Medical Cost and Healthcare Utilization of Amyotrophic Lateral Sclerosis in China: A Study Based on Hospital Data from 2015 to 2018

doi:10.21203/rs.3.rs-21429/v1

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Medical Cost and Healthcare Utilization of Amyotrophic Lateral Sclerosis in China: A Study Based on Hospital Data from 2015 to 2018

https://doi.org/10.21203/rs.3.rs-21429/v1

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Background: Amyotrophic Lateral Sclerosis (ALS), a specific neurodegenerative disease, imposed increased economic and utilizations burden on the healthcare system, especially with the progress of the diseases severity. However, the economic burden on Chinese ALS patients remained unclear. This study therefore was aimed to investigate medical cost and healthcare utilization for Chinese ALS patients.

Methods: Longitudinal health data of over 20 million individuals, including military personnel and civilians, was collected from all Chinese military hospitals. We identified 480 patients with a first major diagnosis for ALS from 2015 to 2018, while matched 400 controlled patients on age, gender, ethnic group, geographic region, length of stay, year of diagnosis and comorbidity. Their medical cost and healthcare utilizations were then measured 1 year before, and 1 year after ALS diagnosis.

Results: The median annual medical cost of ALS patients was about two-fold higher, 17,087 CNY during the index year than 1 year before, 7,859 CNY. The highest increase in utilizations may account for medical costs on ALS patients, which was represented by hospitalizations (Odd Ratio (OR)=4.26, 95% Confidence Interval (CI) 3.52, 5.15), Electromyography (EMG) (OR=4.14, 95% CI 2.37, 7.22), Nerve Conduction Velocity (NCV) (OR=3.26, 95% CI 2.23, 4.77).

Conclusions: This study is the first one reporting direct economic burden on Chinese ALS patients. Efforts should be made to develop cost-effective diagnostic tools in order that sources of medical cost were more effectively allocated, and this disease was detected earlier.

Health Economics & Outcomes Research

Health Policy

Amyotrophic Lateral Sclerosis

Healthcare Utilization

Medical Big Data

Medical Burden

Neuroepidemiology

Amyotrophic Lateral Sclerosis (ALS), also known as a motor neuron disease or Lou Gehrig's disease, is a specific neurodegenerative disease that progressively causes the death of upper and lower motor neurons controlling voluntary muscles. To our knowledge, ALS is an incurable disease, characterized by stiff muscles, muscle twitching, and gradual worsening of weakness. ALS had a poor prognosis and high mortality with patients died within 3-5 years due to respiratory paralysis [1]. The incidence of ALS was estimated to be 1.9/100,000/year worldwide [2], whereas in China, the annual incidence or prevalence of ALS is lower than developed countries, such as Japan, Europe, or Australia [3].

It is estimated that number of ALS patients will increase 69% from 2015 to 2040 across the world [4]. ALS is relatively rare, yet imposing considerable economic and social burden. A recent study reported that its annual total cost per patient ranged from US$ 13,667 in Denmark to as high as US$ 69,475 in the United States [5]. Another study in the USA found monthly costs per patient increased nine months before diagnosis, peaked at the index month (Medicare: US $10,398; commercial: US $9,354) and decreased but remained high post-index [6]. Diagnosis of ALS is primarily based on the symptoms and signs after ruling out other diseases. In the United States, $10,000 to $20,000 per patient was needed for a neurologist to get a confirmative ALS diagnosis [7]. However, economic burden on Chinese ALS patients has not been reported. Phenotypic differences, like mean age-at-onset or diagnostic delay, were found among German and Chinese ALS patients [8]. In addition, clinical characteristics and outcomes of Chinese patients with sporadic ALS were quite different compared with patients from other countries [9]. These findings may indicate the sources of differences in economic burden between Chinese ALS patients and other groups.

