Cost-Effectiveness Analysis of Multiple Sclerosis Rehabilitation in Iran

doi:10.21203/rs.3.rs-1744098/v1

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Cost-Effectiveness Analysis of Multiple Sclerosis Rehabilitation in Iran

https://doi.org/10.21203/rs.3.rs-1744098/v1

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Background and Objectives: Multiple Sclerosis (MS) is associated with a significant impact on quality of life and has various social and economic outcomes. There is ample evidence of the effectiveness of rehabilitation interventions on this disease. So we aimed to evaluate the cost-effectiveness of MS rehabilitation in Iran.

Methods: A full economic evaluation was conducted using a Markov model. The structure of the model was designed according to the nature of interventions and the natural course of the disease. Parameters and variables were extracted from the available evidence. Costs and outcomes were calculated from the social perspective and a 5-year time horizon (60 monthly cycles) was considered for base-case analysis. Costs were estimated based on approved national standards for MS rehabilitation. Deterministic and probabilistic sensitivity analysis was also performed. TreeAge 2020 was used in all stages of analysis.

Results: Average cost of rehabilitation strategy is higher compared to non-rehabilitation strategy, but with higher quality-adjusted life years (QALY) values. The amount of incremental cost-effectiveness ratio (ICER) was equal to $2,845.8 per QALY, which indicated that the rehabilitation strategy is cost-effective. By changing the Markov time horizon from 5 years to 10 years as a deterministic sensitivity analysis (DSA), the rehabilitation strategy was dominant in terms of cost-effectiveness. Probabilistic sensitivity analysis (PSA) results also confirmed the base case results with good probability.

Conclusions: The MS rehabilitation was cost-effective. Also, by increasing the time horizon, the probability of cost-effectiveness of rehabilitation increases. The results of PSA also confirmed these findings.

Multiple Sclerosis (MS)

Rehabilitation

Economic evaluation

Cost-effectiveness analysis

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, which has an unknown etiology and is therefore classified as a complex disease (1). According to the existing evidence, by 2016, more than 2,200,000 people in the world have been diagnosed with MS (2). In Iran, the prevalence of this disease is estimated at 15 to 30 per 100,000 population (3).

MS is clinically divided into several subgroups, the most important of which are relapsing-remitting (RR), primary progressive (PP), and secondary progressive (SP) (4–6). According to available statistics, about 85% of MS cases in the world are RR, which is characterized by a periodic acute exacerbation of disease activity (relapse) following recovery periods, and the remaining 15% are related to PP, SP, and benignant (7). The most common type of MS in Iran, which accounts for approximately 88% of cases, is the RR type (8).

This disease is associated with a significant impact on quality of life and has various social and economic consequences (9–11). According to the National Institute of Neurological Diseases of the United States, the cost of MS in the United States is estimated at more than $2.5 billion annually (12).

The disease affects a wide range of men and women, mainly young people, and the average age of primary diagnosis is estimated at about 30 years (13). There is also evidence in terms of MS mortality and disability. Based on the available evidence, 18,932 people died in the world due to MS in 2016, and the number of disability-adjusted life years (DALYs) was estimated at 115,148 units (2).

Given that the disease often affects young people at working age in countries, paying attention to preventive care and even therapeutic interventions can be very important. A variety of interventions are used to treat MS patients and its treatment includes preventive care, support, rehabilitation, and symptom management (14, 15).

In addition to medication interventions, rehabilitation services are an important part of the treatment process for MS patients that lead to improving the general and motor and cognitive status of patients and ultimately leads to reducing fatigue and improving the patients’ quality of life. In general, rehabilitation interventions for MS patients include exercise therapy, functional education, assistive technology, orthopedic services, family education, and counseling services. These can be considered to compensate for a variety of disorders such as mobility, fatigue, pain, dysphagia, bladder / intestinal dysfunction, decreased independence in activities of daily living, communication, emotional disorders, and cognitive impairment (16).

The main purpose of rehabilitation of patients, in general, is to increase the degree of individual independence and reduce the need for family and companions and increase patient productivity for society and reduce individual and social costs of care and maintenance. Rehabilitation can be done in both inpatient and outpatient methods. Because MS is a disease of the young population, and the need for shorter hospitalization and health insurance to support a short period of inpatient rehabilitation, the outpatient rehabilitation option for these patients in terms of support systems are also more acceptable in terms of patient acceptance of interventions and can provide a long-term and ongoing program. In some patients who have more complex and extensive needs for rehabilitation services, inpatient services are also used (17).

