INTRODUCTION
Parkinson’s disease (PD) is a complex neurodegenerative disease, and persons with PD present with motor and nonmotor symptoms [
1]. Although in the early stages of PD, motor symptoms can often be effectively managed with relatively affordable oral pharmacotherapy, in advanced stages, this treatment becomes more complex and costly. As the disease progresses, the therapeutic window for oral dopaminergic treatment narrows, and areas that are nondopaminergic in nature become more involved, with some symptoms responding poorly to dopaminergic pharmacotherapy [
2,
3]. One possible strategy is to optimize oral pharmacotherapy through dose fractioning, but it is widely believed that a form of therapy with more continuous dopaminergic or nondopamingeric stimulation is a better alternative [
4].
There are currently three types of device-aided therapies (DAT) available, namely, deep brain stimulation (DBS), intraduodenal levodopa pump therapy (LCIG), and apomorphine pump therapy (CSAI). Once the criteria for initiation are met, it is crucial to carefully consider the timing of implementation [
5]. This shift from oral medication to continuous dopaminergic stimulation [
4] has beneficial effects on both motor and nonmotor symptoms and therefore improves quality of life [
6]. Given the latter, as well as the cost-effectiveness of most DATs [
6] and the reduction in caregiver burden [
7], knowledge about the accessibility of DAT is crucial to provide equal opportunities to all people with PD and maintain quality of life.
Data on the accessibility of DAT, however, are lacking and are likely to be needed to further optimize their use. Therefore, we aimed to analyze the use of DAT and its accessibility in Poland.
MATERIALS & METHODS
We obtained the number of persons with PD (International Classification of Diseases 10th Revision [ICD-10] code G20) from the National Health Fund (NHF) database in Poland [
8]. People who underwent DBS were identified using code A04 (5.06.00.0001413). In Poland, pump therapies are exclusively available through the NHF’s drug program, which is limited to specific centers. Approval from a central authority is needed for eligible patients, but centers use a separate NHF reporting system, causing delays in the submission of data to the central registry. To address this, we relied on company-provided data, which are considered more reliable and are based on drug requisition records, from Ever Pharma and AbbVie, who provide CSAI and LCIG, respectively, in Poland. None of these companies were involved in data collection or interpretation.
We extracted data from the NHF database, including the year of reporting, the total number of people with ICD-10 code G20 for each year and per region, sex-specific breakdowns, the population size, and the number of individuals on specific DAT. The number of registered neurologists was obtained from the Polish Chamber of Physicians and Dentists (
https://nil.org.pl), but data on movement disorder neurologists at regional levels were not available.
We calculated the ratio of DAT to neurologists in different regions of Poland to gauge the distribution of this therapy. This indicator was chosen because it has been previously suggested that the number of neurologists could be a factor of influence in relation to awareness and access of persons with Parkinson’s disease for DAT [
7]. Additionally, to better understand regional differences in accessibility to DATs, we correlated the number of people with PD on DATs per neurologist considering the percentage of people with PD who completed higher education [
9] and average annual income [
9].
Data were summarized descriptively and are presented as the mean ± standard deviation or number (percentage), unless otherwise specified. Group comparisons were performed by using the Kruskal–Wallis test, and correlations were performed through Spearman’s rank sum test with Bonferroni correction for multiple testing. All analyses were performed using IBM SPSS Statistics for Windows, version 27.0 (IBM Corp., Armonk, NY, USA).
RESULTS
The use of DAT over the 2015–2021 period is summarized in
Figure 1, showing increased availability of these therapies in Poland across this period. In 2021, the number of persons with PD on DAT was 257, which represents 0.56% of the total number of persons with PD in Poland.
Although overall, there were no differences in the number of persons with PD per neurologist or the number of persons with PD on DAT per neurologist across regions (
p = 0.451 for both), post hoc analyses revealed that, in 2021, both the Podlaskie and Subcarpathia regions had significantly fewer persons with PD on DAT (per neurologist) compared to the Pomorskie and West Pomerania regions, which had the highest number of patients, (
p ≤ 0.037) (
Supplementary Table 1 in the online-only Data Supplement). In addition, we noted regional differences in the use of the specific type of DAT; in the Łódź region, DBS was the preferred DAT method (the ratio of use between CSAI, LCIG, and DBS was 1:1.5:10.5), whereas in the Lower Silesia region, both LCIG and DBS were preferred over CSAI (ratio of 1:11:8.5). The regions where the use of DAT was most evenly spread across the available options were the Pomorskie (ratio of 1:1.9:0.8) and Silesia regions (ratio of 1:3.8:3.5) (
Figure 2).
Finally, we performed univariate analyses between the number of persons with PD on DATs per neurologist and education and average annual income levels per person with PD. These analyses showed a strong positive association between annual income and the number of persons with PD on DATs per neurologist in 2021 (
r = 0.799;
p < 0.001) (
Supplementary Figure 1 in the online-only Data Supplement) but not in 2019 (
r = -0.451;
p = 0.08) or for any of the years or the percentage of people who had completed higher education (
p ≥ 0.053).
DISCUSSION
Our results show that DAT were increasingly used in Poland during 2015–2021, showing a preference for DBS as DAT of first choice but also a steady increase in the use of CSAI and LCIG. This was also observed at a regional level, although regional differences in the proportion of use of each type of DAT were observed, similar to regional differences in other countries [
10]. Part of this regional variation might be related to annual income, with regions where the annual income is higher performing more DAT procedures.