Further, cardiovascular, metabolic or neuropsychiatric comorbidities of ALS, make it difficult to isolate the specific contribution of ALS to medical economic burden[10]. Thus, we aimed to investigate medical cost and healthcare utilization for Chinese patients with ALS in the study where the control group had similar comorbidities, and under the correspondingly the same medical insurance system (Urban Employees (UE), Urban and Rural Residents (URR), Free Medical Care (FMC), and Self-Pay Medical Care (SPMC)). The data set, derived from all military hospitals in China, provided an edge in studying rare disease, like ALS, as it includes over 20 million people, representing a possibly largest scale of Chinese ALS patients of all ages. The estimated medical cost and healthcare utilization will provide insight into offering reasonable amount of financial support for Chinese ALS patients and will improve allocation and efficient use of medical resources.

Data resource

A retrospective analysis was done with medical big data collected from all Chinese military hospitals, which serve not only the military personnel, but also civilians, taking up a significantly high proportion of Chinese health services [11]. Hospitals in this study are mostly located in key cities of provinces. The database includes patients’ demographic information, vital signs, diagnoses of diseases, medical orders, examination reports, lab tests results, drugs, medical supplies or even infections. The present study had analysis performed with historical de-identified data; thus, it was exempt from Institutional Review Board approval.

Study population

Study population comprises patients with a first major diagnosis for ALS by referring to the International Statistical Classification of Diseases, and Related Health Problems (ICD-10) G12.2 (motor neuron disease). We excluded subjects diagnosed with other systemic atrophies including G10 (Huntington's disease), G11 (Hereditary ataxia), G13 (Systemic atrophies primarily affecting central nervous system in diseases classified elsewhere). The Day 1 for hospitalization of ALS patients was defined as the index date.

A total number of 880 inpatients of all military hospitals from 2015 to 2018 were included as subjects by non-probability sampling using structured query language expression of Oracle databases. Records lacking in any primary keys, including hospital information, patient’s identity, and visit times, were excluded. The control groups were set with criteria that patients should have at least one hospitalization visit and no diagnosis code for ALS or other nervous system diseases. The controls were match on age, gender, ethnic group, geographic region, length of stay, year of diagnosis and comorbidity. Figure 1 illustrates the detailed scheme.

Covariates and outcomes of interest

The ALS subjects and controls were matched on these comorbidities to maximize the association of medical cost and health care utilization with ALS. The structures of medical cost, outpatient visits, hospitalizations, emergency department visits, laboratory tests, imaging (Electromyography (EMG), Nerve Conduction Velocity (NCV), Ultrasound, Computed Tomography, and Magnetic Resonance Imaging (MRI)) were selected as outcomes of interest. We measured the outcomes at two time points in reference to the index date: 1 year before, 1 year after.

Statistical analysis

Demographic factors of patients, including gender, age, ethnic group, blood type, marital status, pre-admission conditions, insurance type, and comorbidities were depicted as count. Medical cost was showed as median. We compared outcomes of interest between ALS patients and controls on 1 year before, 1 year after their diagnosis date. Medical cost structure was analyzed based on all details of medical expenses. Healthcare utilization was identified as events and Odd Ratio (OR) (events 1 year after ALS diagnosis/controls/ events 1 year prior to ALS diagnosis/controls). Data were analyzed with SPSS version 24.0, illustrated using GraphPad Prism 6, and Python (version 5.1.0; Anaconda3).

We identified 3,946 people with a first diagnosis of Spinal Muscular Atrophy and Related Syndromes (G12) from 2015 to 2018, of which 3,447 were excluded for lack of medical records 1 year prior to and 1 years after the index diagnosis. The remained 480 people with ALS (G12.2) and 400 non-ALS patients, hitting a total of 880 people (Figure 1) as the study population, were matched by age, gender, ethnic group, geographic region, length of stay, year of diagnosis.

Demographic characteristics

The mean ± S.D. (range) age of ALS patients in our study was 57.37 ± 15.09 (7-92) years old at the index date. Male or female patients accounted for 61.88% or 38.12%, respectively. We depicted demographic factors including gender, age, ethnic group, marital status, pre-admission conditions, blood type (ABO & Rh), insurance type among ALS patients and matched controls (Table 1). Interestingly, in terms of ABO blood type, type-O took the highest proportion, 20.21% in ALS groups, in contrast to a mere 7.00% in control groups. As rare blood types, proportions of Rh negative in ALS patients (10.63%) were far higher than that of the controlled cases (0.50%).