Various studies in recent years show growing evidence of the effectiveness and efficacy of rehabilitation interventions, including inpatient and outpatient interventions in MS patients (18, 19), but given that these interventions cause a significant economic burden on the system, it is necessary to check the affordability of these interventions for the service delivery system of countries.

Due to the increasing incidence of MS in Iran and the other hand various aspects of MS rehabilitation services, evaluating various aspects of rehabilitation services and providing evidence and information needed for policymaking and decisions about the use or expansion of these services is very important in the country's health system. Therefore, according to this goal, the present economic evaluation has examined the cost-effectiveness (CEA) of inpatient and outpatient rehabilitation services in the treatment of MS in Iran. The results of the present study can provide appropriate evidence for policymakers and other potential users to decide on public resource allocation for the MS rehabilitation services.

The present study is a full economic evaluation that compared the MS rehabilitation strategy with the non-intervention strategy in Iran from a social perspective.

Modeling

We developed a Markov model to simulate the natural history of the disease and assess the cost-effectiveness of MS rehabilitation services. To design the model, different sessions were formed with the presence of clinical specialists and economic team, and after a discussion of different models, the best model was finalized.

To evaluate the clinical efficacy of rehabilitation in this study, based on the available evidence as well as other economic evaluation studies on MS, the Expanded Disability Status Scale (EDSS) was considered.

The designed decision-analytic model can be seen in Figure 1. The Markov model had five mutually exclusive health states including severe disease health state (EDSS> = 8), moderate disease health state (6 <EDSS <7.5), mild disease health state (3 <EDSS <5.5), very-mild health state (EDSS <3) and death. Patients in the first cycle were distributed between health states according to the initial distribution. The Markov process was such that individuals in each group and health state remain in the same state at the end of each cycle, transfer to another health state or die. The model time horizon was 5-year and the cycle duration was one month. Outcomes were Quality Adjusted Life Years (QALYs), and costs.

According to the available evidence on the rehabilitation interventions, one month was considered as cycle length. Also, the effectiveness of rehabilitation interventions (18) was considered in different transition probabilities of compared strategies. The time horizon in the base case analysis as mentioned was considered to be 5 years equivalent to 60 cycles.

The final outcome of the evaluation was the quality-adjusted life years (QALYs) and QALY values are defined in each health state according to the EDSS score and health-related quality of life.

To extract evidence on mortality rate and other evidence, according to the average age of MS patients in Iran, the average age of 30 years was considered for patients at the beginning of Markov cycles. The period and frequency of the rehabilitation in each group have been done in accordance with Iran’s Ministry of Health standards for MS rehabilitation services in each subgroup.

Model Assumptions and Parameters

According to the natural course of the disease and the rehabilitation protocol for MS patients in Iran, the efficacy of MS rehabilitation (as a transition to better health status) was considered in only one cycle, and in the following cycles, rehabilitation was considered with the aim of stabilizing the health condition.

In each health state, in addition to the costs of rehabilitation interventions, the costs of patients’ care and maintenance and the costs of absenteeism were also considered.

The costs of inpatient and outpatient rehabilitation costs were calculated based on the unit cost used in each intervention. To calculate the average costs per patient and to calculate the total cost of rehabilitation services, a bottom-up approach was used. For this purpose, the extracted data of relevant evidence and Iran’s Ministry of Health standards for MS rehabilitation services were used and the list of rehabilitation services and their frequency divided different levels of the disease severity was extracted based on the EDSS index and also the type of rehabilitation services, then by multiplying the number of rehabilitation services per patient in the tariff of services, the average cost of rehabilitation services per patient was calculated.

In this study, all tariffs, including rehabilitation services, were extracted using the public sector official tariffs of Iran’s Ministry of Health in 2019. Accordingly, the average cost of MS rehabilitation services per patient was calculated based on public sector tariffs. Rehabilitation cost items included hospitalization costs, physiotherapy, speech therapy, occupational therapy, monitoring, and maintenance costs.

Home care and maintenance costs were calculated based on the average salary of a full-time and part-time nurse at a home care center. Absenteeism costs were also calculated based on the monthly number of days off work of different groups and also based on the minimum wage in 2019. For the severe and moderate disease group, due to the relatively high level of disability and lack of relative independence, the number of days off work was considered 30 days per month, and for the mild group, 15 days were considered.

In general, according to Iran’s Ministry of Health standards for MS rehabilitation services, as well as the opinions of clinical specialists, the length of the rehabilitation period was considered 2 years, so the cost of rehabilitation is only included in the model for 2 years (24 cycles).

