The dynamics of the breakthrough in Eastern Europe: the Polish experience
These events include unique historical circumstances such as the emergence of the "globalist" faction in Mosow, with its new, world-system perception of crisis, and the discovery of the round-table technique as a productive ritual of communication, imitated all over Eastern Europe. After describing the development, collapse, and reorganization of a "new center" in Poland in , she discusses the first attempt at privatizing the economy.
Her analysis of the dilemmas accompanying breakthrough and transition is an invaluable guide to the challenges that face both capitalism and democracy in Eastern Europe. Chester A.
About the Author
Kisiel is a professional translator living in Warsaw. In all countries, except Bulgaria and Latvia which did not provide specific information, biosimilars belong to a homogenous group of drugs. In Estonia, the homogenous group is made with a transitional period of 3 months. Internal reference pricing was used in all countries, except Latvia for which this particular data is not available. We analyzed the reimbursement status of selected biologic drugs for which biosimilars are available, separately for each country, and indication.
The level of reimbursement the percentage of the drug price covered by public payer per drug and country is shown in Table 3. The biologic drugs were reimbursed in the majority of cases in all countries: filgrastim for neutropenia or febrile neutropenia; etanercept for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis; infliximab for all approved indications except plaque psoriasis in Latvia ; insulin glargine for diabetes mellitus; and somatropin for growth disturbance or growth hormone deficiency. Epoetin alfa and epoetin zeta was not reimbursed in Estonia, while in each other country epoetin alfa or zeta was financed from public funds in at least one indication no data for Lithuania.
Etanercept was not reimbursed in Latvia in the treatment of axial spondyloarthritis and plaque psoriasis. Enoxaparin for thromboembolic disorders of venous origin was reimbursed in all countries except Lithuania. Follatropin alfa and teriparatide are reimbursed in majority of countries—only in Romania follitropin alfa was not financed from public funds, and teriparatide was not reimbursed in Estonia and Poland no data for Lithuania. In Slovakia selected insulin glargine, somatropin, and enoxaparin products were fully reimbursed, and for the remaining products patients had to pay from On average, Romania and Bulgaria were excluded from this analysis owing to lack of information on expenditures according to the type of drug—original or biosimilar.
The shares of expenditures on the reimbursement of biosimilars and original drugs for each biologic in the years and are shown in Figures 1 , 2 , respectively. Figure 1. The shares of expenditures for the reimbursement of biosimilars and original drugs for each biologic in Figure 2. The shares of expenditures for the reimbursement of biosimilars and originals for each biologic drug in On average, the lowest expenditure was shown for the reimbursement of epoetin zeta—1. Biosimilars to etanercept, enoxaparin, and teriparatide were not reimbursed from public funds in any of the countries either in or , while biosimilars to insulin glargine and follitropin alfa were not reimbursed in Therefore, no costs of reimbursement of those biosimilars were observed.
Among original products, the lowest expenditure was shown for the reimbursement of epoetin alfa in the year 4. Among biosimilars, the lowest reimbursement cost in was shown for epoetin zeta 1. The highest reimbursement cost in and was shown for filgrastim The shares of expenditures on the reimbursement of biosimilars in individual countries ranged from 8. The data were presented separately for the years and in Figures 3 , 4 , respectively. Figure 3. The shares of expenditures on the reimbursement of biosimilars in individual countries in Figure 4. The highest expenditure on the reimbursement of biologic drugs was observed for Poland The highest expenditure on the reimbursement of original drugs was also observed for Poland As for the reimbursement of biosimilars, the highest expenditure was revealed for Poland Romania and Bulgaria were excluded from this analysis due to lack of information on expenditures according to the type of drug—original or biosimilar.
The total public pharmaceutical budget and total health care budget differed significantly between the countries. The lowest pharmaceutical and health care budgets were observed for Estonia and the highest—for Poland see Table 4. The expenditures on the reimbursement of biosimilars were presented as the percentage of the total pharmaceutical budget Figure 5 and percentage of the total health care budget Figure 6.
