical and direct nonmedical costs), indirect costs, and intangible costs [12]. Based on the availability of data and operation limitations, this research only used direct medical costs, which were based on the actual medical costs recorded by the system, mainly including the costs of researched drugs, concomitant medication use, consultation fees, physical examination, and laboratory testing. Direct nonmedical costs were the transportation costs distinguished based on local and offsite medical treatment. Indirect costs and intangible costs were not included.

Efficacy determination

Clinical efficacy was used to measure health outcomes following the ‘Guidelines for Pharmacoeconomic Evaluation in China 2020’ [12]. The clinical efficacy data were derived from systematic reviews or randomized controlled clinical trials (RCTs) in the Chinese population. Referring to the published literature [13], the effective rates of PPER and PP1M were 73.17 and 97.37%, respectively.

Pharmacoeconomic evaluation

The cost-effectiveness analysis (CEA) identifies the treatment scheme with the lowest cost per unit treatment effect. The cost-effectiveness ratio (C/E) links the cost with the effect and is expressed as the cost-per-unit effect. A smaller ratio highlights the significance of the scheme implementation. The incremental cost-effectiveness ratio (ICER) was calculated by the incremental analysis method, and its economic characteristics were evaluated based on its magnitude.

Statistical analysis

Statistical analyses were performed using SPSS version 23.0 software. Demographic characteristics including age and gender were described at baseline. Data means and standard deviations (SDs) were used for continuous variables using the T-test, while counts and percentages were used for categorical variables using the chi-square test or Fisher’s exact probability test. Statistical differences were considered significant at P < 0.05.

Demographic data

Among the 112 patients using PP1M, only 62 patients (55.36%) received all 13 continuous doses within one year after the first injection (Table 1). This indicates that PP1M was not widely used, and many patients did not take all 13 doses, highlighting poor compliance.

Table 1

Total doses of paliperidone palmitate once-monthly after the first injection within one year (n = 112)
Doses	Cases	Percentage (%)
≤ 5	8	7.14
6–9	28	25.00
10–12	14	12.50
13	62	55.36

Among the 62 qualified patients in the PP1M group, 33 were males and 29 were females with an age of 36.00 ± 12.11 years. In the PPER group, there were 84 patients, including 42 males and 42 females, aged 37.36 ± 12.61 years. There were no significant differences in gender (χ2 = 1.08, P = 0.299) or age (t = 0.655, P = 0.514) between the two groups. The frequency of registration was significantly higher in the PPER group (68.48 ± 47.54) than in the PP1M group (20.71 ± 8.85) (t = 7.806, P < 0.001).

Expense statistics data

The costs are expressed in Chinese currency yuan (Table 2). We found that the PP1M group had obvious economic advantages in terms of diagnosis fees and transportation costs, with average savings of 48.25% and 66.89%, respectively. Compared to the PPER group, the pharmacy cost and total treatment cost in the PP1M group were 116.16% and 37.46% higher, respectively. In the PP1M group, since the increase in the target drug cost was partially offset by the cost of diagnosis and transportation, the rate of increase in the total cost was significantly lower than the increase in the target drug cost. Meanwhile, the reduced frequency of registration and travel time also saved direct nonmedical costs and indirect costs. Nevertheless, concomitant medication costs and physical examination/laboratory assay costs were not different between the two dosage groups.

Table 2

Direct costs of the treatment with PPER or PP1M in yuan.
Expense category	PPER group	PP1M group	t-value	P-value
Diagnosis expense	1081.33± 717.13	559.6±518.54	4.865	< 0.001
Target pharmacy expenses	12350.4±5596.61	26696.65±3431.19	-17.85	< 0.001
Concomitant medication expense	3575.15±7499.21	2204.19±4167.47	1.298	0.196
Physical examination/ laboratory testing expense	801.46±1966.61	1252.88±3147.52	-1.064	0.289
Travel expense	5873.21±4096.65	1944.35±1235.68	7.304	< 0.001
Total expense	23845.28±13920.22	32776.77±8113.17	-4.515	< 0.001
Note: PPER: Paliperidone extended-release tablets; PP1M: Paliperidone palmitate once-monthly

Results of economic evaluation

We also calculated the cost-effect ratio (C/E) of the two groups and the results showed that the C/E value was slightly higher in the PP1M group than in the PPER group (Table 3).

