What pricing and reimbursement policies to use for off -patent biologicals? – Results from the EBE 2014 biological medicines policy survey European Biopharmaceutical Enterprises

26 Feb 2015

Objective: One of the questions that the advent of biosimilars raises is whether the diferent nature of biological medicines would also imply the need for a diferent policy approach by Member States in the European Union (EU). To assess the policy environment the European Biopharmaceutical Enterprises (EBE) conducted a brief descriptive policy survey of pricing and reimbursement policies for off-patent biologicals.

EBE conducted a survey in 31 countries, the 28 EU Member States plus Norway, Serbia and Switzerland. The questionnaire was developed by the EBE Biosimilars Working Group and contained 24 questions about five policy areas: Tendering, Health Technology Assessment, International Nonproprietary Name (INN) prescribing, Internal Reference Pricing, and Substitution. The focus was on the most relevant policies which: a) were applied to the off -patent market; and b) were of specific relevance for biological medicines.

No country required substitution of patients on treatment at the time of the survey. Nearly two thirds of the countries have either laws or guidelines in place that prohibit substitution of biological medicines. In 12 countries it is possible for patients on a given treatment to be changed to a diferent product due to tender outcomes. While prescribing by INN is mandatory or recommended in 13 of 31 countries the majority of countries have introduced mechanisms to exempt biological medicines from INN prescribing.

This initial high-level survey of EBE indicates that nearly all jurisdictions have policies in place that reflect the diferent nature of biological medicines. However, policies and their implementation vary among diferent jurisdictions. 

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