Figure 5. Expenditures on the reimbursement of biosimilars as percentage of the total pharmaceutical budget. Figure 6.
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Expenditures on the reimbursement of biosimilars as percentage of the total health care budget. The expenditures on the reimbursement of biosimilars constituted the highest share of the total pharmaceutical budget and total health care budget in Hungary and Slovakia 1. The expenditures on the reimbursement of biosimilars as the share of the total pharmaceutical budget were higher in than in in all countries, except Slovakia and Hungary where the shares were lower in The expenditures on the reimbursement of biosimilars as the share of the total health care budget were also higher in than in in all countries, again except Slovakia and Hungary where the expenditures were higher in Biological drugs are highly effective but also very costly.
The high price of original drugs limits access to treatment, especially in low-income CEE countries. The widespread use of biosimilars might significantly reduce the cost of biologic treatment, also for individual patients. In this study we identified biologic drugs that have their biosimilar counterparts. We also discussed issues relating to the reimbursement and pricing of biosimilars, as well as their reimbursement status in CEE countries. Our review revealed that the access to biologic treatment within specific drug groups was similar but the level of the patient's co-payment for particular drugs differed between the CEE countries.
For example in Bulgaria for 12 of the indications out of 25 biological therapy is co-paid by outpatients thus becoming unaffordable in case of high prices. The use of biosimilars was quite common, and the percentage of biosimilars used in the treatment of specific disease groups increased during the study period. No reimbursement was observed for etanercept, insulin glargine in , follitropin alfa in , teriparatide, and enoxaparin, which may suggest that no biosimilars to those drugs were available in those countries. Only for filgrastim, somatropin, and epoetin alfa and zeta the reimbursement costs were higher for biosimilars than for original drugs.
Expenditures on the reimbursement of biosimilars constituted from 0. The shares of expenditures on the reimbursement of biosimilars in the total health care budget were also similar between the year and —from 0. In Hungary it is mandatory to use the cheapest available biological product in newly treated patients. They are organized annually, and in each group of biologics the preferred drugs are those with the lowest price. Increased co-payment is therefore a disincentive for patients to use these products.
Until then, they have a co-payment of 3, HUF. This allows some time for the patient and the treating physician to switch to a preferred product. In Estonia, inpatient drugs, such as filgrastim, infliximab, and etanercept, are reimbursed by the hospital, and it is hospital authorities who decide, usually through tendering procedure, which products and at what prices will be acquired.
The data are usually confidential and hospitals do not have to officially report which products they use in provision of health care services. Therefore, there are limited data on the reimbursement costs for Estonia, both for original drugs and biosimilars. The physician can choose a specific product and the difference between the drug's price and the reference price is paid by patient, but in the case of biosimilars this difference is 0.
In Croatia the pricing and reimbursement process for biosimilars may sometimes require cost-effectiveness or cost-utility analysis 3. In Latvia cost-minimization analysis and budget impact analysis are needed, while in Czech Republic an abbreviated clinical dossier should be presented, without economic evidence. In Czech Republic and Slovakia physicians prefer to treat new patients with biosimilars, while previously treated patients usually remain on the original product.
However, we found no publications in line with the scope of our study, which emphasizes the novelty of our research. The review revealed only some papers on issues relating to the cost and reimbursement of biosimilars, but focusing mainly on the budget impact of biosimilar reimbursement or including a simplified discussion of an individual aspect e. Thus, the price competition bid of biosimilar products showed a health insurance reimbursement of these drugs to have significantly decreased Nagy et al.
We also identified an abstract Vogler et al. While 23 of the 33 countries set the price of the generic in relation to the price of the originator, only 13 countries reported to do so for biosimilar medicines. Usually, the price difference between the biosimilar and originator medicine was set at a lower percentage rate than that between the generic and originator e.
It occurred that only Austria, Latvia, and Turkey applied the same price difference for generic and biosimilar medicines. The Netherlands have been tendering for generics in the outpatient sector during the last decade, but biosimilars have been included in tenders only recently. The authors concluded that European countries tend to apply similar pricing policies for generic and biosimilar medicines Vogler et al.
