Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure

Abstract

Introduction: Biosimilar medicines are considered promising alternatives to new biologicals with high price tags. The extent of savings resulting from biosimilar use depends on their price and uptake, which are largely shaped by pricing, reimbursement, and demand-side policies. This article informs about different policy measures employed by European countries to design the biologicals market and explores potential savings from the increased use of biosimilar medicines in Germany.Methods: Policy measures that target the price and uptake of biosimilar medicines were identified based on a prefilled questionnaire survey with public authorities in 16 European countries, who were the members of the Pharmaceutical Pricing and Reimbursement Information network (July 2020). Potential savings that could have been generated in Germany if different measures identified in the surveyed countries had been implemented were calculated for six publicly funded biological molecules. Price data of the Pharma Price Information service and German consumption data for 2018 were used for the calculation of five scenarios.Results: Several countries use a price link policy, setting the biosimilar price as a percentage of the price of the reference biological. Also lowering the price of the reference biological upon market entry of a biosimilar is less frequently used. While tendering of biosimilar medicines in the inpatient setting is the norm, it is rarely employed for biosimilars in outpatient use. Reference price systems and INN prescribing of medicines are the commonly used policy measures in the off-patent market, but some countries define exemptions for biologicals. Substituting biosimilars at the pharmacy level is rather an exception. Potential savings in Germany ranged from 5% (simple price link) to 55% (prices at the level of other countries) for the six studied molecules.Conclusion: Despite some differences, there are discernible tendencies across European countries with regard to their applications of certain policy measures targeting the price and uptake of biosimilar medicines. The potential for savings of some of these policies was clearly demonstrated. Monitoring and evaluation of these rather recent measures is key for obtaining a more comprehensive picture of their impact.

Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan

“…According to definition of biosimilar, an interchangeable biosimilar must be highly similar to reference product and produces the same clinical result in any given patient [ 3 , 49 ]. It is important to know that the biosimilar substitution policy is not the same among different counties in the world [ 50 , 51 ]. Our surveyed pharmacists indicated neutral to positive attitudes about interchangeability.…”

Assessing, Pricing and Funding Point-of-Care Diagnostic Tests for Community-Acquired Acute Respiratory Tract Infections–Overview of Policies Applied in 17 European Countries

“…Our study findings allow making some high-level observations. It is known (e.g., from other health technologies) that pricing policies contribute to affordable and equitable prices [ 35 ] and that policymakers can implement them strategically to achieve defined policy objectives (e.g., in the area of medicines, to foster competition in the off-patent market and to benefit from efficiency gains due to the use of generic and biosimilar medicines [ 32 , 59 ]). From economic theory, high prices are, in principle, an incentive for suppliers; however, this is only the case if there is the ability to pay and willingness to pay from the purchasers’ side.…”

“…Policymakers are responsible for developing and implementing appropriate policies to achieve intended policy objectives [ 30 ]. For medicines, several policies (e.g., related to pricing, procurement and reimbursement (funding/coverage) have been introduced in European countries [ 31 , 32 , 33 , 34 ] that aim to ensure equitable and sustainable patient access to affordable medicines. Evaluations of the policies have identified strengths and limitations: For instance, pricing policies helped to contain prices and make medicines affordable to patients and health systems.…”

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

“…The availability of biosimilars may support competition for biological medicinal products; this may also result in the reduction of prices and increase the dynamics of the pharmaceutical market ( Moorkens et al, 2019 ; Dutta et al, 2020 ). There are noticeable trends in drug policies among EU Member States concerning the price and uptake of biosimilar; this is because the potential for savings was clearly demonstrated ( Vogler et al, 2021 ). However, the specific plan for biosimilar policies can be defined differently in countries experiencing significant resource limitations, where access to expensive reference medicines is limited ( Brodszky et al, 2016 ; Inotai and Kaló, 2019 ).…”