Although we observed a steady increase in the number of people with PD for whom DAT was initiated, currently, less than 1% of persons with PD in Poland are on DAT, considerably less than in other countries [
11-
13]. It is estimated that 15%–30% of persons with PD should ultimately receive a form of DAT [
14], but several factors can influence the actual number of people receiving DAT, which could be a reflection of conservative patterns of healthcare practices [
15]. Alternatively, it might be argued that these low numbers reflect the lack of awareness and education regarding DAT in people with PD [
16]. People with PD should ideally be given insight and access to all different modalities using a shared decision process [
17,
18].
According to newly proposed guidelines on DATs, DBS could be recommended at a relatively early stage of PD, as soon as fluctuations are present, as this intervention can significantly improve quality of life and reduce fluctuations [
19]. However, timely intervention may be hampered by waiting lists; nonetheless, data from 2023 showed that 19 out of 23 centers in Poland offer DBS within 1–7 weeks, three centers offer DBS within 7 to 12 months, and only one center offers DBS within 3 years [
20]. Infusion therapies, on the other hand, are less widespread in Poland; in 2017, only two centers offered infusion therapies, increasing to nine in 2018, and 17 centers currently offer these therapies [
20]. In view of the cost-effectiveness of DAT therapies [
10], this is an encouraging development, especially taking into account the recommended use of DAT [
14].
The barriers to and the possible reasons for underutilization of DAT in Poland remain unclear, but it can be speculated that several factors may be involved: 1) the relatively high initial costs of DAT [
6]; 2) the limited availability of DATs; 3) the relatively low number of specialized movement disorder neurologists [
10]; 4) a conservative approach to PD treatment in general [
15]; 5) the low number of referrals by general neurologists and general practitioners due to limited knowledge about DAT [
21,
22]; and 6) limited knowledge about DAT among persons with PD [
23].
While using a national registry helps minimize selection bias, there are still some limitations to consider. In the case of the NHF, patients who received fully covered procedures through private health insurance were not included, potentially causing an underestimation of the number of persons with PD on DAT in Poland. Regional variations can be influenced by specific centers’ preferences for DAT, driven by personal experiences. Patient choices of centers, possibly outside their local area, could also impact regional data, but we had no access to these data. Additionally, limitations in available databases, such as missing data on disease duration, severity, and the number of movement disorder neurologists per region, may have constrained the interpretation of our findings.
In summary, we highlighted the increasing role of DATs in the treatment of persons with PD and demonstrated the increasing use of this treatment modality in Poland. Further efforts should be undertaken to optimize the care for persons with PD in Poland, including promoting more widespread use of DAT and addressing current barriers for their use.
Notes
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Ethics Statement
Because this work was based on anonymized data from National Health Fund in Poland database, no approval from an institutional review board was necessary. Similarly, informed patient consent was not necessary for this work. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.
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Availability of Data and Material
The data supporting the findings of this study are available within the article and/or its supplementary material.
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Conflicts of Interest
KS has received a travel grant and speaker fees from AbbVie. TP no relevant financial disclosures. KRC has received funding from Parkinson’s UK, NIHR, UCB, and the European Union; he received honoraria from UCB, Abbott, Britannia, US Worldmeds, and Otsuka Pharmaceuticals; and acted as a consultant for AbbVie, UCB, and Britannia. BRB is co-Editor in Chief for the Journal of Parkinson’s Disease. He is on the editorial board of Practical Neurology and Digital Biomarkers, has received honoraria from being on the scientific advisory board for AbbVie, Biogen, and UCB, has received fees for speaking at conferences from AbbVie, Zambon, Roche, GE Healthcare, and Bial, and has received research support from the Netherlands Organization for Scientific Research, the Michael J Fox Foundation, UCB, Not Impossible, the Hersenstichting Nederland, the Parkinson’s Foundation, Verily Life Sciences, Horizon 2020, and the Parkinson Vereniging (all paid to the institute). DvW has received a travel grant and speaker fees from Bial, as well as speaker fees from Britannia Pharmaceuticals, and is supported by a research grant from CHDI.
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Funding Statement
None
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Author Contributions
Conceptualization: Katarzyna Smilowska, Daniel J. van Wamelen. Formal analysis: Katarzyna Smilowska, Daniel J. van Wamelen. Investigation: Katarzyna Smilowska, Daniel J. van Wamelen. Methodology: Katarzyna Smilowska, Daniel J. van Wamelen. Project administration: Katarzyna Smilowska, Daniel J. van Wamelen. Resources: Katarzyna Smilowska, Daniel J. van Wamelen, Tomasz Pietrzykowski. Software: Daniel J. van Wamelen. Supervision: Daniel J. van Wamelen, Tomasz Pietrzykowski, K. Ray Chaudhuri, Bastiaan R. Bloem. Visualization: Katarzyna Smilowska, Daniel J. van Wamelen, Bastiaan R. Bloem. Writing—original draft: Katarzyna Smilowska, Daniel J. van Wamelen. Writing—review & editing: Tomasz Pietrzykowski, K. Ray Chaudhuri, Bastiaan R. Bloem.