Introduction

The development of medical technologies, both in the area of medical and drug technologies, allows better patient care and a more effective treatment of various diseases which have not had enough therapeutic options so far. At the same time, the public payer in Poland has been asked to cover additional expenses. In the organization of the health care system in Poland, which is financed entirely by the public payer, so-called therapeutic programmes have been introduced, which allow strict spending control, and they are considered to be a temporary stage before adding the drug to the reimbursement drug list. Financing new and expensive technologies in the form of a separate budget, meant for therapies of particular diseases, began in Poland in 2004. The first of such programmes was the rheumatoid joint inflammation program financed in the Silesian Province. In spite of the fact that the programme lasted for 8 years there are no publications which would allow an effective assessment of this form of payment for health care services, which makes one think, that an attempt to make such an assessment is a necessity. In rheumatology, financial settlement of health services in the form of therapeutic programmes was used in rheumatoid joint inflammation treatment with leflunomid and biological drugs (adalimumab, etanercept, infliksimab, rituksimab). The goal of this study was to analyze the health programme used in 2004 in various forms in rheumatology to assess:

1/ if the form of the therapeutic programme allows limiting therapy costs in the observed period of time;

2/ if the form of the therapeutic programme does not have any negative influence on the availability of the therapy and the drug distribution in particular regions of Poland;

3/ the level of the therapeutic programme budget use and regional differences.

Material and methods

Health services are financed by the National Health Fund in Poland (NFZ) on the basis of the Act and Health Ministry Ordinance [1,2,3]. Treating patients within the scope of rheumatological diseases on the therapeutic/drug programme is based on the health services contract on the conditions of hospital health service (so-called hospital contract). The organization, financing, and financial settlement of health services are specified for service contractors in the NFZ CEO fiats [4,5]. The financial settlement is based on an xml announcement specified by the Ministry of Health ordinance, which includes unique patient identification number (PESEL number) and the medical procedure code which was used with the particular patient [6,7]. The reporting has a hierarchical character, which means the code of the signed contract and the code of the medical procedure which was used are reported. The NFZ data has been analysed in terms of: contracts and reporting when it comes to contract realization for therapeutic/drug programmes in rheumatology. Analysis of the data related to the period 2004-2012, in which biological treatment in therapeutic programmes was funded. Different drugs are incorporated into the programme at different times and this is reflected in the description of tables and figures. In the search, SQL query has been used and computer application Business Object in 6.5 version and XI using a filter which is in accordance with the scope code (different for different years), for which contracts have been signed and the code of the medical procedure used (different in reference to various active substances). The data concerning the drug gross costs in particular countries was taken from IMS Health company (1st quarter of 2010). For the correlation analysis r-Pearson correlation factor has been used for the data set “Region population” vs. “Drug costs” and “Region population” vs. “The number of patients” included in the Excel spreadsheet and Statistica 9.0 program. In order to standardize the results concerning patient therapy costs in various European countries the index weights have been calculated according to the formula:

• for prices – the total price for 1mg of particular drugs (where cena=price)

• for the cost of annual therapy – the total price of the therapy with particular drugs (where roczny koszt=annual cost and wart terapii=the cost of the therapy)

The assumption which was made during the research is that a higher index value corresponds with higher patient therapy cost in the country regardless of the drug with which the therapy was conducted. In calculating the cost of the treatment, the treatment regimen defined in the Product Characteristics was used.

Results

The potential population of patients, with the assumption that the epidemiology will be similar to other countries, could account for approx. 60,000 people [8,9]. According to the information reported by the service providers, this is the number of patients who were diagnosed with M05, M06 or M08 (Table 1):

Table 1. Number of patients with diagnoses M05; M06; M08 between 2004-2012

The number of all the patients in 2012 exceeded 80,000 people, but among this number there are people who were diagnosed with the disease and the therapy was not conducted (the diagnosis was then changed in the process). The conducted analyses of drug prices and costs revealed considerable differences, the biggest differences exist in Austria for biological drugs, the lowest in Great Britain (Etanercept), Hungary (Adalimumab, Rituximab) and France (Infliximab).The range of drug costs (the price of 1mg in Euro) between the countries chosen for the analysis is (with the minimal price basis): for Leflunomid approx. 650%; for Etanercept 224%; for Adalimumab 248%; for Rituximab 291%; for Infliximab 268%.

Figure 1. Comparison of 1 ampoule of biological drug in various countries (producer net price in 2009)

The data analysis has confirmed the results of the Kobelt-Kasteng report [10]. The difference in the average cost of treatment of a patient has been observed between Western Europe (12,900 Euro which is 52,995 PLN) and Central-Eastern Europe (3,750 € which is 15,405 PLN). The total cost of the Rheumatoid Joint Inflammation treatment (RZS) in Europe reaches € 25.1 billion (103.1 billion PLN).

