Neuromyelitis optica spectrum disorder in Germany: A claims data analysis of incidence,prevalence,treatment patterns,and diagnostic overlap with multiple sclerosis

Abstract

Background

Neuromyelitis optica spectrum disorders (NMOSD) are rare autoimmune diseases of the central nervous system. Global prevalence estimates vary widely, and data for Germany are limited.

Objectives

To estimate NMOSD prevalence, incidence, diagnostic settings, comorbid coding with multiple sclerosis (MS), and treatment patterns in Germany.

Methods

We analyzed German BARMER health insurance claims data (approximately 9 million persons; 2015–2022). NMOSD cases were identified by ICD-10-GM code G36.0. Frequencies, diagnostic settings, comorbid MS coding (G35.-), and treatment patterns (Anatomical Therapeutic Chemical codes) were assessed.

Results

We identified 527 incident NMOSD cases (0.82 per 100,000 insured persons per year); 69% were female, and 42% aged 40–59 years. Most diagnoses occurred in outpatient care (63%), primarily by neurologists (48%) or general practitioners (28%). Prevalence increased from 2.9 to 4.7 per 100,000 between 2015 and 2022, while NMOSD-specific medication use rose from 16% to 31%. NMOSD and MS codes co-occurred in 64% of cases; 49% had concurrent diagnoses within 9 months, and 42% were first diagnosed with MS.

Conclusion

NMOSD prevalence and incidence in Germany are increasing, with frequent diagnostic overlap with MS. Findings highlight the need for improved diagnostic differentiation and early specialist involvement.

Keywords

NMOSD prevalence incidence epidemiology

Introduction

Neuromyelitis optica spectrum disorders (NMOSD) are rare autoimmune diseases characterized by inflammatory demyelination of the optic nerves and spinal cord, often associated with anti-aquaporin-4 antibodies (AQP4).^1,2 Although NMOSD shares certain clinical features with multiple sclerosis (MS), it is now well established as a distinct disease entity with differing immunopathogenesis, treatment response, and disease trajectories.^1,2 However, a diagnostic delay in NMOSD is common, with studies suggesting up to 35% of the patients being misdiagnosed,^3,4 and MS as the most frequent misdiagnosis, with proportions up to 60%.⁴

In recent years, considerable progress has been made in the understanding and management of NMOSD. The refinement of diagnostic criteria, identification of novel biomarkers, and the introduction of targeted immunotherapies such as Eculizumab, Inebilizumab, Satralizumab, and Ravulizumab have markedly improved clinical care and prognosis.^1,5–8 Real-world registry data revealed a shift toward these highly effective and approved drugs in the treatment of patients with NMOSD.⁹ However, most published studies originate from tertiary academic centers or specialized outpatient services, raising concerns about selection bias and limiting the generalizability of findings to the broader NMOSD population.

Understanding the prevalence of NMOSD is critical for estimating its disease burden in a country, planning healthcare resources, and evaluating access to care. Population-based estimates from various countries show a wide range of prevalences worldwide, with approximately 0.7–2.0 per 100,000 individuals in Europe and Australia/New Zealand, 6.9 per 100,000 in North America, 0.9–2.0 in Middle Asia, and between 2.1 and 4.1 per 100,000 in East Asia.^10–12 Due to the low disease frequency, most of these prevalence estimates and treatment patterns rely mainly on clinical disease registries or health insurance data.^10,12–14 These different data sources provide insight into clinical practice, and therefore the reality of medical care, but can introduce heterogeneity into frequency estimates. Among these global data, there is a notable lack of population-based data for Germany, limiting the ability to compare disease burden and conduct health-economic analyses for the broader NMOSD population in a limited central European country.

In Germany, the International Classification of Diseases, 10th revision (ICD-10-GM) is used for medical coding in all healthcare settings. NMOSD is typically recorded under the G36 category, with G36.0 representing the most specific diagnostic code available. There may also be other codes, such as H46 (optic neuritis), as one of the main symptoms. However, there have been no systematic studies on this either.