Table 3

Cost-effect ratio (C/E) analysis of two groups of patients.
Group	Cost	Effectiveness (%)	C/E
PPER (n = 84)	23845.28	73.17	325.89
PP1M (n = 62)	32776.77	97.37	336.62
Note: PPER: Paliperidone extended-release tablets; PP1M: Paliperidone palmitate
once-monthly

As per the pharmacoeconomic evaluation guide, if the intervention scheme has a higher cost and higher output than the control scheme, the incremental cost-effectiveness ratio (ICER) between the two schemes needs to be calculated. The ICER =(32776.77-23845.28)/(97.37–73.17) = 369.07 (yuan). According to the pharmacoeconomic evaluation recommendation of the World Health Organization, if ICER is less than GDP per capita, the increased cost is rational: per capita GDP < ICER < 3 times of GDP, the increased cost is acceptable; ICER > 3 times GDP, the increased cost is not justified [12]. Our study is based on the real-world data of the region, so the threshold of willingness to pay was calculated based on the local GDP per capita in the last year of the study period (2019); the per capita regional GDP of the permanent population was 142739 yuan, equivalent to 20691 U.S. dollars [14]. The results showed that the ICER of PP1M was less than GDP per capita, so the incremental cost is not an economic issue.

The growing incidence of SZ, a major mental disorder, is a serious concern causing a greater economic burden on the patient's family and straining health resources [15–16]. The most important risk factor is the relapse of SZ in patients with poor drug compliance, which can be attributed to patients' negative attitudes toward antipsychotics. Additionally, the lack of psychosocial support and complex medical history increase the risk of relapse of SZ [17]. Compared to oral antipsychotics, LAI has significantly higher treatment compliance by reducing disease recurrence, readmission rate, and cost-savings [18]. This retrospective survey focused on the economic burden of using PPER or PP1M for one year and understanding the pharmacoeconomics of PP1M using real-world data.

The results showed that PP1M expenses and total treatment expenses were significantly higher than PPER; however, PP1M significantly reduced direct medical costs such as the frequency of registration, diagnosis expenses, and accompanying direct nonmedical costs such as transportation expenses. Additionally, PP1M somewhat alleviated the problems of limited healthcare resources and implicit costs. Moreover, PP1M had a slightly higher C/E value than PPER, and the incremental cost of PP1M was justifiable.

The effective drug ingredient in this study was paliperidone. In PP1M treatment, the long-acting paliperidone aqueous suspension is injected intramuscularly once a month and the active drug improves the positive and negative symptoms, emotional symptoms, and cognitive function in SZ [19]. The efficacy and safety of the two dosage forms in acute and stable SZ have been confirmed by many domestic studies, and both had similar types of adverse reactions, while the incidence is lower for PP1M compared to PPER [20–21].

Although PP1M is cost-saving compared to oral antipsychotics [22], the opposite conclusions were reported when compared to other LAI. He Rubang et al. compared the cost-effectiveness of PP1M and risperidone LAI through a decision tree model and found that the average treatment cost and expected cost of risperidone LAI were lower than those of PP1M [23]. Similarly, Citrome L et al. compared aripiprazole LAI with PP1M and found aripiprazole LAI to be more economical [24]. Furthermore, another study found that haloperidol LAI had more economic advantages over PP1M and noted that the slightly higher benefits of PP1M in the management of SZ patients could not match the high patent fee [25].

In the above studies, the small sample size was one of the main limitations, and it could be possible that fewer SZ patients received LAIs. Many reasons may account for this phenomenon including clinicians and patients. In addition, the high expense of LAIs is one of the main reasons limiting their widespread use. Jiang Yingci et al found that male patients, patients at a high-risk, patients who were accompanied in the hospital, patients who were given drugs by others, and patients who were hospitalized for a longer duration were more willing to accept LAIs [26].