Figure 2. The ranking of particular countries according to the drug cost index (1mg, gross, in PLN)

The calculated price index showed absolutely the highest value of drug prices in Austria, Switzerland and Germany ranked second, while the lowest price index occurs in England, Hungary and Poland. A comparison of therapy costs is possible with the use of the calculated price weight index. One can also use weights specified by the cost of one-shot and annual therapy. In the case of one-shot therapy per patient, the weight index of one-shot therapy has been calculated.

Figure 3. The ranking of particular countries according to the one-shot therapy value

The highest cost of one-shot drug therapy is in Austria and Switzerland, the lowest one is in Great Britain and France. Costs of annual therapy with particular drugs depend on the price of the drug, the dosing method and, in the case of Infliximab, the patient’s weight.

Figure 4. The value of the annual therapy of one patient (in PLN) with a particular drug molecule in particular countries

The highest costs of biological treatment per patient are in:

• Austria – adalimumab treatment is the most expenisve one among the analysed countries (over 145,000 PLN for annual therapy);
• Switzerland – adalimumab treatment is over 129,000 PLN for annual treatment;
• Germany – adalimumab treatment is over 12,000 PLN for annual treatment

The following, most costly medical procedures concern the use of etanercept in Austria (over 107,000 PLN), Switzerland (over 106,000 PLN) and Germany (over 96,000 PLN). 

Therapies with individual active substances

The reports on the therapies using etanercept and infliximab in the years 2004-2005 was accounted for in the form of a monthly lump sum, so it is not possible to isolate the individual values. In the scope of the programmes, the population included in them continued to increase in 2010, reaching the number of about 6,000, which represents about 5% of the population in Poland.

Table 2. The number of patients, together with the kind of drug used, treated in rheumatology therapeutic programmes in 2004-2010

An analysis, that takes into account the performance of services with the division into individual active substances, rendered the following results:

Leflunomide - the value of the funds amounted to 14% of the share in the rheumatology-dedicated programmes, the greatest funds - approx. 5.5 million PLN (2005-2005) were paid by the Masovian and Łódź divisions.

Table 3. The value of money spent on leflunomid therapy in particular provinces in 2004-2009

In total, approx. 2,600 patients were treated, the largest number of patients, i.e. approx. 2,000, were treated in the Masovian, Łódź and Lesser Poland divisions and the number of patients was the lowest in the Lubuskie division. 

Table 4. The number of patients who were treated with leflunomid in a particular year and province in 2005-2010

The highest incidence of the disease occurs at the age of 55 and women account for 83% of the patients. The average cost of the treatment amounted to 2,500-3,000 PLN.

Infliximab - the value of the funds spent on the treatment of patients was 47 million PLN (in the years 2006-2010). The highest amount of the funds (11 million PLN) was used in the Masovian Province and the Kuyavian-Pomeranian Province (9.3 million PLN) and it was the lowest in the Lubuskie Province (approx. 0.55 million PLN).

Table 5. The province participation in infliximab treatment budget spending in 2004-2010

The highest number of patients (556 persons) was treated in the Masovian Province (approx. 80 patients per year) and the Kuyavian-Pomeranian Province (419 patients, 26 persons per year). The lowest number of patients was treated in the Opole Province (75 persons in total). 

Table 6. The number of patients treated with infliximab in 2004-2010

The distribution of the number of the patients according to their age indicates the dominance of patients aged 48-57. Women make up 79% of the patients. The average annual cost of the therapy amounted to 18,000-25,000 PLN per patient.

Etanercept - the value of the funds paid to service providers amounted to 166.7 million PLN in the years 2006-2010. The largest amount of the funds was used in the Silesian Province (22.2 million PLN) the Lesser Poland Province (18.9 million PLN) and the Masovian Province (1.1 million PLN) and the lowest was in the Lubuskie Province. 

Table 7. The distribution of money spent on etanercept in 2006-2009

The highest number of patients was treated in the Silesian Province (approx. 200 patients per year, 864 in total) and the Masovian Province (170 patients per year, 815 patients in total).

Table 8. The number of patients treated with etanercept in 2006-2010 in particular provinces

Etanercept is the only biological drug approved for the treatment of children, so there are two predominating groups: children at approx. 15 years of age and adults at the age of 56 years. Female patients dominate both the population of children (70%) and adults (69%). The average annual cost of the therapy amounted to 24,000-32,000 PLN per patient.

Adalimumab - was funded by the therapeutic programme from the end of 2007. At that time, 23.53 million PLN was spent in total for the treatment with this molecule, the largest amount of the funds was used in the Silesian Province (3.6 million PLN, 15.33%), the Masovian Province (3 million PLN, 12.9%) and in the Lesser Poland Province (3 million PLN, 11.65%) and the lowest amount (0.14 million PLN) was spent in the Lubuskie Province. 

