Chorobowość i koszty bezpośrednie terapii stwardnienia rozsianego w Polsce w latach 2008–2016

Introduction

Multiple sclerosis (MS) is a chronic and highly disabling disease with heavy economic and social burdens [1–5]. A systematic review of the literature indicated that the mean utility scores varied between 0.80–0.92, 0.49–0.71, 0.39–0.54, and –0.19–0.1, for patients with Expanded Disability Status Scale (EDSS) scores of 0–1, 3, 6, and 8, respectively [6]. A negative value of health utility indicates that some patients with the highest disability defined their health state as worse than death. Treatments that delay disability progression can make positive impact on patients’ quality of life.
In the recent years, significant progress has been made in Poland in the treatment of patients with MS. In 2011, the interferon therapy fully reimbursed by National Health Fund (NHF) as a drug program was extended from three to five years and in 2014, the duration of treatment was dependent on the clinical status of patients. In 2013, a drug program was introduced that allowed the use of a second-line disease-modifying drugs. Now in Poland, the following medications for moderately and highly active form of SM are reimbursed: interferon -1, interferon -2, peginterferon -1a, glatiramer, teriflunomide, fingolimod, dimethyl fumarate, natalizumab, and alemtuzumab.
To assess the state of health care and actual needs in the area of MS treatment in Poland, accurate and up-to-date estimates of the number of people affected by MS as well as the analysis of the organization and costs of each element of MS health care are required. Due to the lack of a nationwide registry of patients with MS, reliable data on MS epidemiology and costs can be obtained from the NHF database, which collects information on the health care services in conjunction with the patient’s ID and the code identifying the reason for intervention. The aim of our study was to analyze MS morbidity as well as components of a comprehensive treatment plan for MS patients in the years 2008–2016, based on information on the utilization of health care services reported to the public payer.

Material and methods

All types of healthcare services covered by public payer (NHF) in Poland in years 2009–2016 were retrospectively analyzed. From information reported to the NHF through the xml announcement [7] after performing medical procedures, only data linked to patients with MS (ICD-10: G35) were extracted. Based on the number of unique patient ID’s (PESEL) diagnosed with SM (ICD10: G35), the annual and nine-year morbidity was estimated. We calculated the percentage proportion of patients “consuming” different categories of services (e.g. hospitalization, specialized care, primary care, rehabilitation, emergency, long-term care, psychiatric care, nursing care, transport) during the 9-year period. Direct costs were calculated from the public payer perspective and reported in EuroPPP (adjusted for purchasing power parity, Table 1), which enabled omitting the values of inflation and exchange rate variations in the analysis. Mean cost per patient resulted from the total cost divided by the number of patients. Annual growth rates of the number of patients and costs were calculated. The results were presented in absolute numbers, frequency (in %) and graphically. The Pearson’s correlation was used to test the association between the number of patients treated and costs. All calculations were performed using SAS EG 7.1 and MS Office 2016 software.

