CEE countries bring up the rear in Europe in access to innovative MS treatments

2010-01-13

Access to innovative multiple sclerosis (MS) treatments in Central and Eastern European (CEE) countries is significantly more limited than it is in the “old” European Union countries. Access to innovative drugs and the percentage of patients treated by 2008 in Western Europe greatly surpassed the CEE region, reflecting the latter’s generally inferior economic status and the weaker condition of its healthcare systems.

Access to innovative MS drugs in CEE countries a burden on healthcare systems

The Access to innovative treatments for multiple sclerosis in Europe , recently published report for the EFPIA, estimated that the percentage of MS patients on immunomodulating medicine in Western Europe (the “old” EU + 3) was 40-50%, and in CEE (the “new” EU) countries only 5-25%.The disparity in access to disease-modifying MS treatment (DMT) in Europe is mainly a result of two conditions: macroeconomic indicators, reflecting a country’s wealth, and thus the affordability of DMTs, and reimbursement policies which place restrictions on expensive medicines. The price level factor finally appeared not to have a significant impact on access to MS treatment. Whereas the general price level in the “new” EU countries is somewhat lower than that of the “old” EU, as a consequence of the lower prices established in the former countries prior to EU accession, the differences are not particularly substantial. This is because of the policy of manufacturers, fearing the effect of parallel trade, of keeping global drug prices fixed. The average annual cost of the disease per patient was estimated in the report to be €11,950 in the Western EU countries and €9,830 in the CEE countries.
However, the lower price levels in the CEE countries seem not to influence drug uptake. The reason is not always the affordability of the treatment in individual countries, but, rather, specific conditions governing the rules of distribution of DMTs in a given country. On the markets on which these drugs are not subject to the official approval of the payer, such as Germany, prices are at their highest, whereas on the highly-regulated markets for these treatments, e.g. Poland, where they are subject to the so-called therapeutic programme and are available only within the closed hospital distribution system, prices are much lower for patients, and manufacturers are not afraid of parallel trade. Furthermore, there are also significant MS treatment price variations among the CEE countries. The price in Slovakia is relatively close to that of Germany, and yet this is one of the countries which treats the highest number of patients. Conversely, the Czech Republic, where the price is lower than that of Slovakia, treats fewer patients. Price does, however, explain the low rate of usage in Romania, where it is the same as that of most Western European countries, and the affordability about one-third that of Germany.




The disparities in access to immunomodulative MS treatments across Europe are, in most cases, correlated with the condition of healthcare, as expensive treatments have a significant impact on the healthcare budget.
We believe, therefore, that the most important factor which affects access to innovative MS treatment is the ability of the national reimbursement systems to carry the cost of refunding such expensive therapies. Access to medicines at such prices is considered to have a significant impact on the budgets of the CEE countries. As proof of this the
Polish Health Technology Assessment Agency (AOTM), in its analysis of immunomodulative MS treatments, stated that the cost-effectiveness threshold¹ of this group of medicines is much higher than that recommended by the WHO, i.e. it is three times per capita GDP, which is regarded by the Agency as the ceiling at or below which it recommends the therapy for reimbursement.


Disparities in access to MS innovative treatments match variations in MS-related costs across Europe

The total cost of MS, defined in the EFPIA report as the proportional combined costs of healthcare, non-medical costs, production losses and informal care costs in Europe, was estimated to be €15bn. The bulk of this (€14bn) was accounted for by the old EU countries, with the estimated number of treated patients being 165,000-170,000 of a diagnosed group of 412,000 MS patients, and €650m in the CEE countries, with 59,000 diagnosed patients, where affordability remains an issue despite the lower prices. The average cost per patient was estimated in the report to be €36,000, which shows a discrepancy between Western Europe (€39,000) and the CEE countries, with an annual cost of €11,600 per patient.
The analysis of cost distribution shows the dominance of the costs which lie outside the healthcare market (i.e. production losses, informal care and non-medical costs). In the Western EU countries these constitute two-thirds of all costs, whereas biologics in both EU regions represent 12% of the total cost of MS.