Medical costs in ALS

Within the specific three-character category G12, we compared the number of patients and corresponding medical cost between its subcategories, where G12.2 (motor neuron disease) took the largest proportion of the medical expenses, 12,852 CNY (Fig. 2-A). Further, we carried out an analysis on geographical characteristics of ALS patients via their birthplace codes in county areas in China, which showed that major ALS patients came from Shaanxi (65), Chongqing (44), Hebei (37), Shandong (28), Jiangsu (23), Sichuan (21) (Fig. 2-B). As for medical cost per patient, Guizhou, Guangdong, Henan reported higher medical cost than the rest provinces and regions, with a total of 117,665 CNY, 85,040 CNY, and 69,281 CNY, respectively (Fig. 2-C).

Figure 2D shows the annual total medical costs per patient among ALS patients and controlled patients during peri-diagnosis period (1 year before versus 1 year post). The median cost of ALS patients was about two-fold higher 17,087 CNY (Interquartile Range (IQR) 8,623 CNY - 41,584 CNY), during the index year than 1 year before, 7,859 CNY (IQR 2,477 CNY - 25,703 CNY). We further investigated the annual cost of following medical insurance system UE, URR, FMC or SPMC. Specifically, the median cost of medical care increased highest at SPMC groups, by 3.41-fold during the year following ALS diagnosis, from 7,633 CNY (IQR 2,646 CNY - 19,291 CNY) to 26,083 CNY (IQR 7,232 CNY - 63,241 CNY) the year after diagnosis. The average cost for UE, URR or FMC increased by 2.29, 1.86, or 1,51-fold respectively (Figure 2E). For reference, the annual healthcare cost of non-ALS controls was almost constant between 1 year before (17,676 CNY (IQR 9,518 CNY - 42,856 CNY)) and 1 year post 17,498 CNY (IQR 8,909 CNY - 38,495 CNY) (Figure 2D). We further analyzed the structure of medical cost for ALS patients, where drug cost took up a large proportion of the medical expenses, with median of drug cost climbing from 3,615 CNY (IQR 929 CNY - 10,410 CNY) to 7,709 CNY (IQR 3,098 CNY - 22,207 CNY) during the year after diagnosis. In comparison, the consultation fee increased, about 11-fold, from 305 CNY (IQR 188 CNY - 623 CNY) to 3,400 CNY (IQR 1,700 CNY - 6,600 CNY) (Figure 2F), highest among all the factors.

Healthcare utilization in ALS

On the basis of estimating medical cost, we further determined healthcare utilization parameters at the index date and 1 year before, respectively. Compared with the year prior to the index date, utilization parameters, like hospitalizations, EMG, NCV, MRI, increased markedly during the following year among ALS patients, which were not observed in controlled group. The largest increase in utilization(cumulative events) for ALS patients was hospitalizations, 4.67-fold, followed by EMG, 4-fold, NCV, 2.77-fold. The OR and 95% Confidence Interval (CI) for hospitalizations, EMG, NCV or MRI were 4.26 (3.52, 5.15), 4.14 (2.37, 7.22), 3.26 (2.23, 4.77), or 2.29 (1.77, 2.95) respectively. However, imaging tests and ultrasound showed minimal increase (OR=0.83, 95% CI 0.68, 1.00) (Table 2).

Figure 3 demonstrates the utilization ratio among URR, UE, FMC or SPMC patients with ALS compared with matched controls. Patients experienced large increase of hospitalizations for UE (6.23-fold) and SPMC (6.60-fold) patients, but relatively mild increase for URR (2.84-fold), FMC (2.18-fold) 1 year after ALS diagnosis when compared with 1 year prior to indexed date. As vital ALS diagnosis tools, URR, UE, FMC or SPMC patients with ALS reported 3.29, 5.97, 4.67, or 2.79-fold increase of EMG tests, 4.38, 4.22, 4.00, or 2.72 increase of NCV tests, respectively.