The aim of this study is threefold: (1) to estimate the prevalence and incidence of NMOSD in Germany based on nationwide health insurance claims data; (2) to examine temporal trends in diagnostic coding and therapeutic prescriptions over 8 years; and (3) to provide insights into real-world treatment patterns outside specialized tertiary care. In doing so, this study seeks to address a critical lack of data in a European NMOSD population and support future efforts in health service planning and disease management.

Methods

We conducted a retrospective, population-based observational study using claims data from a large German health insurance covering the years 2015 to 2022. NMOSD cases were identified via ICD-10-GM code G36.0, and frequencies, diagnostic settings, comorbid coding with MS (G35.-), and treatment patterns (anatomical therapeutic chemical (ATC) codes) were analyzed.

Data source and study sample

Around 90% of the German population, thus about 70 million people, are insured by a statutory health insurance fund. BARMER is one of the largest public insurance companies in Germany with about 9 million persons insured nationwide. This study used reimbursement data from the scientific data warehouse of the BARMER insurance for the years 2015 to 2022.

The used claims data provide information about patients’ inpatient and outpatient care with diagnoses coded according to the ICD-10-GM (10th revision). Inpatient diagnoses are stored with exact dates, information about outpatient health services is saved on a quarterly basis, and they are differentiated by their diagnostic certainty (confirmed/suspected/status post/diagnosis excluded).

Patients with one confirmed ICD-10-GM diagnosis code G36.0 were included in the study population. The NMOSD-specific diagnosis code G36.0 was analyzed between the years 2015 and 2022 for patients who were at least 20 years old. Patients were grouped by age (20–39 years, 40–59 years, and 60+ years). To identify incident diagnoses, patients needed at least two years of continuous insurance without a diagnosis of NMOSD before a first, confirmed (see above) documentation of ICD-10 Code G36.0. The evaluation included the specialist group for the first contact to the healthcare system because of NMOSD. Comorbidities that occurred up to three quarters before and after the initial diagnosis were also subject to the analyses.

Further, we analyzed cases in which a patient had an additional diagnosis of MS (G35.X) within three quarters before or after the quarter of an incident NMOSD diagnosis. Finally, we investigated specific treatments according to the ATC Classifications (https://www.bfarm.de/DE/Kodiersysteme/Klassifikationen/ATC/_node.htm), including Azathioprine (L04AX01), Mycophenolic Acid (L04AA06), Rituximab (L01XC02 + LO1FAO1), Eculizumab (L04AJ01), Sartralizumab (L04AC19), Inebilizumab (L04AG10), Tocilizumab (L04AC07), and Ravulizumab (L04AJ02).

Ethics approval was not sought for the present study since it is not required for non-interventional studies that analyze completely anonymized secondary data sources, such as claims data, according to the local ethics board of the Westphalian Chamber of Physicians.

Informed consent was not sought for the present study since it is not required for non-interventional studies that analyze completely anonymized secondary data sources, such as claims data, according to the German data security regulations (Section 27 Abs.1 BDSG).

Statistical analysis

We performed all analyses within the research environment of the BARMER Scientific Data Warehouse using RStudio (version 4.4.2). Simple descriptive statistics and percentages were applied. Frequencies are extrapolated per 100,000 persons based on the structure of the insured members of the BARMER health insurance, or alternatively stated in percentages.

Results

In the 8-year study period from 2015 to 2022, a total of 780 patients had at least one confirmed ICD-10: G36.0 diagnosis and were included in the analysis (Table 1). The vast majority were women (72%). The annual prevalence increased from 2.9 per 100,000 in 2015 to 4.7 cases among 100,000 insured members in 2022. Among all cases, 527 patients had an incident NMOSD diagnosis within the time period (69% women), which corresponds to an incidence rate of 0.82 per 100,000 persons per year. About one third of all incident NMOSD diagnoses were made during hospitalization (37%) and two thirds (63%) in outpatient settings, that is, practices or hospital-based outpatient services. Incident diagnoses were provided by neurologists in most cases (48%), followed by general practitioners in 28%, and in 8% by ophthalmologists (Table 1).

Table 1.

Total number of neuromyelitis optica spectrum disorders (NMOSD) patients, incident diagnoses, and diagnosis pattern during the years 2015–2022.