Other related parameters and variables include the transition probabilities between health states in compared strategies, mortality risk in each health state, initial distributions, the effectiveness of rehabilitation interventions in each health state and other parameters extracted from international evidence. In this regard, each parameter was searched separately based on keywords and specific strategies in scientific databases, studies that had appropriate evidence were classified and studied, and finally, the best available evidence was extracted. The values of parameters and variables of the model and their sources can be seen in Table 1.

Table 1: Model Inputs and Sources

Statistic variable	Base case	SD/(CI)	Distribution	Source
Initial Prevalence (Severe)	26.4%			(19)
Initial Prevalence (Moderate)	58.6%
Initial Prevalence (Mild/Very Mild)	15%
Annual discount rate	0.05	(0.03-0.12)	Beta
Time Horizon(years)	5 years (60 cycles)	(+5 years)
DMTs Efficacy	51%	±13%	Beta	(20)
*Transition Probabilities* *(Non-rehabilitation strategy)*
Mild to Moderate	0.008			(21)and Calibration
Mild to Severe	0.00042
Mild to Very Mild	0.0126
Moderate to Mild	0.0069
Moderate to Severe	0.0045
Moderate to Very Mild	0.00041
Severe to Mild	0.000089
Severe to Very Mild	0.00000314
Severe to Moderate	0.0051
Very Mild to Mild	0.0046
Very Mild to Moderate	0.00043
Very Mild to Severe	0.0000099
*Transition Probabilities* *(MS Rehabilitation strategy)*
Mild to Moderate	0.008			(21)and Calibration
Mild to Severe	0.00042			(21)and Calibration
Mild to Very Mild	0.047	±0.0094	Beta	(19)
Moderate to Mild	0.047	±0.0094	Beta	(19)
Moderate to Severe	0.0045			(21) and Calibration
Moderate to Very Mild	0.00041
Severe to Mild	0.000089
Severe to Very Mild	0.00000314
Severe to Moderate	0.04	±0.008	Beta	(19)
Very Mild to Mild	0.0046			(21) and Calibration
Very Mild to Moderate	0.00043
Very Mild to Severe	0.0000099
*Mortality*
Probability of Death (Severe State)	0.00040875		Beta	(22, 23)
Probability of Death (Moderate State)	0.000201375		Beta
Probability of Death (Mild State)	0.00012875		Beta
Probability of Death (Very Mild State)	0.000113625		Beta
*Costs($)*
Monthly cost of care and maintenance and patient absenteeism (Mild State)	11.164	±1.116	Gamma	Survey and Calibration
Monthly cost of care and maintenance and patient absenteeism (Moderate State)	515.364	±51.536	Gamma	Survey and Calibration
Monthly cost of care and maintenance and patient absenteeism (Severe State)	807.454	±80.745	Gamma	Survey and Calibration
*Monthly Outpatient Rehabilitation Cost* (Mild State)	10.191	±1.019	Gamma	Survey and Calibration
*Monthly Outpatient Rehabilitation Cost* (Moderate State)	13.604	±1.36	Gamma	Survey and Calibration
*Monthly Outpatient Rehabilitation Cost* (Severe State)	13.604	±1.36	Gamma	Survey and Calibration
*Monthly Inpatient Rehabilitation Cost* (Mild State)	462.408	±46.241	Gamma	Survey and Calibration
*Monthly Inpatient Rehabilitation Cost* (Moderate State)	520.249	±52.025	Gamma	Survey and Calibration
*Monthly Inpatient Rehabilitation Cost* (Severe State)	520.249	±52.025	Gamma	Survey and Calibration
*Annual* *Utilities*
Severe Health State	0.155	±0.14	Beta	(24)
Moderate Health State	0.385	±0.09	Beta
Mild Health State	0.606	±0.081	Beta
Very Mild Health State	0.81	±0.065	Beta

Economic Evaluation Analysis

The incremental cost-effectiveness ratio (ICER) index was used to analyze and determine the most cost-effective strategy according to the cost and outcome of each strategy. The formula of this index is as follows:

ICER=C₁-C₂/E₁-E₂

In this regard, C represents the cost of strategies 1, 2 and E represents the effectiveness of the strategies. The calculated ICER was compared with the cost-effectiveness threshold and the most cost-effective strategy was determined. It should be noted that in this study, the cost-effectiveness threshold was considered according to the World Health Organization proposal for developing countries as 1-3 times the GDP per capita. According to the World Bank report in 2019, the threshold was considered equivalent to $3114.623 (Iran’s GDP per capita in 2019) (25).