Results

The number of patients with MS in years 2008–2016 is presented in Table 2. During the analyzed period, there was 10.6% increase in the number of MS patients, and the dynamic of growth (year/year) was around +1.3%. In 2009, after complementary registration, the number of patients stabilized at 43.5 thousand with SD ± 3.4% in the period 2010–2016. The prevalence calculated based on the NHF data was 103,06 and 113,06 per 100,000 population in 2008 and 2016, respectively.
The public payer’s spending on the treatment of MS during the 9-year period amounted to 1,794 million EuroPPP. The expenditures have steadily grown annually by an average of 14% (Table 2). The average spending per patient increased from 2,762 EuroPPP in 2008 to 6,902 EuroPPP in 2016 (+149.9%). The Pearson’s correlation of 0.63 showed that strong positive correlation exists between the number of patients and the amounts spent on treatment of MS.
Figure 1 shows the percentage proportion of patients “consuming” each specific category of services during the 9-year period. The largest group of patients was treated in the out-patient setting: specialized (36%), primary care (29.3%), and 18.4% of patients were hospitalized.
In terms of costs, the main item was hospitalization (84.2% of costs), followed by rehabilitation (6.8% of costs), and nursing care (5.5% of costs). For specialized ambulatory care, the NHF spent only 2.3% of total MS budget (Figure 2).
Between 2008 and 2016, the number of hospitalized patients increases by 52.5% (by 5.4% annually), from 11,183 to 17,051, while NHF spending for hospitalizations has risen by 203.7% (by 15.5% annually), from 87,375,624 EuroPPP to 265,327,760 EuroPPP (Table 3). The mean yearly cost of in-patient care per patient was in 2016 two times higher than in 2008: 15,561 EuroPPP vs. 7,813 EuroPPP, and mean annual growth rate was 9.3%.
A separate path within in-patient care are therapeutic programs covered by the public payer. The number of patients who benefit from these therapies have steadily grown from under 3,000 (25.4% of hospitalized patients) in 2008 to over 10,000 (63% of hospitalized patients) in 2016 (Table 4). Utilization of disease modifying therapies was the main driver of costs reaching 80–90% of total NHF expenditure for hospitalizations associated with MS. For the implementation of MS drug programs throughout the analyzed period, NHF spent in total 1,222 mln EuroPPP, which constitutes 68% of the total budget on MS. Both the number of patients treated and the spending on therapeutic/drug programs indicate positive periodic dynamic rate (+277.8% and +295.4%, respectively) and an average annual rate (+18.2% and +19.3%, respectively) and are strongly positively correlated (Pearson’s correlation coefficient = 0.99547). The mean cost per patient remained at similar level: 20,814 in 2008 and 21,786 in 2016.

Discussion

Our study revealed that over the past 9 years, public payer’s annual expenditures on the treatment of MS patients were continuously rising. The average spending per patient increased by 150%, from 2,762 EuroPPP in 2008 to 6,902 EuroPPP in 2016. Although the largest group of patients was treated in out-patient settings (36% specialized, 29.3% primary care), 84% of funds was allocated to the in-patient care. Such a breakdown of expenses is because the drug programs are funded through hospital procedures. Therapeutic/drug programs were the main drivers for both the total MS expenditures and hospital cost, accounting for 68% and 80–90%, respectively. Although according to the data published by the European MS Platform [8], the percentage of Polish MS patients who receive the disease modifying therapy still belongs within the lowest in Europe, the situation of Polish MS patients is steadily improving. Currently, 25% of the MS population has access to publicly funded drug programs, three times more than 9 years back.
Expenditures on the rehabilitation treatment were relatively low (6.8% of total spending) and a low percentage of people received such benefits (12.5%). This is probably due to the lack of reliable evidence on the effectiveness of rehabilitation treatments for MS [9, 10], although many clinicians and patients consider that the comprehensive individualized rehabilitation improves patients’ quality of life [11].
The strength of our study is that it is based on the data from the entire Polish population and includes a long, 9-year time horizon. Unfortunately, the scope of data collected routinely by the public payer was limited and did not allow to conduct a distinction between types of MS as well as individual stages of disease progression. Like other administrative database-based studies, it does not contain information about patients’ clinical state, making it impossible to directly assess the impact of the use of various therapies on health outcomes. Since the analyzed data only relate to the public payer’s spending, our study does not include out-of-pocket costs (expenses that aren’t reimbursed by insurance) and indirect costs. Despite these limitations, the results of our research provide useful information on the number of patients with MS and the organization of their treatment in Poland, and may also serve as a basis for planning further actions to improve the care of patients with MS.

Conflict of interest

The authors declare no conflict of interest.

References

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Address for correspondence:

Andrzej Śliwczyński, PhD
Division of Quality Services, Procedures and Medical Standards
Medical University in Lodz
Pl. Gen. J. Hallera 1
90-647 Łódź, Poland
phone: +48 42 272 50 25, 42 272 50 26
fax: +48 42 639 32 82