The 2016 EBE survey was a follow-up of their previous survey conducted in 2014 [2]. It was conducted among national pharmaceutical trade associations in the 28 EU Member States and Norway, Serbia, Switzerland and Turkey. It contained questions relating to eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas.

Findings related to substitution, prescribing by International Nonproprietary Name (INN) and interchangeability were key. Substitution is the practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber. In 81% of countries surveyed, pharmacy-level substitution is prohibited. Prescribing by the INN of the active ingredient of the medicine is mandatory or recommended in a minority of the countries. However, biologicals are only included in INN prescribing in four countries. Only half of the countries surveyed have an official position on interchangeability, or switching. This practice describes a decision made by a physician to change a patient’s treatment between reference product and a biosimilar, or between biosimilars.

Tendering biologicals can generate appreciable saving for payers. This practice is adopted by 81% of the countries surveyed. In half of these, switching of patients for non-medical reasons can happen, which is a concern. Most tenders are national or hospital tenders and in many cases only one supplier can win which can create a barrier to entry for competing products. This is in line with the results of a recent study that reports on the differences between usage-enhancing policies of biosimilars and generics [3].

With respect to the use of quotas, some countries with quotas in place focus on prescribing the cheapest product, while others require prescribing a certain amount of biosimilar products. In addition, in some countries, quotas mean that physicians lose freedom to prescribe.

Overall, the majority of European countries have specific policies in place that reflect the difference between biological medicines and small-molecule medicines. In addition, the prescribing physician retains a decision-making role when it comes to treatment. There have been shifts in biologicals policies and their implementation since the last EBE survey, particularly regarding substitution and interchangeability.

Editor’s comment
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Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

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Increasing access to biosimilars and generics in Europe

References
1. Roediger A, Freischem B, Reiland J-B. What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):61-78. doi:10.5639/gabij.2017.0602.014
2. Acha V, Allin P, Bergunde S, Bisordi F, Roediger A. What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(1):17-24. doi:10.5639/gabij.2015.0401.006
3. Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):79-88. doi:10.5639/gabij.2017.0602.015

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