Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia
Of the 54 biosimilars approved by the European Medicines Agency (EMA) as of August 2019, fewer than half (24) are available in Slovakia, but if the remaining 30 biosimilars were available the nation’s health fund could save €35 million to €50 million (approximately $41 million to $59 million) per year, according to a new study.
Biosimilar Availability in Slovakia
The authors first compared biosimilar use among Visegrád Group (V4) countries: the Czech Republic, Hungary, Poland, and Slovakia. Of the 54 biosimilars approved by the EMA, 29 were available in the Czech Republic, 28 in Poland, 27 in Hungary, and only 24 in Slovakia.
Looking at biosimilar availability over time, the authors noted that 6 biosimilars became available in Slovakia between 2013 and 2015, but no new biosimilar drugs were added to the reimbursement list until the second half of 2018. Since then, the Ministry of Health added 15 more biosimilar drugs. Some of these biosimilars were added following expiration of patents on the reference drugs, and others were able to enter the market once Slovakia’s Ministry of Health reduced their compulsory price discount for biosimilars, which took effect in January 2019.
As of January 2019, Slovakia’s Ministry of Health requires that the first biosimilar marketed for a particular active substance to cost 25% less than the reference product (down from 30%). The second marketed biosimilar must cost 30% less than the reference drug, and the third must cost 35% less.
The authors also noted that biosimilar drugs containing the active substances somatotropin, enoxaparin, and insulin lispro are not yet available in Slovakia.
In 2018, filgrastim biosimilars had the greatest market share of biosimilars in Slovakia at 99.93%, followed by erythropoietin biosimilars at 75.44%, insulin glargine biosimilars at 36.29%, infliximab biosimilars at 25.07%, and follitropin alfa biosimilars at 21.11%. Rituximab and trastuzumab biosimilars have been introduced since 2018 but have so far gained paltry market share at 2.31% and 0.07%, respectively.
The authors argued biosimilars could improve health system sustainability in Slovakia, remarking that reference biologics are often too expensive for Central and Eastern European countries, since “the launch price of high-cost biologic medicines is set according to the highest acceptable price by payers in large and high-income countries with the greatest market potential. These prices are frequently not acceptable in lower income countries.”
The researchers calculated potential cost savings using 2018 price data, assumed no increase in the use of biosimilars, and estimated a 25% to 35% lower price compared with reference products, consistent with Slovak Ministry of Health requirements.
Based on data provided by drug distributors to the State Institute for Drug Control, the authors calculated cost savings of between €35.44 million and €49.62 million (approximately $41.60 million to $58.25 million) per year if more biosimilars were more widely available in Slovakia. They validated their calculations using data from payers provided to the National Health Information Center, which resulted in estimated cost savings of €26.65 million to €37.32 million (approximately $31.28 million to $43.81 million) per year.
Appropriate Regulation of Pricing
The authors acknowledged that cost savings are limited by the complexity and expense of the manufacturing process for biosimilars; however, they wrote that “absolute cost savings could still be significant because of the high prices and volumes of the reference medicines.”
The authors also cautioned that Slovakia’s mandatory price discounts and strict rules for international price referencing undermine the overall strategy of trying to lower biosimilar prices by discouraging manufacturers from marketing their products in the country. Most European Union member states, they wrote, regulate drug prices similarly based on referrals from other member states, which may motivate manufacturers “to maintain higher list prices even for less affluent countries, so that list prices do not drop across the European market.”
The authors argued, “It is therefore important for buyers to set appropriate price reduction rules. From an economic point of view, price regulation is needed unless fair competition generates a market price.”
They also pointed out the ultimate goal is the potential benefit to the health of the society, saying “the role of biosimilars is not only about cost-saving potential but improving patient access to needed biological pharmacotherapy and ultimately to improve health status of the society.”
Maximizing the Social Benefit of Biosimilars
The authors concluded with a list of recommended policy practices to maximize the social benefit of biosimilars. These included:
Tesar T, Golias P, Kobliskova Z, Wawruch M, Kawalec P, Inotai A. Potential cost-savings from the use of the biosimilars in Slovakia. Front Public Health. Published online August 21, 2020. doi:10.3389/fpubh.2020.00431