Do pricing and usage-enhancing policies for biosimilar medicines differ from generic policies? Findings from a PPRI survey with competent authorities in 42 countries

Category: Original Research
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Keywords: biosimilar pharmaceuticals, generic medicines, policy, pricing, substitution, tender

Abstract:
Study Objectives: 
The article aims to survey policies that European countries implemented for pricing and promoting the use of biosimilar medicines and to explore possible similarities and differences between policies for generic and biosimilar medicines.
Methods: Literature review was supplemented by primary data collection with policy-makers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network responded to a survey in 2016.
Results: Information is available from 40 European countries, thereof 28 European Union Member States, as well as Canada and South Africa. A commonly used method for pricing generics (31 countries) and biosimilar medicines (15 countries) is to set their prices at a defined percentage below the originator price (‘generic / biosimilar price link’). Apart from six countries, the required difference between originator and biosimilar medicine prices tends to be lower than the one between originator and generic medicine. Tendering procedures are used for off-patent medicines in some countries (e.g. Denmark and the Netherlands – outpatient; Norway – inpatient), however biosimilars tended to be included only recently. While generic substitution is in place in most surveyed countries, substituting a biosimilar medicine for an originator at community pharmacy level is solely applied in some countries, mainly in the Central and Eastern European region.
Discussion and Conclusion: Pricing policies and instruments to enhance the uptake of generics are well-advanced in the surveyed countries. However, countries appear to be struggling to find the most appropriate approach for biosimilar medicines.

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