	N	%
All NMOSD cases, N (%)	780	100
Women among all cases, N (%)	561	72

All incident NMOSD cases, N (%)	527
Women among all incident cases, N (%)	363	69
Age groups of incident cases
20–39 years (%)		30
40–59 years (%)		42
60+ years (%)		27
Setting of incident NMOSD diagnosis (%)
During hospitalization (%)		37
Outpatient setting (%)		63
Specialist group for incident diagnosis*
Neurologist		48
General practitioner		28
Ophthalmologist		8
Gynecologist		2
Psychotherapist		1
Not mentioned		6

*The difference to 100% is due to the low absolute numbers in other specialist groups.

The diagnoses of NMOSD and MS co-occurred in 339 patients (64%) of the incident cases during the 8-year time period. In this group, these competing diagnoses were made concurrently, defined as within three quarters (9 months), in 49% of the cases (166 out of 339 patients). Interestingly, the frequency of 31% concurrent diagnoses of MS and NMOSD (166 out of 527 patients) decreased from 38% in 2015–2016, via 29% in 2017–2018, to 27% in 2019–2020 and 2021–2022. In additional 42%, however, a sequence with first the MS diagnosis followed by the NMOSD diagnosis more than 9 months later was documented, and in 9% the reverse order (Table 2).

Table 2.

Co-occurrence of NMOSD and MS diagnoses in prevalent cases during the study period 2015–2022.

	N	%
All incident NMOSD cases	527	100
Cases with NMOSD plus MS Diagnosis	339	64/100
Diagnoses concurrent within 9 months	166	49
Diagnosis sequence: NMOSD→MS	30	9
Diagnosis sequence: MS→NMOSD	142	42

NMOSD: neuromyelitis optica spectrum disorders; MS: multiple sclerosis.

The diagnoses are categorized as concurrent if they occurred within 9 months.

Depending on the year within the study period of 2015 to 2022, 16% to 31% of all NMOSD patients received an NMOSD-related medication (Table 3). First, Azathioprine (L04AX01) was the most frequent treatment between 2015 and 2018. But from 2019 to the end of the study period in 2022, the most common prescribed medication was Rituximab (L01XC02 and L01FA01).

Table 3.

Proportion of patients with specific NMOSD-treatment (patients per 100,000) among all members of the BARMER health insurance and percentage among those with a prevalent NMOSD diagnosis.

Year	NMOSD patients per 100,000	NMOSD patients with NMOSD-specific ATC code per 100,000	Proportion treated among NMOSD cases
2015	2.90	0.57	20%
2016	3.46	0.57	16%
2017	3.66	0.80	22%
2018	3.76	0.93	25%
2019	4.25	0.93	22%
2020	4.35	1.14	26%
2021	4.57	1.17	26%
2022	4.71	1.44	31%

NMOSD: neuromyelitis optica spectrum disorders; ATC: anatomical therapeutic chemical.

In Table 4, the frequent comorbidities among the NMOSD patients are shown in descending order. MS is the most frequent one, documented in one third of the cases, followed by Neuritis nervi optici and essential hypertension. We included diagnoses that were made in the quarter of the year when the initial NMOSD diagnosis was made, or within a time frame of 9 months (three quarters) before or after that quarter. Prior to their initial NMOSD diagnosis, 21% of the patients also received a diagnosis of optic neuritis or encephalitis, myelitis, and encephalomyelitis. In this group, 19% received this diagnosis in the same quarter and 4% after their initial NMOSD diagnosis. Patients with an incident NMOSD who also had an MS diagnosis plus an optic neuritis or encephalitis (142 patients) received the diagnosis of MS in 23% of the cases before the optic neuritis or encephalitis, 49% had the diagnoses in the same quarter, and 28% received the MS diagnosis after the diagnosis of optic neuritis or encephalitis.

Table 4.

The 10 most common comorbidities among all prevalent NMOSD cases.