Sensitivity Analysis

Due to the uncertainty about some parameters used in the model, Deterministic Sensitivity Analysis (DSA) and Probabilistic Sensitivity Analysis (PSA) were performed. DSA was performed by changing the Markov time horizon from 5 years to 10 years as scenario analysis. Accordingly, in the new scenario, 120 monthly cycles were considered for the implementation of the Markov model.

The distributions of the uncertain parameters used in the PSA are given in Table 2. In cases where no evidence was found regarding the range of the variable amount, 10 to 20% of the mean of the parameters was considered as the standard deviation, and the appropriate distribution was selected according to the type of variable.

Preparation of preliminary data including cost data and cost calculations of different stages of rehabilitation services in each health state was conducted using Excel 2016 software. Modeling, analysis of base case cost-effectiveness results, as well as all steps of sensitivity analysis was performed using TreeAge software version 2020.

Base Case CEA

Table 2 shows the base case results of CEA over a 5-year time horizon. The average cost of rehabilitation strategy is higher compared to non-rehabilitation strategy, but with higher QALY values. The amount of ICER was equal to $2845.8 per QALY unit, which in comparison with the cost-effectiveness threshold indicated that the rehabilitation strategy was cost-effective (Table 2).

Figure 2 also shows the base case cost-effectiveness analysis, which shows the placement of each of the compared strategies in the plane. As can be seen, the rehabilitation strategy has a higher cost and on the other hand higher effectiveness than the non-rehabilitation strategy.

Table 2: CEA of MS-Rehabilitation vs Non-Rehabilitation

(5-Year Time Horizon)

Strategy	Non- Rehabilitation	MS-Rehabilitation
Cost ($)	26183.589	26322.935
Incremental Cost ($)	-	139.346
Effectiveness	1.328	1.377
Incremental Effectiveness	-	0.049
ICER($/QALY)	-	2845.856

Sensitivity Analysis

DSA

By changing the Markov time horizon from 5 years to 10 years as scenario analysis, the average cost of the rehabilitation strategy was estimated to be lower than the non-rehabilitation strategy. However, the obtained QALY values were also higher than the non-rehabilitation strategy. Thus, in this scenario, the rehabilitation strategy was dominant in terms of cost-effectiveness (Table 3).

Table 3: CEA of MS-Rehabilitation vs Non-Rehabilitation

(10-Year Time Horizon)

Strategy	Non- Rehabilitation	MS-Rehabilitation
Cost ($)	44,420	44,205
Incremental Cost ($)	-	-216.65
Effectiveness	2.442	2.523
Incremental Effectiveness	-	0.081
ICER($/QALY)	-	-2,645

PSA

Considering the distribution function of uncertain parameters, PSA was performed using Monte Carlo Simulation by considering 1000 times of simulation repetition and sampling. Accordingly, the cost-effectiveness acceptability curve was extracted (Figure 3). As can be seen, as the cost-effectiveness threshold increases, the likelihood that the MS rehabilitation strategy will be a cost-effective strategy increases. The probability of cost-effectiveness of the non-rehabilitation strategy is initially higher than rehabilitation, and with increasing the value of the cost-effectiveness threshold, this probability decreases to the point that at the threshold of about $3000, the probability of cost-effectiveness for both strategies was equal.

Figure 4 shows the probability of optimization or in other words the probability of cost-effectiveness of each strategy by considering the cost-effectiveness threshold of $3114.623 and 1000 repetitions of Monte Carlo. Accordingly, as can be seen, the probability of cost-effectiveness of rehabilitation strategy based on several changes in uncertain parameters value and simulations was 51.5% and was higher than the non-rehabilitation strategy.

Figure 5 also shows the incremental cost-effectiveness scatter plot of the rehabilitation strategy versus the non-rehabilitation strategy in the Monte-Carlo simulation. Table 4 also provides a report on the probability of placing the rehabilitation strategy in each of the cost-effectiveness plane quadrants compared to the non-rehabilitation strategy. As can be seen, in 1000 repetitions of sampling of parameters and performing simulations, the probability of cost-effectiveness of the rehabilitation strategy (I, III, and IV quadrants) is equal to 51.5%, which, similar to the above sections, confirms the results of the base case analysis with a good probability but it showed that the model result is relatively sensitive to changing uncertain parameters value.