Table 9. The value of the money reported as a cost of the adalimumab therapy in particular provinces

The average annual cost of the therapy amounted to approx. 16,000-23,000 PLN per patient.

Table 10. The number of patients treated with adalimumab in 2007-2010

The largest number of patients was treated in the Silesian Province (227 persons), the Masovian Province (162 person) and the number of patients was the lowest in the Lubuskie Province (5). Women predominate among the patients and the predominating age of the patients was 55.

Rituximab - this molecule was the second-line treatment after using previous therapeutic options. Since 2007, 24 million PLN was spent on it, the highest amount of the funds, i.e. 4.3 million PLN was used in the Masovian Province and not much less was used in the Lesser Poland Province (2.9 million PLN) and the lowest share of the funds (0.28 million PLN) was used in the Lubuskie Province.

Table 11. The value of money spent on the rituximab therapy on the therapeutic programmes with the division into provinces

The highest number of patients was treated in the Masovian Province (approx. 50 patients per year), and the Lesser Poland Province ranked second (approx. 30 patients per year, followed by the Silesian Province (111 in total) and the Greater Poland Province (approx. 100 patients).

Table 12. The number of patients treated with rituximab on rheumatology therapeutic programmes in 2007-2010

The average annual number of patients treated with rituximab was approx. 230. There are two peaks in the dominant numbers of patients: the first one at the age of approx. 26 and the other at the age of 58; there are more women among the patients - 83.5%. The average cost of the treatment for one patient is slightly higher than 25,000 PLN. 

Discussion

The prices of the drugs under analysis in Poland fall within the range of the lowest prices in Europe (3-4 rank in this respect), apart from rituximab, which is available at a price close to the average price in Europe. The cheapest is the annual infliximab therapy in patients weighing less than 70 kg. Lower prices of biological drugs in Poland are the results of the adoption of the negotiation system by the National Health Fund and the Ministry of Health that made it possible, during the analyzed period, to cut the prices of drugs, which led to a reduction in the annual cost of treatment per patient. Infliximab is followed by rituximab and etanercept and then adalimumab and the therapy with infliximab in patients weighing over 70 kg is the most expensive. The number of centres conducting the treatment within the therapeutic programme gradually increased in the period under analysis from 34 to 81. The number of centres was correlated with the population of the individual provinces at the correlation coefficient ranging from 0.61 to 0.73. The value of renegotiated therapeutic contracts (which were subsequently performed) increased from 4,964,882 PLN in 2004 to 89,804,313 PLN in 2009, the value of the used budget was lower and amounted from 3.1 mln PLN in 2004 to 75.5 mln PLN in 2009. It amounted to, relatively, 62.5% in 2004 and 84% in 2009 of the budget. The highest expenses per inhabitant were incurred in the Kuyavian-Pomeranian Province and in the Podlasie Province, the expenses were the lowest in the Lubuskie Province and the Pearson correlation coefficient ranged from 0.46 to 0.88 for the individual provinces and substances, indicating similar expenses and physicians’ preferences forced by the programme. The expenditure for therapeutic programmes ranged from 1.18% to 18.53% of the total rheumatology expenditure in various provinces and years. The number of patients treated within the programme increased from 140 in the year 2004 to 5864 in the year 2010. Women accounted for approx. 75-80% of the patients, usually at an age ranging from 50 to 60 (37%). Leflunomide was the most frequently used drug (the largest number of patients in 2009 was 2804), etanercept was the most frequently used biological drug (the largest number of patients in 2010 was 1730), followed by adalimumab (937 patients in 2010), infliximab was used less frequently (739 patients in 2009) and rituximab (401 patients in 2010). Etanercept had the highest reimbursement value (166,739,247 PLN), and the reimbursement value was the lowest for adalimumab (23,560,530 PLN). The unit cost of the therapy incurred by the payer per patient treated since 2008 has remained practically stable and it amounts to 13,500 PLN, despite inflation observed in this period (less than 3,000 PLN for leflunomide, 20,000 PLN for infliximab, 27,000 PLN etanercept, 18,000 PLN for adalimumab and 25,000 PLN for rituximab). 

Summary

As a result of the analysis, it was shown that:

1/ The therapeutic programme kept a stable cost of the therapy over the observed period of time. The organization of the health provision having a clearly defined framework allows the use of high-cost treatments for patients more efficiently and precise definition of the population allows all stakeholders to achieve their goals.

2/ The form of the therapeutic programme did not have any negative influence on the distribution and use of the drugs in individual regions of Poland. In the analyzed period, the number of patient treatment in therapeutic programmes grew steadily.

3/ It has been shown that 90% of the budget dedicated to the programme was used despite differences between regions. In order to achieve efficiency in the use of resources, the contract value must be correlated with the ability of health providers and the population size in the region. Healthcare providers (hospitals) are utilizing the granted resources in the optimal way.