Comorbidity	Frequency (%)
Multiple sclerosis, unspecified	33%
Neuritis nervi optici	25%
Essential hypertension, unspecified without indication of hypertensive urgency	23%
Encephalitis, myelitis, and encephalomyelitis, unspecified	23%
Astigmatism	21%
Benign essential hypertension, without indication of hypertensive urgency	19%
Other special examinations and investigations of persons without symptoms or reported diagnosis	19%
Special screening examination for infectious and parasitic diseases	18%
Relapsing-remitting multiple sclerosis, with no mention of acute flare or progression	17%
Special screening examination for SARS-CoV-2	15%

NMOSD: neuromyelitis optica spectrum disorders; SARS-CoV-2: severe acute respiratory syndrome-coronavirus-2.

Discussion

Our study provides novel insights into trends of NMOSD diagnoses in Germany, revealing an increasing prevalence between 2015 and 2022. Our findings highlight a considerable diagnostic overlap with MS, as well as a notably low frequency of pharmacological treatment among cases.

In this health insurance database, the prevalence of NMOSD in Germany almost doubled between 2015 and 2022. This is comparable to prevalences in several other countries, but higher compared to other European studies.^10,12,15 The rising trend across the eight-year observation time is of particular interest, since a similar increase in NMOSD prevalence has been demonstrated in the US.^11,16 The underlying factors contributing to this increase remain uncertain. Possible explanations include improved disease recognition and a broader dissemination and use of diagnostic criteria among the respective physicians and specialist groups. Further, better access to and more frequent neuroimmunological services are infrastructural explanations. But a genuine increase in the disease incidence is also possible. Prior data comparing the 2006 and 2015 diagnostic criteria in a cohort of 176 patients revealed an increase in the diagnosis of 76%,¹⁷ suggesting that the prevalence increase observed in our study might, in part, be due to more sensitive diagnostic criteria. Another important topic related to the prevalence is differences by sex and race. With our data source, we are not able to differentiate between different races, but confirmed the female predominance.^1,10,12 Furthermore, this study was able to delineate incidences from prevalences, which remain sparsely reported in prior studies. Within the analyzed timespan, 0.82 out of 100,000 persons per year had a first NMOSD diagnosis, with a peak in the age group 40–59 years, confirming the slightly older peak age of onset compared to MS.^1,12 Strikingly, 63% of initial diagnoses were documented in outpatient settings, and only 48% were made by neurologists as the specialist group. This suggests that a significant proportion of NMOSD diagnoses are being made outside of specialized neurological or ophthalmological services. In a recent study in a Canadian cohort, hospitalization for the first relapse was associated with a shorter time to diagnosis in NMOSD.¹⁸ We were not able to address this finding, but our results also reflect potential diagnostic delays or misclassifications in early stages of the disease. The limited role of neurologists in establishing diagnoses raises concerns about the level of clinical expertise available to non-specialists and underscores the importance of improving awareness and referral pathways, especially as a longer time to see a neuroimmunology specialist is associated not only with delayed, but also with misdiagnosis in NMOSD.³

A particularly salient finding in our cohort is the high degree of diagnostic overlap between NMOSD and MS. In 339 out of 527 incident patients, a diagnostic sequence involving both MS and NMOSD was documented. This substantial proportion highlights the persistent challenges in distinguishing NMOSD from MS, especially in early or antibody-negative presentations,⁴ although more recent literature attempts to differentiate specific features.¹⁹ The slight decrease in concomitant diagnoses from 2015–2016 to 2021–2022 also confirms previous findings.²⁰ Such overlap likely reflects both the similarities in symptomatology and potential diagnostic uncertainties in clinical practice. It is well recognized that MS and NMOSD differ significantly in pathophysiology, treatment response, and prognosis.^1,21 Therefore, misclassification may result in substantial clinical consequences, particularly regarding treatment efficacy and safety.