Investigation on the data retrieved from a large military medical database show that medical costs for ALS patients were close to that of the non-ALS control group under similar conditions. However, the total annual cost increased about 2-fold during the ALS diagnosis year, far higher than the controls, among which medical costs during the ALS diagnosis year reached 10,170 CNY, 15,734 CNY, 41,253 CNY, 26,083 CNY with URR, UE, FMC or SPMC, respectively. As major sources of medical costs, drug usage took a high proportion of economic burden for ALS patients. As the healthcare utilization encompassed hospitalizations, laboratory tests, EMG, or NCV test, of its increment may, to some extent, explain the increase of medical costs.

The onset of ALS is insidious and to our knowledge, it’s difficult to get definite diagnosis with single diagnostic tool, therefore physicians always determined the ALS based on symptoms and signs[12]. Differential diagnosis were needed to rule out diseases, such as multifocal motor neuropathy or multiple sclerosis, whose symptoms closely resemble ALS.[13] Compared to the 11 months (range: 6-21) diagnostic delay from ALS onset in a cohort of 260 patients in Italy[14], median diagnostic delay in China was 14 months [9], indicating a relatively high medical costs during outpatient visits or hospitalizations in the extended process for ALS diagnosis indicated.

The mean age or male to female ratio was consistent with previous results. The mean age at onset was 52.4 years at ten ALS centers of Chinese ALS Association from March 1, 2009 to August 31, 2009[15]. The male to female ratio was 1.69:1 among 2101 ALS patients collected in the University Third Hospital, Beijing, China[16]. To our knowledge, practical diagnostic biomarkers in the blood or cerebrospinal fluid has not been developed for the ALS disease[17]. As rare blood type, the proportion of Rh-negative patients in ALS groups were about 20-fold compared with the matched controls. In previous report, no association of specific blood groups was found between ALS and controls[18]. The differences may be derived from the study population, or the study design. Though there is no proper account for this high constituent ratio of type-O or Rh-negative type yet, these findings may contribute potentially to the early detection of ALS in Chinese patients.

As a relatively rare disease, the most cost-effective modality to predict the severity of ALS has not been clearly illustrated. In this study, ALS treatment was examined by referring to existing medical practices, like EMG, NCV or MRI test. To be specific, EMG, as key differential diagnosis tools, was used to detect electrical activity in muscles, identifying loss of lower motor neurons[19]; EMG abnormalities were observed in approximately 40% of asymptomatic limb muscles in 150 Chinese ALS patients[20]. NCV, another diagnostic tool to assess peripheral nerve conduction function, were used to exclude the possibility of peripheral neuropathy or myopathy[21]. The computed tomography and ultrasound tests increased slightly during ALS diagnosis compared with controls, implying that some examinations may have been used unnecessarily. Thus, the medical cost and corresponding utilizations during the first diagnosis of ALS suggested that more efficient tools of screening and assessment were needed.

This study also bridged some gaps in the existing literature. First, until our study, no direct economic burden for Chinese ALS patients from a large medical database was reported. Unlike in USA[22], Ireland[23], and Canada[24], annual medical costs per Chinese ALS patient with four system, URR, UE, FMC or SPMC were far lower than western developed countries, reflecting the gap of economic level. Second, by establishing matched controls with similar conditions as references, we eliminated confounding factors driven by other complications. Third, we retrieved medical record during outpatient visits or hospitalizations before the first ALS diagnosis and made it possible to analyze variances of cost and healthcare utilizations brought by this disease.

This study has some limitations. There may exist population selection bias, for patients with ALS who once visited civilian hospitals, are not captured in this medical database. Besides, economic burden outside hospitals, such as assistive devices or caregiver burden, has not been calculated into the overall medical burden of ALS. Third, we were not able to distinguish among appropriate and excessive use of medical resource because of the inherent limitation of hospital-derived databases.