It was also suggested to popularize LAIs among doctors in medical institutions, focusing on their use in high-risk patients to improve compliance with regular medication. The main factors affecting the treatment compliance of SZ with PP1M included family income, self-knowledge, a score of Positive and Negative Syndrome Scale(PANSS) reduction, concomitant propranolol, and sedative-hypnotics [27–28]. Additionally, the key to reducing the interruption of treatment was to select appropriate patients and pay attention to the improvement of early symptoms and concomitant medications. Here, we showed that PP1M has obvious economic advantages, which is consistent with many previous studies [29–30], while the differences with those studies in other countries can be attributed to differences in healthcare policies [31].

Nevertheless, this study had limitations of being a retrospective observational study with a relatively small sample size. Population migration and the lack of full registration information were important factors in reducing the sample size. Data loss included, but was not limited to, data on patients’ education, disease course, clinical efficacy, and adverse reactions. The incomplete data may lead to some bias in the research results. Moreover, the lack of information on direct and indirect costs may also affect the pharmacoeconomic evaluation, as indirect costs account for a large proportion of the costs in the management of SZ [13].

This is the main pharmacoeconomic study in the treatment and long-term maintenance of SZ in the local district. In this retrospective study, the health affairs that had already been collected and stored in an electronic database had already taken place, and there were no interventions from investigators, patients, or policy. All of the databases involved in the analysis were based on the hospital information system and should have guaranteed accuracy.

Further research should explore reliable designs based on local clinical practice. Prospective observational research or mirror observation can be considered to obtain more comprehensive real-world data on the cost of healthcare and clinical efficacy. Such studies may provide reliable evidence for the clinical evaluation of antipsychotics, especially LAIs.

In this retrospective analysis, primary data on the economic burden on SZ patients using PPER and PP1M for one year were examined. The results showed no statistically significant difference in concomitant medication expense, physical examination/ laboratory testing expense, and total costs between the two dosage forms. The increase in pharmacy costs for PP1M was offset by a decrease in diagnosis expenses and travel expenses. Concisely, PP1M should be a relevant cost-saving option in the long-term management of SZ patients, and the advantage will be strengthened with the expiration of patents of the LAIs. These findings provide a new perspective on the pharmacoeconomic evaluation of antipsychotics for adjusting healthcare policy.

PPER:paliperidone extended-release tablets

PP1M:paliperidone palmitate once-monthly

GDP: Gross Domestic Product

SZ:Schizophrenia

LAI:long-acting injection

PP: paliperidone palmitate

HIS: hospital information system

RCTs: randomized controlled clinical trials

CEA : cost-effectiveness analysis

ICER: incremental cost-effectiveness ratio

SD: standard deviations

C/E:cost-effect ratio

PANSS:Positive and Negative Syndrome Scale

Ethics approval and consent to participate: Ethics approval was obtained from the Medical Ethical Committee of Xiamen Xianyue Hospital (2020-KY-014). As the retrospective study was conducted using hospital information system records and the patients were not subjected to any intervention, informed consent was waived by the Medical Ethical Committee of Xiamen Xianyue Hospital. All methods were carried out in accordance with relevant guidelines and regulations.

Consent for publication:Not applicable

Availability of data and materials:The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests:The authors declare that they have no competing interests.

Funding:This work was supported by a scientific research project of Xiamen Xianyue Hospital (Grant No. 2020-XYYB02).

Authors' contributions:Yixiang Zhou contributed to the study design,data collection and original draft preparation. Binbin Chen contributed to the design of methodology and data analysis and reviewing and editing the manuscript. Yinghua Huang contributed to oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team. All authors read and approved the final manuscript.

Acknowledgement:The authors thank the staff members at the study pharmacy for their time and cooperation throughout this evaluation.

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No competing interests reported.

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Version 1

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Real-World Cost-analysis of Paliperidone Palmitate for Schizophrenia Management:A Retrospective Analysis in Xiamen, China

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Version 1

Abstract

Background

Methods

Subjects

Cost estimation

Efficacy determination

Pharmacoeconomic evaluation

Statistical analysis

Results

Demographic data

Expense statistics data

Results of economic evaluation

Discussion

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1