Policy Practices to Maximise Social Benefit from Biosimilars

Inotai, András; Csanádi, Marcell; Vitezić, Dinko; Francetic, I; Tesař, Tomáš; Bochenek, Tomasz; Lorenzovici, László; Dylst, Pieter; Kaló, Zoltán

doi:10.4172/jbb.1000346

Cited by 5 publications

(10 citation statements)

References 23 publications

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“…The increasing use of biosimilars is important across Europe with global expenditure on medicines likely to reach US$1.5trillion by 2023, driven by increasing use of biological medicines (IQVIA, 2019), and resources saved from their increasing use can help fund increased use of medicines for patients with non-communicable diseases with aging populations as well as new premium priced medicines (Inotai et al, 2017;Povero and Pradelli, 2020). In addition, enhance the opportunity for greater access to effective biological medicines among Central and Eastern European (CEE) countries as well as other lower-and middle-income countries where access has been an issue due to high prices, sustainability of healthcare systems, and high co-payment levels (Mihajlo, 2014;Putrik et al, 2014;Jakovljevic et al, 2015;Kovacevic et al, 2015;Pichon-Riviere et al, 2015;Baumgart et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

et al. 2021

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Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

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Section: Introductionmentioning

confidence: 99%

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

et al. 2021

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“…Inotai (24) argued that the main aim of public healthcare payers is to enhance the allocative efficiency of healthcare spending. The high launch prices of original medicines, including biologics, may necessitate confidential price discounts, using managed entry agreements or, sub-optimally, the implementation of transparent or hidden access restrictions in order to ensure their financial sustainability (22).…”

Section: Discussionmentioning

confidence: 99%

“…The objective of biosimilar medicine policy, provided that patients have full access to the relevant original biologic products prior to the expiration of their patent, is usually defined as reducing health expenditures without compromising health outcomes (24). Mulcahy (38) demonstrated that a reduction in drug costs can be expected not just from the introduction of biosimilar medicines, but also from the leveraging of competition so as to alter the market dynamics between the biosimilar and reference medicine and their associated prices.…”

Section: Discussionmentioning

confidence: 99%

“…However, while we discussed the issues of Slovakia, we believe that even other countries with low availability of biosimilars can benefit from this research. The aim of biosimilar policies can be determined differently in countries with significant resource limitations, where access to high-cost biologics is restricted (22,24,43).…”

Section: Discussionmentioning

confidence: 99%

“…Kaló (23) pointed out that 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 (24).…”

Section: Introductionmentioning

confidence: 99%

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Potential Cost-Savings From the Use of the Biosimilars in Slovakia

Tesař

Golias²,

Koblišková

et al. 2020

Front. Public Health

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Objectives: To analyse the market shares of biosimilars in Slovakia and to calculate the potential cost-savings from the use of biosimilars in Slovakia based on two different data sources. Methods: National reimbursement lists from the Czech Republic, Hungary, Poland and Slovakia were used for analyzing the availability of biosimilars with public funding. In addition, the reimbursement dossiers of biosimilars, the justifications of reimbursement decisions by the Slovak Ministry of Health, and final reimbursement decrees, which are published on the webpage of the Slovak Ministry of Health, were utilized for this study. Reimbursement decisions regarding biosimilars by the Slovak Ministry of Health from 2006 to August 2019 were considered and the detailed utilization of biosimilars in 2018 was analyzed based on data from the State Institute for Drug Control. The study was validated based on data from the Slovak National Health Information Center. Results: Fifty four biosimilars were approved by the European Medicines Agency (EMA) in August 2019. Of the total group of licensed biosimilars on the market, 29 biosimilars (54%) were available in the Czech Republic, 28 biosimilars (52%) were available in Poland, and 27 biosimilars (50%) were available in Hungary and 24 biosimilars (44%) were available in Slovakia. Our analysis, based on the data provided by distributors of medicinal products to the State Institute for Drug Control, revealed that the health fund in Slovakia could have saved 35 to 50 million euros per year if biosimilars with marketing authorisations had been available on the Slovak market. The calculations assumed a 25-35% price decrease against the original biological medical products, and that there would be no increase in the utilization of biosimilars in Slovakia. Conclusions: To achieve significant improvement in patient access to biosimilars in Slovakia, a top-down approach establishing targets and quotas for the procurement of biosimilars should be applied.

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Maximizing the benefits of using biosimilars in Egypt

Fasseeh,

Elezbawy,

El-Fass

et al. 2023

J of Pharm Policy and Pract

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Background Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. Methods A narrative literature review was conducted to identify biosimilars’ policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. Results The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30–40% less than its originator’s price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. Conclusions A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.

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Policy Practices to Maximise Social Benefit from Biosimilars

Cited by 5 publications

References 23 publications

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

Potential Cost-Savings From the Use of the Biosimilars in Slovakia

Maximizing the benefits of using biosimilars in Egypt

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