In summary, this study reported current status of economic burden for Chinese ALS patients. Currently, no effective cures for ALS or treatments were found to stop disease progression. From perspective of medical big data development, efforts should be made to develop cost-effective diagnostic tools so that this disease was detected earlier and economic burden was reduced for each ALS patient.

ALS: Amyotrophic Lateral Sclerosis; OR: Odd Ratio; CI: Confidence Interval; EMG: Electromyography; NCV: Nerve Conduction Velocity; UE: Urban Employees; URR: Urban and Rural Residents; FMC: Free Medical Care; SPMC: Self-Pay Medical Care; ICD: International Statistical Classification of Diseases, and Related Health Problems; MRI: Magnetic Resonance Imaging; IQR: Interquartile Range.

Ethics approval and consent to participate

The present study had analysis performed with historical de-identified data. Given that patients’ privacies have been eliminated before data analyses, Institutional review boards (IRB) Committee of Fourth Military Medical University hereby waived the need of ethical approval of this research. This study was deemed minimal risk by the boards and waiver of consent was also approved.

Consent for publication

Not applicable.

Availability of data and material

The data that support the findings of this study are available from Directorate of Medical Services, Logistics Support Department of PLA, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Directorate of Medical Services, Logistics Support Department of PLA.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was supported by the National Key Research and Development Plan [grant number 2017YFC1307705], PLAGH Medical Big Data and Artificial Intelligence Projects [grant number 2019MBD-059], PLAGH Military Medicine for Young Scholars [grant number QNF19078], National Clinical Research Center for Geriatric Diseases [grant number NCRCG-PLAGH-2019001]. The funders did not have any role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Authors' contributions

HS and WL designed the study. HS collected and analyzed the data and drafted the manuscript. JL collected data and provided expert statistical advice. HS and ZC researched and collected articles. JC provided medical big data support and research advice. All authors were involved in editing of the manuscript, and read and approved the final version.

Acknowledgements

We thank Qing-Yi, Wang for English improving.

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Table 1 Characteristics of ALS Patients and Matched Controls

Categorical	Variables		ALS (n=480)	Controls (n=400)
Gender		Male	297	203
Gender		Female	183	197
Age		<18	1	-
		18-45	81	19
		45-60	169	57
		> 60	229	324
Ethnic group		Han	467	400
Ethnic group		Minority	13	-
Marital status		Married	448	391
		Unmarried	27	1
		Divorced	3	1
		Widowed	2	7
Pre-admission conditions		Normal	443	348
		Urgent	37	49
		Dangerous	-	3
Blood type (ABO)		A	51	35
		B	49	17
		O	97	28
		AB	10	9
		Untested	273	311
Blood type (Rh)		Negative	51	2
		Positive	104	61
		Untested	325	337
Insurance Type		URR	80	17
		UE	215	319
		FMC	77	9
		SPMC	108	55

Table 2 Cumulative events for Patients within Peri-Diagnosis Period

	ALS before	ALS after	Control before		Control after	OR (CI)
n		480			400
Hospitalizations	157	733		1147	1258		4.26 (3.52, 5.15)
Outpatient visits	1444	2273		1715	1552		1.74 (1.58, 1.91)
ED visits	169	392		109	255		0.99 (0.74, 1.32)
Laboratory tests	4025	9973		6934	7604		2.26 (2.15, 2.37)
EMG	97	388		30	29		4.14 (2.37, 7.22)
NCV	113	313		86	73		3.26 (2.23, 4.77)
Ultrasound	368	681		283	635		0.83 (0.68, 1.00)
CT	128	225		134	175		1.35 (0.99, 1.84)
MRI	206	455		205	198		2.29 (1.77, 2.95)

Abbreviation: OR, Odd Ratio; CI, Confidence Interval; ED, Emergency Department, EMG, Electromyography; NCV, Nerve Conduction Velocity; CT, Computed Tomography; MRI, Magnetic Resonance Imaging.

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Medical Cost and Healthcare Utilization of Amyotrophic Lateral Sclerosis in China: A Study Based on Hospital Data from 2015 to 2018

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