Another unexpected observation in this study was the low proportion of NMOSD patients receiving any immunosuppressive treatments. Treatment proportions ranged from 16% in 2016 to 31% in 2022. These small and variable numbers hinder meaningful statistical comparisons and suggest that a substantial proportion of patients are either untreated or potentially undertreated. Among those with medication, the main usage of Rituximab and Azathioprine is confirmed by a very recent overview on real-world treatment of NMOSD in Germany.^9,13 Nevertheless, the overall low treatment proportion is a concern, especially given the availability of targeted biological agents. Of particular note is the widespread absence of therapies such as Eculizumab,²² Sartralizumab,²³ Inebilizumab,²⁴ and Ravulizumab²⁵ in our database, especially as all of them have been approved by the European Medical Agency for AQP4-positive NMOSD cases between 2019 and 2022, with long-term data confirming their efficacy.^26,27 These discrepancies suggest a significant delay before recommended treatment guidelines come into real-world practice. One possible explanation is that advanced NMOSD care is provided mainly in specialized centers. Patients managed in peripheral or generalist settings may not receive the same level of diagnostic or therapeutic expertise. These findings emphasize the importance of centralized care models in rare diseases and raise questions about access barriers and the dissemination of guideline-concordant care that enunciate treatment recommendations,⁸ in particular, to reduce the high socioeconomic costs of untreated patients.^28,29

With regard to comorbidities, beyond the anticipated associations with MS or optic neuritis, which might also represent the description and assessment of the initial symptoms, our dataset identified essential hypertension and astigmatism as the most common concurrent diagnoses. These results are in line with previous findings from other German health insurance datasets in NMOSD patients.¹³ While the presence of hypertension may reflect the older age at onset and chronic disease burden, the frequency of astigmatism likely correlates with visual pathway involvement inherent in NMOSD pathology. These comorbidity patterns may influence overall disease management and highlight the need for integrated care approaches. Furthermore, recent publications have shown that comorbidities are also associated with disabilities, underscoring the need for appropriate comorbidity management.^30,31

Several limitations of the present study must be acknowledged. The most significant constraint relates to the use of claims data, which is designed primarily for administrative and billing purposes, rather than for clinical research. As such, granular clinical data, including results from AQP4 antibody testing, cerebrospinal fluid analysis, or magnetic resonance imaging findings, were not available. The absence of specific billing codes for diagnostic procedures such as AQP4 testing also limits our ability to validate diagnoses or stratify patients by serostatus. Additionally, the ICD-10 code G36.0, which was used to identify NMOSD patients, encompasses a broad spectrum of disorders, including AQP4-positive, AQP4-negative, and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) cases. This taxonomic limitation reduces diagnostic specificity and may have introduced heterogeneity into our cases. It is noteworthy that in 2023, the ICD-10 code G37.81 was introduced specifically for MOGAD, allowing future research to more accurately distinguish between these clinically overlapping yet distinct entities.^1,21 This lack of distinguishability may also have an impact on sex distribution, particularly since this differs between neuromyelitis optica and MOGAD. This, together with the lack of clear assignability with regard to the increase in migration to Germany, further weakens the generalizability of the results. Another limitation is the inability to verify diagnostic accuracy or account for cases with revised diagnoses. Despite these drawbacks, claims data remain the only viable source for systematic nationwide analyses in Germany, given the low disease frequency and a lack of centralized clinical registries. Furthermore, sociodemographic clinical characteristics of members may vary between insurance companies; thus, no single company is representative for all statutory health insurances. Several other publications have been performed in the BARMER cohort, illustrating its generalizability.^32,33

Conclusion

Our study documents an increasing prevalence of NMOSD patients in Germany, significant diagnostic overlap with MS, and a low use of disease-modifying treatments. These findings underscore the need for enhanced awareness, diagnostic precision, and broader implementation of evidence-based therapies, particularly in non-specialist settings. Future research should focus on integrating clinical data sources, improving disease coding specificity, and addressing healthcare disparities in NMOSD management.

Footnotes

Data availability statement

The data used in this study are derived from German health insurance claims and contain individual-level patient information. Due to data protection regulations and confidentiality requirements, these datasets are not publicly available. Access to anonymized data was granted to the authors under a specific research agreement. Data were used under license for this study and cannot be shared or redistributed. Researchers may apply for access to similar data directly from the respective sickness fund, subject to legal and ethical approval.

Declaration of conflicting interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MG received honoraria or speaking fees from Bayer, Biogen, BMS, JJ, Merck, Novartis, Roche, Sanofi, and Teva. MG received research honoraria from the BMBF, DFG, Merck, and Novartis. KN and KB have nothing to declare. UM is an employee of the Barmer Health Insurance.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Matthias Grothe

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