Table 4: ICE Scatter Plot Report of CEA of MS-Rehabilitation vs Non-Rehabilitation

(5-Year Time Horizon)

COMPONENT	Cost-Effectiveness QUADRANT	INCR EFF	INCR COST	INCR CE	FREQUENCY	PROPORTION
C1	IV	IE>0	IC<0	Superior	137	0.137
C2	I	IE>0	IC>0	ICER<3.0E8	378	0.378
C3	III	IE<0	IC<0	ICER>3.0E8	0	0
C4	I	IE>0	IC>0	ICER>3.0E8	485	0.485
C5	III	IE<0	IC<0	ICER<3.0E8	0	0
C6	II	IE<0	IC>0	Inferior	0	0
Indiff	origin	IE=0	IC=0	0/0	0	0

Based on recent evidence the largest share of the economic burden of MS after medications is allocated to rehabilitation costs with a 19% share of the total medical cost (26). The highest rehabilitation costs were related to groups with more severe disease status, and patients with higher EDSS scores create more economic burden due to the need for outpatient and even inpatient rehabilitation courses (27).

In the present study, a full economic evaluation study was conducted to compare the MS rehabilitation strategy versus non-rehabilitation which was performed under different scenarios. To our knowledge, this study is the first full economic evaluation study of MS multidisciplinary rehabilitation services, and few similar studies in the past have only evaluated rehabilitation services separately.

In general, in both scenarios of the 5-year and 10-year time horizon, the rehabilitation strategy was a cost-effective option. In this regard, with the increase in the number of Markov cycles, it was found that the probability of cost-effectiveness of rehabilitation strategy increased so that considering the time horizon of 10-year, the rehabilitation strategy was a dominant strategy, which means that along with gaining more effectiveness, cost savings were made. In this regard, the results of sensitivity analysis also confirm the base case results with good probability but PSA results showed that the model was relatively sensitive to changes in parameters value.

It should be noted that in this study, due to the lack of sufficient evidence for the stability of the efficacy of rehabilitation services, we considered the time horizon only 5 and 10 years, but as the results showed, if the efficacy of rehabilitation remains for more than 10 years, the probability of cost-effectiveness of rehabilitation strategy is increasing. In fact, with an increasing time horizon, treatment costs do not change (because they all occurred in the first 2 years), but the outcomes gained over time, and therefore the likelihood of cost-effectiveness of rehabilitation strategy increases.

As mentioned, the lack of sufficient evidence for the stability of the efficacy of rehabilitation services was the main limitation in the present study which caused us to reduce the model time horizon. However, the results can change considering different time horizons and stability of rehabilitation effectiveness. Also, The cost of rehabilitation services in this study is calculated based on the national standards for MS rehabilitation and the results of economic evaluation are valid if services are provided on this basis, otherwise, the results of the analysis can be different.

In the present study, we considered multidisciplinary rehabilitation services and extracted the costs and effectiveness of services on this basis. However, separate economic evaluations can be done separately for each rehabilitation service such as physiotherapy, occupational therapy, speech therapy, etc.

In general, the results of this economic evaluation showed that the rehabilitation of MS patients in Iran based on public sector tariffs is cost-effective. Also, by increasing the time horizon, the probability of cost-effectiveness of rehabilitation increases. The results of PSA also confirmed these findings.

MS: Multiple Sclerosis; CEA: Cost-Effectiveness Analysis; INMB: Incremental Net Monetary Benefits; QALY: quality-adjusted life years; ICER: Incremental Cost-Effectiveness Ratio; DSA: Deterministic Sensitivity Analysis; PSA: Probabilistic Sensitivity Analysis

Acknowledgments

Not Applicable

Author contributions:

R,D, M.M, M.S and M.AZ designed the study. A.D, H.H and F.J were in charge of collecting the data. A.D and H.H and F.J took the lead in writing the article. M.M, M.S and M.AZ was in charge of clinical and specialized research sections. A.D and R.D did the modeling and analyses. A.D and R.D and M.S helped with interpreting the outcomes and edition the article. All authors read, edited and approved the ﬁnal article.

Funding

Not applicable

Availability of data and material

All data obtained during this study are included in this article. The datasets used and/or analyzed during the present study are available from the corresponding author on reasonable request.

Ethics approval and consent to participate:

This study was performed in accordance to the standards set and was approved by the ethical committee of the University of Rehabilitation Sciences and Social Health by the code of IR.USWR.REC.1398.004.

Competing interests:

The authors declare no competing interests.

Consent for publication

Not applicable

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No competing interests reported.

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Cost-Effectiveness Analysis of Multiple Sclerosis Rehabilitation in Iran

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