Another study Brodszky et al.
This budget impact model estimated the potential impact of biosimilar infliximab on health care budget over 3-year timeframe from the third-party payer perspective. The model tracked movement of the population of patients with CD between main states: 1 immune therapy, 2 infliximab, 3 biosimilar infliximab, and 4 adalimumab. Switching between biologics and biosimilar infliximab was also considered. Budget impact was calculated as a difference in the total cost of scenarios with and without biosimilar infliximab.
In the scenario in which interchangeability was not allowed, the budget savings amounted to 7,, EUR. Based on these calculations, the introduction of biosimilar infliximab treatment for CD in CEE countries should bring about substantial cost savings or increase the number of patients with access to biologic therapy Brodszky et al. Rovira et al. Authors tried to identify the key parameters associated with biosimilars market dynamics and included three molecules as references: somatropin, epoetin, filgrastim.
The results of this analysis showed that the market share of biosimilars for included molecules has risen rapidly in the years from to The key drivers responsible for market dynamics were: generics price control policy, countries' gross national income and expenditure on health, pharmacists' generics substitution and medicines' price level index. Introduction of biosimilars resulted in reduction of biologics' cost, however this reduction seems to be smaller than for conventional generics.
Authors of another study Remuzat et al. Ten EU member states were included in the analysis and 20 biosimilars.click here
It was concluded, that incentive policies applied to biosimilars and biosimilars' uptakes were heterogeneous across analyzed countries. Incentive policies and the date of first biosimilar market entry were positively correlated with biosimilar uptake, while pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Also the average generic price discount over originator and the number of biosimilars seemed to influence the biosimilar uptake, however biosimilar price discounts had no impact on the uptake.
Grabowski et al. One major finding was that although the EU has a common regulatory system for approving biosimilars, differences in reimbursement practices and incentives as well as variations in medical practices are observed across countries. It was observed that biosimilar price discounts were likely to be modest compared to generics. Another finding was that cost savings from the introduction of biosimilars in the European countries have been tempered by the fact that competition has been limited to the first-generation reference products.
Dynamic competition through the market entry of next-generation biologics is an important consideration in analyzing the market impact of biosimilars and their potential savings to the health-care system. In countries of the EU as well as outside the EU evaluations on costs of biologic drugs were also performed Jakovljevic, but with no sophisticated analyses of market share and reimbursement costs between original biologics and biosimilars corresponding to results of our study.
Our study revealed that biosimilars significantly influenced the reimbursement systems in the selected CEE countries. Expenditures on the reimbursement of biosimilars are increasing, and the access of patients to this type of treatment is improving. The share of expenditures on the reimbursement of biosimilars in the considered CEE countries increased during the study period, along with an increase in expenditures on the reimbursement of biosimilars as percentage of the total pharmaceutical budget.
The considered CEE countries are similar in terms of the requirements for the pricing and reimbursement of biosimilars. PK conceived the conception and design of the study, including protocol and questionnaires preparation, and coordinated the project. PK contributed in acquisition of data.
PK and ES carried out the data management, statistical analysis, interpretation of data and prepared the draft of the manuscript. All authors contributed to editing the manuscript and approved the final version submitted for publication. PK is the guarantor. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
The study was self-financed. The authors would like to thank Karoline Garuoliene for providing relevant data for our project relating to Lithuania.
The Dynamics of the Breakthrough in Eastern Europe
Available online at: www. Brodszky, V. Budget impact analysis of biosimilar infliximab for the treatment of crohn's disease in six central eastern European countries. Value Health A Expert Rev. Outcomes Res. Derbyshire, M. Patent expiry dates for best-selling biological. Biosimilars Initiat. CrossRef Full Text.
ESzCsM Decree ESC Accessed February 13, European Medicines Agency European Public Assessment Reports. Grabowski, H. Biosimilar competition: lessons from Europe. Drug Discov. Experiences with price competition of biosimilar drugs in Hungary. Acta Pharm. Experiences with price competition of biosimilar drugs in hungary in case of colony-stimulating factor products.